MDedge Dermatology

More than one-quarter of patients undergoing dermatologic surgery said they would prefer not to take an oral antibiotic, even if it could eliminate the risk of a surgical-site infection (SSI) and had negligible side effects, in a prospective multicenter study.

In addition, a similar proportion of patients preferred to take an antibiotic if there was no SSI reduction and a high risk of adverse events.

Those are two key findings from the study aimed at understanding patient preferences for prophylactic oral antibiotic use following dermatologic surgery, which was published in Dermatologic Surgery.

“Patient risk-benefit thresholds for using antibiotics vary considerably,” the study’s corresponding author, Jeremy R. Etzkorn, MD, MS, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia, told this news organization. “Physicians should appreciate and consider the variation between patients before deciding to send in a prescription after skin surgery.”

To investigate patient preferences about taking antibiotics to prevent SSI relative to antibiotic efficacy and antibiotic-associated adverse drug reactions, Dr. Etzkorn and colleagues at six U.S. medical centers prospectively administered a web-based survey and discrete choice experiment to 388 adults including dermatologic surgery patients and their family members, as well as health care workers (defined as dermatologic surgery patients who work in health care, individuals who work in health care and are accompanying patients to their surgery, or staff in the dermatology clinic.) “A lot has been published about physician preferences and practice patterns with respect to antibiotic prescribing after dermatologic surgery,” Dr. Etzkorn noted. “This is the first study to evaluate patient preferences in a rigorous way.”

He and his coinvestigators used a technique from marketing and product research (conjoint analysis/discrete choice experiments) to quantify what patients think about using antibiotics and what trade-offs they are – or are not – willing to make to reduce their risk of infection.

Nearly half of the respondents (47%) were patients, 29% were family members of patients, 19% were health care workers, and the rest were described as patient caregivers or “other.” More than half (59%) were female, the mean age at surgery was 59 years, and 69% had college or postgraduate degrees.

More than half of respondents (55%) would choose to take an antibiotic if it reduced the SSI rate from 5% to 2.5% and if the risk of adverse drug reactions was low (defined as a 1% risk gastrointestinal upset, 0.5% risk itchy skin rash, and 0.01% risk ED visit). Even if an antibiotic could eliminate SSI risk entirely and had a low adverse drug reaction profile, 27% of respondents preferred not to take prophylactic oral antibiotics.

A subgroup analysis revealed that only 21% of health care workers would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 41% of those who do not work in health care. Respondent age also drove treatment choice. For example, only 33% of respondents younger than age 65 would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 45% of those aged 65 years and older.

“We knew patients would likely trade some antibiotic efficacy for some side effects, just as one would trade price for features when shopping for a car,” Dr. Etzkorn said. “We were shocked to see that over a quarter – 27% – of respondents preferred to not take antibiotics even if they were able to prevent all infections and had minimal side effects.”

“It’s interesting that between 27% [and] 55% of patients preferred no operative antibiotic prophylaxis despite a theoretical 100% cure rate for surgical-site infections,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study results.

“I think this mirrors dermatologist’s preferences, as a majority also prefer not to prescribe postoperative antibiotic therapy, unless operating in an area of or a patient with a high risk for infection. It would also be interesting to see if a less educated population would also have similar preferences.”

Dr. Etzkorn acknowledged certain limitations of the study, including that while it evaluated patient reported preferences, it did not include all possible risks and benefits, and “it does not measure actual patient behaviors.”

The researchers reported having no relevant financial disclosures. Dr. Etzkorn disclosed that he serves as a data safety monitoring board member for a clinical trial of Replimmune. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

More than one-quarter of patients undergoing dermatologic surgery said they would prefer not to take an oral antibiotic, even if it could eliminate the risk of a surgical-site infection (SSI) and had negligible side effects, in a prospective multicenter study.

In addition, a similar proportion of patients preferred to take an antibiotic if there was no SSI reduction and a high risk of adverse events.

Those are two key findings from the study aimed at understanding patient preferences for prophylactic oral antibiotic use following dermatologic surgery, which was published in Dermatologic Surgery.

“Patient risk-benefit thresholds for using antibiotics vary considerably,” the study’s corresponding author, Jeremy R. Etzkorn, MD, MS, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia, told this news organization. “Physicians should appreciate and consider the variation between patients before deciding to send in a prescription after skin surgery.”

To investigate patient preferences about taking antibiotics to prevent SSI relative to antibiotic efficacy and antibiotic-associated adverse drug reactions, Dr. Etzkorn and colleagues at six U.S. medical centers prospectively administered a web-based survey and discrete choice experiment to 388 adults including dermatologic surgery patients and their family members, as well as health care workers (defined as dermatologic surgery patients who work in health care, individuals who work in health care and are accompanying patients to their surgery, or staff in the dermatology clinic.) “A lot has been published about physician preferences and practice patterns with respect to antibiotic prescribing after dermatologic surgery,” Dr. Etzkorn noted. “This is the first study to evaluate patient preferences in a rigorous way.”

He and his coinvestigators used a technique from marketing and product research (conjoint analysis/discrete choice experiments) to quantify what patients think about using antibiotics and what trade-offs they are – or are not – willing to make to reduce their risk of infection.

Nearly half of the respondents (47%) were patients, 29% were family members of patients, 19% were health care workers, and the rest were described as patient caregivers or “other.” More than half (59%) were female, the mean age at surgery was 59 years, and 69% had college or postgraduate degrees.

More than half of respondents (55%) would choose to take an antibiotic if it reduced the SSI rate from 5% to 2.5% and if the risk of adverse drug reactions was low (defined as a 1% risk gastrointestinal upset, 0.5% risk itchy skin rash, and 0.01% risk ED visit). Even if an antibiotic could eliminate SSI risk entirely and had a low adverse drug reaction profile, 27% of respondents preferred not to take prophylactic oral antibiotics.

A subgroup analysis revealed that only 21% of health care workers would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 41% of those who do not work in health care. Respondent age also drove treatment choice. For example, only 33% of respondents younger than age 65 would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 45% of those aged 65 years and older.

“We knew patients would likely trade some antibiotic efficacy for some side effects, just as one would trade price for features when shopping for a car,” Dr. Etzkorn said. “We were shocked to see that over a quarter – 27% – of respondents preferred to not take antibiotics even if they were able to prevent all infections and had minimal side effects.”

“It’s interesting that between 27% [and] 55% of patients preferred no operative antibiotic prophylaxis despite a theoretical 100% cure rate for surgical-site infections,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study results.

“I think this mirrors dermatologist’s preferences, as a majority also prefer not to prescribe postoperative antibiotic therapy, unless operating in an area of or a patient with a high risk for infection. It would also be interesting to see if a less educated population would also have similar preferences.”

Dr. Etzkorn acknowledged certain limitations of the study, including that while it evaluated patient reported preferences, it did not include all possible risks and benefits, and “it does not measure actual patient behaviors.”

The researchers reported having no relevant financial disclosures. Dr. Etzkorn disclosed that he serves as a data safety monitoring board member for a clinical trial of Replimmune. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

More than one-quarter of patients undergoing dermatologic surgery said they would prefer not to take an oral antibiotic, even if it could eliminate the risk of a surgical-site infection (SSI) and had negligible side effects, in a prospective multicenter study.

In addition, a similar proportion of patients preferred to take an antibiotic if there was no SSI reduction and a high risk of adverse events.

Those are two key findings from the study aimed at understanding patient preferences for prophylactic oral antibiotic use following dermatologic surgery, which was published in Dermatologic Surgery.

“Patient risk-benefit thresholds for using antibiotics vary considerably,” the study’s corresponding author, Jeremy R. Etzkorn, MD, MS, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia, told this news organization. “Physicians should appreciate and consider the variation between patients before deciding to send in a prescription after skin surgery.”

