Conference Coverage

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

---

Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

---

Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

---

Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

The combination of nivolumab and vidutolimod led to a high rate of pathologic complete response and pathologic major response in a phase 2 trial of patients with stage 3 resectable melanoma. The result led researchers to call for a future study comparing the regimen against a suitable control group.

“We were very excited to see the ability of intratumoral vidutolimod to augment T-cell infiltrate. (Pathologic) response was associated with a dense infiltrate of CD8 T cells. We were also able to demonstrate for what I think may be the first time, that intratumoral CpG resulted in clear evidence of CD303+ plasmacytoid dendritic cells [pDCs],” said Diwakar Davar, MD, assistant professor of medicine at the University of Pittsburgh, during a presentation of the results at the annual meeting of the Society for Immunotherapy of Cancer. He noted that pDCs represent a very rare cell population, less than 0.4% of circulating peripheral blood mononuclear cells, and tend to be found in lymph nodes.

The current standard of care for stage 3 melanoma is up-front surgery followed by adjuvant therapy – anti–PD-1 therapy for patients with wild-type or BRAF-mutant cancers, and targeted therapy with BRAF/MEK inhibitors in patients with BRAF mutations. However, preclinical studies suggest that neoadjuvant immunotherapy could lead to a stronger antitumor T-cell response than adjuvant immunotherapy.

Vidutolimod targets the toll-like receptor 9 (TLR-9) endosomal receptor found in B cells and pDC cells. The formulation is a virus-like particle (VLP) that contains unmethylated cytosine guanine–rich oligonucleotides (CpG ODN). Bacterial and viral genomes tend to be enriched in CpG ODN, and this acts as a TLR-9 agonist. TLR-9 activation in turn triggers an interferon response, and this may help overcome PD-1 blockade resistance in metastatic melanoma.

The researchers conducted a nonrandomized, open-label trial that included 30 patients with stage 3 melanoma (14 women; median age, 61 years). Patients received neoadjuvant nivolumab and vidutolimod for 8 weeks, then were evaluated for surgery. Patients continued both drugs in the adjuvant setting for 48 weeks. 47% experienced complete pathologic response, 10% a major pathologic response, and 10% a partial pathologic response.

Analysis of resected samples revealed clear evidence of an immune response, Dr. Davar said during a press conference held in advance of the meeting. “Pathologic response was associated with compelling evidence of immune activation both peripherally and within the tumor, with clear evidence of pDC infiltrate and pDC activation – something that has not previously been seen in human specimens.”

The study regimen appeared safe, with no dose-limiting toxicities or grade 4 or 5 adverse events. He noted that the regimen is now being tested in the phase 2 ECOG-ACRIN trial.

The results are “very exciting,” said Pamela Ohashi, PhD, who commented on the study during the press conference. The virus-like nature of vidutolimod may be an important element of the therapy. “I think scientifically we would have predicted that the VLP carrying the CPG would be very good at activating the CD8 cells, which in fact is what you’re seeing. So I think it’s very exciting and has lots of potential for future combinations,” said Dr. Ohashi, who is director of the tumor immunotherapy program at the Princess Margaret Cancer Centre, Toronto.

The study was funded by Checkmate Pharmaceuticals. Dr. Davar has financial relationships with Checkmate Pharmaceuticals and Regeneron, which has acquired Checkmate Pharmaceuticals.

The combination of nivolumab and vidutolimod led to a high rate of pathologic complete response and pathologic major response in a phase 2 trial of patients with stage 3 resectable melanoma. The result led researchers to call for a future study comparing the regimen against a suitable control group.

“We were very excited to see the ability of intratumoral vidutolimod to augment T-cell infiltrate. (Pathologic) response was associated with a dense infiltrate of CD8 T cells. We were also able to demonstrate for what I think may be the first time, that intratumoral CpG resulted in clear evidence of CD303+ plasmacytoid dendritic cells [pDCs],” said Diwakar Davar, MD, assistant professor of medicine at the University of Pittsburgh, during a presentation of the results at the annual meeting of the Society for Immunotherapy of Cancer. He noted that pDCs represent a very rare cell population, less than 0.4% of circulating peripheral blood mononuclear cells, and tend to be found in lymph nodes.

The current standard of care for stage 3 melanoma is up-front surgery followed by adjuvant therapy – anti–PD-1 therapy for patients with wild-type or BRAF-mutant cancers, and targeted therapy with BRAF/MEK inhibitors in patients with BRAF mutations. However, preclinical studies suggest that neoadjuvant immunotherapy could lead to a stronger antitumor T-cell response than adjuvant immunotherapy.

Vidutolimod targets the toll-like receptor 9 (TLR-9) endosomal receptor found in B cells and pDC cells. The formulation is a virus-like particle (VLP) that contains unmethylated cytosine guanine–rich oligonucleotides (CpG ODN). Bacterial and viral genomes tend to be enriched in CpG ODN, and this acts as a TLR-9 agonist. TLR-9 activation in turn triggers an interferon response, and this may help overcome PD-1 blockade resistance in metastatic melanoma.

The researchers conducted a nonrandomized, open-label trial that included 30 patients with stage 3 melanoma (14 women; median age, 61 years). Patients received neoadjuvant nivolumab and vidutolimod for 8 weeks, then were evaluated for surgery. Patients continued both drugs in the adjuvant setting for 48 weeks. 47% experienced complete pathologic response, 10% a major pathologic response, and 10% a partial pathologic response.

Analysis of resected samples revealed clear evidence of an immune response, Dr. Davar said during a press conference held in advance of the meeting. “Pathologic response was associated with compelling evidence of immune activation both peripherally and within the tumor, with clear evidence of pDC infiltrate and pDC activation – something that has not previously been seen in human specimens.”

The study regimen appeared safe, with no dose-limiting toxicities or grade 4 or 5 adverse events. He noted that the regimen is now being tested in the phase 2 ECOG-ACRIN trial.

The results are “very exciting,” said Pamela Ohashi, PhD, who commented on the study during the press conference. The virus-like nature of vidutolimod may be an important element of the therapy. “I think scientifically we would have predicted that the VLP carrying the CPG would be very good at activating the CD8 cells, which in fact is what you’re seeing. So I think it’s very exciting and has lots of potential for future combinations,” said Dr. Ohashi, who is director of the tumor immunotherapy program at the Princess Margaret Cancer Centre, Toronto.

The study was funded by Checkmate Pharmaceuticals. Dr. Davar has financial relationships with Checkmate Pharmaceuticals and Regeneron, which has acquired Checkmate Pharmaceuticals.

The combination of nivolumab and vidutolimod led to a high rate of pathologic complete response and pathologic major response in a phase 2 trial of patients with stage 3 resectable melanoma. The result led researchers to call for a future study comparing the regimen against a suitable control group.

“We were very excited to see the ability of intratumoral vidutolimod to augment T-cell infiltrate. (Pathologic) response was associated with a dense infiltrate of CD8 T cells. We were also able to demonstrate for what I think may be the first time, that intratumoral CpG resulted in clear evidence of CD303+ plasmacytoid dendritic cells [pDCs],” said Diwakar Davar, MD, assistant professor of medicine at the University of Pittsburgh, during a presentation of the results at the annual meeting of the Society for Immunotherapy of Cancer. He noted that pDCs represent a very rare cell population, less than 0.4% of circulating peripheral blood mononuclear cells, and tend to be found in lymph nodes.

The current standard of care for stage 3 melanoma is up-front surgery followed by adjuvant therapy – anti–PD-1 therapy for patients with wild-type or BRAF-mutant cancers, and targeted therapy with BRAF/MEK inhibitors in patients with BRAF mutations. However, preclinical studies suggest that neoadjuvant immunotherapy could lead to a stronger antitumor T-cell response than adjuvant immunotherapy.

Vidutolimod targets the toll-like receptor 9 (TLR-9) endosomal receptor found in B cells and pDC cells. The formulation is a virus-like particle (VLP) that contains unmethylated cytosine guanine–rich oligonucleotides (CpG ODN). Bacterial and viral genomes tend to be enriched in CpG ODN, and this acts as a TLR-9 agonist. TLR-9 activation in turn triggers an interferon response, and this may help overcome PD-1 blockade resistance in metastatic melanoma.

The researchers conducted a nonrandomized, open-label trial that included 30 patients with stage 3 melanoma (14 women; median age, 61 years). Patients received neoadjuvant nivolumab and vidutolimod for 8 weeks, then were evaluated for surgery. Patients continued both drugs in the adjuvant setting for 48 weeks. 47% experienced complete pathologic response, 10% a major pathologic response, and 10% a partial pathologic response.

Analysis of resected samples revealed clear evidence of an immune response, Dr. Davar said during a press conference held in advance of the meeting. “Pathologic response was associated with compelling evidence of immune activation both peripherally and within the tumor, with clear evidence of pDC infiltrate and pDC activation – something that has not previously been seen in human specimens.”

The study regimen appeared safe, with no dose-limiting toxicities or grade 4 or 5 adverse events. He noted that the regimen is now being tested in the phase 2 ECOG-ACRIN trial.

The results are “very exciting,” said Pamela Ohashi, PhD, who commented on the study during the press conference. The virus-like nature of vidutolimod may be an important element of the therapy. “I think scientifically we would have predicted that the VLP carrying the CPG would be very good at activating the CD8 cells, which in fact is what you’re seeing. So I think it’s very exciting and has lots of potential for future combinations,” said Dr. Ohashi, who is director of the tumor immunotherapy program at the Princess Margaret Cancer Centre, Toronto.

The study was funded by Checkmate Pharmaceuticals. Dr. Davar has financial relationships with Checkmate Pharmaceuticals and Regeneron, which has acquired Checkmate Pharmaceuticals.

NASHVILLE, TENN. – Supported by several cases series, a large cohort analysis has associated exposure to probiotics in the intensive care unit with a measurable increase in bacteremia and bacteremia-related mortality due to organisms in these preparations, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).

According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.

“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.

The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.

For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).

“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.

These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.

“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.

“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.

To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.

“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.

The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.

“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.

This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).

Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.

“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.

“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.

Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.

Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).

The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.

For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”

She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”

Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.

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

NASHVILLE, TENN. – Supported by several cases series, a large cohort analysis has associated exposure to probiotics in the intensive care unit with a measurable increase in bacteremia and bacteremia-related mortality due to organisms in these preparations, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).

