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.

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.

Physical examination revealed an irregularly shaped conjunctival cyst on the lateral (temporal) field of the right eye. (This diagnosis is usually made based on the clinical examination alone.)

Primary care physicians encounter patients with a variety of eye conditions; pruritis and foreign body sensation are among the most common complaints.¹ While viral or allergic conjunctivitis is often to blame for “itchy eyes,” the cause can also be a conjunctival mass.

Conjunctival masses can be divided into 2 groups: solid tumors or cysts.² Conjunctival cysts form due to trauma, infection, or inflammation that disrupts the conjunctival epithelium. They can be congenital or acquired (more common) and are rarely caused by over-the-counter eye drops.^2,3 The differential diagnosis for a conjunctival cyst includes conjunctival bleb, pinguecula, pterygium, pyogenic granuloma, and tumors of the conjunctiva. An external eye exam plus a slit-lamp examination can help confirm the diagnosis.

Small, asymptomatic conjunctival cysts will mostly resolve on their own and can be managed conservatively with lubricating eye drops.³ When inflammation surrounds the cyst, short-term use of a mild topical corticosteroid is reasonable.² Simple needle aspiration can be performed but may lead to recurrence of the cyst. Lesions larger than 15 mm, or those that have grown or changed, should be evaluated by an ophthalmologist for biopsy and further management.^2,3

After a discussion of the benefits and risks of different approaches, this patient decided on conservative management. Supportive care with lubricating eye drops was started. At her 1-month follow-up, all symptoms had resolved.

‌

Photos courtesy of Morteza Khodaee, MD, MPH. Text courtesy of Amy S. Li, MD, Department of Internal Medicine, Jennifer Cogburn, MD, and Morteza Khodaee, MD, MPH, Department of Family Medicine, University of Colorado School of Medicine, Denver

Physical examination revealed an irregularly shaped conjunctival cyst on the lateral (temporal) field of the right eye. (This diagnosis is usually made based on the clinical examination alone.)

Primary care physicians encounter patients with a variety of eye conditions; pruritis and foreign body sensation are among the most common complaints.¹ While viral or allergic conjunctivitis is often to blame for “itchy eyes,” the cause can also be a conjunctival mass.

Conjunctival masses can be divided into 2 groups: solid tumors or cysts.² Conjunctival cysts form due to trauma, infection, or inflammation that disrupts the conjunctival epithelium. They can be congenital or acquired (more common) and are rarely caused by over-the-counter eye drops.^2,3 The differential diagnosis for a conjunctival cyst includes conjunctival bleb, pinguecula, pterygium, pyogenic granuloma, and tumors of the conjunctiva. An external eye exam plus a slit-lamp examination can help confirm the diagnosis.

Small, asymptomatic conjunctival cysts will mostly resolve on their own and can be managed conservatively with lubricating eye drops.³ When inflammation surrounds the cyst, short-term use of a mild topical corticosteroid is reasonable.² Simple needle aspiration can be performed but may lead to recurrence of the cyst. Lesions larger than 15 mm, or those that have grown or changed, should be evaluated by an ophthalmologist for biopsy and further management.^2,3

After a discussion of the benefits and risks of different approaches, this patient decided on conservative management. Supportive care with lubricating eye drops was started. At her 1-month follow-up, all symptoms had resolved.

‌

Photos courtesy of Morteza Khodaee, MD, MPH. Text courtesy of Amy S. Li, MD, Department of Internal Medicine, Jennifer Cogburn, MD, and Morteza Khodaee, MD, MPH, Department of Family Medicine, University of Colorado School of Medicine, Denver

Physical examination revealed an irregularly shaped conjunctival cyst on the lateral (temporal) field of the right eye. (This diagnosis is usually made based on the clinical examination alone.)

Primary care physicians encounter patients with a variety of eye conditions; pruritis and foreign body sensation are among the most common complaints.¹ While viral or allergic conjunctivitis is often to blame for “itchy eyes,” the cause can also be a conjunctival mass.

Conjunctival masses can be divided into 2 groups: solid tumors or cysts.² Conjunctival cysts form due to trauma, infection, or inflammation that disrupts the conjunctival epithelium. They can be congenital or acquired (more common) and are rarely caused by over-the-counter eye drops.^2,3 The differential diagnosis for a conjunctival cyst includes conjunctival bleb, pinguecula, pterygium, pyogenic granuloma, and tumors of the conjunctiva. An external eye exam plus a slit-lamp examination can help confirm the diagnosis.

Small, asymptomatic conjunctival cysts will mostly resolve on their own and can be managed conservatively with lubricating eye drops.³ When inflammation surrounds the cyst, short-term use of a mild topical corticosteroid is reasonable.² Simple needle aspiration can be performed but may lead to recurrence of the cyst. Lesions larger than 15 mm, or those that have grown or changed, should be evaluated by an ophthalmologist for biopsy and further management.^2,3

After a discussion of the benefits and risks of different approaches, this patient decided on conservative management. Supportive care with lubricating eye drops was started. At her 1-month follow-up, all symptoms had resolved.

‌

Photos courtesy of Morteza Khodaee, MD, MPH. Text courtesy of Amy S. Li, MD, Department of Internal Medicine, Jennifer Cogburn, MD, and Morteza Khodaee, MD, MPH, Department of Family Medicine, University of Colorado School of Medicine, Denver

Dr Aaron Miller, from the Icahn School of Medicine at Mount Sinai in New York, discusses updates in relapsing-remitting multiple sclerosis (RRMS) presented at the 2022 American Academy of Neurology (AAN) Annual Meeting.

Dr Miller reports on compelling outcomes linking adherence to an MS-prescribed Mediterranean diet with increased thalamic volume and an enhanced predictability of functional composite scoring.

Next, Dr Miller turns to DMTs and discusses two abstracts looking at results of ublituximab in regard to expanded disability status scale (EDSS) scores and no evidence of disease activity (NEDA) status, and a third comparing ublituximab with teriflunomide.

Finally, Dr Miller presents promising data on Bruton tyrosine kinase inhibitors tolebrutinib and evobrutinib, and the latest results of the NOVA study on the monoclonal antibody natalizumab.

--

Professor, Department of Neurology; Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Academic Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY

Aaron Miller, MD, has disclosed no relevant financial relationships.

Dr Aaron Miller, from the Icahn School of Medicine at Mount Sinai in New York, discusses updates in relapsing-remitting multiple sclerosis (RRMS) presented at the 2022 American Academy of Neurology (AAN) Annual Meeting.