To investigate patient preferences about taking antibiotics to prevent SSI relative to antibiotic efficacy and antibiotic-associated adverse drug reactions, Dr. Etzkorn and colleagues at six U.S. medical centers prospectively administered a web-based survey and discrete choice experiment to 388 adults including dermatologic surgery patients and their family members, as well as health care workers (defined as dermatologic surgery patients who work in health care, individuals who work in health care and are accompanying patients to their surgery, or staff in the dermatology clinic.) “A lot has been published about physician preferences and practice patterns with respect to antibiotic prescribing after dermatologic surgery,” Dr. Etzkorn noted. “This is the first study to evaluate patient preferences in a rigorous way.”

He and his coinvestigators used a technique from marketing and product research (conjoint analysis/discrete choice experiments) to quantify what patients think about using antibiotics and what trade-offs they are – or are not – willing to make to reduce their risk of infection.

Nearly half of the respondents (47%) were patients, 29% were family members of patients, 19% were health care workers, and the rest were described as patient caregivers or “other.” More than half (59%) were female, the mean age at surgery was 59 years, and 69% had college or postgraduate degrees.

More than half of respondents (55%) would choose to take an antibiotic if it reduced the SSI rate from 5% to 2.5% and if the risk of adverse drug reactions was low (defined as a 1% risk gastrointestinal upset, 0.5% risk itchy skin rash, and 0.01% risk ED visit). Even if an antibiotic could eliminate SSI risk entirely and had a low adverse drug reaction profile, 27% of respondents preferred not to take prophylactic oral antibiotics.

A subgroup analysis revealed that only 21% of health care workers would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 41% of those who do not work in health care. Respondent age also drove treatment choice. For example, only 33% of respondents younger than age 65 would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 45% of those aged 65 years and older.

“We knew patients would likely trade some antibiotic efficacy for some side effects, just as one would trade price for features when shopping for a car,” Dr. Etzkorn said. “We were shocked to see that over a quarter – 27% – of respondents preferred to not take antibiotics even if they were able to prevent all infections and had minimal side effects.”

“It’s interesting that between 27% [and] 55% of patients preferred no operative antibiotic prophylaxis despite a theoretical 100% cure rate for surgical-site infections,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study results.

“I think this mirrors dermatologist’s preferences, as a majority also prefer not to prescribe postoperative antibiotic therapy, unless operating in an area of or a patient with a high risk for infection. It would also be interesting to see if a less educated population would also have similar preferences.”

Dr. Etzkorn acknowledged certain limitations of the study, including that while it evaluated patient reported preferences, it did not include all possible risks and benefits, and “it does not measure actual patient behaviors.”

The researchers reported having no relevant financial disclosures. Dr. Etzkorn disclosed that he serves as a data safety monitoring board member for a clinical trial of Replimmune. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris.

The biosimilars, both developed by STADA Arzneimittel AG, will be available as a 40-mg solution for injection in a pre-filled syringe and pre-filled pen and 80-mg solution for injection in a pre-filled syringe. Both biosimilars will have 15 indications:

• rheumatoid arthritis
• polyarticular juvenile idiopathic arthritis
• enthesitis-related arthritis
• ankylosing spondylitis
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• psoriatic arthritis
• chronic plaque psoriasis (adults and children)
• hidradenitis suppurativa
• Crohn’s disease (adults and children)
• ulcerative colitis (adults and children)
• uveitis (adults and children)

Data show that both Hukyndra and Libmyris are highly similar to the reference product Humira (adalimumab), a monoclonal antibody to tumor necrosis factor alpha, and have comparable quality, safety, and efficacy.

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

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris.

The biosimilars, both developed by STADA Arzneimittel AG, will be available as a 40-mg solution for injection in a pre-filled syringe and pre-filled pen and 80-mg solution for injection in a pre-filled syringe. Both biosimilars will have 15 indications:

• rheumatoid arthritis
• polyarticular juvenile idiopathic arthritis
• enthesitis-related arthritis
• ankylosing spondylitis
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• psoriatic arthritis
• chronic plaque psoriasis (adults and children)
• hidradenitis suppurativa
• Crohn’s disease (adults and children)
• ulcerative colitis (adults and children)
• uveitis (adults and children)

Data show that both Hukyndra and Libmyris are highly similar to the reference product Humira (adalimumab), a monoclonal antibody to tumor necrosis factor alpha, and have comparable quality, safety, and efficacy.

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

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris.

The biosimilars, both developed by STADA Arzneimittel AG, will be available as a 40-mg solution for injection in a pre-filled syringe and pre-filled pen and 80-mg solution for injection in a pre-filled syringe. Both biosimilars will have 15 indications:

• rheumatoid arthritis
• polyarticular juvenile idiopathic arthritis
• enthesitis-related arthritis
• ankylosing spondylitis
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• psoriatic arthritis
• chronic plaque psoriasis (adults and children)
• hidradenitis suppurativa
• Crohn’s disease (adults and children)
• ulcerative colitis (adults and children)
• uveitis (adults and children)

Data show that both Hukyndra and Libmyris are highly similar to the reference product Humira (adalimumab), a monoclonal antibody to tumor necrosis factor alpha, and have comparable quality, safety, and efficacy.

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

I once answered online skin questions. The most popular one was, “Is my penis supposed to look like that?”

Then the site was bought by an entrepreneur with a corporate sensibility. He opened two forums: for 15 bucks, you could access the Medical Forum and ask a doctor. For 10, you could join the Community Forum and ask anybody with an opinion. One guess about which forum was more popular.

Years later, a colleague referred a fellow who had run a poison ivy website for a decade and wanted to interview a doctor. He had never spoken with one before, “because it never occurred to me.” His site featured the usual folklore: that blister fluid spreads the poison, that you can catch it from your dog. His website had many pictures. Some were in focus, and a few actually showed poison ivy.

I checked a year later and found that he had never uploaded our interview to his website. When I emailed to ask how come, he said he’d been busy, and did I want him to? I told him I was OK.

What made me think of these old episodes was a phone chat I had the other day with an IT guy about my laptop.

After I told him my problem, he said, “Since you’re a doctor, could I ask you a medical question?”

“Sure.”

“Is the COVID vaccine safe?” he asked.

“I had two shots myself,” I said, “and I’m planning a third. Does that tell you what I think about how safe it is?”

He didn’t answer, and we got back to the laptop.

Five minutes later he said, “I just wonder whether we should mess with vaccines. Maybe we should let nature take its course.”

“How about polio and diphtheria?” I said. “Should we let nature take its course with them?”

He thought for a moment and said, “If you don’t get vaccinated, can you spread the virus to other people?”

“Yes, you can,” I said. “It’s not just that you can get sick, but you can make other people sick, and possibly die if they’re old or vulnerable.”

Again, no response. We finished up with the laptop.

“Thanks for your medical advice,” he said. “I get conflicting information from so many sources.”

Yes, he does. He and everybody else always have. When the issues are poison ivy and genital blotchiness, the stakes are not high enough for anyone to talk about. To a large extent, people have always made their minds up about things based on what their friends think and tell them.

If your friends all wear masks, they will stare at you if you don’t. If your friends don’t wear masks, they will stare at you if you do. Or more than that. Very few people like to be stared at. Or worse.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now retired, after more than 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His latest book, “Doctoring from the Outside In,” was recently published. This is his last column for Dermatology News. Write to him at [email protected].

I once answered online skin questions. The most popular one was, “Is my penis supposed to look like that?”

Then the site was bought by an entrepreneur with a corporate sensibility. He opened two forums: for 15 bucks, you could access the Medical Forum and ask a doctor. For 10, you could join the Community Forum and ask anybody with an opinion. One guess about which forum was more popular.

Years later, a colleague referred a fellow who had run a poison ivy website for a decade and wanted to interview a doctor. He had never spoken with one before, “because it never occurred to me.” His site featured the usual folklore: that blister fluid spreads the poison, that you can catch it from your dog. His website had many pictures. Some were in focus, and a few actually showed poison ivy.

I checked a year later and found that he had never uploaded our interview to his website. When I emailed to ask how come, he said he’d been busy, and did I want him to? I told him I was OK.

