Conference Coverage

BOSTON – Though hydroquinone, retinoids, steroids, and triple combination cream remain gold standards for the topical treatment of melasma, new synthetic and botanical topicals are emerging as adjuvant and alternative treatments, according to Nada Elbuluk, MD, MSc.

One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”

Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.

One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.

“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”

Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.

“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.

Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.


 

Botanicals

Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.

The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.

Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.

“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.

Platelet-rich plasma

Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”

A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.

A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.

“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”

Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”



Other emerging topical therapies

Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.

The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.

Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.

BOSTON – Though hydroquinone, retinoids, steroids, and triple combination cream remain gold standards for the topical treatment of melasma, new synthetic and botanical topicals are emerging as adjuvant and alternative treatments, according to Nada Elbuluk, MD, MSc.

One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”

Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.

One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.

“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”

Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.

“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.

Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.


 

Botanicals

Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.

The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.

Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.

“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.

Platelet-rich plasma

Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”

A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.

A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.

“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”

Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”



Other emerging topical therapies

Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.

The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.

Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.

BOSTON – Though hydroquinone, retinoids, steroids, and triple combination cream remain gold standards for the topical treatment of melasma, new synthetic and botanical topicals are emerging as adjuvant and alternative treatments, according to Nada Elbuluk, MD, MSc.

One such agent is topical tranexamic acid, an antifibrinolytic medication that inhibits plasminogen activator from converting plasminogen in epidermal basal cells and keratinocytes to plasmin. “What makes tranexamic acid exciting is that it’s not just targeting melanogenesis; it’s also targeting the vascular component of melasma,” Dr. Elbuluk, director of the University of Southern California Skin of Color Center and Pigmentary Disorders Program, said at the annual meeting of the American Academy of Dermatology. “We really don’t have any topical agents that are doing that.”

Topical tranexamic acid is available in cream and solution formulations ranging from 2% to 5%. It has been studied in different drug delivery carriers (liposomal, liquid crystalline nanoparticle, and glycol co-enhancer carriers), has been combined with other lightening agents, and has been found to reduce Melasma Area and Severity Index (MASI) scores and reduce melanin while also improving erythema. “That’s where it really stands out from hydroquinone and triple combination cream,” Dr. Elbuluk said.

One study of patients with melasma found that topical tranexamic acid can decrease the number of CD31-positive vessels and expression of vascular endothelial growth factor (VEGF), and downregulated endothelin-1.

“Compared to hydroquinone, some studies have found a similar efficacy; others have found it inferior,” she continued. “But none of our patients can be on hydroquinone yearlong, so you have to bring in other agents that are efficacious. This is why you could consider having patients on topical tranexamic acid at different times of the year. It can cause some irritation for patients, but overall, it’s pretty well tolerated, and patients are often very happy with the overall improvement in the texture and appearance of their skin.”

Another emerging option, flutamide, is an anti-androgenic agent used topically and orally to treat acne, hirsutism, and hair loss. “It has not been excessively studied for melasma, but it may improve the condition through modifying alpha-MSH [alpha melanocyte-stimulating hormone] or cAMP [cyclic adenosine monophosphate] agents that play a role in melanin synthesis,” Dr. Elbuluk said. A randomized, controlled trial of 74 women with melasma treated with 1% flutamide vs. 4% hydroquinone showed a significant improvement in the MASI score and patient satisfaction but no difference in the mexameter melanin assay results.

“We need more data, but I think this is the right approach for us to start thinking about different factors that are addressing all of the components of the pathogenesis of melasma,” she said.

Other synthetic topicals that are being used or studied for melasma include N-acetyl glucosamine, linoleic acid, pidobenzone, methimazole, metformin, magnolignan, N-acetyl-4-S-cysteaminylphenol, dioic acid, melatonin, and silymarin.


 

Botanicals

Botanically-derived topicals for melasma are also being evaluated, including niacinamide, an anti-inflammatory agent that inhibits melanosome transfer to keratinocytes. Niacinamide decreases mast cell infiltrate and solar elastosis and enhances the epidermal barrier.

The antioxidants ascorbic acid (vitamin C) and zinc are also being studied. Ascorbic acid has photoprotective effects, inhibits tyrosinase, and promotes collagen synthesis. “One of the challenges with vitamin C is that it’s not very stable and it has limited permeability and bioavailability in the skin,” Dr. Elbuluk said. Zinc, meanwhile, boasts anti-inflammatory, photoprotective, and exfoliative properties and is a cofactor in wound healing.

Other botanical lightening agents being studied, in addition to silymarin, include arbutin, aloe vera, bakuchiol, soy, Ananas comosus (pineapple), parsley, Bellis perennis (daisy), mulberry extract, ellagic acid, gentisic acid, cinnamic acid, Hippophae rhamnoides (sea buckthorn), Cassia fistula extracts, licorice root extract, lignin peroxidase, and Polypodium leucotomos.

“I do think there really is a place for these in our therapeutic armamentarium, but we need more studies,” she said. “There aren’t many randomized, controlled studies looking at these agents specifically.” A recent systematic review on the efficacy and safety of topical therapy with botanical products for treating melasma included 12 trials composed of 695 patients from seven countries. The authors concluded that the trials lacked sufficient pooled evidence on efficacy and safety. However, many of the studies showed that these agents did improve melasma and MASI scores.

Platelet-rich plasma

Platelet-rich plasma (PRP) is being used as monotherapy and adjuvant therapy for melasma. “It’s believed to release platelet-derived growth factors, which can affect collagen synthesis,” Dr. Elbuluk explained. “It also has effects on TGF-B1 [transforming growth factor-beta 1], which inhibits melanin synthesis and epidermal growth factor, which has a downstream effect on lowering melanin production.”

A 2021 systematic review of 10 studies involving 395 adults with melasma found that PRP plus microneedling was most efficacious compared with PRP alone or combined with intradermal injection.

A separate systematic review of seven trials evaluating PRP for melasma found that most studies showed moderate improvements in melasma, which led the researchers to assign a moderate grade recommendation to PRP for melasma.

“I think we need more studies, but you may see PRP being used more commonly for melasma,” Dr. Elbuluk said. “The reality with melasma is that you are rarely using just one agent. Combination therapies are often superior to monotherapies in efficacy.” Combination therapy does not include just topicals, she added, but consideration of topicals with procedural modalities “and figuring out what your patient can tolerate and what they can afford.”

Since melasma is a chronic condition, “you want to emphasize to your patients that there is no cure for melasma. We are constantly trying to keep it in remission and keep it in control. That’s an active process.”



Other emerging topical therapies

Meanwhile, researchers continue to evaluate new targets for emerging treatments including a topical combination of an anti-estrogen with a VEGF inhibitor. In a separate pilot study of six women with melasma, investigators described treatment success with a novel combination of 12% hydroquinone, 6% kojic acid, and 5% vitamin C cream. “It’s the right thinking, combining different factors that address different aspects of pathogenesis of melasma,” Dr. Elbuluk said.

The mode of topical drug delivery also plays a role in treatment success. For example, she said, liposomal formulations have been found to enhance drug delivery and skin permeation and to improve the moisturizing effect, stability, and tolerability.

Dr. Elbuluk disclosed that she is a consultant for Avita, Scientis, VisualDx, Zosana, Incyte, La Roche-Posay, and Beiersdorf. She is an advisory board member for Allergan, Galderma, Incyte, and Janssen.

Women with systemic lupus erythematosus (SLE) experience worse outcomes after an acute stroke than does the general population, but men with SLE do not, according to an analysis of the U.S. National Inpatient Sample presented at the annual meeting of the British Society for Rheumatology.

In a study of more than 1.5 million cases of acute stroke recorded in the United States between 2015 and 2018, women with SLE were more likely to be hospitalized for longer and less likely to be routinely discharged into their home environment than were those without SLE. No such association was found for men with SLE.

“The findings imply that primary stroke prevention is of utmost importance, especially in females with SLE,” said Sona Jesenakova, a fourth-year medical student at the University of Aberdeen (Scotland).

“There might be a need to explore more effective and targeted treatment strategies to try and minimize these excessive adverse acute stroke outcomes, especially in females with SLE suffering from stroke,” she suggested.

“Even though males form only a minority of the SLE patient population, some studies have shown that they are prone to suffer from worse disease outcomes,” Ms. Jesenakova said.

Importantly, “male sex has been identified as a risk factor for death early in the course of SLE,” she added, highlighting that sex differences do seem to exist in SLE.

Stroke is an important outcome to look at because people with SLE are known to be at higher risk for developing atherosclerosis, which is a widely known risk factor for ischemic stroke, and with antiphospholipid antibody positivity and uncontrolled disease activity, that risk can be increased. A meta-analysis of older studies has suggested that the risk for death after a stroke is 68% higher in people with SLE than in those without.

To examine the risk for death and other in-hospital outcomes in a more contemporary population, Ms. Jesenakova and associates used data from the National Inpatient Sample, a large, publicly available database that contains inpatient health care information from across the United States. Their sample population consisted of 1,581,430 individuals who had been hospitalized for stroke. Of these, there were 6,100 women and 940 men who had SLE; the remainder served as the ‘no-SLE’ control population.

As might be expected, patients with SLE were about 10 years younger than those without SLE; the median age of women and men with SLE and those without SLE were a respective 60, 61, and 71 years.

There was no difference in the type of stroke between the SLE and no-SLE groups; most had an ischemic stroke (around 89%) rather than a hemorrhagic stroke (around 11%).

The researchers analyzed three key outcomes: mortality at discharge, hospitalization prolonged to a stay of more than 4 days, and routine home discharge, meaning that the patient was able to be discharged home versus more specialist facilities such as a nursing home.

They conducted a multivariate analysis with adjustments made for potential confounding factors such as age, ethnicity, type of stroke, and revascularization treatment. Comorbidities, including major cardiovascular disease, were also accounted for.

Although women with SLE were 21% more likely to die than patients without SLE, men with SLE were 24% less likely to die than was the no-SLE population. However, these differences were not statistically significant.

Women with SLE were 20% more likely to have a prolonged hospital stay and 28% less likely to have a routine home discharge, compared with patients who did not have SLE. The 95% confidence intervals were statistically significant, which was not seen when comparing the same outcomes in men with SLE (odds ratios of 1.06 and 1.18, respectively).

“As for males, even though we didn’t find anything of statistical significance, we have to bear in mind that the sample we had was quite small, and thus these results need to be interpreted with caution,” Ms. Jesenakova said. “We also think that we identified a gap in the current knowledge, and as such, further research is needed to help us understand the influence of male sex on acute stroke outcomes in patients with comorbid SLE.”

The researchers performed a secondary analysis looking at the use of revascularization treatments for ischemic stroke and found that there were no differences between individuals with and without SLE. This analysis considered the use of intravenous thrombolysis and endovascular thrombectomy in just over 1.4 million cases but did not look at sex-specific differences.

Ms. Jesenakova had no conflicts of interest to disclose.

Women with systemic lupus erythematosus (SLE) experience worse outcomes after an acute stroke than does the general population, but men with SLE do not, according to an analysis of the U.S. National Inpatient Sample presented at the annual meeting of the British Society for Rheumatology.

In a study of more than 1.5 million cases of acute stroke recorded in the United States between 2015 and 2018, women with SLE were more likely to be hospitalized for longer and less likely to be routinely discharged into their home environment than were those without SLE. No such association was found for men with SLE.

“The findings imply that primary stroke prevention is of utmost importance, especially in females with SLE,” said Sona Jesenakova, a fourth-year medical student at the University of Aberdeen (Scotland).

“There might be a need to explore more effective and targeted treatment strategies to try and minimize these excessive adverse acute stroke outcomes, especially in females with SLE suffering from stroke,” she suggested.

“Even though males form only a minority of the SLE patient population, some studies have shown that they are prone to suffer from worse disease outcomes,” Ms. Jesenakova said.

Importantly, “male sex has been identified as a risk factor for death early in the course of SLE,” she added, highlighting that sex differences do seem to exist in SLE.

Stroke is an important outcome to look at because people with SLE are known to be at higher risk for developing atherosclerosis, which is a widely known risk factor for ischemic stroke, and with antiphospholipid antibody positivity and uncontrolled disease activity, that risk can be increased. A meta-analysis of older studies has suggested that the risk for death after a stroke is 68% higher in people with SLE than in those without.

To examine the risk for death and other in-hospital outcomes in a more contemporary population, Ms. Jesenakova and associates used data from the National Inpatient Sample, a large, publicly available database that contains inpatient health care information from across the United States. Their sample population consisted of 1,581,430 individuals who had been hospitalized for stroke. Of these, there were 6,100 women and 940 men who had SLE; the remainder served as the ‘no-SLE’ control population.

As might be expected, patients with SLE were about 10 years younger than those without SLE; the median age of women and men with SLE and those without SLE were a respective 60, 61, and 71 years.

There was no difference in the type of stroke between the SLE and no-SLE groups; most had an ischemic stroke (around 89%) rather than a hemorrhagic stroke (around 11%).

The researchers analyzed three key outcomes: mortality at discharge, hospitalization prolonged to a stay of more than 4 days, and routine home discharge, meaning that the patient was able to be discharged home versus more specialist facilities such as a nursing home.

They conducted a multivariate analysis with adjustments made for potential confounding factors such as age, ethnicity, type of stroke, and revascularization treatment. Comorbidities, including major cardiovascular disease, were also accounted for.

Although women with SLE were 21% more likely to die than patients without SLE, men with SLE were 24% less likely to die than was the no-SLE population. However, these differences were not statistically significant.

Women with SLE were 20% more likely to have a prolonged hospital stay and 28% less likely to have a routine home discharge, compared with patients who did not have SLE. The 95% confidence intervals were statistically significant, which was not seen when comparing the same outcomes in men with SLE (odds ratios of 1.06 and 1.18, respectively).