According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.

“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.

The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.

For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).

“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.

These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.

“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.

“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.

To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.

“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.

The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.

“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.

This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).

Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.

“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.

“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.

Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.

Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).

The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.

For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”

She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”

Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.

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

NASHVILLE, TENN. – Supported by several cases series, a large cohort analysis has associated exposure to probiotics in the intensive care unit with a measurable increase in bacteremia and bacteremia-related mortality due to organisms in these preparations, according to new findings presented at the annual meeting of the American College of Chest Physicians (CHEST).

According to data presented by Scott Mayer, MD, chief resident at HealthONE Denver, which is part of the HCA Healthcare chain of hospitals, the risk is increased by any probiotic exposure. However, the risk is particularly acute for powdered formulations, presumably because powder more easily disseminates to contaminate central venous catheters.

“We think that probiotics should be eliminated entirely from the ICU. If not, we encourage eliminating the powder formulations,” said Dr. Mayer, who led the study.

The data linking probiotics to ICU bacteremia were drawn from 23,533 ICU admissions over a 5-year period in the HCA hospital database. Bacteremia proven to be probiotic-related was uncommon (0.37%), but the consequences were serious.

For those with probiotic-related bacteremia, the mortality rate was 25.6% or essentially twofold greater than the 13.5% mortality rate among those without probiotic bacteremia. An odds ratio drawn from a regression analysis confirmed a significant difference (OR, 2.23; 95% confidence interval, 1.30-3.71; P < .01).

“The absolute risk of mortality is modest but not insignificant,” said Dr. Mayer. This suggests one probiotic-related mortality for about every 200 patients taking a probiotic in the ICU.

These deaths occur without any clear compensatory benefit from taking probiotics, according to Dr. Mayer. There is a long list of potential benefits from probiotics that might be relevant to patients in the ICU, particularly prophylaxis for Clostridioides difficile infection, but also including a variety of gastrointestinal disorders, such as irritable bowel syndrome; however, none of these are firmly established in general, and particularly for patients in the ICU.

“The American College of Gastroenterology currently recommends against probiotics for the prevention of C. diff.,” Dr. Mayer said. Although the American Gastroenterological Association has issued a “conditional recommendation” for prevention of C. diff. infection with probiotics, Dr. Mayer pointed out this is qualified by a “low quality of evidence” and it is not specific to the ICU setting.

“The evidence for benefit is weak or nonexistent, but the risks are real,” Dr. Mayer said.

To confirm that probiotic-associated ICU bacteremias in the HCA hospital database were, in fact, related to probiotics being taken by patients at time of admission, Dr. Mayer evaluated the record of each of the 86 patients with probiotic bacteremia–associated mortality.

“I identified the organism that grew from the blood cultures to confirm that it was contained in the probiotic the patient was taking,” explained Dr. Mayer, who said this information was available in the electronic medical records.

The risk of probiotic-associated bacteremia in ICU patients was consistent with a series of case series that prompted the study. Dr. Mayer explained that he became interested when he encountered patients on his ICU rounds who were taking probiotics. He knew very little about these agents and explored the medical literature to see what evidence was available.

“I found several case reports of ICU patients with probiotic-associated infections, several of which were suspected of being associated with contamination of the central lines,” Dr. Mayer said. In one case, the patient was not taking a probiotic, but a patient in an adjacent bed was receiving a powdered probiotic that was implicated. This prompted suspicion that the cause was central-line contamination.

This was evaluated in the HCA ICU database and also found to be a significant risk. Among the 67 patients in whom a capsule or tablet was used, the rate of probiotic-associated bacteremia was 0.33%. For those in which the probiotic was a powdered formulation, the rate was 0.76%, a significant difference (P < .01).

Dr. Mayer acknowledged that these data do not rule out all potential benefits from probiotics in the ICU. He believes an obstacle to proving benefit has been the heterogeneity of available products, which are likely to be relevant to any therapeutic role, including prevention of C. diff. infection.

“There are now a large number of products available, and they contain a large variety of strains of organisms, so this has been a difficult area to study,” he said. However, he maintains it is prudent at this point to avoid probiotics in the ICU because the risks are not confined to the patient making this choice.

“My concern is not just the lack of evidence of benefit relative to the risk for the patient but the potential for probiotics in the ICU to place other patients at risk,” Dr. Mayer said.

Others have also noted the potential benefits of probiotics in the ICU, but the promise remains elusive. In a 2018 review article published in the Journal of Emergency and Critical Care Medicine, the authors evaluated a series of potential applications of probiotics in critically ill patients. These included treatment of ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and surgical-site infections (SSI). For each, the data were negative or inconclusive.

Over the 4 years that have passed since the review was published, several trials have further explored the potential benefits of probiotics in the ICU but none have changed this basic conclusion. For example, a 2021 multinational trial, published in The Lancet, randomized more than 2,600 patients to probiotics or placebo and showed no effect on VAP incidence (21.9% vs. 21.3%).

The lead author of the 2018 review, Heather A. Vitko, PhD, an associate professor in the department of acute and tertiary care, University of Pittsburgh School of Nursing, also emphasized that the potential for benefit cannot be considered without the potential for risk. She, like Dr. Mayer, cited the case studies implicating probiotics in systemic infections.

For administration, probiotic capsules or sachets “often need to be opened for administration through a feeding tube,” she noted. The risk of contamination comes from both the air and contaminated hands, the latter of which “can cause a translocation to a central line catheter where the microbes have direct entry into the systemic circulation.”

She did not call for a ban of probiotics in the ICU, but she did recommend “a precautionary approach,” encouraging clinicians to “distinguish between reality [of what has been proven] and what is presented in the marketing of antibiotics.”

Dr. Mayer and Dr. Vitko have reported no relevant financial relationships.

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

In advanced and metastatic melanoma patients, fecal microbiota transplant (FMT) from healthy donors in advance of anti–PD-1 immunotherapy led to a 75% clinical benefit rate, defined as complete response, partial response, or stable disease that lasted 6 months or longer. The results come from a small, single arm phase 1 study whose primary endpoint was safety.

“We know that the gut microbiome has shown the ability to affect the systemic antitumor immunity by affecting the CD8+ T cells and CD4+ T cells, and these are the cells that are ultimately important for the function of checkpoint inhibitors. There is now clinical evidence that has shown that changing patient microbiota via fecal microbiota transplantation using stool from previous responder patients has the capacity to sensitize immunotherapy refractory melanomas to anti–PD-1 therapy, (with) about 30% response in this setting,” said Saman Maleki, PhD, during his presentation of the results at the Society for Immunotherapy of Cancer’s 37th Annual Meeting. He also noted that broad-spectrum antibiotics have been shown to negatively influence responses to immunotherapy.

Rather than using stool from donors who responded to immunotherapy, the researchers chose instead to use stool from healthy donors.

The study included 20 patients with advanced melanoma who had not been treated with anti–PD-1 therapy. The median age was 75.5 years, 40% were female, and 75% had wild type BRAF. All patients underwent bowel prep and then received fecal transplants from healthy donors, followed by a 7-day engraftment period before initiating anti–PD-1 therapy in the form of nivolumab or pembrolizumab.

The primary endpoint of the study was safety, and no grade 3 or 4 toxicities were observed during the FMT, and safety signals associated with anti–PD-1 therapies were in line with previous experience.

Fifteen percent of patients had a complete response, 50% had a partial response, 15% had stable disease, and 20% had progressive disease. Seventy-five percent of patients had a complete response, partial response, or stable disease that lasted at least 6 months.

Analysis of the microbiomes showed much higher diversity in the donor microbiomes than in patients. “What was really interesting was that the success of engraftment and retention of the donor microbiome was really key in determining between responders and nonresponders. Responders had successful engraftment that lasted over time, and in nonresponders we did not see that,” said Dr. Maleki, who is a cancer immunology researcher at the University of Western Ontario, London.

They also saw differences between responders and nonresponders in how their microbiome evolved over time. Responders had enrichment in Ruminococcus callidus and other bacteria, while nonresponders had enrichment in different bacteria, among them Catabacter hongkongensis, which has previously been implicated as negatively impacting anti–PD-1 responses, according to Dr. Maleki.

Microbiomes from healthy donors had greater diversity than the patients. Following FMT, patients’ microbiomes increased regardless of clinical response to immunotherapy. However, the tendency for patients to trend toward and retain greater diversity over time was associated with treatment success. “What we saw that was key in patients’ response to immunotherapy was the ability of the patients to retain the donor microbiome. All patients’ microbiomes changed and shifted toward the donors’ post FMT. However, only the responders were able to keep the donor microbiome over time, and the nonresponders’ microbiomes reverted to the previous microbiome,” Dr. Maleki said.

The researchers also conducted a mouse version of the clinical trial. They transplanted mice with the baseline fecal samples of a human responder and then exposed the animals to tumors. They then conducted a second FMT with stool from the human donor, and the animals then responded to anti–PD-1 therapy. The results further confirm “that the donor still has the capacity to drive response in this setting,” Dr. Maleki said.

Dr. Maleki is a board member of IMV Inc.

In advanced and metastatic melanoma patients, fecal microbiota transplant (FMT) from healthy donors in advance of anti–PD-1 immunotherapy led to a 75% clinical benefit rate, defined as complete response, partial response, or stable disease that lasted 6 months or longer. The results come from a small, single arm phase 1 study whose primary endpoint was safety.

“We know that the gut microbiome has shown the ability to affect the systemic antitumor immunity by affecting the CD8+ T cells and CD4+ T cells, and these are the cells that are ultimately important for the function of checkpoint inhibitors. There is now clinical evidence that has shown that changing patient microbiota via fecal microbiota transplantation using stool from previous responder patients has the capacity to sensitize immunotherapy refractory melanomas to anti–PD-1 therapy, (with) about 30% response in this setting,” said Saman Maleki, PhD, during his presentation of the results at the Society for Immunotherapy of Cancer’s 37th Annual Meeting. He also noted that broad-spectrum antibiotics have been shown to negatively influence responses to immunotherapy.

Rather than using stool from donors who responded to immunotherapy, the researchers chose instead to use stool from healthy donors.