What made me think of these old episodes was a phone chat I had the other day with an IT guy about my laptop.

After I told him my problem, he said, “Since you’re a doctor, could I ask you a medical question?”

“Sure.”

“Is the COVID vaccine safe?” he asked.

“I had two shots myself,” I said, “and I’m planning a third. Does that tell you what I think about how safe it is?”

He didn’t answer, and we got back to the laptop.

Five minutes later he said, “I just wonder whether we should mess with vaccines. Maybe we should let nature take its course.”

“How about polio and diphtheria?” I said. “Should we let nature take its course with them?”

He thought for a moment and said, “If you don’t get vaccinated, can you spread the virus to other people?”

“Yes, you can,” I said. “It’s not just that you can get sick, but you can make other people sick, and possibly die if they’re old or vulnerable.”

Again, no response. We finished up with the laptop.

“Thanks for your medical advice,” he said. “I get conflicting information from so many sources.”

Yes, he does. He and everybody else always have. When the issues are poison ivy and genital blotchiness, the stakes are not high enough for anyone to talk about. To a large extent, people have always made their minds up about things based on what their friends think and tell them.

If your friends all wear masks, they will stare at you if you don’t. If your friends don’t wear masks, they will stare at you if you do. Or more than that. Very few people like to be stared at. Or worse.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now retired, after more than 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His latest book, “Doctoring from the Outside In,” was recently published. This is his last column for Dermatology News. Write to him at [email protected].

I once answered online skin questions. The most popular one was, “Is my penis supposed to look like that?”

Then the site was bought by an entrepreneur with a corporate sensibility. He opened two forums: for 15 bucks, you could access the Medical Forum and ask a doctor. For 10, you could join the Community Forum and ask anybody with an opinion. One guess about which forum was more popular.

Years later, a colleague referred a fellow who had run a poison ivy website for a decade and wanted to interview a doctor. He had never spoken with one before, “because it never occurred to me.” His site featured the usual folklore: that blister fluid spreads the poison, that you can catch it from your dog. His website had many pictures. Some were in focus, and a few actually showed poison ivy.

I checked a year later and found that he had never uploaded our interview to his website. When I emailed to ask how come, he said he’d been busy, and did I want him to? I told him I was OK.

What made me think of these old episodes was a phone chat I had the other day with an IT guy about my laptop.

After I told him my problem, he said, “Since you’re a doctor, could I ask you a medical question?”

“Sure.”

“Is the COVID vaccine safe?” he asked.

“I had two shots myself,” I said, “and I’m planning a third. Does that tell you what I think about how safe it is?”

He didn’t answer, and we got back to the laptop.

Five minutes later he said, “I just wonder whether we should mess with vaccines. Maybe we should let nature take its course.”

“How about polio and diphtheria?” I said. “Should we let nature take its course with them?”

He thought for a moment and said, “If you don’t get vaccinated, can you spread the virus to other people?”

“Yes, you can,” I said. “It’s not just that you can get sick, but you can make other people sick, and possibly die if they’re old or vulnerable.”

Again, no response. We finished up with the laptop.

“Thanks for your medical advice,” he said. “I get conflicting information from so many sources.”

Yes, he does. He and everybody else always have. When the issues are poison ivy and genital blotchiness, the stakes are not high enough for anyone to talk about. To a large extent, people have always made their minds up about things based on what their friends think and tell them.

If your friends all wear masks, they will stare at you if you don’t. If your friends don’t wear masks, they will stare at you if you do. Or more than that. Very few people like to be stared at. Or worse.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now retired, after more than 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His latest book, “Doctoring from the Outside In,” was recently published. This is his last column for Dermatology News. Write to him at [email protected].

Adjuvant pembrolizumab (Keytruda) following complete melanoma resection could soon move to an earlier stage in the management of high-risk disease, suggest results from KEYNOTE-716. However, the results raise many questions, says an expert invited to discuss the new data.

Adjuvant pembrolizumab is already approved in the United States for use in patients with melanoma with lymph node involvement following complete resection, having been shown to prolong both recurrence-free and distant metastasis-free survival (DMFS) in stage 3 melanoma.

This latest trial involved patients with slightly earlier disease, those with resected stage 2B and 2C melanoma. These patients are at “high risk” of disease recurrence and have similar outcomes to stage 3A and 3B melanoma patients, explained study presenter Jason J. Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center, Pittsburgh.

Results from the KEYNOTE-716 trial showed that adjuvant pembrolizumab is also beneficial in this earlier stage disease: it improved recurrence-free survival (RFS) by 35% and improved distant metastasis-free survival by 40% compared with placebo.

Adjuvant pembrolizumab is an “effective treatment option with a favorable benefit-risk profile for patients with high-risk stage 2 melanoma,” Dr. Luke concluded.

The manufacturer, Merck, has said that these new results have already been accepted for priority review by the U.S. Food and Drug Administration, making it likely that the indication will be extended to include patients with earlier disease.  

Dr. Luke presented the results at the European Society of Medical Oncology 2021 annual meeting.

Invited discussant Omid Hamid, MD, chief of research/immuno-oncology, the Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, said that Dr. Luke’s presentation was “amazing.”

However, these new results have “sabotaged how we think about how we treat our patients and how we’re going to think about what we do in the future.”

Dr. Hamid noted that the incidence of stage 2B and 2C melanoma is “equal” to that of stage 3 disease, “so with a proposed approval” of pembrolizumab in this earlier setting, “we will have a lot more patients” to treat earlier in their disease course.

Of course, this raises the inevitable question of how to treat these patients when they relapse, and how to treat these patients in the metastatic setting “having already exhausted single-agent PD-1 therapy,” he commented.

Dr. Hamid said that the current results also reveal the “current problem” with adjuvant therapy, which is that “we don’t know who benefits,” and there is a subset patients who “never recur” even if they are untreated.

So the questions are: “How come all get treated? What about the risks of toxicity? The costs? And where do we fit these patients into clinic?”

As with so many presentations of immunotherapy trial data, the need for biomarkers was raised, with Dr. Hamid emphasizing the need for predictive biomarkers that could exclude patients, and save them from toxicity.

He noted that there were data with another checkpoint inhibitor, nivolumab (Opdivo), in the adjuvant setting (from the CheckMate 238 trial) that suggested higher tumor mutation burden and tumor interferon-gamma levels could play a role, and he hopes that similar data may be available from this latest trial.

Also, there are ongoing and upcoming trials in patients with stage 2B and 2C melanoma that may answer some of the outstanding questions, including a study of neoadjuvant PD-1 blockade before resection, and the DETECTION trial, which is exploring circulating tumor DNA-guided therapy postsurgery.

Then there is the NivoMela trial that will look at nivolumab in stage 2A as well as 2B and 2C disease, while the REFINE trial will assess whether giving immunotherapy less often to patients with advanced cancer, including those with melanoma, results in fewer side effects while continuing to be effective.

The current results also raise the question of whether to go “earlier and earlier” with adjuvant immunotherapy into “poor risk” stage 1 melanoma, which is already being tried in the United States, although there is “no clear understanding of what to do for those patients.”

Overall, Dr. Hamid said that the results of KEYNOTE-716 have “created more questions than answers,” including its impact on the inclusion criteria for phase 3/4 clinical trials, “which now exclude patients who have received adjuvant therapy within 6 months.”

“That will have to change,” he suggested.

Some of the questions raised by Dr. Hamid were discussed on social media, sparking a lively Twitter debate on how best to take the results forward and into the clinic.

Florentia Dimitriou, MD, a dermatology consultant in the Skin Cancer Clinic, University Hospital Zurich, Switzerland, said the data were “great” but she was “still unclear” over who needs adjuvant immunotherapy in this setting.

She also emphasized that, for her, the greater RFS benefit seen in T3b than in T4b disease “doesn’t make sense,” and she also highlighted the finding of long-term toxicity in approximately 18% of patients.