“As for males, even though we didn’t find anything of statistical significance, we have to bear in mind that the sample we had was quite small, and thus these results need to be interpreted with caution,” Ms. Jesenakova said. “We also think that we identified a gap in the current knowledge, and as such, further research is needed to help us understand the influence of male sex on acute stroke outcomes in patients with comorbid SLE.”

The researchers performed a secondary analysis looking at the use of revascularization treatments for ischemic stroke and found that there were no differences between individuals with and without SLE. This analysis considered the use of intravenous thrombolysis and endovascular thrombectomy in just over 1.4 million cases but did not look at sex-specific differences.

Ms. Jesenakova had no conflicts of interest to disclose.

Women with systemic lupus erythematosus (SLE) experience worse outcomes after an acute stroke than does the general population, but men with SLE do not, according to an analysis of the U.S. National Inpatient Sample presented at the annual meeting of the British Society for Rheumatology.

In a study of more than 1.5 million cases of acute stroke recorded in the United States between 2015 and 2018, women with SLE were more likely to be hospitalized for longer and less likely to be routinely discharged into their home environment than were those without SLE. No such association was found for men with SLE.

“The findings imply that primary stroke prevention is of utmost importance, especially in females with SLE,” said Sona Jesenakova, a fourth-year medical student at the University of Aberdeen (Scotland).

“There might be a need to explore more effective and targeted treatment strategies to try and minimize these excessive adverse acute stroke outcomes, especially in females with SLE suffering from stroke,” she suggested.

“Even though males form only a minority of the SLE patient population, some studies have shown that they are prone to suffer from worse disease outcomes,” Ms. Jesenakova said.

Importantly, “male sex has been identified as a risk factor for death early in the course of SLE,” she added, highlighting that sex differences do seem to exist in SLE.

Stroke is an important outcome to look at because people with SLE are known to be at higher risk for developing atherosclerosis, which is a widely known risk factor for ischemic stroke, and with antiphospholipid antibody positivity and uncontrolled disease activity, that risk can be increased. A meta-analysis of older studies has suggested that the risk for death after a stroke is 68% higher in people with SLE than in those without.

To examine the risk for death and other in-hospital outcomes in a more contemporary population, Ms. Jesenakova and associates used data from the National Inpatient Sample, a large, publicly available database that contains inpatient health care information from across the United States. Their sample population consisted of 1,581,430 individuals who had been hospitalized for stroke. Of these, there were 6,100 women and 940 men who had SLE; the remainder served as the ‘no-SLE’ control population.

As might be expected, patients with SLE were about 10 years younger than those without SLE; the median age of women and men with SLE and those without SLE were a respective 60, 61, and 71 years.

There was no difference in the type of stroke between the SLE and no-SLE groups; most had an ischemic stroke (around 89%) rather than a hemorrhagic stroke (around 11%).

The researchers analyzed three key outcomes: mortality at discharge, hospitalization prolonged to a stay of more than 4 days, and routine home discharge, meaning that the patient was able to be discharged home versus more specialist facilities such as a nursing home.

They conducted a multivariate analysis with adjustments made for potential confounding factors such as age, ethnicity, type of stroke, and revascularization treatment. Comorbidities, including major cardiovascular disease, were also accounted for.

Although women with SLE were 21% more likely to die than patients without SLE, men with SLE were 24% less likely to die than was the no-SLE population. However, these differences were not statistically significant.

Women with SLE were 20% more likely to have a prolonged hospital stay and 28% less likely to have a routine home discharge, compared with patients who did not have SLE. The 95% confidence intervals were statistically significant, which was not seen when comparing the same outcomes in men with SLE (odds ratios of 1.06 and 1.18, respectively).

“As for males, even though we didn’t find anything of statistical significance, we have to bear in mind that the sample we had was quite small, and thus these results need to be interpreted with caution,” Ms. Jesenakova said. “We also think that we identified a gap in the current knowledge, and as such, further research is needed to help us understand the influence of male sex on acute stroke outcomes in patients with comorbid SLE.”

The researchers performed a secondary analysis looking at the use of revascularization treatments for ischemic stroke and found that there were no differences between individuals with and without SLE. This analysis considered the use of intravenous thrombolysis and endovascular thrombectomy in just over 1.4 million cases but did not look at sex-specific differences.

Ms. Jesenakova had no conflicts of interest to disclose.

CHICAGO – To give a sense of how social factors affect someone’s health, Sarah Candler, MD, MPH, described this case: A 70-year-old woman with diabetes, rheumatoid arthritis, and high blood pressure and a high hemoglobin A1C, even though she’s on insulin.

This patient is on prednisone for her RA because she can’t afford better drugs, and she has been occasionally skipping her insulin, Dr. Candler said during her presentation, at the annual meeting of the American College of Physicians

Plus, her first language is Turkish, and she’s missed many doctor appointments because she lives too far from the center-city clinics, said Dr. Candler, who is the care team medical director at Iora Primary Care in Houston.

How are this woman’s needs supposed to be met in a fee-for-service system that allows medical staff 15 to 30 minutes to help solve her problems?

Potential regulatory fixes

A panel of experts talked about potential policies and regulatory fixes that take into account the impact of “social determinants of health.” Some of these are gaining traction, but there is still a huge gap between how medicine in practiced in the United States and the health needs of people in the community, the panelists said.

The ACO REACH (Realizing Equity, Access and Community Health) model is a recent step forward, said Josh Liao, MD, MSc, associate chair for health systems at the University of Washington, Seattle. The accountable care organization model pays doctors more for caring for Medicare patients in underserved communities.

“To me, it represents that at least we’re moving in the direction where we’re acknowledging directly that social environment matters,” he said.

The American College of Physicians’ Medical Practice and Quality Committee helped improve payment for telehealth, an important step for equity to the underserved, said William Fox, MD, at Fox and Brantley Internal Medicine in Charlottesville, Va., and chair of the committee for ACP’s Virginia chapter. But many policies require much more work, he said.

One aim is getting to universal health coverage – 31 million people in the United States still don’t have health insurance, a number that is greatly improved since the Affordable Care Act but has plateaued recently.

Another is to invest more in primary care – which accounts for about 5% of spending even though 35% of patient visits are to primary care.

Dr. Fox said the U.S. system also needs to evolve beyond fee-for-service, invest in information technology to bridge the gap between the access for the rich and poor, continue to expand telehealth, and reform payment programs to recognize social factors.

“The current finance system and the quality payment program are focused on downstream impacts of poor health,” Dr. Fox said.

Primary care needs to shed the expectation that it must show that it reduces costs in order to be valued, he continued. Care sometimes is necessary but doesn’t reduce cost. Also, cost reduction is often seen in the long run, but studied only in the short term, and therefore the evidence for cost reduction can be elusive.

What can internists do to help?

Dr. Candler said internal medicine physicians can do their part by collecting data on patients and staff and measuring outcomes to identify disparities. Additionally, they could run their practices with community and cultural needs in mind, she said.

“Some of that might mean hiring differently. Think about it – if you’re in a position to start building new practices, go where they need you,” Dr. Candler explained. “It might mean a little bit more of a commute for you. But your patients are already doing that with their untreated cataracts, so who’s safer on the roads?”

George Abraham, MD, MPH – president of ACP and professor of medicine at the University of Massachusetts , Boston, who did not present in the session – suggested physicians should be looking at their own practice style, location, and the way their practice runs, and see where there are opportunities to be more in touch.

“I’m sure we all have practices where we have a diverse patient population,” he said. What doctors can do is to specifically focus on their minority population and ask: ‘What do they experience that others don’t experience as my patient coming into my office?’ he said.

Dr. Abraham, who received his medical degree in India and is ACP’s first president who is an international medical graduate, pointed to ACP’s emphasis on diversifying the internal medicine workforce to reflect the communities.

Recent measures have included the creation of an ACP international medical graduate task force and establishing an antiharassment policy and reporting process.

“The conversation has started a lot more,” he said.

Dr. Candler reports financial relationships with Abbott, AbbVie, Johnson & Johnson, Merck, Medtronic, Pfizer, and other companies. She is also a member of the editorial advisory board of Internal Medicine News. Dr. Fox reports financial relationships with Obagi Cosmeceuticals. Dr. Liao reports financial relationships with Eli Lilly, Gilead, Johnson & Johnson, Novavax, and other companies. Dr. Abraham reports no relevant financial relationships.

CHICAGO – To give a sense of how social factors affect someone’s health, Sarah Candler, MD, MPH, described this case: A 70-year-old woman with diabetes, rheumatoid arthritis, and high blood pressure and a high hemoglobin A1C, even though she’s on insulin.

This patient is on prednisone for her RA because she can’t afford better drugs, and she has been occasionally skipping her insulin, Dr. Candler said during her presentation, at the annual meeting of the American College of Physicians

Plus, her first language is Turkish, and she’s missed many doctor appointments because she lives too far from the center-city clinics, said Dr. Candler, who is the care team medical director at Iora Primary Care in Houston.

How are this woman’s needs supposed to be met in a fee-for-service system that allows medical staff 15 to 30 minutes to help solve her problems?

Potential regulatory fixes

A panel of experts talked about potential policies and regulatory fixes that take into account the impact of “social determinants of health.” Some of these are gaining traction, but there is still a huge gap between how medicine in practiced in the United States and the health needs of people in the community, the panelists said.

The ACO REACH (Realizing Equity, Access and Community Health) model is a recent step forward, said Josh Liao, MD, MSc, associate chair for health systems at the University of Washington, Seattle. The accountable care organization model pays doctors more for caring for Medicare patients in underserved communities.

“To me, it represents that at least we’re moving in the direction where we’re acknowledging directly that social environment matters,” he said.

The American College of Physicians’ Medical Practice and Quality Committee helped improve payment for telehealth, an important step for equity to the underserved, said William Fox, MD, at Fox and Brantley Internal Medicine in Charlottesville, Va., and chair of the committee for ACP’s Virginia chapter. But many policies require much more work, he said.

One aim is getting to universal health coverage – 31 million people in the United States still don’t have health insurance, a number that is greatly improved since the Affordable Care Act but has plateaued recently.

Another is to invest more in primary care – which accounts for about 5% of spending even though 35% of patient visits are to primary care.

Dr. Fox said the U.S. system also needs to evolve beyond fee-for-service, invest in information technology to bridge the gap between the access for the rich and poor, continue to expand telehealth, and reform payment programs to recognize social factors.

“The current finance system and the quality payment program are focused on downstream impacts of poor health,” Dr. Fox said.

Primary care needs to shed the expectation that it must show that it reduces costs in order to be valued, he continued. Care sometimes is necessary but doesn’t reduce cost. Also, cost reduction is often seen in the long run, but studied only in the short term, and therefore the evidence for cost reduction can be elusive.

What can internists do to help?

Dr. Candler said internal medicine physicians can do their part by collecting data on patients and staff and measuring outcomes to identify disparities. Additionally, they could run their practices with community and cultural needs in mind, she said.

“Some of that might mean hiring differently. Think about it – if you’re in a position to start building new practices, go where they need you,” Dr. Candler explained. “It might mean a little bit more of a commute for you. But your patients are already doing that with their untreated cataracts, so who’s safer on the roads?”

George Abraham, MD, MPH – president of ACP and professor of medicine at the University of Massachusetts , Boston, who did not present in the session – suggested physicians should be looking at their own practice style, location, and the way their practice runs, and see where there are opportunities to be more in touch.

“I’m sure we all have practices where we have a diverse patient population,” he said. What doctors can do is to specifically focus on their minority population and ask: ‘What do they experience that others don’t experience as my patient coming into my office?’ he said.

Dr. Abraham, who received his medical degree in India and is ACP’s first president who is an international medical graduate, pointed to ACP’s emphasis on diversifying the internal medicine workforce to reflect the communities.

Recent measures have included the creation of an ACP international medical graduate task force and establishing an antiharassment policy and reporting process.

“The conversation has started a lot more,” he said.

Dr. Candler reports financial relationships with Abbott, AbbVie, Johnson & Johnson, Merck, Medtronic, Pfizer, and other companies. She is also a member of the editorial advisory board of Internal Medicine News. Dr. Fox reports financial relationships with Obagi Cosmeceuticals. Dr. Liao reports financial relationships with Eli Lilly, Gilead, Johnson & Johnson, Novavax, and other companies. Dr. Abraham reports no relevant financial relationships.

CHICAGO – To give a sense of how social factors affect someone’s health, Sarah Candler, MD, MPH, described this case: A 70-year-old woman with diabetes, rheumatoid arthritis, and high blood pressure and a high hemoglobin A1C, even though she’s on insulin.

This patient is on prednisone for her RA because she can’t afford better drugs, and she has been occasionally skipping her insulin, Dr. Candler said during her presentation, at the annual meeting of the American College of Physicians

Plus, her first language is Turkish, and she’s missed many doctor appointments because she lives too far from the center-city clinics, said Dr. Candler, who is the care team medical director at Iora Primary Care in Houston.

How are this woman’s needs supposed to be met in a fee-for-service system that allows medical staff 15 to 30 minutes to help solve her problems?

Potential regulatory fixes

A panel of experts talked about potential policies and regulatory fixes that take into account the impact of “social determinants of health.” Some of these are gaining traction, but there is still a huge gap between how medicine in practiced in the United States and the health needs of people in the community, the panelists said.

The ACO REACH (Realizing Equity, Access and Community Health) model is a recent step forward, said Josh Liao, MD, MSc, associate chair for health systems at the University of Washington, Seattle. The accountable care organization model pays doctors more for caring for Medicare patients in underserved communities.