Dr Miller reports on compelling outcomes linking adherence to an MS-prescribed Mediterranean diet with increased thalamic volume and an enhanced predictability of functional composite scoring.

Next, Dr Miller turns to DMTs and discusses two abstracts looking at results of ublituximab in regard to expanded disability status scale (EDSS) scores and no evidence of disease activity (NEDA) status, and a third comparing ublituximab with teriflunomide.

Finally, Dr Miller presents promising data on Bruton tyrosine kinase inhibitors tolebrutinib and evobrutinib, and the latest results of the NOVA study on the monoclonal antibody natalizumab.

--

Professor, Department of Neurology; Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Academic Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY

Aaron Miller, MD, has disclosed no relevant financial relationships.

Dr Aaron Miller, from the Icahn School of Medicine at Mount Sinai in New York, discusses updates in relapsing-remitting multiple sclerosis (RRMS) presented at the 2022 American Academy of Neurology (AAN) Annual Meeting.

Dr Miller reports on compelling outcomes linking adherence to an MS-prescribed Mediterranean diet with increased thalamic volume and an enhanced predictability of functional composite scoring.

Next, Dr Miller turns to DMTs and discusses two abstracts looking at results of ublituximab in regard to expanded disability status scale (EDSS) scores and no evidence of disease activity (NEDA) status, and a third comparing ublituximab with teriflunomide.

Finally, Dr Miller presents promising data on Bruton tyrosine kinase inhibitors tolebrutinib and evobrutinib, and the latest results of the NOVA study on the monoclonal antibody natalizumab.

--

Professor, Department of Neurology; Medical Director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Academic Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY

Aaron Miller, MD, has disclosed no relevant financial relationships.

Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

Deaths from COVID-19 may have caught more attention lately, but heart disease remains the leading cause of death in the United States.

More than 300,000 Americans will die this year of sudden cardiac arrest (also called sudden cardiac death, or SCD), when the heart abruptly stops working.

These events happen suddenly and often without warning, making them nearly impossible to predict. But that may be changing, thanks to 3D imaging and artificial intelligence (AI) technology under study at Johns Hopkins University, Baltimore.

Svisio/Thinkstock

There, researchers are working to create more accurate and personalized models of the heart – and not just any heart, your heart, if you have heart disease.

“Right now, a clinician can only say whether a patient is at risk or not at risk for sudden death,” says Dan Popescu, PhD, a Johns Hopkins research scientist and first author of a new study on AI’s ability to predict sudden cardiac arrest. “With this new technology, you can have much more nuanced predictions of probability of an event over time.”

Put another way: With AI, clinicians may be able not only to predict if someone is at risk for sudden cardiac arrest, but also when it is most likely to happen. They can do this using a much clearer and more personalized look at the electrical “wiring” of your heart.
 

Your heart, the conductor

Your heart isn’t just a metronome responsible for keeping a steady stream of blood pumping to tissues with every beat. It’s also a conductor through which vital energy flows.

To make the heart beat, electrical impulses flow from the top to the bottom of the organ. Healthy heart cells relay this electricity seamlessly. But in a heart damaged by inflammation or a past heart attack, scar tissue will block the energy flow.

When an electrical impulse encounters a scarred area, the signal can become erratic, disrupting the set top-to-bottom path and causing irregular heartbeats (arrhythmias), which increase someone’s danger of sudden cardiac death.
 

Seeing the heart in 3D

Today’s tests offer some insights into the heart’s makeup. For example, MRI scans can reveal damaged areas. PET scans can show inflammation. And EKGs can record the heart’s electrical signals from beat to beat.

But all these technologies offer only a snapshot, showing heart health at a moment in time. They can’t predict the future. That’s why scientists at Johns Hopkins are going further to develop 3D digital replicas of a person’s heart, known as computational heart models.

Computational models are computer-simulated replicas that combine mathematics, physics, and computer science. These models have been around for a long time and are used in many fields, ranging from manufacturing to economics.

In heart medicine, these models are populated with digital “cells,” which imitate living cells and can be programmed with different electrical properties, depending on whether they are healthy or diseased.

“Currently available imaging and testing (MRIs, PETs, EKGs) give some representation of the scarring, but you cannot translate that to what is going to happen over time,” says Natalia Trayanova, PhD, of the Johns Hopkins department of biomedical engineering.

“With computational heart models, we create a dynamic digital image of the heart. We can then give the digital image an electrical stimulus and assess how the heart is able to respond. Then you can better predict what is going to happen.”

The computerized 3D models also mean better, more accurate treatment for heart conditions.

For example, a common treatment for a type of arrhythmia known as atrial fibrillation is ablation, or burning some heart tissue. Ablation stops the erratic electrical impulses causing the arrhythmia, but it can also damage otherwise healthy heart cells.

A personalized computational heart model could allow doctors to see more accurately what areas should and shouldn’t be treated for a specific patient.
 

Using deep learning AI to predict health outcomes

Dr. Trayanova’s colleague Dr. Popescu is applying deep learning and AI to do more with computerized heart models to predict the future.

In a recent paper in Nature Cardiovascular Research, the research team showed their algorithm assessed the health of 269 patients and was able to predict the chance of sudden cardiac arrest up to 10 years in advance.

“This is really the first time ever, as far as we know, where deep learning technology has been proven to analyze scarring of the heart in a successful way,” Dr. Popescu says.

Dr. Popescu and Dr. Trayanova say the AI algorithm gathers information from the 3D computational heart models with patient data like MRIs, ethnicity, age, lifestyle, and other clinical information. Analyzing all these data can produce accurate and consistent estimates about how long patients might live if they are at risk for sudden death.

“You can’t afford to be wrong. If you are wrong, you can actually impact a patient’s quality of life dramatically,” Dr. Popescu says. “Having clinicians use this technology in the decision-making process will provide confidence in a better diagnosis and prognosis.”

While the current study was specifically about patients with a particular type of heart disease, Dr. Popescu says his algorithm can also be trained to assess other health conditions.

So when might you see this being used outside of a research study? Dr. Trayanova predicts 3D imaging of heart models could be available in 2 years, but first the technique must be tested in more clinical trials – some of which are happening right now.

Adding AI to the heart models will require more studies and Food and Drug Administration approval, so the timeline is less clear. But perhaps the biggest hurdle is that after approval the technologies would need to be adopted and used by clinicians and caregivers.

“The much harder question to answer is, ‘When will doctors be perfectly comfortable with AI tools?’ And I don’t know the answer,” Dr. Popescu says. “How to use AI as an aid in the decision-making process is something that’s not currently taught.”