The study included 20 patients with advanced melanoma who had not been treated with anti–PD-1 therapy. The median age was 75.5 years, 40% were female, and 75% had wild type BRAF. All patients underwent bowel prep and then received fecal transplants from healthy donors, followed by a 7-day engraftment period before initiating anti–PD-1 therapy in the form of nivolumab or pembrolizumab.

The primary endpoint of the study was safety, and no grade 3 or 4 toxicities were observed during the FMT, and safety signals associated with anti–PD-1 therapies were in line with previous experience.

Fifteen percent of patients had a complete response, 50% had a partial response, 15% had stable disease, and 20% had progressive disease. Seventy-five percent of patients had a complete response, partial response, or stable disease that lasted at least 6 months.

Analysis of the microbiomes showed much higher diversity in the donor microbiomes than in patients. “What was really interesting was that the success of engraftment and retention of the donor microbiome was really key in determining between responders and nonresponders. Responders had successful engraftment that lasted over time, and in nonresponders we did not see that,” said Dr. Maleki, who is a cancer immunology researcher at the University of Western Ontario, London.

They also saw differences between responders and nonresponders in how their microbiome evolved over time. Responders had enrichment in Ruminococcus callidus and other bacteria, while nonresponders had enrichment in different bacteria, among them Catabacter hongkongensis, which has previously been implicated as negatively impacting anti–PD-1 responses, according to Dr. Maleki.

Microbiomes from healthy donors had greater diversity than the patients. Following FMT, patients’ microbiomes increased regardless of clinical response to immunotherapy. However, the tendency for patients to trend toward and retain greater diversity over time was associated with treatment success. “What we saw that was key in patients’ response to immunotherapy was the ability of the patients to retain the donor microbiome. All patients’ microbiomes changed and shifted toward the donors’ post FMT. However, only the responders were able to keep the donor microbiome over time, and the nonresponders’ microbiomes reverted to the previous microbiome,” Dr. Maleki said.

The researchers also conducted a mouse version of the clinical trial. They transplanted mice with the baseline fecal samples of a human responder and then exposed the animals to tumors. They then conducted a second FMT with stool from the human donor, and the animals then responded to anti–PD-1 therapy. The results further confirm “that the donor still has the capacity to drive response in this setting,” Dr. Maleki said.

Dr. Maleki is a board member of IMV Inc.

In advanced and metastatic melanoma patients, fecal microbiota transplant (FMT) from healthy donors in advance of anti–PD-1 immunotherapy led to a 75% clinical benefit rate, defined as complete response, partial response, or stable disease that lasted 6 months or longer. The results come from a small, single arm phase 1 study whose primary endpoint was safety.

“We know that the gut microbiome has shown the ability to affect the systemic antitumor immunity by affecting the CD8+ T cells and CD4+ T cells, and these are the cells that are ultimately important for the function of checkpoint inhibitors. There is now clinical evidence that has shown that changing patient microbiota via fecal microbiota transplantation using stool from previous responder patients has the capacity to sensitize immunotherapy refractory melanomas to anti–PD-1 therapy, (with) about 30% response in this setting,” said Saman Maleki, PhD, during his presentation of the results at the Society for Immunotherapy of Cancer’s 37th Annual Meeting. He also noted that broad-spectrum antibiotics have been shown to negatively influence responses to immunotherapy.

Rather than using stool from donors who responded to immunotherapy, the researchers chose instead to use stool from healthy donors.

The study included 20 patients with advanced melanoma who had not been treated with anti–PD-1 therapy. The median age was 75.5 years, 40% were female, and 75% had wild type BRAF. All patients underwent bowel prep and then received fecal transplants from healthy donors, followed by a 7-day engraftment period before initiating anti–PD-1 therapy in the form of nivolumab or pembrolizumab.

The primary endpoint of the study was safety, and no grade 3 or 4 toxicities were observed during the FMT, and safety signals associated with anti–PD-1 therapies were in line with previous experience.

Fifteen percent of patients had a complete response, 50% had a partial response, 15% had stable disease, and 20% had progressive disease. Seventy-five percent of patients had a complete response, partial response, or stable disease that lasted at least 6 months.

Analysis of the microbiomes showed much higher diversity in the donor microbiomes than in patients. “What was really interesting was that the success of engraftment and retention of the donor microbiome was really key in determining between responders and nonresponders. Responders had successful engraftment that lasted over time, and in nonresponders we did not see that,” said Dr. Maleki, who is a cancer immunology researcher at the University of Western Ontario, London.

They also saw differences between responders and nonresponders in how their microbiome evolved over time. Responders had enrichment in Ruminococcus callidus and other bacteria, while nonresponders had enrichment in different bacteria, among them Catabacter hongkongensis, which has previously been implicated as negatively impacting anti–PD-1 responses, according to Dr. Maleki.

Microbiomes from healthy donors had greater diversity than the patients. Following FMT, patients’ microbiomes increased regardless of clinical response to immunotherapy. However, the tendency for patients to trend toward and retain greater diversity over time was associated with treatment success. “What we saw that was key in patients’ response to immunotherapy was the ability of the patients to retain the donor microbiome. All patients’ microbiomes changed and shifted toward the donors’ post FMT. However, only the responders were able to keep the donor microbiome over time, and the nonresponders’ microbiomes reverted to the previous microbiome,” Dr. Maleki said.

The researchers also conducted a mouse version of the clinical trial. They transplanted mice with the baseline fecal samples of a human responder and then exposed the animals to tumors. They then conducted a second FMT with stool from the human donor, and the animals then responded to anti–PD-1 therapy. The results further confirm “that the donor still has the capacity to drive response in this setting,” Dr. Maleki said.

Dr. Maleki is a board member of IMV Inc.

LAS VEGAS – Disparities in the diagnosis and treatment of skin of color can stem from incorrect diagnoses and lack of knowledge on the part of clinicians, and also from knowledge gaps on the part of other health care providers and patients, Susan C. Taylor, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Additionally, some disparities occur because of gaps in access to health care, said Dr. Taylor, vice chair, diversity, equity and inclusion, in the department of dermatology at the University of Pennsylvania, Philadelphia, who moderated an expert panel discussion of treatment tips for several common dermatologic conditions in skin of color patients.

Atopic dermatitis angles

Atopic dermatitis (AD) is the fourth most common dermatologic complaint in Black patients, based on data from the United States National Ambulatory Medical Care Survey. Also, data from the National Health and Nutrition Examination Survey show that Black children are nearly twice as likely as White children to develop AD after controlling for socioeconomic factors, Dr. Taylor said.

When Black patients present with AD, “you may not see the erythema,” said Valerie D. Callender, MD, of Howard University, Washington, who presented on AD. Instead, “you may see more follicular and papular presentations.” Erythema and erythroderma can present as shades of violet, gray, or dark brown in patients with rich skin tones, added Dr. Callender, who practices in Glenn Dale, Md.

Consequently, disease severity can be misinterpreted, she said, noting that data suggest that scoring systems such as the Eczema Area and Severity Index and Scoring Atopic Dermatitis underestimate AD severity in dark skin.

As for treatment, skin of color patients with AD are often as bothered by postinflammatory hyperpigmentation (PIH) as by active lesions, so treatment should take these concerns into account, Dr. Callender said. Studies evaluating the effectiveness of AD treatments in diverse populations are limited by lack of representation of racial groups in clinical trials and lack of subset analyses by race.
 

Acne awareness

An important consideration of acne in skin of color patients is that the acne “might not be red, it might just be darker,” said Andrew F. Alexis, MD, vice-chair for diversity and inclusion in the department of dermatology, and professor of clinical dermatology at Weill Cornell Medicine, New York. A study published in JAMA Dermatology of nearly 30,000 patients with acne from 2007 to 2017 found that non-Hispanic Black patients were more likely than non-Hispanic White patients to see a dermatologist for acne, but Black patients received fewer prescriptions for acne medications than White patients.

The study also showed that Black patients who received prescriptions for acne were more likely to receive topical retinoids and topical antibiotics, and less likely to receive oral antibiotics, spironolactone, or isotretinoin, compared with White patients. Similarly, Asian patients were more likely to receive topical antibiotics and less likely to receive oral antibiotics, compared with White patients.

Other panelists shared some of their best practices for acne in patients with skin of color, including treatment with topical retinoids (for inflammation) and spironolactone, and therapies that address both inflammation and pigmentation, such as salicylic acid and azelaic acid. Dr. Callender also advised asking patients about makeup, as they may not know that many types of makeup used to cover acne are in fact comedogenic.
 

Melanoma misconceptions

One of the most common misperceptions about melanoma among skin of color patients is that they don’t think they can get it, Dr. Taylor said. Many health care providers don’t think about melanoma in skin of color patients because of the dramatically lower incidence in this population, but as a result, cases may go undiagnosed, and as studies have shown, the mortality rate from melanoma is higher in Black patients.

Consider the palms, soles, nails, and web spaces as possible melanoma sites, Dr. Taylor added.

Educating skin of color patients about melanoma is important, although the incidence is 20 to 30 times lower than in non-Hispanic Whites, said Nada Elbuluk, MD, the founder and director of the University of Southern California Skin of Color Center and Pigmentary Disorders Clinic, Los Angeles. A 2020 editorial published in Cancer Cytopathology pointed out that 1 in 3 Black men or women with a melanoma diagnosis in the United States dies of the disease, compared with 1 in 7 non-Hispanic White men and 1 in 11 non-Hispanic White women with melanoma.

Don’t skip the total body skin exam in these patients, Dr. Elbuluk emphasized. Many patients will only partially undress, and areas such as toes can be missed.
 

Rosacea review

For patients with skin of color, clinicians need to look for different signs of rosacea than those typically seen in White patients, Dr. Elbuluk said. “The most common presentation of rosacea in skin of color is papulopustular,” and the granulomatous variant.

“These patients will often give you a history of sensitivity to products,” Dr. Elbuluk noted. They may not always have the flushing, but they may report warmth or itching, in addition to product sensitivity.

When considering rosacea in skin of color patients, be sure to have good lighting for close examination, as skin thickening is another subtle sign of rosacea in these patients, she said. Skin thickening “is a very early sign that will present in skin of color with no erythema, so keep that in mind.”

Stinging and burning sensations may be reported by skin of color patients with rosacea. Use patient history to confirm the diagnosis of rosacea, which is often delayed in skin of color patients because of a low index of suspicion, she said.