“To me, it represents that at least we’re moving in the direction where we’re acknowledging directly that social environment matters,” he said.

The American College of Physicians’ Medical Practice and Quality Committee helped improve payment for telehealth, an important step for equity to the underserved, said William Fox, MD, at Fox and Brantley Internal Medicine in Charlottesville, Va., and chair of the committee for ACP’s Virginia chapter. But many policies require much more work, he said.

One aim is getting to universal health coverage – 31 million people in the United States still don’t have health insurance, a number that is greatly improved since the Affordable Care Act but has plateaued recently.

Another is to invest more in primary care – which accounts for about 5% of spending even though 35% of patient visits are to primary care.

Dr. Fox said the U.S. system also needs to evolve beyond fee-for-service, invest in information technology to bridge the gap between the access for the rich and poor, continue to expand telehealth, and reform payment programs to recognize social factors.

“The current finance system and the quality payment program are focused on downstream impacts of poor health,” Dr. Fox said.

Primary care needs to shed the expectation that it must show that it reduces costs in order to be valued, he continued. Care sometimes is necessary but doesn’t reduce cost. Also, cost reduction is often seen in the long run, but studied only in the short term, and therefore the evidence for cost reduction can be elusive.

What can internists do to help?

Dr. Candler said internal medicine physicians can do their part by collecting data on patients and staff and measuring outcomes to identify disparities. Additionally, they could run their practices with community and cultural needs in mind, she said.

“Some of that might mean hiring differently. Think about it – if you’re in a position to start building new practices, go where they need you,” Dr. Candler explained. “It might mean a little bit more of a commute for you. But your patients are already doing that with their untreated cataracts, so who’s safer on the roads?”

George Abraham, MD, MPH – president of ACP and professor of medicine at the University of Massachusetts , Boston, who did not present in the session – suggested physicians should be looking at their own practice style, location, and the way their practice runs, and see where there are opportunities to be more in touch.

“I’m sure we all have practices where we have a diverse patient population,” he said. What doctors can do is to specifically focus on their minority population and ask: ‘What do they experience that others don’t experience as my patient coming into my office?’ he said.

Dr. Abraham, who received his medical degree in India and is ACP’s first president who is an international medical graduate, pointed to ACP’s emphasis on diversifying the internal medicine workforce to reflect the communities.

Recent measures have included the creation of an ACP international medical graduate task force and establishing an antiharassment policy and reporting process.

“The conversation has started a lot more,” he said.

Dr. Candler reports financial relationships with Abbott, AbbVie, Johnson & Johnson, Merck, Medtronic, Pfizer, and other companies. She is also a member of the editorial advisory board of Internal Medicine News. Dr. Fox reports financial relationships with Obagi Cosmeceuticals. Dr. Liao reports financial relationships with Eli Lilly, Gilead, Johnson & Johnson, Novavax, and other companies. Dr. Abraham reports no relevant financial relationships.

LISBON – During the pandemic, critical and acute care hospitals with medium and high rates of antimicrobial resistance (AMR) showed significant increases in antibiotic prescriptions and longer durations of antibiotic treatment among all hospital admissions, and also in those patients who were bacterial culture negative, according to a large U.S.-based study.

The analysis across 271 U.S. hospitals also showed that AMR rates were significantly higher for pathogens during the pandemic period, compared with the prepandemic period in patients who were tested for SARS-CoV-2, and highest in SARS-CoV-2–positive patients.

More than a third of SARS-CoV-2–positive patients who were prescribed antibiotics were bacterial culture negative.

Findings of the study were presented by Vikas Gupta, PharmD, director of medical affairs at medical technology firm Becton Dickinson, at this year’s European Congress of Clinical Microbiology & Infectious Diseases. He conducted the study jointly with Karri Bauer, PharmD, from Merck Sharp & Dohme, Kenilworth, N.J., and colleagues.

“There are differences in AMR that go beyond COVID-positive admissions,” Dr. Gupta told this news organization. “There is opportunity for improvement especially with those hospitalized patients who had a negative culture result, or no culture collected.”

“We found a higher percentage of COVID-positive admissions that were prescribed antibacterial therapy even in those having [tested negative for bacteria] or no culture result,” said Dr. Gupta. “Our data also shows that the percentage of admissions with duration of antibacterial therapy over 3 days was significantly higher in COVID-positive but culture-negative/no culture patients, compared to other groups evaluated.”

Of all admissions prescribed antibiotics during the pandemic, 57.8% of SARS-CoV-2–positive patients were prescribed antibiotics whereas 88.1% of SARS-CoV-2–positive admissions were bacterial culture negative/no culture. Overall, prepandemic, 35% of admissions were prescribed antibiotics.

Duration of antibiotic therapy in the prepandemic era was an average of 3.5 days, compared with an average of 3.8 days overall in the pandemic and 5.7 days in patients who tested positive for SARS-CoV-2. Similarly, the percentage of patients who were bacterial culture negative or had no culture and received antibiotic therapy for more than 72 hours was 17.6% in the prepandemic era, compared with 19.2% overall in the pandemic era, and 41.1% in patients who tested positive for COVID-19.  

Dr. Gupta and Dr. Bauer wanted to look at all patients admitted to hospitals segmented by SARS-CoV-2 positive, negative, and not tested, to get a sense of how much antibiotic use there was and how long patients were on antibiotics. “We ultimately want to optimize and not overuse antibiotics and prescribe them for right period of time,” said Dr. Gupta.

“To date, there has been no conclusive evidence about the suggestion that the pandemic has led to increased AMR rates, so we aimed to evaluate the pandemic’s impact on AMR and antibiotic use across U.S. hospitals,” he explained.

The multicenter, retrospective cohort analysis made use of BD’s infection surveillance platform (BD HealthSight Infection Advisor with MedMined Insights) and was conducted across 271 U.S. critical access/acute care facilities, representing approximately 10%-13% of U.S. hospital admissions. It included all hospitalized patients with more than 1 day of in-patient admission. Patients were considered SARS-CoV-2 positive by polymerase chain reaction test or antigen test either 7 days or less prior to or within 14 days of admission.

Patients were categorized as hospitalized during the “prepandemic” period (July 1, 2019 through February 29, 2020) and the “pandemic” period (March 1, 2020 through Oct. 30, 2021) and were stratified based on their SARS-CoV-2 result. 

Investigators included all hospital admissions with an AMR event (first positive culture for select gram-negative or gram-positive pathogens that were reported as nonsusceptible across blood, urine, respiratory, intra-abdominal, skin/wound, and other sources).

The investigators calculated AMR rates at the patient-admission level and defined per 100 admissions. Also, they further evaluated AMR rates based on community onset (defined as culture collected ≤2 days from admission) or hospital onset (>2 days from admission). Finally, AMR rates were determined according to whether they related to prepandemic or pandemic periods. 

Hospitals were also categorized according to their AMR rates as low (<25%), medium (25%-75%), and high (>75%). 

Overall AMR rates were lower in the pandemic period, compared with the prepandemic period. However, reported Dr.Gupta, for hospital-onset pathogens specifically, AMR rates were significantly higher overall in the pandemic period and mostly driven by admissions tested for SARS-CoV-2 (whether positive or negative).

Hospitals with high AMR rates also tended to have more SARS-CoV-2 positive admissions (6.1% in high-AMR hospitals vs. 3% in low-AMR hospitals). The highest antibiotic-prescribing rates and highest duration of antibiotic use was also seen in those hospitals with highest AMR rates. 

Of the SARS-CoV-2 patients who were bacterial culture negative/no culture and were prescribed antibiotics, 36.5% were in hospitals with a high AMR rate. “Roughly one-third of patients without culture evidence of a bacterial infection were prescribed antibiotics in hospitals with a high AMR rate,” said Dr. Gupta.

The researchers wanted to tease out whether hospitals with high, moderate, or low AMR rates look different with respect to antibiotic-prescribing patterns. During the pandemic period, they found that hospitals with high and medium AMR rates experienced significant increases in antibiotic prescriptions and longer durations. Prepandemic, the overall hospital-onset AMR rate was 0.8 per 100 admissions, whereas during the pandemic this rose to 1.4 per 100 admissions in high-AMR hospitals and dropped to 0.4 in low-AMR hospitals.

SARS-CoV-2–positive admission rates were higher in facilities with medium (5.6%) and high AMR (6.1%) rates than those with low (3%) AMR rates. “We found that those with medium and high AMR rates were more likely to have COVID-positive admissions than facilities with low AMR rates,” Dr. Gupta said. “It appears as if COVID is contributing to AMR in the facilities.”

Asked for independent comment, Jason C. Gallagher, PharmD, BCPS, clinical professor at Temple University School of Pharmacy in Philadelphia, said in an interview, “It is not surprising that there was more antimicrobial resistance in patients with COVID than those without. Even though antibiotics do not work for COVID, they are often prescribed, and antibiotic use is a major risk factor for antimicrobial resistance. This is likely because clinicians are sometimes concerned about coinfections with bacteria (which are rare) and because hospitalized patients with severe COVID can acquire other infections as they are treated.”
 

Antibiotic stewardship programs

Antibiotic stewardship programs have been highly stressed during the pandemic, so the researchers hope their data support the need for better antibiotic stewardship practices during pandemic surges when control is more challenging.

Dr. Gupta explained that they were seeing interesting associations that can inform antimicrobial stewardship programs and teams. “We are not trying to imply causality,” he stressed.

It is a common practice for stewardship teams to evaluate the need for continuation of antibiotic therapy at 3 days, especially in patients who are culture negative or did not have a culture collected.

“Antibiotic time-out at 3 days is a recommended practice to evaluate for continuing antibiotic therapy based on the patient’s condition and culture results,” he said. “This is what made our study unique because we wanted to look at what percentage of admissions were prescribed antibiotics beyond 3 days and compare to the prepandemic period.”

Session moderator Evangelos J. Giamarellos-Bourboulis, MD, PhD, an assistant professor of internal medicine and infectious diseases, University of Athens, Greece, thanked Dr. Gupta for his “eloquent presentation” and sought to clarify whether the data “refer to antimicrobial use that was empirical or whether use was in hospitals with high AMR rates, or whether the approach was driven through microbiology?”

Dr. Gupta replied that this was why they evaluated the negative-culture and no-culture patients. “We wanted to get a measure of antibacterial use in this population too,” he said. “Definitely, there is empirical therapy as well as definitive therapy, but I think the negative and no-culture group provide a reference point where we see similar signals and trends to that of the overall population.”

An audience member also addressed a question to Dr. Gupta: “Did you look at the patient population, because in many cases, during COVID, these patients may have been more severe than in the prepandemic period?”

Dr. Gupta replied: “In our manuscript we’ve done an analysis where we adjusted for patient-level facility and regional-level factors. There are definitely differences in the patient populations but overall, these are pretty sick patients when we look at the level of severity overall.”

Dr. Gupta is an employee of and a shareholder in Becton Dickinson. Dr. Bauer is an employee of and a shareholder in Merck. Dr. Gallagher consults for many pharmaceutical companies including Merck.

Dr. Giamarellos-Bourboulis disclosed honoraria (paid to the University of Athens) from Abbott CH, Brahms Thermo Fisher GMBH Germany, GlaxoSmithKline, and Sobi; serving as a consultant for Abbott CH, Fab’nTech, InflaRx GmbH, UCB, Sobi, and Xbiotech; research grants (paid to the Hellenic Institute for the Study of Sepsis) from Abbott CH, BioMerieux France, Johnson & Johnson, MSD, Sobi, Thermo Fisher Brahms GmbH; and EU research funding: Horizon 2020 ITN European Sepsis Academy (granted to the University of Athens); Horizon 2020 ImmunoSep and RISinCOVID (granted to the Hellenic Institute for the Study of Sepsis); Horizon Health EPIC-CROWN-2 (granted to the Hellenic Institute for the Study of Sepsis).

A version of this article first appeared on Medscape.com.

LISBON – During the pandemic, critical and acute care hospitals with medium and high rates of antimicrobial resistance (AMR) showed significant increases in antibiotic prescriptions and longer durations of antibiotic treatment among all hospital admissions, and also in those patients who were bacterial culture negative, according to a large U.S.-based study.

The analysis across 271 U.S. hospitals also showed that AMR rates were significantly higher for pathogens during the pandemic period, compared with the prepandemic period in patients who were tested for SARS-CoV-2, and highest in SARS-CoV-2–positive patients.

More than a third of SARS-CoV-2–positive patients who were prescribed antibiotics were bacterial culture negative.

Findings of the study were presented by Vikas Gupta, PharmD, director of medical affairs at medical technology firm Becton Dickinson, at this year’s European Congress of Clinical Microbiology & Infectious Diseases. He conducted the study jointly with Karri Bauer, PharmD, from Merck Sharp & Dohme, Kenilworth, N.J., and colleagues.

“There are differences in AMR that go beyond COVID-positive admissions,” Dr. Gupta told this news organization. “There is opportunity for improvement especially with those hospitalized patients who had a negative culture result, or no culture collected.”

“We found a higher percentage of COVID-positive admissions that were prescribed antibacterial therapy even in those having [tested negative for bacteria] or no culture result,” said Dr. Gupta. “Our data also shows that the percentage of admissions with duration of antibacterial therapy over 3 days was significantly higher in COVID-positive but culture-negative/no culture patients, compared to other groups evaluated.”

Of all admissions prescribed antibiotics during the pandemic, 57.8% of SARS-CoV-2–positive patients were prescribed antibiotics whereas 88.1% of SARS-CoV-2–positive admissions were bacterial culture negative/no culture. Overall, prepandemic, 35% of admissions were prescribed antibiotics.