Dr. Luke replied that he agrees that the T3b/T4b results are puzzling but he said the event rate was “low” and the data are “immature,” and that he hopes to have “more info soon.”

He acknowledged that around 18% of patients taking pembrolizumab went on to receive hormone therapy for adverse events, including 13.9% due to hypothyroidism, and others including hypophysitis, adrenal sufficiency, and type 1 diabetes. However, he also pointed out that about 5% of patients in this study had background thyroid issues. The risks and benefits of treatment need to be discussed with patients, he added.

Over a series of tweets, Rebecca J. Lee, PhD, NIHR clinical lecturer in medical oncology at the University of Manchester, United Kingdom, said, “we need to know more” about the distant metastasis-free survival results, and that results for overall survival are “really” needed.

She also emphasized the need for biomarkers to identify those patients who are likely to benefit, and whether benefit can be upfront or early on in treatment. Dr. Lee added that, as endocrine thyroid toxicity occurs after a median of 3.3 months, “pretreatment biomarkers will be more important than on-treatment biomarkers in this setting.”

Details of the results in earlier stage disease

The KEYNOTE-716 trial enrolled patients with newly diagnosed, resected, high-risk stage 2 melanoma aged ≥ 12 years and a good performance status. The majority (~64%) had stage 2B melanoma, and the rest had stage 2C. T3b disease was present in 41% of patients, 23% had T4a disease, and 35% had T4b disease.

Patients were randomized to receive pembrolizumab or placebo.

In a subsequent part of the study, patients with recurrence will be unblended, with either crossover from the placebo to active treatment group or rechallenge with pembrolizumab for up to 2 years.

Presenting the first part, Dr. Luke said that, of 487 patients assigned to pembrolizumab, 483 started treatment, of whom 206 have completed treatment, 133 are still on therapy, and 144 have discontinued.

In the placebo group, 489 patients were assigned and 486 began treatment. Of those, 229 completed treatment, 152 are still ongoing, and 105 discontinued.

The two groups were well balanced in terms of baseline characteristics. The median age was approximately 60 years, with only one patient enrolled who was aged 12-17 years.

At 12 months, the study met its primary endpoint.

Relapse-fee survival was 90.5% in patients treated with pembrolizumab versus 83.1% in the placebo group, at a hazard ratio for recurrence of 0.65 (P = .00658).

“Despite this trial hitting this primary endpoint very early, there are a number of patients who are censored later in the curves,” Dr. Luke said, adding that “we will continue to see these data mature.”

“In fact, it’s our full expectation that curves will continue to separate over time.”

When looking at key subgroups, Dr. Luke showed that the results favored pembrolizumab when stratifying patients by age, gender, race, and performance status.

Interestingly, patients with T3b disease did a lot better on pembrolizumab compared with those who had T4b disease, at a hazard ratio for recurrence of 0.44 versus 0.94.

Data on recurrence patterns revealed that 11.1% of patients taking pembrolizumab had an event, with 6.4% experiencing skin and/or lymph node regional recurrence and 4.7% distant recurrence.

In the placebo group, 16.8% of patients had a recurrence event, with 8.4% having a loco-regional recurrence and 7.8% a distant recurrence.

Dr. Luke explained that this equates to an approximate 40% reduction in distant recurrence with pembrolizumab over placebo.

Finally, the researchers examined change in global health status on the EORTC QLQ-C30 quality of life score. Examining mean change over time, they found that there were no clinically meaningful changes, and the scores in the pembrolizumab and placebo groups tracked each other during the course of follow-up.

Quality of life was, therefore, “only minimally changed,” Dr. Luke said.

The study was funded by MSD. Dr. Luke and Dr. Hamid have declared relationships with multiple companies.

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

Adjuvant pembrolizumab (Keytruda) following complete melanoma resection could soon move to an earlier stage in the management of high-risk disease, suggest results from KEYNOTE-716. However, the results raise many questions, says an expert invited to discuss the new data.

Adjuvant pembrolizumab is already approved in the United States for use in patients with melanoma with lymph node involvement following complete resection, having been shown to prolong both recurrence-free and distant metastasis-free survival (DMFS) in stage 3 melanoma.

This latest trial involved patients with slightly earlier disease, those with resected stage 2B and 2C melanoma. These patients are at “high risk” of disease recurrence and have similar outcomes to stage 3A and 3B melanoma patients, explained study presenter Jason J. Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center, Pittsburgh.

Results from the KEYNOTE-716 trial showed that adjuvant pembrolizumab is also beneficial in this earlier stage disease: it improved recurrence-free survival (RFS) by 35% and improved distant metastasis-free survival by 40% compared with placebo.

Adjuvant pembrolizumab is an “effective treatment option with a favorable benefit-risk profile for patients with high-risk stage 2 melanoma,” Dr. Luke concluded.

The manufacturer, Merck, has said that these new results have already been accepted for priority review by the U.S. Food and Drug Administration, making it likely that the indication will be extended to include patients with earlier disease.  

Dr. Luke presented the results at the European Society of Medical Oncology 2021 annual meeting.

Invited discussant Omid Hamid, MD, chief of research/immuno-oncology, the Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, said that Dr. Luke’s presentation was “amazing.”

However, these new results have “sabotaged how we think about how we treat our patients and how we’re going to think about what we do in the future.”

Dr. Hamid noted that the incidence of stage 2B and 2C melanoma is “equal” to that of stage 3 disease, “so with a proposed approval” of pembrolizumab in this earlier setting, “we will have a lot more patients” to treat earlier in their disease course.

Of course, this raises the inevitable question of how to treat these patients when they relapse, and how to treat these patients in the metastatic setting “having already exhausted single-agent PD-1 therapy,” he commented.

Dr. Hamid said that the current results also reveal the “current problem” with adjuvant therapy, which is that “we don’t know who benefits,” and there is a subset patients who “never recur” even if they are untreated.

So the questions are: “How come all get treated? What about the risks of toxicity? The costs? And where do we fit these patients into clinic?”

As with so many presentations of immunotherapy trial data, the need for biomarkers was raised, with Dr. Hamid emphasizing the need for predictive biomarkers that could exclude patients, and save them from toxicity.

He noted that there were data with another checkpoint inhibitor, nivolumab (Opdivo), in the adjuvant setting (from the CheckMate 238 trial) that suggested higher tumor mutation burden and tumor interferon-gamma levels could play a role, and he hopes that similar data may be available from this latest trial.

Also, there are ongoing and upcoming trials in patients with stage 2B and 2C melanoma that may answer some of the outstanding questions, including a study of neoadjuvant PD-1 blockade before resection, and the DETECTION trial, which is exploring circulating tumor DNA-guided therapy postsurgery.

Then there is the NivoMela trial that will look at nivolumab in stage 2A as well as 2B and 2C disease, while the REFINE trial will assess whether giving immunotherapy less often to patients with advanced cancer, including those with melanoma, results in fewer side effects while continuing to be effective.

The current results also raise the question of whether to go “earlier and earlier” with adjuvant immunotherapy into “poor risk” stage 1 melanoma, which is already being tried in the United States, although there is “no clear understanding of what to do for those patients.”

Overall, Dr. Hamid said that the results of KEYNOTE-716 have “created more questions than answers,” including its impact on the inclusion criteria for phase 3/4 clinical trials, “which now exclude patients who have received adjuvant therapy within 6 months.”

“That will have to change,” he suggested.

Some of the questions raised by Dr. Hamid were discussed on social media, sparking a lively Twitter debate on how best to take the results forward and into the clinic.

Florentia Dimitriou, MD, a dermatology consultant in the Skin Cancer Clinic, University Hospital Zurich, Switzerland, said the data were “great” but she was “still unclear” over who needs adjuvant immunotherapy in this setting.

She also emphasized that, for her, the greater RFS benefit seen in T3b than in T4b disease “doesn’t make sense,” and she also highlighted the finding of long-term toxicity in approximately 18% of patients.

Dr. Luke replied that he agrees that the T3b/T4b results are puzzling but he said the event rate was “low” and the data are “immature,” and that he hopes to have “more info soon.”