Psoriasis pointers

Psoriasis in skin of color patients used to be considered rare, “but that is far from true,” Dr. Alexis said. In fact, many cases of psoriasis are undiagnosed or the diagnosis is delayed in these patients.

The panelists noted that current guidelines for psoriasis treatment are based on clinical trials composed mainly of White patients, and do not contain specific recommendations for skin of color patients.

Notably, the morphology, location, and color of psoriasis lesions may be different for patients with darker skin, such as thicker plaques and more scaling over larger areas, they said. Also, skin of color patients may experience long-lasting dyspigmentation from psoriasis lesions that have resolved.

When developing a strategy for psoriasis in skin of color patients, consider not only disease severity, but also comorbidities and medications, response (if any) to prior therapies, patient preferences, and quality of life, the panelists said.

Dr. Callender, Dr. Elbuluk, Dr. Taylor, and Dr. Alexis reported conflicts of interest from numerous sources in industry. MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – Disparities in the diagnosis and treatment of skin of color can stem from incorrect diagnoses and lack of knowledge on the part of clinicians, and also from knowledge gaps on the part of other health care providers and patients, Susan C. Taylor, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Additionally, some disparities occur because of gaps in access to health care, said Dr. Taylor, vice chair, diversity, equity and inclusion, in the department of dermatology at the University of Pennsylvania, Philadelphia, who moderated an expert panel discussion of treatment tips for several common dermatologic conditions in skin of color patients.

Atopic dermatitis angles

Atopic dermatitis (AD) is the fourth most common dermatologic complaint in Black patients, based on data from the United States National Ambulatory Medical Care Survey. Also, data from the National Health and Nutrition Examination Survey show that Black children are nearly twice as likely as White children to develop AD after controlling for socioeconomic factors, Dr. Taylor said.

When Black patients present with AD, “you may not see the erythema,” said Valerie D. Callender, MD, of Howard University, Washington, who presented on AD. Instead, “you may see more follicular and papular presentations.” Erythema and erythroderma can present as shades of violet, gray, or dark brown in patients with rich skin tones, added Dr. Callender, who practices in Glenn Dale, Md.

Consequently, disease severity can be misinterpreted, she said, noting that data suggest that scoring systems such as the Eczema Area and Severity Index and Scoring Atopic Dermatitis underestimate AD severity in dark skin.

As for treatment, skin of color patients with AD are often as bothered by postinflammatory hyperpigmentation (PIH) as by active lesions, so treatment should take these concerns into account, Dr. Callender said. Studies evaluating the effectiveness of AD treatments in diverse populations are limited by lack of representation of racial groups in clinical trials and lack of subset analyses by race.
 

Acne awareness

An important consideration of acne in skin of color patients is that the acne “might not be red, it might just be darker,” said Andrew F. Alexis, MD, vice-chair for diversity and inclusion in the department of dermatology, and professor of clinical dermatology at Weill Cornell Medicine, New York. A study published in JAMA Dermatology of nearly 30,000 patients with acne from 2007 to 2017 found that non-Hispanic Black patients were more likely than non-Hispanic White patients to see a dermatologist for acne, but Black patients received fewer prescriptions for acne medications than White patients.

The study also showed that Black patients who received prescriptions for acne were more likely to receive topical retinoids and topical antibiotics, and less likely to receive oral antibiotics, spironolactone, or isotretinoin, compared with White patients. Similarly, Asian patients were more likely to receive topical antibiotics and less likely to receive oral antibiotics, compared with White patients.

Other panelists shared some of their best practices for acne in patients with skin of color, including treatment with topical retinoids (for inflammation) and spironolactone, and therapies that address both inflammation and pigmentation, such as salicylic acid and azelaic acid. Dr. Callender also advised asking patients about makeup, as they may not know that many types of makeup used to cover acne are in fact comedogenic.
 

Melanoma misconceptions

One of the most common misperceptions about melanoma among skin of color patients is that they don’t think they can get it, Dr. Taylor said. Many health care providers don’t think about melanoma in skin of color patients because of the dramatically lower incidence in this population, but as a result, cases may go undiagnosed, and as studies have shown, the mortality rate from melanoma is higher in Black patients.

Consider the palms, soles, nails, and web spaces as possible melanoma sites, Dr. Taylor added.

Educating skin of color patients about melanoma is important, although the incidence is 20 to 30 times lower than in non-Hispanic Whites, said Nada Elbuluk, MD, the founder and director of the University of Southern California Skin of Color Center and Pigmentary Disorders Clinic, Los Angeles. A 2020 editorial published in Cancer Cytopathology pointed out that 1 in 3 Black men or women with a melanoma diagnosis in the United States dies of the disease, compared with 1 in 7 non-Hispanic White men and 1 in 11 non-Hispanic White women with melanoma.

Don’t skip the total body skin exam in these patients, Dr. Elbuluk emphasized. Many patients will only partially undress, and areas such as toes can be missed.
 

Rosacea review

For patients with skin of color, clinicians need to look for different signs of rosacea than those typically seen in White patients, Dr. Elbuluk said. “The most common presentation of rosacea in skin of color is papulopustular,” and the granulomatous variant.

“These patients will often give you a history of sensitivity to products,” Dr. Elbuluk noted. They may not always have the flushing, but they may report warmth or itching, in addition to product sensitivity.

When considering rosacea in skin of color patients, be sure to have good lighting for close examination, as skin thickening is another subtle sign of rosacea in these patients, she said. Skin thickening “is a very early sign that will present in skin of color with no erythema, so keep that in mind.”

Stinging and burning sensations may be reported by skin of color patients with rosacea. Use patient history to confirm the diagnosis of rosacea, which is often delayed in skin of color patients because of a low index of suspicion, she said.

Psoriasis pointers

Psoriasis in skin of color patients used to be considered rare, “but that is far from true,” Dr. Alexis said. In fact, many cases of psoriasis are undiagnosed or the diagnosis is delayed in these patients.

The panelists noted that current guidelines for psoriasis treatment are based on clinical trials composed mainly of White patients, and do not contain specific recommendations for skin of color patients.

Notably, the morphology, location, and color of psoriasis lesions may be different for patients with darker skin, such as thicker plaques and more scaling over larger areas, they said. Also, skin of color patients may experience long-lasting dyspigmentation from psoriasis lesions that have resolved.

When developing a strategy for psoriasis in skin of color patients, consider not only disease severity, but also comorbidities and medications, response (if any) to prior therapies, patient preferences, and quality of life, the panelists said.

Dr. Callender, Dr. Elbuluk, Dr. Taylor, and Dr. Alexis reported conflicts of interest from numerous sources in industry. MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – Disparities in the diagnosis and treatment of skin of color can stem from incorrect diagnoses and lack of knowledge on the part of clinicians, and also from knowledge gaps on the part of other health care providers and patients, Susan C. Taylor, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Additionally, some disparities occur because of gaps in access to health care, said Dr. Taylor, vice chair, diversity, equity and inclusion, in the department of dermatology at the University of Pennsylvania, Philadelphia, who moderated an expert panel discussion of treatment tips for several common dermatologic conditions in skin of color patients.

Atopic dermatitis angles

Atopic dermatitis (AD) is the fourth most common dermatologic complaint in Black patients, based on data from the United States National Ambulatory Medical Care Survey. Also, data from the National Health and Nutrition Examination Survey show that Black children are nearly twice as likely as White children to develop AD after controlling for socioeconomic factors, Dr. Taylor said.

When Black patients present with AD, “you may not see the erythema,” said Valerie D. Callender, MD, of Howard University, Washington, who presented on AD. Instead, “you may see more follicular and papular presentations.” Erythema and erythroderma can present as shades of violet, gray, or dark brown in patients with rich skin tones, added Dr. Callender, who practices in Glenn Dale, Md.

Consequently, disease severity can be misinterpreted, she said, noting that data suggest that scoring systems such as the Eczema Area and Severity Index and Scoring Atopic Dermatitis underestimate AD severity in dark skin.

As for treatment, skin of color patients with AD are often as bothered by postinflammatory hyperpigmentation (PIH) as by active lesions, so treatment should take these concerns into account, Dr. Callender said. Studies evaluating the effectiveness of AD treatments in diverse populations are limited by lack of representation of racial groups in clinical trials and lack of subset analyses by race.
 

Acne awareness

An important consideration of acne in skin of color patients is that the acne “might not be red, it might just be darker,” said Andrew F. Alexis, MD, vice-chair for diversity and inclusion in the department of dermatology, and professor of clinical dermatology at Weill Cornell Medicine, New York. A study published in JAMA Dermatology of nearly 30,000 patients with acne from 2007 to 2017 found that non-Hispanic Black patients were more likely than non-Hispanic White patients to see a dermatologist for acne, but Black patients received fewer prescriptions for acne medications than White patients.

The study also showed that Black patients who received prescriptions for acne were more likely to receive topical retinoids and topical antibiotics, and less likely to receive oral antibiotics, spironolactone, or isotretinoin, compared with White patients. Similarly, Asian patients were more likely to receive topical antibiotics and less likely to receive oral antibiotics, compared with White patients.

Other panelists shared some of their best practices for acne in patients with skin of color, including treatment with topical retinoids (for inflammation) and spironolactone, and therapies that address both inflammation and pigmentation, such as salicylic acid and azelaic acid. Dr. Callender also advised asking patients about makeup, as they may not know that many types of makeup used to cover acne are in fact comedogenic.
 

Melanoma misconceptions

One of the most common misperceptions about melanoma among skin of color patients is that they don’t think they can get it, Dr. Taylor said. Many health care providers don’t think about melanoma in skin of color patients because of the dramatically lower incidence in this population, but as a result, cases may go undiagnosed, and as studies have shown, the mortality rate from melanoma is higher in Black patients.

Consider the palms, soles, nails, and web spaces as possible melanoma sites, Dr. Taylor added.

Educating skin of color patients about melanoma is important, although the incidence is 20 to 30 times lower than in non-Hispanic Whites, said Nada Elbuluk, MD, the founder and director of the University of Southern California Skin of Color Center and Pigmentary Disorders Clinic, Los Angeles. A 2020 editorial published in Cancer Cytopathology pointed out that 1 in 3 Black men or women with a melanoma diagnosis in the United States dies of the disease, compared with 1 in 7 non-Hispanic White men and 1 in 11 non-Hispanic White women with melanoma.