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

Deaths from COVID-19 may have caught more attention lately, but heart disease remains the leading cause of death in the United States.

More than 300,000 Americans will die this year of sudden cardiac arrest (also called sudden cardiac death, or SCD), when the heart abruptly stops working.

These events happen suddenly and often without warning, making them nearly impossible to predict. But that may be changing, thanks to 3D imaging and artificial intelligence (AI) technology under study at Johns Hopkins University, Baltimore.

Svisio/Thinkstock

There, researchers are working to create more accurate and personalized models of the heart – and not just any heart, your heart, if you have heart disease.

“Right now, a clinician can only say whether a patient is at risk or not at risk for sudden death,” says Dan Popescu, PhD, a Johns Hopkins research scientist and first author of a new study on AI’s ability to predict sudden cardiac arrest. “With this new technology, you can have much more nuanced predictions of probability of an event over time.”

Put another way: With AI, clinicians may be able not only to predict if someone is at risk for sudden cardiac arrest, but also when it is most likely to happen. They can do this using a much clearer and more personalized look at the electrical “wiring” of your heart.
 

Your heart, the conductor

Your heart isn’t just a metronome responsible for keeping a steady stream of blood pumping to tissues with every beat. It’s also a conductor through which vital energy flows.

To make the heart beat, electrical impulses flow from the top to the bottom of the organ. Healthy heart cells relay this electricity seamlessly. But in a heart damaged by inflammation or a past heart attack, scar tissue will block the energy flow.

When an electrical impulse encounters a scarred area, the signal can become erratic, disrupting the set top-to-bottom path and causing irregular heartbeats (arrhythmias), which increase someone’s danger of sudden cardiac death.
 

Seeing the heart in 3D

Today’s tests offer some insights into the heart’s makeup. For example, MRI scans can reveal damaged areas. PET scans can show inflammation. And EKGs can record the heart’s electrical signals from beat to beat.

But all these technologies offer only a snapshot, showing heart health at a moment in time. They can’t predict the future. That’s why scientists at Johns Hopkins are going further to develop 3D digital replicas of a person’s heart, known as computational heart models.

Computational models are computer-simulated replicas that combine mathematics, physics, and computer science. These models have been around for a long time and are used in many fields, ranging from manufacturing to economics.

In heart medicine, these models are populated with digital “cells,” which imitate living cells and can be programmed with different electrical properties, depending on whether they are healthy or diseased.

“Currently available imaging and testing (MRIs, PETs, EKGs) give some representation of the scarring, but you cannot translate that to what is going to happen over time,” says Natalia Trayanova, PhD, of the Johns Hopkins department of biomedical engineering.

“With computational heart models, we create a dynamic digital image of the heart. We can then give the digital image an electrical stimulus and assess how the heart is able to respond. Then you can better predict what is going to happen.”

The computerized 3D models also mean better, more accurate treatment for heart conditions.

For example, a common treatment for a type of arrhythmia known as atrial fibrillation is ablation, or burning some heart tissue. Ablation stops the erratic electrical impulses causing the arrhythmia, but it can also damage otherwise healthy heart cells.

A personalized computational heart model could allow doctors to see more accurately what areas should and shouldn’t be treated for a specific patient.
 

Using deep learning AI to predict health outcomes

Dr. Trayanova’s colleague Dr. Popescu is applying deep learning and AI to do more with computerized heart models to predict the future.

In a recent paper in Nature Cardiovascular Research, the research team showed their algorithm assessed the health of 269 patients and was able to predict the chance of sudden cardiac arrest up to 10 years in advance.

“This is really the first time ever, as far as we know, where deep learning technology has been proven to analyze scarring of the heart in a successful way,” Dr. Popescu says.

Dr. Popescu and Dr. Trayanova say the AI algorithm gathers information from the 3D computational heart models with patient data like MRIs, ethnicity, age, lifestyle, and other clinical information. Analyzing all these data can produce accurate and consistent estimates about how long patients might live if they are at risk for sudden death.

“You can’t afford to be wrong. If you are wrong, you can actually impact a patient’s quality of life dramatically,” Dr. Popescu says. “Having clinicians use this technology in the decision-making process will provide confidence in a better diagnosis and prognosis.”

While the current study was specifically about patients with a particular type of heart disease, Dr. Popescu says his algorithm can also be trained to assess other health conditions.

So when might you see this being used outside of a research study? Dr. Trayanova predicts 3D imaging of heart models could be available in 2 years, but first the technique must be tested in more clinical trials – some of which are happening right now.

Adding AI to the heart models will require more studies and Food and Drug Administration approval, so the timeline is less clear. But perhaps the biggest hurdle is that after approval the technologies would need to be adopted and used by clinicians and caregivers.

“The much harder question to answer is, ‘When will doctors be perfectly comfortable with AI tools?’ And I don’t know the answer,” Dr. Popescu says. “How to use AI as an aid in the decision-making process is something that’s not currently taught.”

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

Deaths from COVID-19 may have caught more attention lately, but heart disease remains the leading cause of death in the United States.

More than 300,000 Americans will die this year of sudden cardiac arrest (also called sudden cardiac death, or SCD), when the heart abruptly stops working.

These events happen suddenly and often without warning, making them nearly impossible to predict. But that may be changing, thanks to 3D imaging and artificial intelligence (AI) technology under study at Johns Hopkins University, Baltimore.

Svisio/Thinkstock

There, researchers are working to create more accurate and personalized models of the heart – and not just any heart, your heart, if you have heart disease.

“Right now, a clinician can only say whether a patient is at risk or not at risk for sudden death,” says Dan Popescu, PhD, a Johns Hopkins research scientist and first author of a new study on AI’s ability to predict sudden cardiac arrest. “With this new technology, you can have much more nuanced predictions of probability of an event over time.”

Put another way: With AI, clinicians may be able not only to predict if someone is at risk for sudden cardiac arrest, but also when it is most likely to happen. They can do this using a much clearer and more personalized look at the electrical “wiring” of your heart.
 

Your heart, the conductor

Your heart isn’t just a metronome responsible for keeping a steady stream of blood pumping to tissues with every beat. It’s also a conductor through which vital energy flows.

To make the heart beat, electrical impulses flow from the top to the bottom of the organ. Healthy heart cells relay this electricity seamlessly. But in a heart damaged by inflammation or a past heart attack, scar tissue will block the energy flow.

When an electrical impulse encounters a scarred area, the signal can become erratic, disrupting the set top-to-bottom path and causing irregular heartbeats (arrhythmias), which increase someone’s danger of sudden cardiac death.
 