He acknowledged that around 18% of patients taking pembrolizumab went on to receive hormone therapy for adverse events, including 13.9% due to hypothyroidism, and others including hypophysitis, adrenal sufficiency, and type 1 diabetes. However, he also pointed out that about 5% of patients in this study had background thyroid issues. The risks and benefits of treatment need to be discussed with patients, he added.

Over a series of tweets, Rebecca J. Lee, PhD, NIHR clinical lecturer in medical oncology at the University of Manchester, United Kingdom, said, “we need to know more” about the distant metastasis-free survival results, and that results for overall survival are “really” needed.

She also emphasized the need for biomarkers to identify those patients who are likely to benefit, and whether benefit can be upfront or early on in treatment. Dr. Lee added that, as endocrine thyroid toxicity occurs after a median of 3.3 months, “pretreatment biomarkers will be more important than on-treatment biomarkers in this setting.”

Details of the results in earlier stage disease

The KEYNOTE-716 trial enrolled patients with newly diagnosed, resected, high-risk stage 2 melanoma aged ≥ 12 years and a good performance status. The majority (~64%) had stage 2B melanoma, and the rest had stage 2C. T3b disease was present in 41% of patients, 23% had T4a disease, and 35% had T4b disease.

Patients were randomized to receive pembrolizumab or placebo.

In a subsequent part of the study, patients with recurrence will be unblended, with either crossover from the placebo to active treatment group or rechallenge with pembrolizumab for up to 2 years.

Presenting the first part, Dr. Luke said that, of 487 patients assigned to pembrolizumab, 483 started treatment, of whom 206 have completed treatment, 133 are still on therapy, and 144 have discontinued.

In the placebo group, 489 patients were assigned and 486 began treatment. Of those, 229 completed treatment, 152 are still ongoing, and 105 discontinued.

The two groups were well balanced in terms of baseline characteristics. The median age was approximately 60 years, with only one patient enrolled who was aged 12-17 years.

At 12 months, the study met its primary endpoint.

Relapse-fee survival was 90.5% in patients treated with pembrolizumab versus 83.1% in the placebo group, at a hazard ratio for recurrence of 0.65 (P = .00658).

“Despite this trial hitting this primary endpoint very early, there are a number of patients who are censored later in the curves,” Dr. Luke said, adding that “we will continue to see these data mature.”

“In fact, it’s our full expectation that curves will continue to separate over time.”

When looking at key subgroups, Dr. Luke showed that the results favored pembrolizumab when stratifying patients by age, gender, race, and performance status.

Interestingly, patients with T3b disease did a lot better on pembrolizumab compared with those who had T4b disease, at a hazard ratio for recurrence of 0.44 versus 0.94.

Data on recurrence patterns revealed that 11.1% of patients taking pembrolizumab had an event, with 6.4% experiencing skin and/or lymph node regional recurrence and 4.7% distant recurrence.

In the placebo group, 16.8% of patients had a recurrence event, with 8.4% having a loco-regional recurrence and 7.8% a distant recurrence.

Dr. Luke explained that this equates to an approximate 40% reduction in distant recurrence with pembrolizumab over placebo.

Finally, the researchers examined change in global health status on the EORTC QLQ-C30 quality of life score. Examining mean change over time, they found that there were no clinically meaningful changes, and the scores in the pembrolizumab and placebo groups tracked each other during the course of follow-up.

Quality of life was, therefore, “only minimally changed,” Dr. Luke said.

The study was funded by MSD. Dr. Luke and Dr. Hamid have declared relationships with multiple companies.

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

Adjuvant pembrolizumab (Keytruda) following complete melanoma resection could soon move to an earlier stage in the management of high-risk disease, suggest results from KEYNOTE-716. However, the results raise many questions, says an expert invited to discuss the new data.

Adjuvant pembrolizumab is already approved in the United States for use in patients with melanoma with lymph node involvement following complete resection, having been shown to prolong both recurrence-free and distant metastasis-free survival (DMFS) in stage 3 melanoma.

This latest trial involved patients with slightly earlier disease, those with resected stage 2B and 2C melanoma. These patients are at “high risk” of disease recurrence and have similar outcomes to stage 3A and 3B melanoma patients, explained study presenter Jason J. Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center, Pittsburgh.

Results from the KEYNOTE-716 trial showed that adjuvant pembrolizumab is also beneficial in this earlier stage disease: it improved recurrence-free survival (RFS) by 35% and improved distant metastasis-free survival by 40% compared with placebo.

Adjuvant pembrolizumab is an “effective treatment option with a favorable benefit-risk profile for patients with high-risk stage 2 melanoma,” Dr. Luke concluded.

The manufacturer, Merck, has said that these new results have already been accepted for priority review by the U.S. Food and Drug Administration, making it likely that the indication will be extended to include patients with earlier disease.  

Dr. Luke presented the results at the European Society of Medical Oncology 2021 annual meeting.

Invited discussant Omid Hamid, MD, chief of research/immuno-oncology, the Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, said that Dr. Luke’s presentation was “amazing.”

However, these new results have “sabotaged how we think about how we treat our patients and how we’re going to think about what we do in the future.”

Dr. Hamid noted that the incidence of stage 2B and 2C melanoma is “equal” to that of stage 3 disease, “so with a proposed approval” of pembrolizumab in this earlier setting, “we will have a lot more patients” to treat earlier in their disease course.

Of course, this raises the inevitable question of how to treat these patients when they relapse, and how to treat these patients in the metastatic setting “having already exhausted single-agent PD-1 therapy,” he commented.

Dr. Hamid said that the current results also reveal the “current problem” with adjuvant therapy, which is that “we don’t know who benefits,” and there is a subset patients who “never recur” even if they are untreated.

So the questions are: “How come all get treated? What about the risks of toxicity? The costs? And where do we fit these patients into clinic?”

As with so many presentations of immunotherapy trial data, the need for biomarkers was raised, with Dr. Hamid emphasizing the need for predictive biomarkers that could exclude patients, and save them from toxicity.

He noted that there were data with another checkpoint inhibitor, nivolumab (Opdivo), in the adjuvant setting (from the CheckMate 238 trial) that suggested higher tumor mutation burden and tumor interferon-gamma levels could play a role, and he hopes that similar data may be available from this latest trial.

Also, there are ongoing and upcoming trials in patients with stage 2B and 2C melanoma that may answer some of the outstanding questions, including a study of neoadjuvant PD-1 blockade before resection, and the DETECTION trial, which is exploring circulating tumor DNA-guided therapy postsurgery.

Then there is the NivoMela trial that will look at nivolumab in stage 2A as well as 2B and 2C disease, while the REFINE trial will assess whether giving immunotherapy less often to patients with advanced cancer, including those with melanoma, results in fewer side effects while continuing to be effective.

The current results also raise the question of whether to go “earlier and earlier” with adjuvant immunotherapy into “poor risk” stage 1 melanoma, which is already being tried in the United States, although there is “no clear understanding of what to do for those patients.”

Overall, Dr. Hamid said that the results of KEYNOTE-716 have “created more questions than answers,” including its impact on the inclusion criteria for phase 3/4 clinical trials, “which now exclude patients who have received adjuvant therapy within 6 months.”

“That will have to change,” he suggested.

Some of the questions raised by Dr. Hamid were discussed on social media, sparking a lively Twitter debate on how best to take the results forward and into the clinic.

Florentia Dimitriou, MD, a dermatology consultant in the Skin Cancer Clinic, University Hospital Zurich, Switzerland, said the data were “great” but she was “still unclear” over who needs adjuvant immunotherapy in this setting.

She also emphasized that, for her, the greater RFS benefit seen in T3b than in T4b disease “doesn’t make sense,” and she also highlighted the finding of long-term toxicity in approximately 18% of patients.

Dr. Luke replied that he agrees that the T3b/T4b results are puzzling but he said the event rate was “low” and the data are “immature,” and that he hopes to have “more info soon.”