Don’t skip the total body skin exam in these patients, Dr. Elbuluk emphasized. Many patients will only partially undress, and areas such as toes can be missed.
 

Rosacea review

For patients with skin of color, clinicians need to look for different signs of rosacea than those typically seen in White patients, Dr. Elbuluk said. “The most common presentation of rosacea in skin of color is papulopustular,” and the granulomatous variant.

“These patients will often give you a history of sensitivity to products,” Dr. Elbuluk noted. They may not always have the flushing, but they may report warmth or itching, in addition to product sensitivity.

When considering rosacea in skin of color patients, be sure to have good lighting for close examination, as skin thickening is another subtle sign of rosacea in these patients, she said. Skin thickening “is a very early sign that will present in skin of color with no erythema, so keep that in mind.”

Stinging and burning sensations may be reported by skin of color patients with rosacea. Use patient history to confirm the diagnosis of rosacea, which is often delayed in skin of color patients because of a low index of suspicion, she said.

Psoriasis pointers

Psoriasis in skin of color patients used to be considered rare, “but that is far from true,” Dr. Alexis said. In fact, many cases of psoriasis are undiagnosed or the diagnosis is delayed in these patients.

The panelists noted that current guidelines for psoriasis treatment are based on clinical trials composed mainly of White patients, and do not contain specific recommendations for skin of color patients.

Notably, the morphology, location, and color of psoriasis lesions may be different for patients with darker skin, such as thicker plaques and more scaling over larger areas, they said. Also, skin of color patients may experience long-lasting dyspigmentation from psoriasis lesions that have resolved.

When developing a strategy for psoriasis in skin of color patients, consider not only disease severity, but also comorbidities and medications, response (if any) to prior therapies, patient preferences, and quality of life, the panelists said.

Dr. Callender, Dr. Elbuluk, Dr. Taylor, and Dr. Alexis reported conflicts of interest from numerous sources in industry. MedscapeLive and this news organization are owned by the same parent company.

In a phase 2 clinical trial of the soluble lymphocyte-activation gene 3 (LAG-3) as a potential treatment for non–small cell lung cancer (NSCLC), the drug performed well across all levels of PD-L1 expression.

“We observed a very encouraging response rate. Responses were seen across PD-L1 status,” said Wade Iams, MD, at a press conference held in advance of the annual meeting of the Society for Immunotherapy of Cancer. Dr. Iams is a professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn.

“The study was not loaded to PD-L1–high patients. We had a good breakdown across all of our three typical groups in the [NSCLC] treatment setting. Across histology types between squamous and nonsquamous, the median duration of response was almost 22 months. This is very encouraging compared to historical controls,” he said.

Eftilagimod alpha is a soluble form of the LAG-3 protein, which is a stimulator of antigen-presenting cells and CD8+ T cells through its action on MHC class 2 molecules. It suppresses the activation of T cells and therefore has the potential to boost the effect of anti–PD-1 therapy. LAG-3 can have both stimulatory and inhibitor immune effects, leading Immutep, which sponsored the study with Merck Sharp and Dohme, to pursue it in both cancer immunotherapy and autoimmune diseases.

The drug is a departure from other drugs which are LAG-3 antagonists. Those therapies interfere with the interaction between LAG-3 on the surface of activated T cells and MHC class 2 molecules on the surface of resting dendritic cells, which would otherwise dampen immune response in the tumor microenvironment. On the other hand, LAG-3 (or eftilagimod alpha) interacts with MHC class 2 on the surface of activated dendritic cells and monocytes to stimulate production of cytotoxic CD8+ T cells. These in turn can be unleashed further by the downstream action of pembrolizumab.

The phase 2 trial included three parts: In part A, 114 patients with NSCLC received the combination of eftilagimod alpha and pembrolizumab being given as a first-line therapy. Part B looked at the combination in 36 patents who were resistant to PD-1/PD-L1 therapies. Part C included 39 patients with head and neck squamous cell carcinoma who had previously received platinum-based chemotherapy. Patients received combination therapy for up to 1 year, then monotherapy with pembrolizumab for up to another year.

The primary endpoint of the study was a comparison of overall response rate to historical controls, with success set at 35% or higher. In the intent-to-treat analysis of the treatment-naive NSCLC population, ORR was 39.5% (95% confidence interval, 30.5%-49.1%) and the interim median progression-free survival was 6.9 months (95% CI, 4.9-9.3 months). Among 40 responders, the median duration of response was 21.6 months (95% CI, 17.3-30.0 months). ORRs were similar between squamous and nonsquamous subtypes.

In his presentation of the results, Dr. Iams said that 75% of participants had PD-L1 levels below 50%. The ORR was highest at 55% in the PD-L1 greater than 50% group, 44.7% in the PD-L1 1%-49% group, and 31.1% in the PD-L1 less than 1% group. It was a “very impressive response rate” for the low PD-L1 group, Dr. Iams said. Interim median progression-free survival followed a similar trend, with values of 11.4 months, 8.3 months, and 4.2 months, respectively.

Asked about the efficacy across subgroups, Dr. Iams responded that other immune stimulating agents have shown a stepwise improvement across PD-L1 expression levels, similar to what was observed in the current study. “My personal opinion as to why it was still effective at low PD-L1 is in part that PD-L1 is an imperfect biomarker. We know that there’s tumor heterogeneity, and perhaps it’s not fully representative of a one-site evaluation, but also in combination, and we have seen this in patients with [NSCLC] treated with both PD-L1 and CTLA-4 agents of increased efficacy in the PD-L1–low patients. So these combination immunotherapy strategies may be uniquely opportune for the low PD-L1 patients,” Dr. Iams said.

The study was funded by Immutep and Merck Sharp and Dohme. Dr. Iams has financial relationships with Merck.

In a phase 2 clinical trial of the soluble lymphocyte-activation gene 3 (LAG-3) as a potential treatment for non–small cell lung cancer (NSCLC), the drug performed well across all levels of PD-L1 expression.

“We observed a very encouraging response rate. Responses were seen across PD-L1 status,” said Wade Iams, MD, at a press conference held in advance of the annual meeting of the Society for Immunotherapy of Cancer. Dr. Iams is a professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn.

“The study was not loaded to PD-L1–high patients. We had a good breakdown across all of our three typical groups in the [NSCLC] treatment setting. Across histology types between squamous and nonsquamous, the median duration of response was almost 22 months. This is very encouraging compared to historical controls,” he said.

Eftilagimod alpha is a soluble form of the LAG-3 protein, which is a stimulator of antigen-presenting cells and CD8+ T cells through its action on MHC class 2 molecules. It suppresses the activation of T cells and therefore has the potential to boost the effect of anti–PD-1 therapy. LAG-3 can have both stimulatory and inhibitor immune effects, leading Immutep, which sponsored the study with Merck Sharp and Dohme, to pursue it in both cancer immunotherapy and autoimmune diseases.

The drug is a departure from other drugs which are LAG-3 antagonists. Those therapies interfere with the interaction between LAG-3 on the surface of activated T cells and MHC class 2 molecules on the surface of resting dendritic cells, which would otherwise dampen immune response in the tumor microenvironment. On the other hand, LAG-3 (or eftilagimod alpha) interacts with MHC class 2 on the surface of activated dendritic cells and monocytes to stimulate production of cytotoxic CD8+ T cells. These in turn can be unleashed further by the downstream action of pembrolizumab.

The phase 2 trial included three parts: In part A, 114 patients with NSCLC received the combination of eftilagimod alpha and pembrolizumab being given as a first-line therapy. Part B looked at the combination in 36 patents who were resistant to PD-1/PD-L1 therapies. Part C included 39 patients with head and neck squamous cell carcinoma who had previously received platinum-based chemotherapy. Patients received combination therapy for up to 1 year, then monotherapy with pembrolizumab for up to another year.

The primary endpoint of the study was a comparison of overall response rate to historical controls, with success set at 35% or higher. In the intent-to-treat analysis of the treatment-naive NSCLC population, ORR was 39.5% (95% confidence interval, 30.5%-49.1%) and the interim median progression-free survival was 6.9 months (95% CI, 4.9-9.3 months). Among 40 responders, the median duration of response was 21.6 months (95% CI, 17.3-30.0 months). ORRs were similar between squamous and nonsquamous subtypes.

In his presentation of the results, Dr. Iams said that 75% of participants had PD-L1 levels below 50%. The ORR was highest at 55% in the PD-L1 greater than 50% group, 44.7% in the PD-L1 1%-49% group, and 31.1% in the PD-L1 less than 1% group. It was a “very impressive response rate” for the low PD-L1 group, Dr. Iams said. Interim median progression-free survival followed a similar trend, with values of 11.4 months, 8.3 months, and 4.2 months, respectively.

Asked about the efficacy across subgroups, Dr. Iams responded that other immune stimulating agents have shown a stepwise improvement across PD-L1 expression levels, similar to what was observed in the current study. “My personal opinion as to why it was still effective at low PD-L1 is in part that PD-L1 is an imperfect biomarker. We know that there’s tumor heterogeneity, and perhaps it’s not fully representative of a one-site evaluation, but also in combination, and we have seen this in patients with [NSCLC] treated with both PD-L1 and CTLA-4 agents of increased efficacy in the PD-L1–low patients. So these combination immunotherapy strategies may be uniquely opportune for the low PD-L1 patients,” Dr. Iams said.

The study was funded by Immutep and Merck Sharp and Dohme. Dr. Iams has financial relationships with Merck.

In a phase 2 clinical trial of the soluble lymphocyte-activation gene 3 (LAG-3) as a potential treatment for non–small cell lung cancer (NSCLC), the drug performed well across all levels of PD-L1 expression.

“We observed a very encouraging response rate. Responses were seen across PD-L1 status,” said Wade Iams, MD, at a press conference held in advance of the annual meeting of the Society for Immunotherapy of Cancer. Dr. Iams is a professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn.

“The study was not loaded to PD-L1–high patients. We had a good breakdown across all of our three typical groups in the [NSCLC] treatment setting. Across histology types between squamous and nonsquamous, the median duration of response was almost 22 months. This is very encouraging compared to historical controls,” he said.