Seeing the heart in 3D

Today’s tests offer some insights into the heart’s makeup. For example, MRI scans can reveal damaged areas. PET scans can show inflammation. And EKGs can record the heart’s electrical signals from beat to beat.

But all these technologies offer only a snapshot, showing heart health at a moment in time. They can’t predict the future. That’s why scientists at Johns Hopkins are going further to develop 3D digital replicas of a person’s heart, known as computational heart models.

Computational models are computer-simulated replicas that combine mathematics, physics, and computer science. These models have been around for a long time and are used in many fields, ranging from manufacturing to economics.

In heart medicine, these models are populated with digital “cells,” which imitate living cells and can be programmed with different electrical properties, depending on whether they are healthy or diseased.

“Currently available imaging and testing (MRIs, PETs, EKGs) give some representation of the scarring, but you cannot translate that to what is going to happen over time,” says Natalia Trayanova, PhD, of the Johns Hopkins department of biomedical engineering.

“With computational heart models, we create a dynamic digital image of the heart. We can then give the digital image an electrical stimulus and assess how the heart is able to respond. Then you can better predict what is going to happen.”

The computerized 3D models also mean better, more accurate treatment for heart conditions.

For example, a common treatment for a type of arrhythmia known as atrial fibrillation is ablation, or burning some heart tissue. Ablation stops the erratic electrical impulses causing the arrhythmia, but it can also damage otherwise healthy heart cells.

A personalized computational heart model could allow doctors to see more accurately what areas should and shouldn’t be treated for a specific patient.
 

Using deep learning AI to predict health outcomes

Dr. Trayanova’s colleague Dr. Popescu is applying deep learning and AI to do more with computerized heart models to predict the future.

In a recent paper in Nature Cardiovascular Research, the research team showed their algorithm assessed the health of 269 patients and was able to predict the chance of sudden cardiac arrest up to 10 years in advance.

“This is really the first time ever, as far as we know, where deep learning technology has been proven to analyze scarring of the heart in a successful way,” Dr. Popescu says.

Dr. Popescu and Dr. Trayanova say the AI algorithm gathers information from the 3D computational heart models with patient data like MRIs, ethnicity, age, lifestyle, and other clinical information. Analyzing all these data can produce accurate and consistent estimates about how long patients might live if they are at risk for sudden death.

“You can’t afford to be wrong. If you are wrong, you can actually impact a patient’s quality of life dramatically,” Dr. Popescu says. “Having clinicians use this technology in the decision-making process will provide confidence in a better diagnosis and prognosis.”

While the current study was specifically about patients with a particular type of heart disease, Dr. Popescu says his algorithm can also be trained to assess other health conditions.

So when might you see this being used outside of a research study? Dr. Trayanova predicts 3D imaging of heart models could be available in 2 years, but first the technique must be tested in more clinical trials – some of which are happening right now.

Adding AI to the heart models will require more studies and Food and Drug Administration approval, so the timeline is less clear. But perhaps the biggest hurdle is that after approval the technologies would need to be adopted and used by clinicians and caregivers.

“The much harder question to answer is, ‘When will doctors be perfectly comfortable with AI tools?’ And I don’t know the answer,” Dr. Popescu says. “How to use AI as an aid in the decision-making process is something that’s not currently taught.”

A version of this article first appeared on WebMD.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.

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.

A recently published multinational cohort study may be the largest to date that’s found the age of asthma onset is an integral factor in defining the severity of disease and the frequency of comorbidities.

“It’s very simple to ask your patient: ‘Did you have asthma as a child? When did your asthma start?’ ” coauthor Guy Brusselle, MD, a professor at the University of Ghent (Belgium), said in an interview. “You do not need expensive investigations, CT scans or proteomics or genomics; just two simple questions.”

The retrospective cohort study, published in the Journal of Allergy and Clinical Immunology: In Practice, combined national electronic health records databases from five different countries – the United Kingdom, Spain, Italy, the Netherlands, and Denmark – that included 586,436 adult asthma patients. The study divided the patients into three subtypes: childhood-onset asthma, meaning a diagnosis before age 18 (n = 81,691); adult-onset disease, defined as a diagnosis between ages 18 and 40 (n = 218,184); and late onset, defined as a diagnosis made after age 40 (n = 286,561).

Dr. Brusselle said the study found stark differences in characteristics between the three subtypes, including an increasing risk for women with later age of onset. Across the five databases, females comprised approximately 45% of those with childhood-onset asthma, but about 60% of those with later-onset disease, Dr. Brusselle said.

As for characteristics of asthma, 7.2% of the cohort (n = 42,611) had severe asthma, but the proportion was highest in late-onset asthma, 10% versus 5% in adult onset and 3% in childhood onset. The percentage of uncontrolled asthma followed a similar trend: 8%, 6%, and 0.4% in the respective treatment groups.

The most common comorbidities were atopic disorders (31%) and overweight/obesity (50%). The prevalence of atopic disorders was highest in the childhood-onset group, 45% versus 35%, and 25% in the adult-onset and late-onset patients. However, the trend for overweight/obesity was reversed: 30%, 43%, and 61%, respectively.

“The larger differences were when late-onset asthma was compared to adult-onset asthma with respect to comorbidities,” Dr. Brusselle said. “The late-onset asthma patients more frequently had nasal polyposis.” These patients typically lose their sense of smell, as in COVID-19. However, in nasal polyposis the loss is chronic rather than transient.

Pulmonologists should be attuned to the prevalence of overweight/obesity in the late-onset group, Dr. Brusselle said. “We know that obesity is an important risk factor for diabetes, and then obesity is also associated with gastroesophageal reflux – and we know that gastroesophageal reflux is a risk factor for asthma exacerbations.”

Smaller studies have arrived at the same conclusions regarding the relationships between asthma severity and age of onset, Dr. Brusselle said. What’s notable about this study is its size and the consistency of findings across different national databases.

“In childhood onset you need to watch for different allergies – atopic dermatitis and allergic rhinitis – but in late-onset asthma look for obesity, diabetes and reflux disease, and nasal polyposis,” he said.

Sally E. Wenzel, MD, professor at the University of Pittsburgh and director of the Asthma and Environmental Lung Health Institute at the University of Pittsburgh Medical Center, concurred that the size of this study makes it noteworthy.

“It’s certainly far and away the largest study of its kind that’s ever been done, and it’s multinational,” she said in an interview. “Just doing a study like this with thousands and thousands of patients is a step in the right direction. That’s probably what’s very unique about it, to bring all of these clinical cohorts as it were together and to look at what is the relationship of the age of onset.”