Duration of antibiotic therapy in the prepandemic era was an average of 3.5 days, compared with an average of 3.8 days overall in the pandemic and 5.7 days in patients who tested positive for SARS-CoV-2. Similarly, the percentage of patients who were bacterial culture negative or had no culture and received antibiotic therapy for more than 72 hours was 17.6% in the prepandemic era, compared with 19.2% overall in the pandemic era, and 41.1% in patients who tested positive for COVID-19.  

Dr. Gupta and Dr. Bauer wanted to look at all patients admitted to hospitals segmented by SARS-CoV-2 positive, negative, and not tested, to get a sense of how much antibiotic use there was and how long patients were on antibiotics. “We ultimately want to optimize and not overuse antibiotics and prescribe them for right period of time,” said Dr. Gupta.

“To date, there has been no conclusive evidence about the suggestion that the pandemic has led to increased AMR rates, so we aimed to evaluate the pandemic’s impact on AMR and antibiotic use across U.S. hospitals,” he explained.

The multicenter, retrospective cohort analysis made use of BD’s infection surveillance platform (BD HealthSight Infection Advisor with MedMined Insights) and was conducted across 271 U.S. critical access/acute care facilities, representing approximately 10%-13% of U.S. hospital admissions. It included all hospitalized patients with more than 1 day of in-patient admission. Patients were considered SARS-CoV-2 positive by polymerase chain reaction test or antigen test either 7 days or less prior to or within 14 days of admission.

Patients were categorized as hospitalized during the “prepandemic” period (July 1, 2019 through February 29, 2020) and the “pandemic” period (March 1, 2020 through Oct. 30, 2021) and were stratified based on their SARS-CoV-2 result. 

Investigators included all hospital admissions with an AMR event (first positive culture for select gram-negative or gram-positive pathogens that were reported as nonsusceptible across blood, urine, respiratory, intra-abdominal, skin/wound, and other sources).

The investigators calculated AMR rates at the patient-admission level and defined per 100 admissions. Also, they further evaluated AMR rates based on community onset (defined as culture collected ≤2 days from admission) or hospital onset (>2 days from admission). Finally, AMR rates were determined according to whether they related to prepandemic or pandemic periods. 

Hospitals were also categorized according to their AMR rates as low (<25%), medium (25%-75%), and high (>75%). 

Overall AMR rates were lower in the pandemic period, compared with the prepandemic period. However, reported Dr.Gupta, for hospital-onset pathogens specifically, AMR rates were significantly higher overall in the pandemic period and mostly driven by admissions tested for SARS-CoV-2 (whether positive or negative).

Hospitals with high AMR rates also tended to have more SARS-CoV-2 positive admissions (6.1% in high-AMR hospitals vs. 3% in low-AMR hospitals). The highest antibiotic-prescribing rates and highest duration of antibiotic use was also seen in those hospitals with highest AMR rates. 

Of the SARS-CoV-2 patients who were bacterial culture negative/no culture and were prescribed antibiotics, 36.5% were in hospitals with a high AMR rate. “Roughly one-third of patients without culture evidence of a bacterial infection were prescribed antibiotics in hospitals with a high AMR rate,” said Dr. Gupta.

The researchers wanted to tease out whether hospitals with high, moderate, or low AMR rates look different with respect to antibiotic-prescribing patterns. During the pandemic period, they found that hospitals with high and medium AMR rates experienced significant increases in antibiotic prescriptions and longer durations. Prepandemic, the overall hospital-onset AMR rate was 0.8 per 100 admissions, whereas during the pandemic this rose to 1.4 per 100 admissions in high-AMR hospitals and dropped to 0.4 in low-AMR hospitals.

SARS-CoV-2–positive admission rates were higher in facilities with medium (5.6%) and high AMR (6.1%) rates than those with low (3%) AMR rates. “We found that those with medium and high AMR rates were more likely to have COVID-positive admissions than facilities with low AMR rates,” Dr. Gupta said. “It appears as if COVID is contributing to AMR in the facilities.”

Asked for independent comment, Jason C. Gallagher, PharmD, BCPS, clinical professor at Temple University School of Pharmacy in Philadelphia, said in an interview, “It is not surprising that there was more antimicrobial resistance in patients with COVID than those without. Even though antibiotics do not work for COVID, they are often prescribed, and antibiotic use is a major risk factor for antimicrobial resistance. This is likely because clinicians are sometimes concerned about coinfections with bacteria (which are rare) and because hospitalized patients with severe COVID can acquire other infections as they are treated.”
 

Antibiotic stewardship programs

Antibiotic stewardship programs have been highly stressed during the pandemic, so the researchers hope their data support the need for better antibiotic stewardship practices during pandemic surges when control is more challenging.

Dr. Gupta explained that they were seeing interesting associations that can inform antimicrobial stewardship programs and teams. “We are not trying to imply causality,” he stressed.

It is a common practice for stewardship teams to evaluate the need for continuation of antibiotic therapy at 3 days, especially in patients who are culture negative or did not have a culture collected.

“Antibiotic time-out at 3 days is a recommended practice to evaluate for continuing antibiotic therapy based on the patient’s condition and culture results,” he said. “This is what made our study unique because we wanted to look at what percentage of admissions were prescribed antibiotics beyond 3 days and compare to the prepandemic period.”

Session moderator Evangelos J. Giamarellos-Bourboulis, MD, PhD, an assistant professor of internal medicine and infectious diseases, University of Athens, Greece, thanked Dr. Gupta for his “eloquent presentation” and sought to clarify whether the data “refer to antimicrobial use that was empirical or whether use was in hospitals with high AMR rates, or whether the approach was driven through microbiology?”

Dr. Gupta replied that this was why they evaluated the negative-culture and no-culture patients. “We wanted to get a measure of antibacterial use in this population too,” he said. “Definitely, there is empirical therapy as well as definitive therapy, but I think the negative and no-culture group provide a reference point where we see similar signals and trends to that of the overall population.”

An audience member also addressed a question to Dr. Gupta: “Did you look at the patient population, because in many cases, during COVID, these patients may have been more severe than in the prepandemic period?”

Dr. Gupta replied: “In our manuscript we’ve done an analysis where we adjusted for patient-level facility and regional-level factors. There are definitely differences in the patient populations but overall, these are pretty sick patients when we look at the level of severity overall.”

Dr. Gupta is an employee of and a shareholder in Becton Dickinson. Dr. Bauer is an employee of and a shareholder in Merck. Dr. Gallagher consults for many pharmaceutical companies including Merck.

Dr. Giamarellos-Bourboulis disclosed honoraria (paid to the University of Athens) from Abbott CH, Brahms Thermo Fisher GMBH Germany, GlaxoSmithKline, and Sobi; serving as a consultant for Abbott CH, Fab’nTech, InflaRx GmbH, UCB, Sobi, and Xbiotech; research grants (paid to the Hellenic Institute for the Study of Sepsis) from Abbott CH, BioMerieux France, Johnson & Johnson, MSD, Sobi, Thermo Fisher Brahms GmbH; and EU research funding: Horizon 2020 ITN European Sepsis Academy (granted to the University of Athens); Horizon 2020 ImmunoSep and RISinCOVID (granted to the Hellenic Institute for the Study of Sepsis); Horizon Health EPIC-CROWN-2 (granted to the Hellenic Institute for the Study of Sepsis).

A version of this article first appeared on Medscape.com.

LISBON – During the pandemic, critical and acute care hospitals with medium and high rates of antimicrobial resistance (AMR) showed significant increases in antibiotic prescriptions and longer durations of antibiotic treatment among all hospital admissions, and also in those patients who were bacterial culture negative, according to a large U.S.-based study.

The analysis across 271 U.S. hospitals also showed that AMR rates were significantly higher for pathogens during the pandemic period, compared with the prepandemic period in patients who were tested for SARS-CoV-2, and highest in SARS-CoV-2–positive patients.

More than a third of SARS-CoV-2–positive patients who were prescribed antibiotics were bacterial culture negative.

Findings of the study were presented by Vikas Gupta, PharmD, director of medical affairs at medical technology firm Becton Dickinson, at this year’s European Congress of Clinical Microbiology & Infectious Diseases. He conducted the study jointly with Karri Bauer, PharmD, from Merck Sharp & Dohme, Kenilworth, N.J., and colleagues.

“There are differences in AMR that go beyond COVID-positive admissions,” Dr. Gupta told this news organization. “There is opportunity for improvement especially with those hospitalized patients who had a negative culture result, or no culture collected.”

“We found a higher percentage of COVID-positive admissions that were prescribed antibacterial therapy even in those having [tested negative for bacteria] or no culture result,” said Dr. Gupta. “Our data also shows that the percentage of admissions with duration of antibacterial therapy over 3 days was significantly higher in COVID-positive but culture-negative/no culture patients, compared to other groups evaluated.”

Of all admissions prescribed antibiotics during the pandemic, 57.8% of SARS-CoV-2–positive patients were prescribed antibiotics whereas 88.1% of SARS-CoV-2–positive admissions were bacterial culture negative/no culture. Overall, prepandemic, 35% of admissions were prescribed antibiotics.

Duration of antibiotic therapy in the prepandemic era was an average of 3.5 days, compared with an average of 3.8 days overall in the pandemic and 5.7 days in patients who tested positive for SARS-CoV-2. Similarly, the percentage of patients who were bacterial culture negative or had no culture and received antibiotic therapy for more than 72 hours was 17.6% in the prepandemic era, compared with 19.2% overall in the pandemic era, and 41.1% in patients who tested positive for COVID-19.  

Dr. Gupta and Dr. Bauer wanted to look at all patients admitted to hospitals segmented by SARS-CoV-2 positive, negative, and not tested, to get a sense of how much antibiotic use there was and how long patients were on antibiotics. “We ultimately want to optimize and not overuse antibiotics and prescribe them for right period of time,” said Dr. Gupta.

“To date, there has been no conclusive evidence about the suggestion that the pandemic has led to increased AMR rates, so we aimed to evaluate the pandemic’s impact on AMR and antibiotic use across U.S. hospitals,” he explained.

The multicenter, retrospective cohort analysis made use of BD’s infection surveillance platform (BD HealthSight Infection Advisor with MedMined Insights) and was conducted across 271 U.S. critical access/acute care facilities, representing approximately 10%-13% of U.S. hospital admissions. It included all hospitalized patients with more than 1 day of in-patient admission. Patients were considered SARS-CoV-2 positive by polymerase chain reaction test or antigen test either 7 days or less prior to or within 14 days of admission.

Patients were categorized as hospitalized during the “prepandemic” period (July 1, 2019 through February 29, 2020) and the “pandemic” period (March 1, 2020 through Oct. 30, 2021) and were stratified based on their SARS-CoV-2 result. 

Investigators included all hospital admissions with an AMR event (first positive culture for select gram-negative or gram-positive pathogens that were reported as nonsusceptible across blood, urine, respiratory, intra-abdominal, skin/wound, and other sources).

The investigators calculated AMR rates at the patient-admission level and defined per 100 admissions. Also, they further evaluated AMR rates based on community onset (defined as culture collected ≤2 days from admission) or hospital onset (>2 days from admission). Finally, AMR rates were determined according to whether they related to prepandemic or pandemic periods. 

Hospitals were also categorized according to their AMR rates as low (<25%), medium (25%-75%), and high (>75%). 

Overall AMR rates were lower in the pandemic period, compared with the prepandemic period. However, reported Dr.Gupta, for hospital-onset pathogens specifically, AMR rates were significantly higher overall in the pandemic period and mostly driven by admissions tested for SARS-CoV-2 (whether positive or negative).

Hospitals with high AMR rates also tended to have more SARS-CoV-2 positive admissions (6.1% in high-AMR hospitals vs. 3% in low-AMR hospitals). The highest antibiotic-prescribing rates and highest duration of antibiotic use was also seen in those hospitals with highest AMR rates. 

Of the SARS-CoV-2 patients who were bacterial culture negative/no culture and were prescribed antibiotics, 36.5% were in hospitals with a high AMR rate. “Roughly one-third of patients without culture evidence of a bacterial infection were prescribed antibiotics in hospitals with a high AMR rate,” said Dr. Gupta.

The researchers wanted to tease out whether hospitals with high, moderate, or low AMR rates look different with respect to antibiotic-prescribing patterns. During the pandemic period, they found that hospitals with high and medium AMR rates experienced significant increases in antibiotic prescriptions and longer durations. Prepandemic, the overall hospital-onset AMR rate was 0.8 per 100 admissions, whereas during the pandemic this rose to 1.4 per 100 admissions in high-AMR hospitals and dropped to 0.4 in low-AMR hospitals.

SARS-CoV-2–positive admission rates were higher in facilities with medium (5.6%) and high AMR (6.1%) rates than those with low (3%) AMR rates. “We found that those with medium and high AMR rates were more likely to have COVID-positive admissions than facilities with low AMR rates,” Dr. Gupta said. “It appears as if COVID is contributing to AMR in the facilities.”

Asked for independent comment, Jason C. Gallagher, PharmD, BCPS, clinical professor at Temple University School of Pharmacy in Philadelphia, said in an interview, “It is not surprising that there was more antimicrobial resistance in patients with COVID than those without. Even though antibiotics do not work for COVID, they are often prescribed, and antibiotic use is a major risk factor for antimicrobial resistance. This is likely because clinicians are sometimes concerned about coinfections with bacteria (which are rare) and because hospitalized patients with severe COVID can acquire other infections as they are treated.”
 

Antibiotic stewardship programs

Antibiotic stewardship programs have been highly stressed during the pandemic, so the researchers hope their data support the need for better antibiotic stewardship practices during pandemic surges when control is more challenging.