Eftilagimod alpha is a soluble form of the LAG-3 protein, which is a stimulator of antigen-presenting cells and CD8+ T cells through its action on MHC class 2 molecules. It suppresses the activation of T cells and therefore has the potential to boost the effect of anti–PD-1 therapy. LAG-3 can have both stimulatory and inhibitor immune effects, leading Immutep, which sponsored the study with Merck Sharp and Dohme, to pursue it in both cancer immunotherapy and autoimmune diseases.

The drug is a departure from other drugs which are LAG-3 antagonists. Those therapies interfere with the interaction between LAG-3 on the surface of activated T cells and MHC class 2 molecules on the surface of resting dendritic cells, which would otherwise dampen immune response in the tumor microenvironment. On the other hand, LAG-3 (or eftilagimod alpha) interacts with MHC class 2 on the surface of activated dendritic cells and monocytes to stimulate production of cytotoxic CD8+ T cells. These in turn can be unleashed further by the downstream action of pembrolizumab.

The phase 2 trial included three parts: In part A, 114 patients with NSCLC received the combination of eftilagimod alpha and pembrolizumab being given as a first-line therapy. Part B looked at the combination in 36 patents who were resistant to PD-1/PD-L1 therapies. Part C included 39 patients with head and neck squamous cell carcinoma who had previously received platinum-based chemotherapy. Patients received combination therapy for up to 1 year, then monotherapy with pembrolizumab for up to another year.

The primary endpoint of the study was a comparison of overall response rate to historical controls, with success set at 35% or higher. In the intent-to-treat analysis of the treatment-naive NSCLC population, ORR was 39.5% (95% confidence interval, 30.5%-49.1%) and the interim median progression-free survival was 6.9 months (95% CI, 4.9-9.3 months). Among 40 responders, the median duration of response was 21.6 months (95% CI, 17.3-30.0 months). ORRs were similar between squamous and nonsquamous subtypes.

In his presentation of the results, Dr. Iams said that 75% of participants had PD-L1 levels below 50%. The ORR was highest at 55% in the PD-L1 greater than 50% group, 44.7% in the PD-L1 1%-49% group, and 31.1% in the PD-L1 less than 1% group. It was a “very impressive response rate” for the low PD-L1 group, Dr. Iams said. Interim median progression-free survival followed a similar trend, with values of 11.4 months, 8.3 months, and 4.2 months, respectively.

Asked about the efficacy across subgroups, Dr. Iams responded that other immune stimulating agents have shown a stepwise improvement across PD-L1 expression levels, similar to what was observed in the current study. “My personal opinion as to why it was still effective at low PD-L1 is in part that PD-L1 is an imperfect biomarker. We know that there’s tumor heterogeneity, and perhaps it’s not fully representative of a one-site evaluation, but also in combination, and we have seen this in patients with [NSCLC] treated with both PD-L1 and CTLA-4 agents of increased efficacy in the PD-L1–low patients. So these combination immunotherapy strategies may be uniquely opportune for the low PD-L1 patients,” Dr. Iams said.

The study was funded by Immutep and Merck Sharp and Dohme. Dr. Iams has financial relationships with Merck.

The calendar year 2022 has been especially good for advancing acne-focused laser and light devices, most recently with the Food and Drug Administration clearance of the Accure Laser System in late November, for the treatment of mild to severe inflammatory acne vulgaris.

This was preceded by the FDA clearance of AviClear, marketed by Cutera, in March, and the commercial launch of TheraClearX, marketed by StrataSkin, in July.

“It’s an exciting time to be working with acne,” Fernanda H. Sakamoto, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “We’ll see a lot of people using new devices. I’m looking forward to seeing results in the long term.”

AviClear and the Accure Laser System, marketed by Accure, are both powered by a 1,726-nm laser, but they work differently. AviClear, which was cleared for the treatment of mild, moderate, and severe acne, has a maximum fluence of 30 J/cm² in single-pulse mode and a maximum fluence of 20 J/cm² in double-pulse mode. The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern. “It’s a little bit lower powered than the Accure and has a maximum pulse energy of 5 joules and a pulse duration of up to 50 milliseconds,” Dr. Sakamoto said. In the treatment of acne, laser and light treatments target the sebaceous gland.

In pivotal data submitted to the FDA, 104 patients with acne who were enrolled at 7 U.S. sites received 304 treatments with AviClear spaced 2-5 weeks apart. Each treatment took about 30 minutes. Treatment success was defined as having at least 50% fewer inflammatory acne lesions 12 weeks after the final treatment visit, compared with baseline. At the week 4 follow-up visit, there were median and mean reductions of 42% and 37%, respectively, in the inflammatory lesion counts from baseline (P < .001). The researchers found that, at the week 4 follow-up visit, 36% of patients had achieved treatment success, which increased to 78% at the 12-week follow-up visit. Treatment was considered safe and tolerable, according to the manufacturer.

The other newcomer device with a 1,726-nm wavelength is the Accure Laser System, which features a smart laser handpiece for real-time thermal monitoring and precise delivery of laser emissions. The device received CE Mark approval in 2020 for the treatment of moderate acne, and on Nov. 22, 2022, the manufacturer announced that it had been cleared by the FDA for the treatment of mild to severe inflammatory acne vulgaris.

Dr. Sakamoto and her Wellman colleagues have been working with five dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, and Mitchel Goldman, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2022, more than 50 patients with mild to severe acne were enrolled in four studies and an additional 30 were enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.

Among patients enrolled in the facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment after four monthly treatment sessions. The average lesion reduction at week 12 was 82% and the mean visual analog scale score immediately after treatment was 2.09 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device overall with no adverse events reported. At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histologic studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other skin structures.

Dr. Sakamoto emphasized that to date no direct clinical comparisons have been made between the AviClear and Accure devices. “Are all 1,726-nm lasers made equal? That is a question that we have to keep in our mind,” she said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “They are using the same wavelength, but they are different types of lasers.”

For example, the Accure Laser treats to temperature, relies on air cooling, and is targeted to dermatologists and plastic surgeons, while the AviClear treats to fluence, relies on contact cooling, and includes med spas and other nonphysician providers as the target users. “Mathematically, the difference between the two devices is that the Accure can achieve deeper penetration in a single pulse, while the AviClear is a little more superficial,” she said. “Whether that is translated clinically is unknown at this point.”

Dr. Sakamoto also discussed the TheraClearX, which is FDA cleared for the treatment of mild, moderate, and severe acne, including comedonal, pustular, and inflammatory acne vulgaris. The device, which is a new version of the Palomar Acleara, uses a vacuum technique with up to 3 psi pressure in conjunction with broadband light with a wavelength spectrum of 500 nm–1,200 nm delivered through a liquid-cooled, handheld delivery system. The predicate device was the Aesthera Isolaz System. The vacuum extracts buildup of sebaceous material. “At the same time, it takes the blood out of the competing chromophore,” she said. “By doing so, it potentially damages the sebaceous glands and reduces the inflammatory lesions.”

Dr. Sakamoto disclosed that she is the founder of and science advisor for Lightwater Bioscience. She is also a science advisor for Accure Acne and has received portions of patent royalties from Massachusetts General Hospital.

The calendar year 2022 has been especially good for advancing acne-focused laser and light devices, most recently with the Food and Drug Administration clearance of the Accure Laser System in late November, for the treatment of mild to severe inflammatory acne vulgaris.

This was preceded by the FDA clearance of AviClear, marketed by Cutera, in March, and the commercial launch of TheraClearX, marketed by StrataSkin, in July.

“It’s an exciting time to be working with acne,” Fernanda H. Sakamoto, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “We’ll see a lot of people using new devices. I’m looking forward to seeing results in the long term.”

AviClear and the Accure Laser System, marketed by Accure, are both powered by a 1,726-nm laser, but they work differently. AviClear, which was cleared for the treatment of mild, moderate, and severe acne, has a maximum fluence of 30 J/cm² in single-pulse mode and a maximum fluence of 20 J/cm² in double-pulse mode. The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern. “It’s a little bit lower powered than the Accure and has a maximum pulse energy of 5 joules and a pulse duration of up to 50 milliseconds,” Dr. Sakamoto said. In the treatment of acne, laser and light treatments target the sebaceous gland.

In pivotal data submitted to the FDA, 104 patients with acne who were enrolled at 7 U.S. sites received 304 treatments with AviClear spaced 2-5 weeks apart. Each treatment took about 30 minutes. Treatment success was defined as having at least 50% fewer inflammatory acne lesions 12 weeks after the final treatment visit, compared with baseline. At the week 4 follow-up visit, there were median and mean reductions of 42% and 37%, respectively, in the inflammatory lesion counts from baseline (P < .001). The researchers found that, at the week 4 follow-up visit, 36% of patients had achieved treatment success, which increased to 78% at the 12-week follow-up visit. Treatment was considered safe and tolerable, according to the manufacturer.

The other newcomer device with a 1,726-nm wavelength is the Accure Laser System, which features a smart laser handpiece for real-time thermal monitoring and precise delivery of laser emissions. The device received CE Mark approval in 2020 for the treatment of moderate acne, and on Nov. 22, 2022, the manufacturer announced that it had been cleared by the FDA for the treatment of mild to severe inflammatory acne vulgaris.

Dr. Sakamoto and her Wellman colleagues have been working with five dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, and Mitchel Goldman, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2022, more than 50 patients with mild to severe acne were enrolled in four studies and an additional 30 were enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.

Among patients enrolled in the facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment after four monthly treatment sessions. The average lesion reduction at week 12 was 82% and the mean visual analog scale score immediately after treatment was 2.09 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device overall with no adverse events reported. At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histologic studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other skin structures.

Dr. Sakamoto emphasized that to date no direct clinical comparisons have been made between the AviClear and Accure devices. “Are all 1,726-nm lasers made equal? That is a question that we have to keep in our mind,” she said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “They are using the same wavelength, but they are different types of lasers.”

For example, the Accure Laser treats to temperature, relies on air cooling, and is targeted to dermatologists and plastic surgeons, while the AviClear treats to fluence, relies on contact cooling, and includes med spas and other nonphysician providers as the target users. “Mathematically, the difference between the two devices is that the Accure can achieve deeper penetration in a single pulse, while the AviClear is a little more superficial,” she said. “Whether that is translated clinically is unknown at this point.”