He acknowledged that around 18% of patients taking pembrolizumab went on to receive hormone therapy for adverse events, including 13.9% due to hypothyroidism, and others including hypophysitis, adrenal sufficiency, and type 1 diabetes. However, he also pointed out that about 5% of patients in this study had background thyroid issues. The risks and benefits of treatment need to be discussed with patients, he added.

Over a series of tweets, Rebecca J. Lee, PhD, NIHR clinical lecturer in medical oncology at the University of Manchester, United Kingdom, said, “we need to know more” about the distant metastasis-free survival results, and that results for overall survival are “really” needed.

She also emphasized the need for biomarkers to identify those patients who are likely to benefit, and whether benefit can be upfront or early on in treatment. Dr. Lee added that, as endocrine thyroid toxicity occurs after a median of 3.3 months, “pretreatment biomarkers will be more important than on-treatment biomarkers in this setting.”

Details of the results in earlier stage disease

The KEYNOTE-716 trial enrolled patients with newly diagnosed, resected, high-risk stage 2 melanoma aged ≥ 12 years and a good performance status. The majority (~64%) had stage 2B melanoma, and the rest had stage 2C. T3b disease was present in 41% of patients, 23% had T4a disease, and 35% had T4b disease.

Patients were randomized to receive pembrolizumab or placebo.

In a subsequent part of the study, patients with recurrence will be unblended, with either crossover from the placebo to active treatment group or rechallenge with pembrolizumab for up to 2 years.

Presenting the first part, Dr. Luke said that, of 487 patients assigned to pembrolizumab, 483 started treatment, of whom 206 have completed treatment, 133 are still on therapy, and 144 have discontinued.

In the placebo group, 489 patients were assigned and 486 began treatment. Of those, 229 completed treatment, 152 are still ongoing, and 105 discontinued.

The two groups were well balanced in terms of baseline characteristics. The median age was approximately 60 years, with only one patient enrolled who was aged 12-17 years.

At 12 months, the study met its primary endpoint.

Relapse-fee survival was 90.5% in patients treated with pembrolizumab versus 83.1% in the placebo group, at a hazard ratio for recurrence of 0.65 (P = .00658).

“Despite this trial hitting this primary endpoint very early, there are a number of patients who are censored later in the curves,” Dr. Luke said, adding that “we will continue to see these data mature.”

“In fact, it’s our full expectation that curves will continue to separate over time.”

When looking at key subgroups, Dr. Luke showed that the results favored pembrolizumab when stratifying patients by age, gender, race, and performance status.

Interestingly, patients with T3b disease did a lot better on pembrolizumab compared with those who had T4b disease, at a hazard ratio for recurrence of 0.44 versus 0.94.

Data on recurrence patterns revealed that 11.1% of patients taking pembrolizumab had an event, with 6.4% experiencing skin and/or lymph node regional recurrence and 4.7% distant recurrence.

In the placebo group, 16.8% of patients had a recurrence event, with 8.4% having a loco-regional recurrence and 7.8% a distant recurrence.

Dr. Luke explained that this equates to an approximate 40% reduction in distant recurrence with pembrolizumab over placebo.

Finally, the researchers examined change in global health status on the EORTC QLQ-C30 quality of life score. Examining mean change over time, they found that there were no clinically meaningful changes, and the scores in the pembrolizumab and placebo groups tracked each other during the course of follow-up.

Quality of life was, therefore, “only minimally changed,” Dr. Luke said.

The study was funded by MSD. Dr. Luke and Dr. Hamid have declared relationships with multiple companies.

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

Key clinical point: Proton pump inhibitor (PPI) use was positively associated with the risk of developing psoriasis.

Major finding: Compared with PPI use of 30 or less cumulative defined daily doses (cDDD), PPI use of 120-365 (adjusted odds ratio [aOR], 1.52; 95% confidence interval [CI], 1.31-1.76) and higher than 365 (aOR, 1.54; 95% CI, 1.22-1.93) was associated with a significantly higher risk for psoriasis. Lansoprazole (OR, 1.25; 95% CI, 1.11-1.41), but not pantoprazole, esomeprazole, rabeprazole, or omeprazole, significantly contributed to psoriasis risk.

Study details: Findings are from a nationwide nested case-control study including 5,756 patients with prior exposure to PPIs, of which 2,878 patients had psoriasis.

Disclosures: The study was supported by Taipei Veterans General Hospital and Ministry of Science and Technology, Taiwan. The authors declared no potential conflict of interests.

Source: Li CY et al. Dermatology. 2021 Sep 2. doi: 10.1159/000517515.

Key clinical point: Proton pump inhibitor (PPI) use was positively associated with the risk of developing psoriasis.

Major finding: Compared with PPI use of 30 or less cumulative defined daily doses (cDDD), PPI use of 120-365 (adjusted odds ratio [aOR], 1.52; 95% confidence interval [CI], 1.31-1.76) and higher than 365 (aOR, 1.54; 95% CI, 1.22-1.93) was associated with a significantly higher risk for psoriasis. Lansoprazole (OR, 1.25; 95% CI, 1.11-1.41), but not pantoprazole, esomeprazole, rabeprazole, or omeprazole, significantly contributed to psoriasis risk.

Study details: Findings are from a nationwide nested case-control study including 5,756 patients with prior exposure to PPIs, of which 2,878 patients had psoriasis.

Disclosures: The study was supported by Taipei Veterans General Hospital and Ministry of Science and Technology, Taiwan. The authors declared no potential conflict of interests.

Source: Li CY et al. Dermatology. 2021 Sep 2. doi: 10.1159/000517515.

Key clinical point: Proton pump inhibitor (PPI) use was positively associated with the risk of developing psoriasis.

Major finding: Compared with PPI use of 30 or less cumulative defined daily doses (cDDD), PPI use of 120-365 (adjusted odds ratio [aOR], 1.52; 95% confidence interval [CI], 1.31-1.76) and higher than 365 (aOR, 1.54; 95% CI, 1.22-1.93) was associated with a significantly higher risk for psoriasis. Lansoprazole (OR, 1.25; 95% CI, 1.11-1.41), but not pantoprazole, esomeprazole, rabeprazole, or omeprazole, significantly contributed to psoriasis risk.

Study details: Findings are from a nationwide nested case-control study including 5,756 patients with prior exposure to PPIs, of which 2,878 patients had psoriasis.

Disclosures: The study was supported by Taipei Veterans General Hospital and Ministry of Science and Technology, Taiwan. The authors declared no potential conflict of interests.

Source: Li CY et al. Dermatology. 2021 Sep 2. doi: 10.1159/000517515.

Key clinical point: Patients with psoriasis displayed enhanced susceptibility to psychiatric diseases with the highest risk for those with severe psoriasis, necessitating the simultaneous treatment of both conditions.

Major finding: Patients with psoriasis were at a higher risk for depression (adjusted hazard ratio [aHR], 1.18; 95% confidence interval [CI], 1.09-1.26), anxiety disorders (aHR, 1.16; 95% CI, 1.08-1.26), and somatoform disorders (aHR, 1.21; 95% CI, 1.08-1.34) than healthy controls. Patients with moderate-to-severe vs. mild disease showed a higher risk of developing depression (aHR, 1.28; 95% CI, 1.07-1.54 vs aHR, 1.17; 95% CI, 1.07-1.27) and somatoform disorders (aHR, 1.60; 95% CI, 1.26-2.03 vs aHR, 1.13; 95% CI, 1.00-1.28).

Study details: The data come from a nationwide, prospective cohort study including 10,868 patients with psoriasis and 1,620,055 nonpsoriasis patients followed up for a maximum period of 15 years.

Disclosures: The study was sponsored by Ministry of Health and Welfare, Ministry of Science and Information and Communications Technology, Korea Centers for Disease Control and Prevention, and Ministry of Education. The authors declared no potential conflict of interests.

Source: Oh J et al. J Dermatol. 2021 Aug 30. doi: 10.1111/1346-8138.16115.