She also said the study is unique in how it delineates the groups by age of onset.

“In addition to this concept that there’s a difference in asthma by the age that you got diagnosed with it, I think it’s also important to just remember that when any physician, be they a specialist or nonspecialist, sees a patient with asthma, they should ask them when did their symptoms develop,” she said. “These are really simple questions that don’t take any sophisticated training and don’t take any sophisticated instruments to measure, but they can be really helpful.”

GlaxoSmithKline supplied a grant for the study. Dr. Brusselle disclosed relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Sanofi, and Teva. A study coauthor is an employee of GSK. Dr. Wenzel reported no disclosures.

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

A recently published multinational cohort study may be the largest to date that’s found the age of asthma onset is an integral factor in defining the severity of disease and the frequency of comorbidities.

“It’s very simple to ask your patient: ‘Did you have asthma as a child? When did your asthma start?’ ” coauthor Guy Brusselle, MD, a professor at the University of Ghent (Belgium), said in an interview. “You do not need expensive investigations, CT scans or proteomics or genomics; just two simple questions.”

The retrospective cohort study, published in the Journal of Allergy and Clinical Immunology: In Practice, combined national electronic health records databases from five different countries – the United Kingdom, Spain, Italy, the Netherlands, and Denmark – that included 586,436 adult asthma patients. The study divided the patients into three subtypes: childhood-onset asthma, meaning a diagnosis before age 18 (n = 81,691); adult-onset disease, defined as a diagnosis between ages 18 and 40 (n = 218,184); and late onset, defined as a diagnosis made after age 40 (n = 286,561).

Dr. Brusselle said the study found stark differences in characteristics between the three subtypes, including an increasing risk for women with later age of onset. Across the five databases, females comprised approximately 45% of those with childhood-onset asthma, but about 60% of those with later-onset disease, Dr. Brusselle said.

As for characteristics of asthma, 7.2% of the cohort (n = 42,611) had severe asthma, but the proportion was highest in late-onset asthma, 10% versus 5% in adult onset and 3% in childhood onset. The percentage of uncontrolled asthma followed a similar trend: 8%, 6%, and 0.4% in the respective treatment groups.

The most common comorbidities were atopic disorders (31%) and overweight/obesity (50%). The prevalence of atopic disorders was highest in the childhood-onset group, 45% versus 35%, and 25% in the adult-onset and late-onset patients. However, the trend for overweight/obesity was reversed: 30%, 43%, and 61%, respectively.

“The larger differences were when late-onset asthma was compared to adult-onset asthma with respect to comorbidities,” Dr. Brusselle said. “The late-onset asthma patients more frequently had nasal polyposis.” These patients typically lose their sense of smell, as in COVID-19. However, in nasal polyposis the loss is chronic rather than transient.

Pulmonologists should be attuned to the prevalence of overweight/obesity in the late-onset group, Dr. Brusselle said. “We know that obesity is an important risk factor for diabetes, and then obesity is also associated with gastroesophageal reflux – and we know that gastroesophageal reflux is a risk factor for asthma exacerbations.”

Smaller studies have arrived at the same conclusions regarding the relationships between asthma severity and age of onset, Dr. Brusselle said. What’s notable about this study is its size and the consistency of findings across different national databases.

“In childhood onset you need to watch for different allergies – atopic dermatitis and allergic rhinitis – but in late-onset asthma look for obesity, diabetes and reflux disease, and nasal polyposis,” he said.

Sally E. Wenzel, MD, professor at the University of Pittsburgh and director of the Asthma and Environmental Lung Health Institute at the University of Pittsburgh Medical Center, concurred that the size of this study makes it noteworthy.

“It’s certainly far and away the largest study of its kind that’s ever been done, and it’s multinational,” she said in an interview. “Just doing a study like this with thousands and thousands of patients is a step in the right direction. That’s probably what’s very unique about it, to bring all of these clinical cohorts as it were together and to look at what is the relationship of the age of onset.”

She also said the study is unique in how it delineates the groups by age of onset.

“In addition to this concept that there’s a difference in asthma by the age that you got diagnosed with it, I think it’s also important to just remember that when any physician, be they a specialist or nonspecialist, sees a patient with asthma, they should ask them when did their symptoms develop,” she said. “These are really simple questions that don’t take any sophisticated training and don’t take any sophisticated instruments to measure, but they can be really helpful.”

GlaxoSmithKline supplied a grant for the study. Dr. Brusselle disclosed relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Sanofi, and Teva. A study coauthor is an employee of GSK. Dr. Wenzel reported no disclosures.

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

A recently published multinational cohort study may be the largest to date that’s found the age of asthma onset is an integral factor in defining the severity of disease and the frequency of comorbidities.

“It’s very simple to ask your patient: ‘Did you have asthma as a child? When did your asthma start?’ ” coauthor Guy Brusselle, MD, a professor at the University of Ghent (Belgium), said in an interview. “You do not need expensive investigations, CT scans or proteomics or genomics; just two simple questions.”

The retrospective cohort study, published in the Journal of Allergy and Clinical Immunology: In Practice, combined national electronic health records databases from five different countries – the United Kingdom, Spain, Italy, the Netherlands, and Denmark – that included 586,436 adult asthma patients. The study divided the patients into three subtypes: childhood-onset asthma, meaning a diagnosis before age 18 (n = 81,691); adult-onset disease, defined as a diagnosis between ages 18 and 40 (n = 218,184); and late onset, defined as a diagnosis made after age 40 (n = 286,561).

Dr. Brusselle said the study found stark differences in characteristics between the three subtypes, including an increasing risk for women with later age of onset. Across the five databases, females comprised approximately 45% of those with childhood-onset asthma, but about 60% of those with later-onset disease, Dr. Brusselle said.

As for characteristics of asthma, 7.2% of the cohort (n = 42,611) had severe asthma, but the proportion was highest in late-onset asthma, 10% versus 5% in adult onset and 3% in childhood onset. The percentage of uncontrolled asthma followed a similar trend: 8%, 6%, and 0.4% in the respective treatment groups.

The most common comorbidities were atopic disorders (31%) and overweight/obesity (50%). The prevalence of atopic disorders was highest in the childhood-onset group, 45% versus 35%, and 25% in the adult-onset and late-onset patients. However, the trend for overweight/obesity was reversed: 30%, 43%, and 61%, respectively.