Dr. Sakamoto also discussed the TheraClearX, which is FDA cleared for the treatment of mild, moderate, and severe acne, including comedonal, pustular, and inflammatory acne vulgaris. The device, which is a new version of the Palomar Acleara, uses a vacuum technique with up to 3 psi pressure in conjunction with broadband light with a wavelength spectrum of 500 nm–1,200 nm delivered through a liquid-cooled, handheld delivery system. The predicate device was the Aesthera Isolaz System. The vacuum extracts buildup of sebaceous material. “At the same time, it takes the blood out of the competing chromophore,” she said. “By doing so, it potentially damages the sebaceous glands and reduces the inflammatory lesions.”

Dr. Sakamoto disclosed that she is the founder of and science advisor for Lightwater Bioscience. She is also a science advisor for Accure Acne and has received portions of patent royalties from Massachusetts General Hospital.

The calendar year 2022 has been especially good for advancing acne-focused laser and light devices, most recently with the Food and Drug Administration clearance of the Accure Laser System in late November, for the treatment of mild to severe inflammatory acne vulgaris.

This was preceded by the FDA clearance of AviClear, marketed by Cutera, in March, and the commercial launch of TheraClearX, marketed by StrataSkin, in July.

“It’s an exciting time to be working with acne,” Fernanda H. Sakamoto, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “We’ll see a lot of people using new devices. I’m looking forward to seeing results in the long term.”

AviClear and the Accure Laser System, marketed by Accure, are both powered by a 1,726-nm laser, but they work differently. AviClear, which was cleared for the treatment of mild, moderate, and severe acne, has a maximum fluence of 30 J/cm² in single-pulse mode and a maximum fluence of 20 J/cm² in double-pulse mode. The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern. “It’s a little bit lower powered than the Accure and has a maximum pulse energy of 5 joules and a pulse duration of up to 50 milliseconds,” Dr. Sakamoto said. In the treatment of acne, laser and light treatments target the sebaceous gland.

In pivotal data submitted to the FDA, 104 patients with acne who were enrolled at 7 U.S. sites received 304 treatments with AviClear spaced 2-5 weeks apart. Each treatment took about 30 minutes. Treatment success was defined as having at least 50% fewer inflammatory acne lesions 12 weeks after the final treatment visit, compared with baseline. At the week 4 follow-up visit, there were median and mean reductions of 42% and 37%, respectively, in the inflammatory lesion counts from baseline (P < .001). The researchers found that, at the week 4 follow-up visit, 36% of patients had achieved treatment success, which increased to 78% at the 12-week follow-up visit. Treatment was considered safe and tolerable, according to the manufacturer.

The other newcomer device with a 1,726-nm wavelength is the Accure Laser System, which features a smart laser handpiece for real-time thermal monitoring and precise delivery of laser emissions. The device received CE Mark approval in 2020 for the treatment of moderate acne, and on Nov. 22, 2022, the manufacturer announced that it had been cleared by the FDA for the treatment of mild to severe inflammatory acne vulgaris.

Dr. Sakamoto and her Wellman colleagues have been working with five dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, and Mitchel Goldman, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2022, more than 50 patients with mild to severe acne were enrolled in four studies and an additional 30 were enrolled in a pilot facial acne trial, Dr. Sakamoto said. In the trials, patients are followed at 4, 8, 12, and 24 weeks post treatment.

Among patients enrolled in the facial acne trial, researchers have observed a 100% responder rate for patients with more than five acne lesions at 4, 8, 12, and 24 weeks post treatment after four monthly treatment sessions. The average lesion reduction at week 12 was 82% and the mean visual analog scale score immediately after treatment was 2.09 out of 10. Each patient received more than 12,000 trigger pulls of energy from the device overall with no adverse events reported. At 12 months, they observed a 90% inflammatory lesion count reduction from baseline and a rapid response to treatment: a 73% reduction achieved after the first two treatment sessions. Histologic studies revealed selective sebaceous gland destruction with no damage to the epidermis, surrounding dermis, or other skin structures.

Dr. Sakamoto emphasized that to date no direct clinical comparisons have been made between the AviClear and Accure devices. “Are all 1,726-nm lasers made equal? That is a question that we have to keep in our mind,” she said during the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “They are using the same wavelength, but they are different types of lasers.”

For example, the Accure Laser treats to temperature, relies on air cooling, and is targeted to dermatologists and plastic surgeons, while the AviClear treats to fluence, relies on contact cooling, and includes med spas and other nonphysician providers as the target users. “Mathematically, the difference between the two devices is that the Accure can achieve deeper penetration in a single pulse, while the AviClear is a little more superficial,” she said. “Whether that is translated clinically is unknown at this point.”

Dr. Sakamoto also discussed the TheraClearX, which is FDA cleared for the treatment of mild, moderate, and severe acne, including comedonal, pustular, and inflammatory acne vulgaris. The device, which is a new version of the Palomar Acleara, uses a vacuum technique with up to 3 psi pressure in conjunction with broadband light with a wavelength spectrum of 500 nm–1,200 nm delivered through a liquid-cooled, handheld delivery system. The predicate device was the Aesthera Isolaz System. The vacuum extracts buildup of sebaceous material. “At the same time, it takes the blood out of the competing chromophore,” she said. “By doing so, it potentially damages the sebaceous glands and reduces the inflammatory lesions.”

Dr. Sakamoto disclosed that she is the founder of and science advisor for Lightwater Bioscience. She is also a science advisor for Accure Acne and has received portions of patent royalties from Massachusetts General Hospital.

PHILADELPHIA – Treatment with the interleukin-6 receptor antagonist sarilumab (Kevzara), along with a 14-week taper of glucocorticoids, proved to have significant efficacy in patients with relapsing polymyalgia rheumatica (PMR) who were resistant to glucocorticoids in a phase 3 trial.

No new safety concerns were found with sarilumab in the multicenter, randomized, double-blind, placebo-controlled SAPHYR trial. Sarilumab is approved in the United States for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

The results, presented at the annual meeting of the American College of Rheumatology by Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, included clinically meaningful improvement in quality-of-life scores.

The disease, which primarily affects people over age 65, can cause widespread aching and stiffness. It’s one of the most common inflammatory diseases among older adults.

PMR is relatively easy to treat with glucocorticoids, but relapses are common, which means long courses of glucocorticoid therapy and the side effects that come with them.
 

Need for a steroid-sparing therapy

“We recognize that a steroid-sparing drug in polymyalgia rheumatica seems to be an unmet need,” Dr. Spiera said at the meeting.

The trial, sponsored by Sanofi, included active, refractory PMR patients who flared within 3 months of study entry while on at least 7.5 mg/day of prednisone or the equivalent. They were randomly assigned (1:1) to 52 weeks of treatment with subcutaneous sarilumab 200 mg every 2 weeks plus the rapid 14-week glucocorticoid tapering regimen or were given placebo every 2 weeks plus a more traditional 52-week tapering of glucocorticoids.
 

COVID hampered recruitment

Recruitment was stopped early because of complications during the COVID-19 pandemic, so between October 2018 and July 2020, 118 of the intended 280 patients were recruited, and 117 were treated (sarilumab = 59, placebo = 58). Median age was 69 years in the treatment group and 70 among those taking placebo.

Of the 117 treated, only 78 patients (67%) completed treatment (sarilumab = 42, placebo = 36). The main reasons for stopping treatment were adverse events – including seven with sarilumab and four with placebo – and lack of efficacy (sarilumab = four, placebo = nine).

The primary outcome was the proportion of patients who reached sustained remission at 52 weeks, defined as disease remission by week 12 and no disease flare, normal C-reactive protein (CRP), and adherence to the glucocorticoid taper during weeks 12-52.

The researchers found that sustained remission was significantly higher in the sarilumab arm versus the control group (28.3% versus 10.3%; P = .0193).

IL-6 inhibitors lower CRP, but if you take CRP out of the definition, Dr. Spiera said, “we still saw this difference: 31.7% of patients treated with sarilumab and 13.8% treated with placebo and a longer taper achieved that endpoint.”
 

Forty-four percent lower risk of flare with sarilumab

Patients in the sarilumab group also had 44% lower risk of having a flare after achieving clinical remission versus the comparator group (16.7% versus 29.3%; hazard ratio, 0.56; 95% confidence interval, 0.35-0.90; P = .0153).

Patient-reported outcomes, which included physical and mental health scores and disability index results, favored sarilumab.

The incidence of treatment-emergent adverse events (TEAEs) was numerically higher in the sarilumab group, compared with the control group (94.9% versus 84.5%). TEAEs included neutropenia (15.3%) and arthralgia (15.3%) in the sarilumab group and insomnia (15.5%) in the comparator arm.

However, the frequency of serious AEs was higher in the control group, compared with the sarilumab arm (20.7% versus 13.6%). No deaths were reported, and, importantly in this age group treated with concurrent glucocorticoids and an IL-6 inhibitor, Dr. Spiera said, “there were no cases of diverticulitis requiring intervention.”

Dr. Spiera was asked about a seemingly low remission rate. He answered that the bar was very high for remission in this study.

Patients had to achieve remission by week 12 and with the rapid 14-week taper. “That means by week 12 the sarilumab arm patients were only on 2 mg of daily prednisone or its equivalent,” he said.

Patients had to maintain that for another 40 weeks, he noted, adding, “I think especially in the context of quality of life and function indices, these were important results.”

Sebastian E. Sattui, MD, director of the University of Pittsburgh Medical Center vasculitis clinic, told this news organization that prolonged use of glucocorticoids in patients with PMR remains an important concern and the need for other options is critical.

“Around 30% of patients with PMR remain on prednisone 5 years after diagnosis,” he said. “Low-dose glucocorticoids are still associated with significant morbidity. Until recently, there has been a paucity of high-quality data regarding the use of steroid-sparing agents in PMR. “

He noted that the SAPHYR trial data are promising “with sarilumab being successful in achieving remission while minimizing glucocorticoids in patients with relapsing PMR.” The clinically meaningful improvement in patient-reported outcomes was just as important, he added.

The main unanswered question is whether the disease-modifying ability of sarilumab will continue after it is stopped, Dr. Sattui said.

Dr. Spiera is a consultant for Sanofi, which funded the trial. He also disclosed financial relationships with GlaxoSmithKline, Boehringer Ingelheim, Corbus, InflaRx, AbbVie/Abbott, Novartis, Chemocentryx, Roche, and Vera. Dr. Sattui has received research support from AstraZeneca and has done unpaid consulting work for Sanofi.