Dr. Gupta explained that they were seeing interesting associations that can inform antimicrobial stewardship programs and teams. “We are not trying to imply causality,” he stressed.

It is a common practice for stewardship teams to evaluate the need for continuation of antibiotic therapy at 3 days, especially in patients who are culture negative or did not have a culture collected.

“Antibiotic time-out at 3 days is a recommended practice to evaluate for continuing antibiotic therapy based on the patient’s condition and culture results,” he said. “This is what made our study unique because we wanted to look at what percentage of admissions were prescribed antibiotics beyond 3 days and compare to the prepandemic period.”

Session moderator Evangelos J. Giamarellos-Bourboulis, MD, PhD, an assistant professor of internal medicine and infectious diseases, University of Athens, Greece, thanked Dr. Gupta for his “eloquent presentation” and sought to clarify whether the data “refer to antimicrobial use that was empirical or whether use was in hospitals with high AMR rates, or whether the approach was driven through microbiology?”

Dr. Gupta replied that this was why they evaluated the negative-culture and no-culture patients. “We wanted to get a measure of antibacterial use in this population too,” he said. “Definitely, there is empirical therapy as well as definitive therapy, but I think the negative and no-culture group provide a reference point where we see similar signals and trends to that of the overall population.”

An audience member also addressed a question to Dr. Gupta: “Did you look at the patient population, because in many cases, during COVID, these patients may have been more severe than in the prepandemic period?”

Dr. Gupta replied: “In our manuscript we’ve done an analysis where we adjusted for patient-level facility and regional-level factors. There are definitely differences in the patient populations but overall, these are pretty sick patients when we look at the level of severity overall.”

Dr. Gupta is an employee of and a shareholder in Becton Dickinson. Dr. Bauer is an employee of and a shareholder in Merck. Dr. Gallagher consults for many pharmaceutical companies including Merck.

Dr. Giamarellos-Bourboulis disclosed honoraria (paid to the University of Athens) from Abbott CH, Brahms Thermo Fisher GMBH Germany, GlaxoSmithKline, and Sobi; serving as a consultant for Abbott CH, Fab’nTech, InflaRx GmbH, UCB, Sobi, and Xbiotech; research grants (paid to the Hellenic Institute for the Study of Sepsis) from Abbott CH, BioMerieux France, Johnson & Johnson, MSD, Sobi, Thermo Fisher Brahms GmbH; and EU research funding: Horizon 2020 ITN European Sepsis Academy (granted to the University of Athens); Horizon 2020 ImmunoSep and RISinCOVID (granted to the Hellenic Institute for the Study of Sepsis); Horizon Health EPIC-CROWN-2 (granted to the Hellenic Institute for the Study of Sepsis).

A version of this article first appeared on Medscape.com.

Researchers are increasingly turning their attention to virtual reality (VR) for the treatment of psychiatric disorders in older adults.

Recent studies have highlighted the usefulness of VR in treating depression and loneliness in older patients who may be socially isolated because of their age, comorbidities, or the COVID-19 pandemic.

“The unique capability of virtual reality to create an immersive and engaging setting is an exciting opportunity for geriatric psychiatry,” Harmehr Sekhon, PhD, postdoctoral research fellow, Lady Davis Institute/Jewish General Hospital, McGill University, Montreal, and McLean Hospital, Harvard Medical School, Boston, told this news organization.

Because VR can be personalized and tailored for each patient, it represents “a cutting-edge technology” for novel applications, Dr. Sekhon said.

One novel approach involves using VR to administer a mindfulness intervention in older adults. Dr. Sekhon shared information on her own mindfulness study and on other developments in VR and telemedicine at the American Association for Geriatric Psychiatry annual meeting.
 

Potential bridging tool

As the population ages, the prevalence of mental health disorders increases. Telemedicine has proved to be a potential “bridge” to address the health care needs of older adults, Dr. Sekhon noted.

She cited her systematic review of telemedicine for older adults with dementia during COVID-19. Results showed that telemedicine was a “beneficial approach” to assisting these individuals and that it increased accessibility, said Dr. Sekhon.

In addition, a survey published last year showed that 87% of Americans in general want to continue using telehealth services after the pandemic. Most respondents agreed that telehealth had made it easier to get the care they needed. They also reported having received the same level of care via telehealth as with in-person care.

A growing body of research shows that VR has “positive influences on mood and well-being, cognition, pain management, [and] treatment of phobias in younger adults,” Dr. Sekhon said. She added that there is evidence that VR is feasible for older adults, with applications in cognitive disorders.

She cited a recent systematic review of 55 studies that assessed the impact of different types of VR on mental health in older adults. The results showed that VR could be helpful in screening for cognitive impairment – and it was comparable to some paper-based assessment. It was also useful as a training tool for those with cognitive impairment.

Examples of VR interventions that can be used to treat cognitive impairment include “virtual cities, kitchens, supermarkets,” Dr. Sekhon noted.

The technology is increasingly being used as a tool to deliver psychotherapy, in which patient engagement is “a key determinant” of outcomes, she added. “Virtual reality is a cutting-edge, engaging, and immersive technique to administer psychotherapy,” she said.

Such VR approaches are proving successful in older patients. Dr. Sekhon highlighted the case of an 85-year-old woman who engaged in ten sessions of psychodynamic psychotherapy that targeted persistent dysthymia and negativistic mood. The case was part of a proof-of-concept study published in the May issue of the American Journal of Geriatric Psychiatry.

Dr. Sekhon noted the intervention was well tolerated and was associated with minimal side effects.
 

VR-based meditation

Dr. Sekhon and her colleagues are now conducting a randomized controlled trial of VR meditation in older adults. VR-based meditation has been shown to increase relaxation and to decrease anxiety, sadness, and anger in younger adults. However, it has not been studied in the geriatric population.

The pilot study is assessing the feasibility and tolerability of VR meditation for older adults and its effects on stress, anxiety, depression, sleep, and quality of life. The study involves 30 adults aged 60 years and older.

Participants receive either 15-minute VR mindfulness meditation sessions twice a week for 4 weeks or are on a control wait list. The meditation sessions are user friendly and focus on breath meditation and body scans, Dr. Sekhon reported.

Because participants are older and balance is a concern, safety steps are incorporated into the sessions. “We ensure they’re doing this in a seated position, in a chair with arm rests, so that they’re very stable and there’s no risk of falls,” said Dr. Sekhon.

Another concern with VR is motion sickness, she noted. “It’s pretty minimal, but the best way we found so far is giving older adults time to adapt and feel comfortable with the VR,” she said. From the first session, participants learn how to put on the device and are checked to make sure they are comfortable with the process. To help them get used to everything, video and audio are not included during the first session.

Dr. Sekhon noted that results from the study are expected later this year.

In addition to mindfulness, researchers are using VR to deliver other established interventions, such as exposure therapy – and are implementing these approaches in varied environments, including long-term and palliative care settings.

VR-related technology is constantly improving and is becoming easier to use and more affordable, said Dr. Sekhon. She noted that the simplest devices that rely on smartphones cost as little as $15.

Although VR in older adults is promising, there are barriers to its adoption and use in research, she noted. For example, older adults may have cognitive, visual, or hearing impairments. They may have limited digital literacy, and/or they may not have access to the required technology.

These barriers can be overcome through workarounds, including providing instructional videos and digital literacy assistance via Zoom and working with community partners to facilitate study recruitment of older patients, Dr. Sekhon said.

Dr. Sekhon’s research is funded by the Canadian Institutes of Health Research and the Fonds de recherche du Quebec Sante.

A version of this article first appeared on Medscape.com.

Researchers are increasingly turning their attention to virtual reality (VR) for the treatment of psychiatric disorders in older adults.

Recent studies have highlighted the usefulness of VR in treating depression and loneliness in older patients who may be socially isolated because of their age, comorbidities, or the COVID-19 pandemic.

“The unique capability of virtual reality to create an immersive and engaging setting is an exciting opportunity for geriatric psychiatry,” Harmehr Sekhon, PhD, postdoctoral research fellow, Lady Davis Institute/Jewish General Hospital, McGill University, Montreal, and McLean Hospital, Harvard Medical School, Boston, told this news organization.

Because VR can be personalized and tailored for each patient, it represents “a cutting-edge technology” for novel applications, Dr. Sekhon said.

One novel approach involves using VR to administer a mindfulness intervention in older adults. Dr. Sekhon shared information on her own mindfulness study and on other developments in VR and telemedicine at the American Association for Geriatric Psychiatry annual meeting.
 

Potential bridging tool

As the population ages, the prevalence of mental health disorders increases. Telemedicine has proved to be a potential “bridge” to address the health care needs of older adults, Dr. Sekhon noted.

She cited her systematic review of telemedicine for older adults with dementia during COVID-19. Results showed that telemedicine was a “beneficial approach” to assisting these individuals and that it increased accessibility, said Dr. Sekhon.

In addition, a survey published last year showed that 87% of Americans in general want to continue using telehealth services after the pandemic. Most respondents agreed that telehealth had made it easier to get the care they needed. They also reported having received the same level of care via telehealth as with in-person care.

A growing body of research shows that VR has “positive influences on mood and well-being, cognition, pain management, [and] treatment of phobias in younger adults,” Dr. Sekhon said. She added that there is evidence that VR is feasible for older adults, with applications in cognitive disorders.

She cited a recent systematic review of 55 studies that assessed the impact of different types of VR on mental health in older adults. The results showed that VR could be helpful in screening for cognitive impairment – and it was comparable to some paper-based assessment. It was also useful as a training tool for those with cognitive impairment.

Examples of VR interventions that can be used to treat cognitive impairment include “virtual cities, kitchens, supermarkets,” Dr. Sekhon noted.

The technology is increasingly being used as a tool to deliver psychotherapy, in which patient engagement is “a key determinant” of outcomes, she added. “Virtual reality is a cutting-edge, engaging, and immersive technique to administer psychotherapy,” she said.

Such VR approaches are proving successful in older patients. Dr. Sekhon highlighted the case of an 85-year-old woman who engaged in ten sessions of psychodynamic psychotherapy that targeted persistent dysthymia and negativistic mood. The case was part of a proof-of-concept study published in the May issue of the American Journal of Geriatric Psychiatry.

Dr. Sekhon noted the intervention was well tolerated and was associated with minimal side effects.
 

VR-based meditation

Dr. Sekhon and her colleagues are now conducting a randomized controlled trial of VR meditation in older adults. VR-based meditation has been shown to increase relaxation and to decrease anxiety, sadness, and anger in younger adults. However, it has not been studied in the geriatric population.

The pilot study is assessing the feasibility and tolerability of VR meditation for older adults and its effects on stress, anxiety, depression, sleep, and quality of life. The study involves 30 adults aged 60 years and older.

Participants receive either 15-minute VR mindfulness meditation sessions twice a week for 4 weeks or are on a control wait list. The meditation sessions are user friendly and focus on breath meditation and body scans, Dr. Sekhon reported.

Because participants are older and balance is a concern, safety steps are incorporated into the sessions. “We ensure they’re doing this in a seated position, in a chair with arm rests, so that they’re very stable and there’s no risk of falls,” said Dr. Sekhon.

Another concern with VR is motion sickness, she noted. “It’s pretty minimal, but the best way we found so far is giving older adults time to adapt and feel comfortable with the VR,” she said. From the first session, participants learn how to put on the device and are checked to make sure they are comfortable with the process. To help them get used to everything, video and audio are not included during the first session.

Dr. Sekhon noted that results from the study are expected later this year.

In addition to mindfulness, researchers are using VR to deliver other established interventions, such as exposure therapy – and are implementing these approaches in varied environments, including long-term and palliative care settings.

VR-related technology is constantly improving and is becoming easier to use and more affordable, said Dr. Sekhon. She noted that the simplest devices that rely on smartphones cost as little as $15.

Although VR in older adults is promising, there are barriers to its adoption and use in research, she noted. For example, older adults may have cognitive, visual, or hearing impairments. They may have limited digital literacy, and/or they may not have access to the required technology.

These barriers can be overcome through workarounds, including providing instructional videos and digital literacy assistance via Zoom and working with community partners to facilitate study recruitment of older patients, Dr. Sekhon said.

Dr. Sekhon’s research is funded by the Canadian Institutes of Health Research and the Fonds de recherche du Quebec Sante.

A version of this article first appeared on Medscape.com.

Researchers are increasingly turning their attention to virtual reality (VR) for the treatment of psychiatric disorders in older adults.

Recent studies have highlighted the usefulness of VR in treating depression and loneliness in older patients who may be socially isolated because of their age, comorbidities, or the COVID-19 pandemic.

“The unique capability of virtual reality to create an immersive and engaging setting is an exciting opportunity for geriatric psychiatry,” Harmehr Sekhon, PhD, postdoctoral research fellow, Lady Davis Institute/Jewish General Hospital, McGill University, Montreal, and McLean Hospital, Harvard Medical School, Boston, told this news organization.

Because VR can be personalized and tailored for each patient, it represents “a cutting-edge technology” for novel applications, Dr. Sekhon said.

One novel approach involves using VR to administer a mindfulness intervention in older adults. Dr. Sekhon shared information on her own mindfulness study and on other developments in VR and telemedicine at the American Association for Geriatric Psychiatry annual meeting.
 

Potential bridging tool

As the population ages, the prevalence of mental health disorders increases. Telemedicine has proved to be a potential “bridge” to address the health care needs of older adults, Dr. Sekhon noted.

She cited her systematic review of telemedicine for older adults with dementia during COVID-19. Results showed that telemedicine was a “beneficial approach” to assisting these individuals and that it increased accessibility, said Dr. Sekhon.