Key clinical point: Patients with psoriasis displayed enhanced susceptibility to psychiatric diseases with the highest risk for those with severe psoriasis, necessitating the simultaneous treatment of both conditions.

Major finding: Patients with psoriasis were at a higher risk for depression (adjusted hazard ratio [aHR], 1.18; 95% confidence interval [CI], 1.09-1.26), anxiety disorders (aHR, 1.16; 95% CI, 1.08-1.26), and somatoform disorders (aHR, 1.21; 95% CI, 1.08-1.34) than healthy controls. Patients with moderate-to-severe vs. mild disease showed a higher risk of developing depression (aHR, 1.28; 95% CI, 1.07-1.54 vs aHR, 1.17; 95% CI, 1.07-1.27) and somatoform disorders (aHR, 1.60; 95% CI, 1.26-2.03 vs aHR, 1.13; 95% CI, 1.00-1.28).

Study details: The data come from a nationwide, prospective cohort study including 10,868 patients with psoriasis and 1,620,055 nonpsoriasis patients followed up for a maximum period of 15 years.

Disclosures: The study was sponsored by Ministry of Health and Welfare, Ministry of Science and Information and Communications Technology, Korea Centers for Disease Control and Prevention, and Ministry of Education. The authors declared no potential conflict of interests.

Source: Oh J et al. J Dermatol. 2021 Aug 30. doi: 10.1111/1346-8138.16115.

Key clinical point: Patients with psoriasis displayed enhanced susceptibility to psychiatric diseases with the highest risk for those with severe psoriasis, necessitating the simultaneous treatment of both conditions.

Major finding: Patients with psoriasis were at a higher risk for depression (adjusted hazard ratio [aHR], 1.18; 95% confidence interval [CI], 1.09-1.26), anxiety disorders (aHR, 1.16; 95% CI, 1.08-1.26), and somatoform disorders (aHR, 1.21; 95% CI, 1.08-1.34) than healthy controls. Patients with moderate-to-severe vs. mild disease showed a higher risk of developing depression (aHR, 1.28; 95% CI, 1.07-1.54 vs aHR, 1.17; 95% CI, 1.07-1.27) and somatoform disorders (aHR, 1.60; 95% CI, 1.26-2.03 vs aHR, 1.13; 95% CI, 1.00-1.28).

Study details: The data come from a nationwide, prospective cohort study including 10,868 patients with psoriasis and 1,620,055 nonpsoriasis patients followed up for a maximum period of 15 years.

Disclosures: The study was sponsored by Ministry of Health and Welfare, Ministry of Science and Information and Communications Technology, Korea Centers for Disease Control and Prevention, and Ministry of Education. The authors declared no potential conflict of interests.

Source: Oh J et al. J Dermatol. 2021 Aug 30. doi: 10.1111/1346-8138.16115.

Key clinical point: Secukinumab caused substantial and sustained skin clearance irrespective of prior treatment, leading to high patient satisfaction in patients with moderate-to-severe plaque psoriasis.

Major finding: Overall, 82.3% of patients endorsed the skin clearing effect of secukinumab at 6 months, which persisted through 12 (81.7%), 18 (83.3%), and 24 (81.4%) months. Biologic-experienced/naive and systemic-experienced/naive patients showed similar results. Of those dissatisfied at baseline, 77.9% of patients reported satisfaction at 6 months, which lasted through 12 (74.4%), 18 (82.8%), and 24 (71.4%) months.

Study details: The study included 3,680 patients aged 18 years or above with moderate-to-severe plaque psoriasis who received secukinumab.

Disclosures: The study was supported by Novartis Pharmaceuticals Corporation, East Hanover, NJ. AW Armstrong and PS Yamauchi declared serving as an investigator/consultant/advisor/speaker for various organizations. D Patil, E Levi, and E Nguyen declared being employees of Novartis Pharmaceuticals Corporation.

Source: Armstrong AW et al. Dermatol Ther (Heidelb). 2021 Aug 28. doi: 10.1007/s13555-021-00599-5.

Key clinical point: Secukinumab caused substantial and sustained skin clearance irrespective of prior treatment, leading to high patient satisfaction in patients with moderate-to-severe plaque psoriasis.

Major finding: Overall, 82.3% of patients endorsed the skin clearing effect of secukinumab at 6 months, which persisted through 12 (81.7%), 18 (83.3%), and 24 (81.4%) months. Biologic-experienced/naive and systemic-experienced/naive patients showed similar results. Of those dissatisfied at baseline, 77.9% of patients reported satisfaction at 6 months, which lasted through 12 (74.4%), 18 (82.8%), and 24 (71.4%) months.

Study details: The study included 3,680 patients aged 18 years or above with moderate-to-severe plaque psoriasis who received secukinumab.

Disclosures: The study was supported by Novartis Pharmaceuticals Corporation, East Hanover, NJ. AW Armstrong and PS Yamauchi declared serving as an investigator/consultant/advisor/speaker for various organizations. D Patil, E Levi, and E Nguyen declared being employees of Novartis Pharmaceuticals Corporation.

Source: Armstrong AW et al. Dermatol Ther (Heidelb). 2021 Aug 28. doi: 10.1007/s13555-021-00599-5.

Key clinical point: Secukinumab caused substantial and sustained skin clearance irrespective of prior treatment, leading to high patient satisfaction in patients with moderate-to-severe plaque psoriasis.

Major finding: Overall, 82.3% of patients endorsed the skin clearing effect of secukinumab at 6 months, which persisted through 12 (81.7%), 18 (83.3%), and 24 (81.4%) months. Biologic-experienced/naive and systemic-experienced/naive patients showed similar results. Of those dissatisfied at baseline, 77.9% of patients reported satisfaction at 6 months, which lasted through 12 (74.4%), 18 (82.8%), and 24 (71.4%) months.

Study details: The study included 3,680 patients aged 18 years or above with moderate-to-severe plaque psoriasis who received secukinumab.

Disclosures: The study was supported by Novartis Pharmaceuticals Corporation, East Hanover, NJ. AW Armstrong and PS Yamauchi declared serving as an investigator/consultant/advisor/speaker for various organizations. D Patil, E Levi, and E Nguyen declared being employees of Novartis Pharmaceuticals Corporation.

Source: Armstrong AW et al. Dermatol Ther (Heidelb). 2021 Aug 28. doi: 10.1007/s13555-021-00599-5.

Key clinical point: For a certain body mass index (BMI), abdominal subcutaneous adipose tissue (ASAT) was negatively associated with coronary atherosclerosis burden in men with psoriasis.

Major finding: After adjusting for traditional risk factors and each patient's BMI, ASAT was negatively associated with noncalcified and lipid-rich necrotic core burden in men (β, −0.17; P = .03; β, −0.20; P = .03, respectively) but not in women (β, −0.06; P = .57; β, 0.09; P = .49, respectively) with psoriasis.

Study details: The data come from a cross-sectional study of 232 patients with psoriasis and without known cardiovascular disease, of which 92 were women.

Disclosures: The study was supported by National Heart, Lung, and Blood Institute Intramural Research Program (Bethesda, Maryland). Dr. Mehta declared being a current full-time U.S. government employee and receiving a research grant from various sources. Dr. Khera declared serving as a scientific advisor and receiving speaker fees from various sources.

Source: Teklu M et al. Am J Prev Cardiol. 2021 Aug 22. doi: 10.1016/j.ajpc.2021.100231.

Key clinical point: For a certain body mass index (BMI), abdominal subcutaneous adipose tissue (ASAT) was negatively associated with coronary atherosclerosis burden in men with psoriasis.

Major finding: After adjusting for traditional risk factors and each patient's BMI, ASAT was negatively associated with noncalcified and lipid-rich necrotic core burden in men (β, −0.17; P = .03; β, −0.20; P = .03, respectively) but not in women (β, −0.06; P = .57; β, 0.09; P = .49, respectively) with psoriasis.

Study details: The data come from a cross-sectional study of 232 patients with psoriasis and without known cardiovascular disease, of which 92 were women.