“The larger differences were when late-onset asthma was compared to adult-onset asthma with respect to comorbidities,” Dr. Brusselle said. “The late-onset asthma patients more frequently had nasal polyposis.” These patients typically lose their sense of smell, as in COVID-19. However, in nasal polyposis the loss is chronic rather than transient.

Pulmonologists should be attuned to the prevalence of overweight/obesity in the late-onset group, Dr. Brusselle said. “We know that obesity is an important risk factor for diabetes, and then obesity is also associated with gastroesophageal reflux – and we know that gastroesophageal reflux is a risk factor for asthma exacerbations.”

Smaller studies have arrived at the same conclusions regarding the relationships between asthma severity and age of onset, Dr. Brusselle said. What’s notable about this study is its size and the consistency of findings across different national databases.

“In childhood onset you need to watch for different allergies – atopic dermatitis and allergic rhinitis – but in late-onset asthma look for obesity, diabetes and reflux disease, and nasal polyposis,” he said.

Sally E. Wenzel, MD, professor at the University of Pittsburgh and director of the Asthma and Environmental Lung Health Institute at the University of Pittsburgh Medical Center, concurred that the size of this study makes it noteworthy.

“It’s certainly far and away the largest study of its kind that’s ever been done, and it’s multinational,” she said in an interview. “Just doing a study like this with thousands and thousands of patients is a step in the right direction. That’s probably what’s very unique about it, to bring all of these clinical cohorts as it were together and to look at what is the relationship of the age of onset.”

She also said the study is unique in how it delineates the groups by age of onset.

“In addition to this concept that there’s a difference in asthma by the age that you got diagnosed with it, I think it’s also important to just remember that when any physician, be they a specialist or nonspecialist, sees a patient with asthma, they should ask them when did their symptoms develop,” she said. “These are really simple questions that don’t take any sophisticated training and don’t take any sophisticated instruments to measure, but they can be really helpful.”

GlaxoSmithKline supplied a grant for the study. Dr. Brusselle disclosed relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Sanofi, and Teva. A study coauthor is an employee of GSK. Dr. Wenzel reported no disclosures.

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

A topical gel that contains birch bark extract as the active ingredient – Filsuvez (Oleogel-S10) – has been recommended for approval for the treatment of skin wounds in patients with epidermolysis bullosa (EB) by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use.

“The benefit of Filsuvez is its ability to promote healing of EB partial thickness wounds,” the EMA said in an announcement on April 22. “It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound health and closure,” the statement adds.

The recommended indication for the product – developed by Amryt Pharmaceuticals DAC and currently designated as an orphan drug – is for the treatment of partial-thickness wounds associated with dystrophic and junctional EB in patients aged 6 months and older. The recommendation for approval came after the EMA sought and received external advice from independent physicians treating EB and from patients with the rare disease.

The most common side effects, according to the EMA announcement, are wound complications, application site reactions, wound infections, pruritus, and hypersensitivity reactions.

In February 2022, the Food and Drug Administration declined to approve the company’s new drug application as it was presented and asked the company to submit additional evidence of effectiveness for Oleogel-S10 in EB, the company announced at that time. The statement noted that the company was committed to working with the FDA to identify "the most expeditious pathway towards a potential approval.” 

The company’s pivotal phase 3 trial enrolled 223 patients with EB, including 156 pediatric patients. The patients variously had three types of EB. The trial has two components: A 3-month, double-blind, randomized controlled phase, which has been completed, and an ongoing 24-month open-label, single-arm phase. The trial is being performed at 58 sites in 28 countries.

Results from the randomized controlled phase, reported in 2020, include a statistically significant increase in the proportion of patients achieving complete closure of an EB target wound within 45 days: 41.3% in the Oleogel-S10 group and 28.9% in the control group (P = .013). (Target wounds measured 10 cm² to 50 cm² and were present for at least 21 days but less than 9 months.) The safety profile of the treatment gel was acceptable and was well tolerated, compared with the control gel, according to Amryt’s press release. The results were presented at the European Academy of Dermatology and Venereology Congress in October 2020.

Data from a 12-month interim analysis of the follow-up phase were presented at the annual meeting of the American Academy of Dermatology in March 2022. Results showed further reductions in total body surface area percentage wounding to 5.4% among (from 7.4% at the end of the double-blind period and 12.1% at the beginning of the study) among the patients who continued treatment and who underwent assessment, according to a company press release. Treatment was well tolerated, and no new safety signals were identified, the release said.

A decision by the European Commission is expected within the next 2 months.

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

A topical gel that contains birch bark extract as the active ingredient – Filsuvez (Oleogel-S10) – has been recommended for approval for the treatment of skin wounds in patients with epidermolysis bullosa (EB) by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use.

“The benefit of Filsuvez is its ability to promote healing of EB partial thickness wounds,” the EMA said in an announcement on April 22. “It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound health and closure,” the statement adds.

The recommended indication for the product – developed by Amryt Pharmaceuticals DAC and currently designated as an orphan drug – is for the treatment of partial-thickness wounds associated with dystrophic and junctional EB in patients aged 6 months and older. The recommendation for approval came after the EMA sought and received external advice from independent physicians treating EB and from patients with the rare disease.

The most common side effects, according to the EMA announcement, are wound complications, application site reactions, wound infections, pruritus, and hypersensitivity reactions.

In February 2022, the Food and Drug Administration declined to approve the company’s new drug application as it was presented and asked the company to submit additional evidence of effectiveness for Oleogel-S10 in EB, the company announced at that time. The statement noted that the company was committed to working with the FDA to identify "the most expeditious pathway towards a potential approval.” 

The company’s pivotal phase 3 trial enrolled 223 patients with EB, including 156 pediatric patients. The patients variously had three types of EB. The trial has two components: A 3-month, double-blind, randomized controlled phase, which has been completed, and an ongoing 24-month open-label, single-arm phase. The trial is being performed at 58 sites in 28 countries.

Results from the randomized controlled phase, reported in 2020, include a statistically significant increase in the proportion of patients achieving complete closure of an EB target wound within 45 days: 41.3% in the Oleogel-S10 group and 28.9% in the control group (P = .013). (Target wounds measured 10 cm² to 50 cm² and were present for at least 21 days but less than 9 months.) The safety profile of the treatment gel was acceptable and was well tolerated, compared with the control gel, according to Amryt’s press release. The results were presented at the European Academy of Dermatology and Venereology Congress in October 2020.