In addition, a survey published last year showed that 87% of Americans in general want to continue using telehealth services after the pandemic. Most respondents agreed that telehealth had made it easier to get the care they needed. They also reported having received the same level of care via telehealth as with in-person care.

A growing body of research shows that VR has “positive influences on mood and well-being, cognition, pain management, [and] treatment of phobias in younger adults,” Dr. Sekhon said. She added that there is evidence that VR is feasible for older adults, with applications in cognitive disorders.

She cited a recent systematic review of 55 studies that assessed the impact of different types of VR on mental health in older adults. The results showed that VR could be helpful in screening for cognitive impairment – and it was comparable to some paper-based assessment. It was also useful as a training tool for those with cognitive impairment.

Examples of VR interventions that can be used to treat cognitive impairment include “virtual cities, kitchens, supermarkets,” Dr. Sekhon noted.

The technology is increasingly being used as a tool to deliver psychotherapy, in which patient engagement is “a key determinant” of outcomes, she added. “Virtual reality is a cutting-edge, engaging, and immersive technique to administer psychotherapy,” she said.

Such VR approaches are proving successful in older patients. Dr. Sekhon highlighted the case of an 85-year-old woman who engaged in ten sessions of psychodynamic psychotherapy that targeted persistent dysthymia and negativistic mood. The case was part of a proof-of-concept study published in the May issue of the American Journal of Geriatric Psychiatry.

Dr. Sekhon noted the intervention was well tolerated and was associated with minimal side effects.
 

VR-based meditation

Dr. Sekhon and her colleagues are now conducting a randomized controlled trial of VR meditation in older adults. VR-based meditation has been shown to increase relaxation and to decrease anxiety, sadness, and anger in younger adults. However, it has not been studied in the geriatric population.

The pilot study is assessing the feasibility and tolerability of VR meditation for older adults and its effects on stress, anxiety, depression, sleep, and quality of life. The study involves 30 adults aged 60 years and older.

Participants receive either 15-minute VR mindfulness meditation sessions twice a week for 4 weeks or are on a control wait list. The meditation sessions are user friendly and focus on breath meditation and body scans, Dr. Sekhon reported.

Because participants are older and balance is a concern, safety steps are incorporated into the sessions. “We ensure they’re doing this in a seated position, in a chair with arm rests, so that they’re very stable and there’s no risk of falls,” said Dr. Sekhon.

Another concern with VR is motion sickness, she noted. “It’s pretty minimal, but the best way we found so far is giving older adults time to adapt and feel comfortable with the VR,” she said. From the first session, participants learn how to put on the device and are checked to make sure they are comfortable with the process. To help them get used to everything, video and audio are not included during the first session.

Dr. Sekhon noted that results from the study are expected later this year.

In addition to mindfulness, researchers are using VR to deliver other established interventions, such as exposure therapy – and are implementing these approaches in varied environments, including long-term and palliative care settings.

VR-related technology is constantly improving and is becoming easier to use and more affordable, said Dr. Sekhon. She noted that the simplest devices that rely on smartphones cost as little as $15.

Although VR in older adults is promising, there are barriers to its adoption and use in research, she noted. For example, older adults may have cognitive, visual, or hearing impairments. They may have limited digital literacy, and/or they may not have access to the required technology.

These barriers can be overcome through workarounds, including providing instructional videos and digital literacy assistance via Zoom and working with community partners to facilitate study recruitment of older patients, Dr. Sekhon said.

Dr. Sekhon’s research is funded by the Canadian Institutes of Health Research and the Fonds de recherche du Quebec Sante.

A version of this article first appeared on Medscape.com.

Approximately 1 in 5 adolescents hospitalized for nonfatal drug overdoses were readmitted within 6 months, based on data from more than 12,000 individuals.

Previous studies suggest that many adolescents fail to receive timely treatment for addiction after a nonfatal overdose, but the rates of hospital readmission in this population have not been examined, according to Julie Gaither, PhD, of Yale University, New Haven, Conn.

In a study presented at the annual meeting of the Pediatric Academic Societies, Dr. Gaither and her colleague, John M. Leventhal, MD, also of Yale University, used data from the 2016 Nationwide Readmissions Database to examine incidence and recurrent hospitalizations for nonfatal drug overdoses in adolescents. The study population included 12,952 patients aged 11-21 years who were admitted to a hospital after a nonfatal drug overdose in 2016. Of these, 15% were younger than 15 years, and 52.1% were females.

Overall, 76.2% of the overdoses involved opioids; 77.9% involved a prescription opioid, 15.3% involved heroin, and 7.9% involved fentanyl.

Across all drug overdoses, the majority (86.5%) were attributed to accidental intent and 11.8% were attributed to self-harm. Notably, females were nearly four times more likely than males to attempt suicide (odds ratio, 3.57). After the initial hospitalization, 79.3% of the patients were discharged home, and 11.5% went to a short-term care facility.

The 6-month hospital readmission rate was 21.4%. Of the patients readmitted for any cause, 18.2% of readmissions were for recurrent overdoses, and 92.1% of these were attributed to opioids.

The median cost of the initial hospital admission was $23,705 (ranging from $11,902 to $54,682) and the median cost of the first readmission was $25,416 (ranging from $13,905 to $48,810). In 42.1% of all hospitalizations, Medicaid was the primary payer.

The study findings were limited by the relatively high number of Medicaid patients, which may limit generalizability, but is strengthened by the large sample size.

The findings highlight not only the need for prevention efforts to limit opioid use among adolescents, but also “speak to the need for timely evidenced-based addiction treatment and appropriate follow-up care for teens following hospitalization for a nonfatal drug overdose,” the researchers wrote in their abstract.
 

Potential for postpandemic surge in drug use

Interestingly, some recent research has shown a decline in teens’ substance use during the pandemic, Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview.

“However, as the world begins ‘opening up’ again, I suspect rates of drug use will rise – especially with the significant burden of mental health issues adolescents have struggled with during the last few years,” said Dr. Curran, who was not involved with the current study.

“Sadly, I am not surprised by this study’s findings. Too often, teens with substance abuse issues are not connected to effective, evidenced-based treatment, and for those who are, the wait list can be long,” she said.

“Teens who are misusing drugs – either to get high or to attempt suicide – who are admitted for nonfatal overdose have a high rate of readmission for recurrent drug overdose,” Dr. Curran said. “This high rate of readmission has serious social and financial implications,” she added. “This study is part of a growing body of literature that supports the importance of getting adolescents into effective, evidence-based substance abuse treatment, such as medication-assisted treatment in opioid abuse. However, we also should be advocating for improved funding for and access to these treatments for all individuals.”

The study received no outside funding. Dr. Gaither had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Approximately 1 in 5 adolescents hospitalized for nonfatal drug overdoses were readmitted within 6 months, based on data from more than 12,000 individuals.

Previous studies suggest that many adolescents fail to receive timely treatment for addiction after a nonfatal overdose, but the rates of hospital readmission in this population have not been examined, according to Julie Gaither, PhD, of Yale University, New Haven, Conn.

In a study presented at the annual meeting of the Pediatric Academic Societies, Dr. Gaither and her colleague, John M. Leventhal, MD, also of Yale University, used data from the 2016 Nationwide Readmissions Database to examine incidence and recurrent hospitalizations for nonfatal drug overdoses in adolescents. The study population included 12,952 patients aged 11-21 years who were admitted to a hospital after a nonfatal drug overdose in 2016. Of these, 15% were younger than 15 years, and 52.1% were females.

Overall, 76.2% of the overdoses involved opioids; 77.9% involved a prescription opioid, 15.3% involved heroin, and 7.9% involved fentanyl.

Across all drug overdoses, the majority (86.5%) were attributed to accidental intent and 11.8% were attributed to self-harm. Notably, females were nearly four times more likely than males to attempt suicide (odds ratio, 3.57). After the initial hospitalization, 79.3% of the patients were discharged home, and 11.5% went to a short-term care facility.

The 6-month hospital readmission rate was 21.4%. Of the patients readmitted for any cause, 18.2% of readmissions were for recurrent overdoses, and 92.1% of these were attributed to opioids.

The median cost of the initial hospital admission was $23,705 (ranging from $11,902 to $54,682) and the median cost of the first readmission was $25,416 (ranging from $13,905 to $48,810). In 42.1% of all hospitalizations, Medicaid was the primary payer.

The study findings were limited by the relatively high number of Medicaid patients, which may limit generalizability, but is strengthened by the large sample size.

The findings highlight not only the need for prevention efforts to limit opioid use among adolescents, but also “speak to the need for timely evidenced-based addiction treatment and appropriate follow-up care for teens following hospitalization for a nonfatal drug overdose,” the researchers wrote in their abstract.
 

Potential for postpandemic surge in drug use

Interestingly, some recent research has shown a decline in teens’ substance use during the pandemic, Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview.

“However, as the world begins ‘opening up’ again, I suspect rates of drug use will rise – especially with the significant burden of mental health issues adolescents have struggled with during the last few years,” said Dr. Curran, who was not involved with the current study.

“Sadly, I am not surprised by this study’s findings. Too often, teens with substance abuse issues are not connected to effective, evidenced-based treatment, and for those who are, the wait list can be long,” she said.

“Teens who are misusing drugs – either to get high or to attempt suicide – who are admitted for nonfatal overdose have a high rate of readmission for recurrent drug overdose,” Dr. Curran said. “This high rate of readmission has serious social and financial implications,” she added. “This study is part of a growing body of literature that supports the importance of getting adolescents into effective, evidence-based substance abuse treatment, such as medication-assisted treatment in opioid abuse. However, we also should be advocating for improved funding for and access to these treatments for all individuals.”

The study received no outside funding. Dr. Gaither had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Approximately 1 in 5 adolescents hospitalized for nonfatal drug overdoses were readmitted within 6 months, based on data from more than 12,000 individuals.

Previous studies suggest that many adolescents fail to receive timely treatment for addiction after a nonfatal overdose, but the rates of hospital readmission in this population have not been examined, according to Julie Gaither, PhD, of Yale University, New Haven, Conn.

In a study presented at the annual meeting of the Pediatric Academic Societies, Dr. Gaither and her colleague, John M. Leventhal, MD, also of Yale University, used data from the 2016 Nationwide Readmissions Database to examine incidence and recurrent hospitalizations for nonfatal drug overdoses in adolescents. The study population included 12,952 patients aged 11-21 years who were admitted to a hospital after a nonfatal drug overdose in 2016. Of these, 15% were younger than 15 years, and 52.1% were females.

Overall, 76.2% of the overdoses involved opioids; 77.9% involved a prescription opioid, 15.3% involved heroin, and 7.9% involved fentanyl.

Across all drug overdoses, the majority (86.5%) were attributed to accidental intent and 11.8% were attributed to self-harm. Notably, females were nearly four times more likely than males to attempt suicide (odds ratio, 3.57). After the initial hospitalization, 79.3% of the patients were discharged home, and 11.5% went to a short-term care facility.

The 6-month hospital readmission rate was 21.4%. Of the patients readmitted for any cause, 18.2% of readmissions were for recurrent overdoses, and 92.1% of these were attributed to opioids.

The median cost of the initial hospital admission was $23,705 (ranging from $11,902 to $54,682) and the median cost of the first readmission was $25,416 (ranging from $13,905 to $48,810). In 42.1% of all hospitalizations, Medicaid was the primary payer.

The study findings were limited by the relatively high number of Medicaid patients, which may limit generalizability, but is strengthened by the large sample size.

The findings highlight not only the need for prevention efforts to limit opioid use among adolescents, but also “speak to the need for timely evidenced-based addiction treatment and appropriate follow-up care for teens following hospitalization for a nonfatal drug overdose,” the researchers wrote in their abstract.
 

Potential for postpandemic surge in drug use

Interestingly, some recent research has shown a decline in teens’ substance use during the pandemic, Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview.

“However, as the world begins ‘opening up’ again, I suspect rates of drug use will rise – especially with the significant burden of mental health issues adolescents have struggled with during the last few years,” said Dr. Curran, who was not involved with the current study.

“Sadly, I am not surprised by this study’s findings. Too often, teens with substance abuse issues are not connected to effective, evidenced-based treatment, and for those who are, the wait list can be long,” she said.

“Teens who are misusing drugs – either to get high or to attempt suicide – who are admitted for nonfatal overdose have a high rate of readmission for recurrent drug overdose,” Dr. Curran said. “This high rate of readmission has serious social and financial implications,” she added. “This study is part of a growing body of literature that supports the importance of getting adolescents into effective, evidence-based substance abuse treatment, such as medication-assisted treatment in opioid abuse. However, we also should be advocating for improved funding for and access to these treatments for all individuals.”

The study received no outside funding. Dr. Gaither had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.

Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.

“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”

While the newer biologics have surpassed narrowband UVB (NB-UVB) phototherapy in terms of efficacy and rapid onset of action, she continued, NB-UVB performs on par with older biologics. In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.

“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.

Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”

On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).

The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).

It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”

Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.

Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”

For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.

A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.

One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.

“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”

Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”

Dr. Buzney reported having no relevant financial conflicts.

BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.

Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.

“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”

While the newer biologics have surpassed narrowband UVB (NB-UVB) phototherapy in terms of efficacy and rapid onset of action, she continued, NB-UVB performs on par with older biologics. In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.

“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.

Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”

On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).

The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).

It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”

Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.

Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”

For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.

A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.

One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.

“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”

Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”

Dr. Buzney reported having no relevant financial conflicts.

BOSTON – In 2012, about 50% of patients receiving phototherapy at Brigham and Women’s Hospital in Boston were being treated for psoriasis. A decade later, that proportion has dropped to 20%.