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

PHILADELPHIA – Treatment with the interleukin-6 receptor antagonist sarilumab (Kevzara), along with a 14-week taper of glucocorticoids, proved to have significant efficacy in patients with relapsing polymyalgia rheumatica (PMR) who were resistant to glucocorticoids in a phase 3 trial.

No new safety concerns were found with sarilumab in the multicenter, randomized, double-blind, placebo-controlled SAPHYR trial. Sarilumab is approved in the United States for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

The results, presented at the annual meeting of the American College of Rheumatology by Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, included clinically meaningful improvement in quality-of-life scores.

The disease, which primarily affects people over age 65, can cause widespread aching and stiffness. It’s one of the most common inflammatory diseases among older adults.

PMR is relatively easy to treat with glucocorticoids, but relapses are common, which means long courses of glucocorticoid therapy and the side effects that come with them.
 

Need for a steroid-sparing therapy

“We recognize that a steroid-sparing drug in polymyalgia rheumatica seems to be an unmet need,” Dr. Spiera said at the meeting.

The trial, sponsored by Sanofi, included active, refractory PMR patients who flared within 3 months of study entry while on at least 7.5 mg/day of prednisone or the equivalent. They were randomly assigned (1:1) to 52 weeks of treatment with subcutaneous sarilumab 200 mg every 2 weeks plus the rapid 14-week glucocorticoid tapering regimen or were given placebo every 2 weeks plus a more traditional 52-week tapering of glucocorticoids.
 

COVID hampered recruitment

Recruitment was stopped early because of complications during the COVID-19 pandemic, so between October 2018 and July 2020, 118 of the intended 280 patients were recruited, and 117 were treated (sarilumab = 59, placebo = 58). Median age was 69 years in the treatment group and 70 among those taking placebo.

Of the 117 treated, only 78 patients (67%) completed treatment (sarilumab = 42, placebo = 36). The main reasons for stopping treatment were adverse events – including seven with sarilumab and four with placebo – and lack of efficacy (sarilumab = four, placebo = nine).

The primary outcome was the proportion of patients who reached sustained remission at 52 weeks, defined as disease remission by week 12 and no disease flare, normal C-reactive protein (CRP), and adherence to the glucocorticoid taper during weeks 12-52.

The researchers found that sustained remission was significantly higher in the sarilumab arm versus the control group (28.3% versus 10.3%; P = .0193).

IL-6 inhibitors lower CRP, but if you take CRP out of the definition, Dr. Spiera said, “we still saw this difference: 31.7% of patients treated with sarilumab and 13.8% treated with placebo and a longer taper achieved that endpoint.”
 

Forty-four percent lower risk of flare with sarilumab

Patients in the sarilumab group also had 44% lower risk of having a flare after achieving clinical remission versus the comparator group (16.7% versus 29.3%; hazard ratio, 0.56; 95% confidence interval, 0.35-0.90; P = .0153).

Patient-reported outcomes, which included physical and mental health scores and disability index results, favored sarilumab.

The incidence of treatment-emergent adverse events (TEAEs) was numerically higher in the sarilumab group, compared with the control group (94.9% versus 84.5%). TEAEs included neutropenia (15.3%) and arthralgia (15.3%) in the sarilumab group and insomnia (15.5%) in the comparator arm.

However, the frequency of serious AEs was higher in the control group, compared with the sarilumab arm (20.7% versus 13.6%). No deaths were reported, and, importantly in this age group treated with concurrent glucocorticoids and an IL-6 inhibitor, Dr. Spiera said, “there were no cases of diverticulitis requiring intervention.”

Dr. Spiera was asked about a seemingly low remission rate. He answered that the bar was very high for remission in this study.

Patients had to achieve remission by week 12 and with the rapid 14-week taper. “That means by week 12 the sarilumab arm patients were only on 2 mg of daily prednisone or its equivalent,” he said.

Patients had to maintain that for another 40 weeks, he noted, adding, “I think especially in the context of quality of life and function indices, these were important results.”

Sebastian E. Sattui, MD, director of the University of Pittsburgh Medical Center vasculitis clinic, told this news organization that prolonged use of glucocorticoids in patients with PMR remains an important concern and the need for other options is critical.

“Around 30% of patients with PMR remain on prednisone 5 years after diagnosis,” he said. “Low-dose glucocorticoids are still associated with significant morbidity. Until recently, there has been a paucity of high-quality data regarding the use of steroid-sparing agents in PMR. “

He noted that the SAPHYR trial data are promising “with sarilumab being successful in achieving remission while minimizing glucocorticoids in patients with relapsing PMR.” The clinically meaningful improvement in patient-reported outcomes was just as important, he added.

The main unanswered question is whether the disease-modifying ability of sarilumab will continue after it is stopped, Dr. Sattui said.

Dr. Spiera is a consultant for Sanofi, which funded the trial. He also disclosed financial relationships with GlaxoSmithKline, Boehringer Ingelheim, Corbus, InflaRx, AbbVie/Abbott, Novartis, Chemocentryx, Roche, and Vera. Dr. Sattui has received research support from AstraZeneca and has done unpaid consulting work for Sanofi.

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

PHILADELPHIA – Treatment with the interleukin-6 receptor antagonist sarilumab (Kevzara), along with a 14-week taper of glucocorticoids, proved to have significant efficacy in patients with relapsing polymyalgia rheumatica (PMR) who were resistant to glucocorticoids in a phase 3 trial.

No new safety concerns were found with sarilumab in the multicenter, randomized, double-blind, placebo-controlled SAPHYR trial. Sarilumab is approved in the United States for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

The results, presented at the annual meeting of the American College of Rheumatology by Robert Spiera, MD, director of the Scleroderma, Vasculitis, and Myositis Center at the Hospital for Special Surgery in New York, included clinically meaningful improvement in quality-of-life scores.

The disease, which primarily affects people over age 65, can cause widespread aching and stiffness. It’s one of the most common inflammatory diseases among older adults.

PMR is relatively easy to treat with glucocorticoids, but relapses are common, which means long courses of glucocorticoid therapy and the side effects that come with them.
 

Need for a steroid-sparing therapy

“We recognize that a steroid-sparing drug in polymyalgia rheumatica seems to be an unmet need,” Dr. Spiera said at the meeting.

The trial, sponsored by Sanofi, included active, refractory PMR patients who flared within 3 months of study entry while on at least 7.5 mg/day of prednisone or the equivalent. They were randomly assigned (1:1) to 52 weeks of treatment with subcutaneous sarilumab 200 mg every 2 weeks plus the rapid 14-week glucocorticoid tapering regimen or were given placebo every 2 weeks plus a more traditional 52-week tapering of glucocorticoids.
 

COVID hampered recruitment

Recruitment was stopped early because of complications during the COVID-19 pandemic, so between October 2018 and July 2020, 118 of the intended 280 patients were recruited, and 117 were treated (sarilumab = 59, placebo = 58). Median age was 69 years in the treatment group and 70 among those taking placebo.

Of the 117 treated, only 78 patients (67%) completed treatment (sarilumab = 42, placebo = 36). The main reasons for stopping treatment were adverse events – including seven with sarilumab and four with placebo – and lack of efficacy (sarilumab = four, placebo = nine).

The primary outcome was the proportion of patients who reached sustained remission at 52 weeks, defined as disease remission by week 12 and no disease flare, normal C-reactive protein (CRP), and adherence to the glucocorticoid taper during weeks 12-52.

The researchers found that sustained remission was significantly higher in the sarilumab arm versus the control group (28.3% versus 10.3%; P = .0193).

IL-6 inhibitors lower CRP, but if you take CRP out of the definition, Dr. Spiera said, “we still saw this difference: 31.7% of patients treated with sarilumab and 13.8% treated with placebo and a longer taper achieved that endpoint.”
 

Forty-four percent lower risk of flare with sarilumab

Patients in the sarilumab group also had 44% lower risk of having a flare after achieving clinical remission versus the comparator group (16.7% versus 29.3%; hazard ratio, 0.56; 95% confidence interval, 0.35-0.90; P = .0153).

Patient-reported outcomes, which included physical and mental health scores and disability index results, favored sarilumab.

The incidence of treatment-emergent adverse events (TEAEs) was numerically higher in the sarilumab group, compared with the control group (94.9% versus 84.5%). TEAEs included neutropenia (15.3%) and arthralgia (15.3%) in the sarilumab group and insomnia (15.5%) in the comparator arm.

However, the frequency of serious AEs was higher in the control group, compared with the sarilumab arm (20.7% versus 13.6%). No deaths were reported, and, importantly in this age group treated with concurrent glucocorticoids and an IL-6 inhibitor, Dr. Spiera said, “there were no cases of diverticulitis requiring intervention.”

Dr. Spiera was asked about a seemingly low remission rate. He answered that the bar was very high for remission in this study.

Patients had to achieve remission by week 12 and with the rapid 14-week taper. “That means by week 12 the sarilumab arm patients were only on 2 mg of daily prednisone or its equivalent,” he said.

Patients had to maintain that for another 40 weeks, he noted, adding, “I think especially in the context of quality of life and function indices, these were important results.”

Sebastian E. Sattui, MD, director of the University of Pittsburgh Medical Center vasculitis clinic, told this news organization that prolonged use of glucocorticoids in patients with PMR remains an important concern and the need for other options is critical.

“Around 30% of patients with PMR remain on prednisone 5 years after diagnosis,” he said. “Low-dose glucocorticoids are still associated with significant morbidity. Until recently, there has been a paucity of high-quality data regarding the use of steroid-sparing agents in PMR. “

He noted that the SAPHYR trial data are promising “with sarilumab being successful in achieving remission while minimizing glucocorticoids in patients with relapsing PMR.” The clinically meaningful improvement in patient-reported outcomes was just as important, he added.

The main unanswered question is whether the disease-modifying ability of sarilumab will continue after it is stopped, Dr. Sattui said.

Dr. Spiera is a consultant for Sanofi, which funded the trial. He also disclosed financial relationships with GlaxoSmithKline, Boehringer Ingelheim, Corbus, InflaRx, AbbVie/Abbott, Novartis, Chemocentryx, Roche, and Vera. Dr. Sattui has received research support from AstraZeneca and has done unpaid consulting work for Sanofi.

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