Data from a 12-month interim analysis of the follow-up phase were presented at the annual meeting of the American Academy of Dermatology in March 2022. Results showed further reductions in total body surface area percentage wounding to 5.4% among (from 7.4% at the end of the double-blind period and 12.1% at the beginning of the study) among the patients who continued treatment and who underwent assessment, according to a company press release. Treatment was well tolerated, and no new safety signals were identified, the release said.

A decision by the European Commission is expected within the next 2 months.

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

A topical gel that contains birch bark extract as the active ingredient – Filsuvez (Oleogel-S10) – has been recommended for approval for the treatment of skin wounds in patients with epidermolysis bullosa (EB) by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use.

“The benefit of Filsuvez is its ability to promote healing of EB partial thickness wounds,” the EMA said in an announcement on April 22. “It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound health and closure,” the statement adds.

The recommended indication for the product – developed by Amryt Pharmaceuticals DAC and currently designated as an orphan drug – is for the treatment of partial-thickness wounds associated with dystrophic and junctional EB in patients aged 6 months and older. The recommendation for approval came after the EMA sought and received external advice from independent physicians treating EB and from patients with the rare disease.

The most common side effects, according to the EMA announcement, are wound complications, application site reactions, wound infections, pruritus, and hypersensitivity reactions.

In February 2022, the Food and Drug Administration declined to approve the company’s new drug application as it was presented and asked the company to submit additional evidence of effectiveness for Oleogel-S10 in EB, the company announced at that time. The statement noted that the company was committed to working with the FDA to identify "the most expeditious pathway towards a potential approval.” 

The company’s pivotal phase 3 trial enrolled 223 patients with EB, including 156 pediatric patients. The patients variously had three types of EB. The trial has two components: A 3-month, double-blind, randomized controlled phase, which has been completed, and an ongoing 24-month open-label, single-arm phase. The trial is being performed at 58 sites in 28 countries.

Results from the randomized controlled phase, reported in 2020, include a statistically significant increase in the proportion of patients achieving complete closure of an EB target wound within 45 days: 41.3% in the Oleogel-S10 group and 28.9% in the control group (P = .013). (Target wounds measured 10 cm² to 50 cm² and were present for at least 21 days but less than 9 months.) The safety profile of the treatment gel was acceptable and was well tolerated, compared with the control gel, according to Amryt’s press release. The results were presented at the European Academy of Dermatology and Venereology Congress in October 2020.

Data from a 12-month interim analysis of the follow-up phase were presented at the annual meeting of the American Academy of Dermatology in March 2022. Results showed further reductions in total body surface area percentage wounding to 5.4% among (from 7.4% at the end of the double-blind period and 12.1% at the beginning of the study) among the patients who continued treatment and who underwent assessment, according to a company press release. Treatment was well tolerated, and no new safety signals were identified, the release said.

A decision by the European Commission is expected within the next 2 months.

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.

The percentage of Americans who have been infected with COVID-19 jumped from 34% in December 2021 to 58% in February 2022, a new study from the Centers for Disease Control and Prevention reveals.

This is the first time the seroprevalence of prior infection is more than 50% in the American population.

“I definitely expected that we were going to see an increase continue ... but I didn’t expect it to increase quite this much. But we follow the data ... and this is what the evidence is showing us,” lead study researcher Kristie E. N. Clarke, MD, said during a CDC media briefing April 26.

Researchers found that presence of antinucleocapsid (anti-N) antibodies from prior infection varied by age. The rate varied from as high as 75% in children and teenagers 17 years and younger to 33% in those 65 and older, for example.  

The study showed that the anti-N antibodies were more common in age groups with the lowest vaccination numbers.

Combined with up-to-date CDC data on deaths, hospitalizations, and cases, the study provides a clearer picture of where we are now and where we might be headed in terms of the pandemic.
 

Vaccination still valuable

The fact that nearly 60% of Americans have antibodies from prior infection is not a reason to think people with a history of COVID-19 should skip vaccination, said CDC director Rochelle P. Walensky, MD.

“I can’t underscore enough that those with detectable antibodies from previous infection, we encourage them to still get vaccinated,” Dr. Walensky said.

“We do know that reinfections happen,” she said, “so that’s important in terms of thinking forward.”

The CDC continues to encourage all Americans to stay up to date with their COVID-19 vaccinations, said Dr. Clarke, colead for the CDC’s COVID-19 Epidemiology and Surveillance Taskforce Seroprevalence Team. “Having infection-induced antibodies does not necessarily mean you are protected against future infections.”

The study, published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), did not evaluate antibody protection from COVID-19 vaccination.

It should also be noted that the study looked at presence or absence of anti-N antibodies, and not whether certain levels were linked to less or more protection.
 

Where are we now?

Dr. Walensky used the media briefing as an opportunity to share current COVID-19 numbers.

“Overall, we can continue to have some mixed trends. Deaths, fortunately, are continuing to trend downward with a 7-day average of about 300 per day, which represents an estimated 18% decline from the prior week,” she said.

Hospital admissions also remain low, at about 1,500 per day. “But we should note that for the second week in a row, they are slowly trending upwards,” Dr. Walensky said. There was an increase of about 9% at press time compared with the prior week.

Cases remain “comparatively low” to even where we were a month ago, at 44,000 per day,” Dr. Walensky said. “Although this too represents an increase of about 25% in the past week.”

Dr. Walensky noted that positive test numbers are not as reliable a metric as they were before the growth in use of rapid home tests. But it’s not the only measure. “We continue to believe that our PCR testing data, especially when we corroborate it with information from our other surveillance systems – like wastewater surveillance and emergency department surveillance – provide us a reliable picture of the trajectory of COVID-19 across our country.”

She recommended that people continue to consult the CDC’s COVID-19 county tracker to monitor local levels of COVID-19.

Dr. Walensky also shared recent findings from genomic sequencing that continue to show the predominance of the Omicron variant. “Essentially a hundred percent of what we’re finding now is Omicron,” she said. In terms of individual variants, the Omicron BA.1 variant is about 3% of circulating virus, the BA.2 variant is about 68%, and BA.2.12.1 makes up about 35%.

“We’re just starting to learn about the impact of BA2.121,” Dr. Walensky said. “It appears it might have a transmission advantage of about 25% over the BA2 subvariant.”

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

The percentage of Americans who have been infected with COVID-19 jumped from 34% in December 2021 to 58% in February 2022, a new study from the Centers for Disease Control and Prevention reveals.

This is the first time the seroprevalence of prior infection is more than 50% in the American population.