Several factors have contributed to this trend, namely, the development of biologics, the COVID-19 pandemic, “and the rise of home phototherapy options,” Elizabeth A. Buzney, MD, codirector of the phototherapy center at Brigham and Women’s department of dermatology, said at the annual meeting of the American Academy of Dermatology. In her clinical opinion, phototherapy plays an essential role in the treatment of psoriasis.

“It is medically and financially responsible to review the option of phototherapy with every psoriasis patient,” Dr. Buzney said. “Many patients are not medical or financial candidates for biologic/apremilast therapy, or just would prefer nonsystemic therapy.”

While the newer biologics have surpassed narrowband UVB (NB-UVB) phototherapy in terms of efficacy and rapid onset of action, she continued, NB-UVB performs on par with older biologics. In one meta-analysis, the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 with NB-UVB therapy was 70% after 20-40 sessions, just below the efficacy of newer biologics – but better than ustekinumab and adalimumab.

“Phototherapy is not so far out of range as you might think it is,” she said, noting that other studies of NB-UVB therapy show PASI 75 responses of 62% and PASI 90 responses of 40%.

Phototherapy can also be an appealing option because biologics aren’t the best option for all patients with psoriasis. They are expensive for the health care system and potentially for patients, require initial and potentially continued lab testing and monitoring, and require injections, “which some patients don’t like,” said Dr. Buzney, who is also vice-chair of clinical affairs at the Brigham and Women’s Hospital department of dermatology. “There’s an infrequent risk of serious infection and there is risk in patients with HIV, TB, and hepatitis that you have to address. There is also concern for the impact of biologics on patients with a recent cancer.”

On the other hand, few contraindications to NB-UVB exist. According to joint American Academy of Dermatology-National Psoriasis Foundation guidelines on the management and treatment of psoriasis with phototherapy, published in 2019, NB-UVB therapy is only contraindicated in patients with xeroderma pigmentosa and other photosensitive disorders. Concurrent use of cyclosporine and NB-UVB treatment is also contraindicated because of the calculated increase in risk of skin cancer, extrapolated from data on risk with cyclosporine and PUVA (psoralen and ultraviolet A therapy).

The guidelines state that NB-UVB can be used with caution in lupus patients with no history of photosensitivity and who are SS-A negative, as well as patients with a history of melanoma or multiple nonmelanoma skin cancers, a history of recurrent oral herpes simplex virus infection, a history of arsenic intake, prior exposure to ionizing radiation, and those taking photosensitizing medications (since NB-UVB lamps emit “negligible” UVA).

It’s also safe to use during pregnancy and in children. “It’s safe and effective for the right patient,” Dr. Buzney said, discussing how phototherapy can be modified to accommodate children. “You can consider a slower dose-increased regimen. Will children keep the eye protection on? That’s a tricky one. How are you going to manage their anxiety during treatment and involve their family?”

Subgroups of patients who demonstrate a better response to NB-UVB treatment include those with guttate psoriasis, compared with plaque psoriasis, nonsmokers, those with a lower BMI, those with a higher baseline PASI, and those who demonstrate a faster trajectory of clinical response over the first 2-3 weeks of treatment.

Why would one not use phototherapy for psoriasis? “Cost and convenience,” Dr. Buzney said. “There is lost time/revenue to commute to treatment, which may involve multiple times per week. Coming to a public space when COVID-19 is still lingering is another concern, as are the out-of-pocket costs for copays and parking.”

For these reasons, she considers home phototherapy as a transformative option for many patients. Home phototherapy booths provide a safe and effective way to use NB-UVB phototherapy while minimizing copays and commuting costs. The one-time price tag of home NB-UVB booths runs between $5,000 and $7,000, but that is “much less expensive than the biologics,” which can cost $40,000-$50,000 per year, she said.

A small cross-sectional study of office- versus home-based NB-UVB in patients with vitiligo found a cost savings for home-based NB-UVB after 3 months.

One of the challenges with home phototherapy is the lack of long-term studies on patient use. In a small study Dr. Buzney conducted of 30 patients who were prescribed home phototherapy in the last 5 years, 65% practiced (or had practiced) conservative dosing, 83% had continued care with a dermatologist, 19% reported sunburns (5 mild and 1 severe), and 50% had discontinued the therapy at the time of survey because of a perceived lack of efficacy and inconvenience. But 30% of those who had stopped had done so within one month of getting their home booth.

“This tells me that we have to educate our patients better about what expectations should be and make sure they understand how to use their booths,” she said. “Home phototherapy has changed my practice, but not everyone is a candidate for it. Some patients are not dependable. Others are unable to understand instructions.”

Cost to purchase a NB-UVB booth is also an issue, she noted. “Typically, a percentage of cost is covered by insurance, but it’s problematic to purchase a booth if patients don’t know it’s going to work for them or not. Then you have college students who don’t have the space in their apartment or dorm room for a booth.”

Dr. Buzney reported having no relevant financial conflicts.

Considerable uncertainty surrounds whether people with axial spondyloarthritis (axSpA) who are treated with biologic drugs have an increased risk for developing inflammatory bowel disease (IBD) that is higher than if they receive other treatments, according to data reported at the annual meeting of the British Society for Rheumatology.

“We noticed two patterns,” Gary Macfarlane, MD, PhD, Dsc, of the University of Aberdeen (Scotland) said in presenting findings from an analysis of the British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) and a meta-analysis of available studies.

copyright varaphoto/Thinkstock

There was a “large excess risk in observational studies associated with biologic therapies, which was not replicated in RCTs [randomized, controlled trials],” he said, “and trials under extensions suggested a small absolute increased risk associated with etanercept and with [interleukin]-17 [inhibitors], although again with considerable uncertainty.”

While these data make it difficult to draw any firm conclusions, “we should be reassured that the patient groups receiving these specific biologics in routine clinical care have not demonstrated an excess risk of IBD,” Dr. Macfarlane told delegates at the meeting.
 

Addressing clinical questions

IBD is a known extra-articular manifestation of axSpA, with an estimated prevalence of about 7%, according to a 2015 meta-analysis of 69 studies involving more than 30,000 patients.

The idea that people being treated with biologics may be at higher risk for developing IBD than those taking other treatments was suggested by the results of a large (n = 80,326) Danish study in which patients who were treated with an anti–tumor necrosis factor (TNF)–alpha medication were found to be more likely to develop de novo ulcerative colitis or Crohn’s disease than were patients who did not receive biologics.

Notably, the risk for IBD seemed higher with etanercept than with other anti–TNF-alpha agents, such as infliximab and adalimumab.

The aim of the analyses that Dr. Macfarlane presented was therefore to see if there was a difference in IBD risk among patients treated with biologic agents versus other agents, and if etanercept really did pose a greater cause for concern.

“The reason that we are asking this question is that a clinician called us up and asked us if we had any data on it,” Dr. Macfarlane said. “I think that’s really important to say that one of the things the registers are designed for are to answer questions that clinicians may have.”
 

Looking for new-onset IBD

Although no longer recruiting patients, the BSRBR-AS provides a wealth of data on the real-life management of patients with axSpA who were or were not taking a biologic. Patients were recruited into the register between 2012 and 2017, with follow-up until 2018. Data analyses are still ongoing and expected to continue for another couple of years.

The current analysis of data from the BSRBR-AS included patients who did not already have IBD at enrollment into the register, and patients who had been treated with a biologic could have been treated only with a single agent. Of just over 1,800 eligible patients, 793 had been treated with a biologic and 1,058 had been given nonbiologic treatment.

As expected, there were some differences between the two groups of patients studied, with biologic-treated patients having a younger age than non–biologic-treated patients. Those who took a biologic also had higher disease activity, inflammatory scores, and rates of psoriasis, enthesitis, and peripheral joint involvement.

Incidence rates for new-onset IBD per 1,000 person-years of treatment were calculated as 17 (95% confidence interval, 10.7-25.8) for patients taking a biologic and 5.1 (95% CI, 2.7-8.7) for those not taking a biologic, giving an incidence rate difference of 11.9 (95% CI, 4.3-19.6).

There was some observed differences in the incidence of new-onset IBD associated with specific agents. Etanercept did not have a higher rate (13.9/1,000 patient-years; 95% CI, 5.1-30.3) than did other agents. But in comparison, the incidence of new-onset IBD for adalimumab was 20.4 (95% CI, 11.7-33.1) and zero for other anti-TNF agents such as certolizumab pegol and infliximab, although the duration of exposure to these drugs was much lower.

The IRDs for etanercept versus nonbiologic treatment and versus other anti-TNFs were 8.8 (95% CI, –2.7 to 20.3) and -6.4 (95% CI, –21.3 to 8.5), but with “considerable uncertainty” because the confidence intervals were very wide.
 

Uncertainty not helped by meta-analysis

“Given the uncertainty associated with the results from BSRBR-AS, we decided to undertake a meta-analysis to try to accumulate other data that could help us answer this question,” Dr. Macfarlane explained.

However, this didn’t really help clarify things because combining BSRBR-AS data with the results of a couple of observational studies suggested that the odds of of IBD doubled with any biologic treatment versus no biologic treatment (odds ratio, 2.19), and a 2.5-fold higher likelihood considering etanercept versus no biologic treatment, but no difference was seen comparing etanercept to other anti-TNF agents (OR, 0.93).

When the meta-analysis was restricted to RCTs, the rate of IBD per 1,000 person-years was 3.43 for placebo, 5.64 for all biologics, 8.14 for etanercept, 2.35 for other anti-TNFs, and 7.02 for IL-17 inhibitors.

For extensions of RCTs, IBD rates per 1,000 person-years of follow-up were 2.91 for etanercept, 0.83 for other anti-TNFs, 3.61 for IL-17 inhibitors, and 2.79 for all biologics.

“There was only a small difference in IBD incidence between the biologic therapy and the placebo groups” in the RCTs and associated studies, Dr. Macfarlane said, adding that “there was a small excess incidence associated with etanercept, compared to other anti-TNF agents, and [for] IL-17 therapy, compared to nonetanercept, anti–TNF-alpha therapies.”

Of course, the different study designs and durations of exposure to the various treatments raises significant methodological issues.

“Randomized, controlled trials should provide the highest quality evidence as a result of their design and randomizing patients to treatment,” Dr. Macfarlane said. “However, their relatively short follow-up, as well as their restrictive eligibility criteria, may work against finding a difference in IBD incidence if it were to exist.”

Observational studies are very valuable in the data they can provide but are also beset with problems, such as surveillance bias and confounding by indication.

The higher risk of IBD that was observed in observational studies could be an issue with study design, or perhaps, “in routine clinical practice, rheumatologists are taking on board factors that we have not measured, that are negating any slight increased risk,” Dr. Macfarlane said.

Session chair Nicola Goodson, MBChB, PhD, of Liverpool (England) University NHS Foundation Trust, commented: “I think that could well be a very reasonable explanation, because I think as a clinician, you do tend to channel drugs away from some people and channel drugs towards others.

However, Dr. Goodson noted that there was “a glimmer” of signal coming from the RCTs.

“Methodologically, that is what you would have to take as the most robust evidence,” Dr. Macfarlane said, “but even with all the evidence available, it’s still very hard for us to quantify; that has enormous uncertainty.”

Dr. Macfarlane and Dr. Goodson had no relevant conflicts of interest to disclose. The BSRBR-AS is supported by the BSR, which receives funds to support the registry from Pfizer, AbbVie, and UCB.

Considerable uncertainty surrounds whether people with axial spondyloarthritis (axSpA) who are treated with biologic drugs have an increased risk for developing inflammatory bowel disease (IBD) that is higher than if they receive other treatments, according to data reported at the annual meeting of the British Society for Rheumatology.

“We noticed two patterns,” Gary Macfarlane, MD, PhD, Dsc, of the University of Aberdeen (Scotland) said in presenting findings from an analysis of the British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) and a meta-analysis of available studies.

copyright varaphoto/Thinkstock

There was a “large excess risk in observational studies associated with biologic therapies, which was not replicated in RCTs [randomized, controlled trials],” he said, “and trials under extensions suggested a small absolute increased risk associated with etanercept and with [interleukin]-17 [inhibitors], although again with considerable uncertainty.”

While these data make it difficult to draw any firm conclusions, “we should be reassured that the patient groups receiving these specific biologics in routine clinical care have not demonstrated an excess risk of IBD,” Dr. Macfarlane told delegates at the meeting.
 

Addressing clinical questions

IBD is a known extra-articular manifestation of axSpA, with an estimated prevalence of about 7%, according to a 2015 meta-analysis of 69 studies involving more than 30,000 patients.

The idea that people being treated with biologics may be at higher risk for developing IBD than those taking other treatments was suggested by the results of a large (n = 80,326) Danish study in which patients who were treated with an anti–tumor necrosis factor (TNF)–alpha medication were found to be more likely to develop de novo ulcerative colitis or Crohn’s disease than were patients who did not receive biologics.

Notably, the risk for IBD seemed higher with etanercept than with other anti–TNF-alpha agents, such as infliximab and adalimumab.

The aim of the analyses that Dr. Macfarlane presented was therefore to see if there was a difference in IBD risk among patients treated with biologic agents versus other agents, and if etanercept really did pose a greater cause for concern.

“The reason that we are asking this question is that a clinician called us up and asked us if we had any data on it,” Dr. Macfarlane said. “I think that’s really important to say that one of the things the registers are designed for are to answer questions that clinicians may have.”
 

Looking for new-onset IBD

Although no longer recruiting patients, the BSRBR-AS provides a wealth of data on the real-life management of patients with axSpA who were or were not taking a biologic. Patients were recruited into the register between 2012 and 2017, with follow-up until 2018. Data analyses are still ongoing and expected to continue for another couple of years.