“I definitely expected that we were going to see an increase continue ... but I didn’t expect it to increase quite this much. But we follow the data ... and this is what the evidence is showing us,” lead study researcher Kristie E. N. Clarke, MD, said during a CDC media briefing April 26.

Researchers found that presence of antinucleocapsid (anti-N) antibodies from prior infection varied by age. The rate varied from as high as 75% in children and teenagers 17 years and younger to 33% in those 65 and older, for example.  

The study showed that the anti-N antibodies were more common in age groups with the lowest vaccination numbers.

Combined with up-to-date CDC data on deaths, hospitalizations, and cases, the study provides a clearer picture of where we are now and where we might be headed in terms of the pandemic.
 

Vaccination still valuable

The fact that nearly 60% of Americans have antibodies from prior infection is not a reason to think people with a history of COVID-19 should skip vaccination, said CDC director Rochelle P. Walensky, MD.

“I can’t underscore enough that those with detectable antibodies from previous infection, we encourage them to still get vaccinated,” Dr. Walensky said.

“We do know that reinfections happen,” she said, “so that’s important in terms of thinking forward.”

The CDC continues to encourage all Americans to stay up to date with their COVID-19 vaccinations, said Dr. Clarke, colead for the CDC’s COVID-19 Epidemiology and Surveillance Taskforce Seroprevalence Team. “Having infection-induced antibodies does not necessarily mean you are protected against future infections.”

The study, published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), did not evaluate antibody protection from COVID-19 vaccination.

It should also be noted that the study looked at presence or absence of anti-N antibodies, and not whether certain levels were linked to less or more protection.
 

Where are we now?

Dr. Walensky used the media briefing as an opportunity to share current COVID-19 numbers.

“Overall, we can continue to have some mixed trends. Deaths, fortunately, are continuing to trend downward with a 7-day average of about 300 per day, which represents an estimated 18% decline from the prior week,” she said.

Hospital admissions also remain low, at about 1,500 per day. “But we should note that for the second week in a row, they are slowly trending upwards,” Dr. Walensky said. There was an increase of about 9% at press time compared with the prior week.

Cases remain “comparatively low” to even where we were a month ago, at 44,000 per day,” Dr. Walensky said. “Although this too represents an increase of about 25% in the past week.”

Dr. Walensky noted that positive test numbers are not as reliable a metric as they were before the growth in use of rapid home tests. But it’s not the only measure. “We continue to believe that our PCR testing data, especially when we corroborate it with information from our other surveillance systems – like wastewater surveillance and emergency department surveillance – provide us a reliable picture of the trajectory of COVID-19 across our country.”

She recommended that people continue to consult the CDC’s COVID-19 county tracker to monitor local levels of COVID-19.

Dr. Walensky also shared recent findings from genomic sequencing that continue to show the predominance of the Omicron variant. “Essentially a hundred percent of what we’re finding now is Omicron,” she said. In terms of individual variants, the Omicron BA.1 variant is about 3% of circulating virus, the BA.2 variant is about 68%, and BA.2.12.1 makes up about 35%.

“We’re just starting to learn about the impact of BA2.121,” Dr. Walensky said. “It appears it might have a transmission advantage of about 25% over the BA2 subvariant.”

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

The percentage of Americans who have been infected with COVID-19 jumped from 34% in December 2021 to 58% in February 2022, a new study from the Centers for Disease Control and Prevention reveals.

This is the first time the seroprevalence of prior infection is more than 50% in the American population.

“I definitely expected that we were going to see an increase continue ... but I didn’t expect it to increase quite this much. But we follow the data ... and this is what the evidence is showing us,” lead study researcher Kristie E. N. Clarke, MD, said during a CDC media briefing April 26.

Researchers found that presence of antinucleocapsid (anti-N) antibodies from prior infection varied by age. The rate varied from as high as 75% in children and teenagers 17 years and younger to 33% in those 65 and older, for example.  

The study showed that the anti-N antibodies were more common in age groups with the lowest vaccination numbers.

Combined with up-to-date CDC data on deaths, hospitalizations, and cases, the study provides a clearer picture of where we are now and where we might be headed in terms of the pandemic.
 

Vaccination still valuable

The fact that nearly 60% of Americans have antibodies from prior infection is not a reason to think people with a history of COVID-19 should skip vaccination, said CDC director Rochelle P. Walensky, MD.

“I can’t underscore enough that those with detectable antibodies from previous infection, we encourage them to still get vaccinated,” Dr. Walensky said.

“We do know that reinfections happen,” she said, “so that’s important in terms of thinking forward.”

The CDC continues to encourage all Americans to stay up to date with their COVID-19 vaccinations, said Dr. Clarke, colead for the CDC’s COVID-19 Epidemiology and Surveillance Taskforce Seroprevalence Team. “Having infection-induced antibodies does not necessarily mean you are protected against future infections.”

The study, published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), did not evaluate antibody protection from COVID-19 vaccination.

It should also be noted that the study looked at presence or absence of anti-N antibodies, and not whether certain levels were linked to less or more protection.
 

Where are we now?

Dr. Walensky used the media briefing as an opportunity to share current COVID-19 numbers.

“Overall, we can continue to have some mixed trends. Deaths, fortunately, are continuing to trend downward with a 7-day average of about 300 per day, which represents an estimated 18% decline from the prior week,” she said.

Hospital admissions also remain low, at about 1,500 per day. “But we should note that for the second week in a row, they are slowly trending upwards,” Dr. Walensky said. There was an increase of about 9% at press time compared with the prior week.

Cases remain “comparatively low” to even where we were a month ago, at 44,000 per day,” Dr. Walensky said. “Although this too represents an increase of about 25% in the past week.”

Dr. Walensky noted that positive test numbers are not as reliable a metric as they were before the growth in use of rapid home tests. But it’s not the only measure. “We continue to believe that our PCR testing data, especially when we corroborate it with information from our other surveillance systems – like wastewater surveillance and emergency department surveillance – provide us a reliable picture of the trajectory of COVID-19 across our country.”

She recommended that people continue to consult the CDC’s COVID-19 county tracker to monitor local levels of COVID-19.

Dr. Walensky also shared recent findings from genomic sequencing that continue to show the predominance of the Omicron variant. “Essentially a hundred percent of what we’re finding now is Omicron,” she said. In terms of individual variants, the Omicron BA.1 variant is about 3% of circulating virus, the BA.2 variant is about 68%, and BA.2.12.1 makes up about 35%.

“We’re just starting to learn about the impact of BA2.121,” Dr. Walensky said. “It appears it might have a transmission advantage of about 25% over the BA2 subvariant.”

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