The current analysis of data from the BSRBR-AS included patients who did not already have IBD at enrollment into the register, and patients who had been treated with a biologic could have been treated only with a single agent. Of just over 1,800 eligible patients, 793 had been treated with a biologic and 1,058 had been given nonbiologic treatment.

As expected, there were some differences between the two groups of patients studied, with biologic-treated patients having a younger age than non–biologic-treated patients. Those who took a biologic also had higher disease activity, inflammatory scores, and rates of psoriasis, enthesitis, and peripheral joint involvement.

Incidence rates for new-onset IBD per 1,000 person-years of treatment were calculated as 17 (95% confidence interval, 10.7-25.8) for patients taking a biologic and 5.1 (95% CI, 2.7-8.7) for those not taking a biologic, giving an incidence rate difference of 11.9 (95% CI, 4.3-19.6).

There was some observed differences in the incidence of new-onset IBD associated with specific agents. Etanercept did not have a higher rate (13.9/1,000 patient-years; 95% CI, 5.1-30.3) than did other agents. But in comparison, the incidence of new-onset IBD for adalimumab was 20.4 (95% CI, 11.7-33.1) and zero for other anti-TNF agents such as certolizumab pegol and infliximab, although the duration of exposure to these drugs was much lower.

The IRDs for etanercept versus nonbiologic treatment and versus other anti-TNFs were 8.8 (95% CI, –2.7 to 20.3) and -6.4 (95% CI, –21.3 to 8.5), but with “considerable uncertainty” because the confidence intervals were very wide.
 

Uncertainty not helped by meta-analysis

“Given the uncertainty associated with the results from BSRBR-AS, we decided to undertake a meta-analysis to try to accumulate other data that could help us answer this question,” Dr. Macfarlane explained.

However, this didn’t really help clarify things because combining BSRBR-AS data with the results of a couple of observational studies suggested that the odds of of IBD doubled with any biologic treatment versus no biologic treatment (odds ratio, 2.19), and a 2.5-fold higher likelihood considering etanercept versus no biologic treatment, but no difference was seen comparing etanercept to other anti-TNF agents (OR, 0.93).

When the meta-analysis was restricted to RCTs, the rate of IBD per 1,000 person-years was 3.43 for placebo, 5.64 for all biologics, 8.14 for etanercept, 2.35 for other anti-TNFs, and 7.02 for IL-17 inhibitors.

For extensions of RCTs, IBD rates per 1,000 person-years of follow-up were 2.91 for etanercept, 0.83 for other anti-TNFs, 3.61 for IL-17 inhibitors, and 2.79 for all biologics.

“There was only a small difference in IBD incidence between the biologic therapy and the placebo groups” in the RCTs and associated studies, Dr. Macfarlane said, adding that “there was a small excess incidence associated with etanercept, compared to other anti-TNF agents, and [for] IL-17 therapy, compared to nonetanercept, anti–TNF-alpha therapies.”

Of course, the different study designs and durations of exposure to the various treatments raises significant methodological issues.

“Randomized, controlled trials should provide the highest quality evidence as a result of their design and randomizing patients to treatment,” Dr. Macfarlane said. “However, their relatively short follow-up, as well as their restrictive eligibility criteria, may work against finding a difference in IBD incidence if it were to exist.”

Observational studies are very valuable in the data they can provide but are also beset with problems, such as surveillance bias and confounding by indication.

The higher risk of IBD that was observed in observational studies could be an issue with study design, or perhaps, “in routine clinical practice, rheumatologists are taking on board factors that we have not measured, that are negating any slight increased risk,” Dr. Macfarlane said.

Session chair Nicola Goodson, MBChB, PhD, of Liverpool (England) University NHS Foundation Trust, commented: “I think that could well be a very reasonable explanation, because I think as a clinician, you do tend to channel drugs away from some people and channel drugs towards others.

However, Dr. Goodson noted that there was “a glimmer” of signal coming from the RCTs.

“Methodologically, that is what you would have to take as the most robust evidence,” Dr. Macfarlane said, “but even with all the evidence available, it’s still very hard for us to quantify; that has enormous uncertainty.”

Dr. Macfarlane and Dr. Goodson had no relevant conflicts of interest to disclose. The BSRBR-AS is supported by the BSR, which receives funds to support the registry from Pfizer, AbbVie, and UCB.

Considerable uncertainty surrounds whether people with axial spondyloarthritis (axSpA) who are treated with biologic drugs have an increased risk for developing inflammatory bowel disease (IBD) that is higher than if they receive other treatments, according to data reported at the annual meeting of the British Society for Rheumatology.

“We noticed two patterns,” Gary Macfarlane, MD, PhD, Dsc, of the University of Aberdeen (Scotland) said in presenting findings from an analysis of the British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) and a meta-analysis of available studies.

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There was a “large excess risk in observational studies associated with biologic therapies, which was not replicated in RCTs [randomized, controlled trials],” he said, “and trials under extensions suggested a small absolute increased risk associated with etanercept and with [interleukin]-17 [inhibitors], although again with considerable uncertainty.”

While these data make it difficult to draw any firm conclusions, “we should be reassured that the patient groups receiving these specific biologics in routine clinical care have not demonstrated an excess risk of IBD,” Dr. Macfarlane told delegates at the meeting.
 

Addressing clinical questions

IBD is a known extra-articular manifestation of axSpA, with an estimated prevalence of about 7%, according to a 2015 meta-analysis of 69 studies involving more than 30,000 patients.

The idea that people being treated with biologics may be at higher risk for developing IBD than those taking other treatments was suggested by the results of a large (n = 80,326) Danish study in which patients who were treated with an anti–tumor necrosis factor (TNF)–alpha medication were found to be more likely to develop de novo ulcerative colitis or Crohn’s disease than were patients who did not receive biologics.

Notably, the risk for IBD seemed higher with etanercept than with other anti–TNF-alpha agents, such as infliximab and adalimumab.

The aim of the analyses that Dr. Macfarlane presented was therefore to see if there was a difference in IBD risk among patients treated with biologic agents versus other agents, and if etanercept really did pose a greater cause for concern.

“The reason that we are asking this question is that a clinician called us up and asked us if we had any data on it,” Dr. Macfarlane said. “I think that’s really important to say that one of the things the registers are designed for are to answer questions that clinicians may have.”
 

Looking for new-onset IBD

Although no longer recruiting patients, the BSRBR-AS provides a wealth of data on the real-life management of patients with axSpA who were or were not taking a biologic. Patients were recruited into the register between 2012 and 2017, with follow-up until 2018. Data analyses are still ongoing and expected to continue for another couple of years.

The current analysis of data from the BSRBR-AS included patients who did not already have IBD at enrollment into the register, and patients who had been treated with a biologic could have been treated only with a single agent. Of just over 1,800 eligible patients, 793 had been treated with a biologic and 1,058 had been given nonbiologic treatment.

As expected, there were some differences between the two groups of patients studied, with biologic-treated patients having a younger age than non–biologic-treated patients. Those who took a biologic also had higher disease activity, inflammatory scores, and rates of psoriasis, enthesitis, and peripheral joint involvement.

Incidence rates for new-onset IBD per 1,000 person-years of treatment were calculated as 17 (95% confidence interval, 10.7-25.8) for patients taking a biologic and 5.1 (95% CI, 2.7-8.7) for those not taking a biologic, giving an incidence rate difference of 11.9 (95% CI, 4.3-19.6).

There was some observed differences in the incidence of new-onset IBD associated with specific agents. Etanercept did not have a higher rate (13.9/1,000 patient-years; 95% CI, 5.1-30.3) than did other agents. But in comparison, the incidence of new-onset IBD for adalimumab was 20.4 (95% CI, 11.7-33.1) and zero for other anti-TNF agents such as certolizumab pegol and infliximab, although the duration of exposure to these drugs was much lower.

The IRDs for etanercept versus nonbiologic treatment and versus other anti-TNFs were 8.8 (95% CI, –2.7 to 20.3) and -6.4 (95% CI, –21.3 to 8.5), but with “considerable uncertainty” because the confidence intervals were very wide.
 

Uncertainty not helped by meta-analysis

“Given the uncertainty associated with the results from BSRBR-AS, we decided to undertake a meta-analysis to try to accumulate other data that could help us answer this question,” Dr. Macfarlane explained.

However, this didn’t really help clarify things because combining BSRBR-AS data with the results of a couple of observational studies suggested that the odds of of IBD doubled with any biologic treatment versus no biologic treatment (odds ratio, 2.19), and a 2.5-fold higher likelihood considering etanercept versus no biologic treatment, but no difference was seen comparing etanercept to other anti-TNF agents (OR, 0.93).

When the meta-analysis was restricted to RCTs, the rate of IBD per 1,000 person-years was 3.43 for placebo, 5.64 for all biologics, 8.14 for etanercept, 2.35 for other anti-TNFs, and 7.02 for IL-17 inhibitors.

For extensions of RCTs, IBD rates per 1,000 person-years of follow-up were 2.91 for etanercept, 0.83 for other anti-TNFs, 3.61 for IL-17 inhibitors, and 2.79 for all biologics.

“There was only a small difference in IBD incidence between the biologic therapy and the placebo groups” in the RCTs and associated studies, Dr. Macfarlane said, adding that “there was a small excess incidence associated with etanercept, compared to other anti-TNF agents, and [for] IL-17 therapy, compared to nonetanercept, anti–TNF-alpha therapies.”

Of course, the different study designs and durations of exposure to the various treatments raises significant methodological issues.

“Randomized, controlled trials should provide the highest quality evidence as a result of their design and randomizing patients to treatment,” Dr. Macfarlane said. “However, their relatively short follow-up, as well as their restrictive eligibility criteria, may work against finding a difference in IBD incidence if it were to exist.”

Observational studies are very valuable in the data they can provide but are also beset with problems, such as surveillance bias and confounding by indication.

The higher risk of IBD that was observed in observational studies could be an issue with study design, or perhaps, “in routine clinical practice, rheumatologists are taking on board factors that we have not measured, that are negating any slight increased risk,” Dr. Macfarlane said.

Session chair Nicola Goodson, MBChB, PhD, of Liverpool (England) University NHS Foundation Trust, commented: “I think that could well be a very reasonable explanation, because I think as a clinician, you do tend to channel drugs away from some people and channel drugs towards others.

However, Dr. Goodson noted that there was “a glimmer” of signal coming from the RCTs.

“Methodologically, that is what you would have to take as the most robust evidence,” Dr. Macfarlane said, “but even with all the evidence available, it’s still very hard for us to quantify; that has enormous uncertainty.”

Dr. Macfarlane and Dr. Goodson had no relevant conflicts of interest to disclose. The BSRBR-AS is supported by the BSR, which receives funds to support the registry from Pfizer, AbbVie, and UCB.

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

A version of this article first appeared on Medscape.com.

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

A version of this article first appeared on Medscape.com.

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

A version of this article first appeared on Medscape.com.

BOSTON – According to the best available data, solid organ transplant recipients (SOTRs) at highest risk for developing skin cancer are thoracic organ recipients, those aged 50 or older at the time of the transplant, and males.

White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.

The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.

Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.

Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”

To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.

Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.

BOSTON – According to the best available data, solid organ transplant recipients (SOTRs) at highest risk for developing skin cancer are thoracic organ recipients, those aged 50 or older at the time of the transplant, and males.

White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.

The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.

Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.

Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”

To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.

Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.

BOSTON – According to the best available data, solid organ transplant recipients (SOTRs) at highest risk for developing skin cancer are thoracic organ recipients, those aged 50 or older at the time of the transplant, and males.

White patients who meet these criteria should be screening within 2 years after transplant, while Black patients should be screened within 5 years after transplant, Ally-Khan Somani, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

Dr. Somani, director of dermatologic surgery and the division of cutaneous oncology at Indiana University, Indianapolis, based his remarks on consensus screening guidelines assembled from three rounds of Delphi method surveys with 47 dermatologists and 37 transplant physicians, with the goal of establishing skin cancer screening recommendations for SOTRs. Among the dermatologists surveyed, 45% were Mohs surgeons and 55% were general dermatologists.

The panel recommended that the transplant team should perform risk assessment for SOTRs to risk stratify patients for skin cancer screening (high risk vs. low risk). They also proposed that dermatologists perform skin cancer screening by full-body skin examinations, and that SOTRs with a history of skin cancer should continue with routine skin cancer surveillance as recommended by their dermatologists.

Those at low risk for skin cancer include abdominal organ recipients, SOTR age of younger than 50 at time of transplant, and female gender. The guidelines recommend that White, Asian, and Hispanic patients who meet those criteria should be screened within 5 years after transplant, while no consensus was reached for Black patients who meet those criteria.

Based on posttransplant skin cancer incidence rates, risk is increased among males, Whites, thoracic organ recipients, and being age 50 or older, Dr. Somani said. “At our institution, we make sure there’s a good connection between our transplant teams and dermatologists. We recommend rapid referral for suspicious lesions and we educate patients and screen them within 1 year of transplant, or sooner for high-risk patients. Surveillance is increased to every 3 or 4 months for patients with a history of multiple or high-risk cancers or sooner, followed by routine surveillance as recommended by the patient’s dermatologist.”

To risk stratify patients on the development of their first skin cancer post transplantation, researchers developed the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator (SUNTRAC), a prediction tool with a freely available app. Data for the tool were drawn from the Transplant Skin Cancer Network study, a 5-year analysis of 6,340 adult recipients of a first solid organ transplant at 26 transplant centers in the United States. It generates a risk score for SOTRs (low, medium, high, or very high), which informs transplant care providers of a patient’s risk of skin cancer.

Dr. Somani disclosed that he has received grants and funding from Castle Biosciences. He is an adviser to Cook Biotech and a consultant to Sanara MedTech.