Disclosures: The study was supported by National Heart, Lung, and Blood Institute Intramural Research Program (Bethesda, Maryland). Dr. Mehta declared being a current full-time U.S. government employee and receiving a research grant from various sources. Dr. Khera declared serving as a scientific advisor and receiving speaker fees from various sources.

Source: Teklu M et al. Am J Prev Cardiol. 2021 Aug 22. doi: 10.1016/j.ajpc.2021.100231.

Key clinical point: For a certain body mass index (BMI), abdominal subcutaneous adipose tissue (ASAT) was negatively associated with coronary atherosclerosis burden in men with psoriasis.

Major finding: After adjusting for traditional risk factors and each patient's BMI, ASAT was negatively associated with noncalcified and lipid-rich necrotic core burden in men (β, −0.17; P = .03; β, −0.20; P = .03, respectively) but not in women (β, −0.06; P = .57; β, 0.09; P = .49, respectively) with psoriasis.

Study details: The data come from a cross-sectional study of 232 patients with psoriasis and without known cardiovascular disease, of which 92 were women.

Disclosures: The study was supported by National Heart, Lung, and Blood Institute Intramural Research Program (Bethesda, Maryland). Dr. Mehta declared being a current full-time U.S. government employee and receiving a research grant from various sources. Dr. Khera declared serving as a scientific advisor and receiving speaker fees from various sources.

Source: Teklu M et al. Am J Prev Cardiol. 2021 Aug 22. doi: 10.1016/j.ajpc.2021.100231.

Key clinical point: Clobetasol propionate 0.025% vs 0.05% cream displayed comparable efficacy with a better systemic safety profile in moderate-to-severe psoriasis.

Major finding: At day 28 of twice-daily application, patient proportion with an abnormal adrenocorticotropic hormone stimulation test was numerically lower for 0.025% formulations 5 (20.7%) and 13 (17.2%) than for 0.05% cream (30.0%; P = .320). All treatments caused a comparable decrease in burning/stinging/pruritus scores, whereas Psoriasis Global Assessment success rates were higher for formulations 5 (38.9%) and 13 (36.8%) than for 0.05% cream (30.8%).

Study details: Findings are from a phase 2a, randomized, multicenter, investigator-blinded, 3-arm study involving 88 patients aged 18 years or above with moderate-to-severe psoriasis randomly assigned to clobetasol propionate 0.025% formulation 5, clobetasol propionate 0.025% formulation 13, or clobetasol propionate 0.05% cream.

Disclosures: The study was sponsored by Dr. Reddy’s Laboratories. S Sidgiddi, in addition to owning stocks in the company, declared serving as an employee of Dr. Reddy’s Laboratories along with SMH Naqvi, R Mittal, S Mehta, and A Mane. Some of the authors declared receiving research funds from Dr. Reddy’s Laboratories.

Source: Sidgiddi S et al. Dermatol Ther (Heidelb). 2021 Aug 28. doi: 10.1007/s13555-021-00591-z.

Key clinical point: Clobetasol propionate 0.025% vs 0.05% cream displayed comparable efficacy with a better systemic safety profile in moderate-to-severe psoriasis.

Major finding: At day 28 of twice-daily application, patient proportion with an abnormal adrenocorticotropic hormone stimulation test was numerically lower for 0.025% formulations 5 (20.7%) and 13 (17.2%) than for 0.05% cream (30.0%; P = .320). All treatments caused a comparable decrease in burning/stinging/pruritus scores, whereas Psoriasis Global Assessment success rates were higher for formulations 5 (38.9%) and 13 (36.8%) than for 0.05% cream (30.8%).

Study details: Findings are from a phase 2a, randomized, multicenter, investigator-blinded, 3-arm study involving 88 patients aged 18 years or above with moderate-to-severe psoriasis randomly assigned to clobetasol propionate 0.025% formulation 5, clobetasol propionate 0.025% formulation 13, or clobetasol propionate 0.05% cream.

Disclosures: The study was sponsored by Dr. Reddy’s Laboratories. S Sidgiddi, in addition to owning stocks in the company, declared serving as an employee of Dr. Reddy’s Laboratories along with SMH Naqvi, R Mittal, S Mehta, and A Mane. Some of the authors declared receiving research funds from Dr. Reddy’s Laboratories.

Source: Sidgiddi S et al. Dermatol Ther (Heidelb). 2021 Aug 28. doi: 10.1007/s13555-021-00591-z.

Key clinical point: Clobetasol propionate 0.025% vs 0.05% cream displayed comparable efficacy with a better systemic safety profile in moderate-to-severe psoriasis.

Major finding: At day 28 of twice-daily application, patient proportion with an abnormal adrenocorticotropic hormone stimulation test was numerically lower for 0.025% formulations 5 (20.7%) and 13 (17.2%) than for 0.05% cream (30.0%; P = .320). All treatments caused a comparable decrease in burning/stinging/pruritus scores, whereas Psoriasis Global Assessment success rates were higher for formulations 5 (38.9%) and 13 (36.8%) than for 0.05% cream (30.8%).

Study details: Findings are from a phase 2a, randomized, multicenter, investigator-blinded, 3-arm study involving 88 patients aged 18 years or above with moderate-to-severe psoriasis randomly assigned to clobetasol propionate 0.025% formulation 5, clobetasol propionate 0.025% formulation 13, or clobetasol propionate 0.05% cream.

Disclosures: The study was sponsored by Dr. Reddy’s Laboratories. S Sidgiddi, in addition to owning stocks in the company, declared serving as an employee of Dr. Reddy’s Laboratories along with SMH Naqvi, R Mittal, S Mehta, and A Mane. Some of the authors declared receiving research funds from Dr. Reddy’s Laboratories.

Source: Sidgiddi S et al. Dermatol Ther (Heidelb). 2021 Aug 28. doi: 10.1007/s13555-021-00591-z.

Key clinical point: Psoriasis was associated with an unfavorable cardiovascular and venous thromboembolism (VTE) risk profile in patients with pulmonary embolism (PE) but lower in-hospital mortality.

Major finding: Despite patients with PE and psoriasis being younger than those without psoriasis (median age, 68 years vs 72 years; P < .001), those with psoriasis showed a higher prevalence of VTE and traditional cardiovascular risk factors such as obesity, essential arterial hypertension, hyperlipidemia, and diabetes mellitus (all P < .001) but lower in-hospital mortality (11.1% vs 16.0%; P < .001).

Study details: The study evaluated 1,076,384 hospitalized patients with PE, of which 3,145 (0.3%) patients also had psoriasis.

Disclosures: No specific funding was disclosed for the study. JMG disclosed being an editor for a few journals, co-patent holder of resiquimod for treating cutaneous T cell lymphoma, and Board Director for the International Psoriasis Council. Some of the authors declared receiving consultation fees, research grants, or speaker honoraria from various sources.

Source: Keller K et al. Int J Cardiol. 2021 Sep 1. doi: 10.1016/j.ijcard.2021.08.042.

Key clinical point: Psoriasis was associated with an unfavorable cardiovascular and venous thromboembolism (VTE) risk profile in patients with pulmonary embolism (PE) but lower in-hospital mortality.

Major finding: Despite patients with PE and psoriasis being younger than those without psoriasis (median age, 68 years vs 72 years; P < .001), those with psoriasis showed a higher prevalence of VTE and traditional cardiovascular risk factors such as obesity, essential arterial hypertension, hyperlipidemia, and diabetes mellitus (all P < .001) but lower in-hospital mortality (11.1% vs 16.0%; P < .001).

Study details: The study evaluated 1,076,384 hospitalized patients with PE, of which 3,145 (0.3%) patients also had psoriasis.

Disclosures: No specific funding was disclosed for the study. JMG disclosed being an editor for a few journals, co-patent holder of resiquimod for treating cutaneous T cell lymphoma, and Board Director for the International Psoriasis Council. Some of the authors declared receiving consultation fees, research grants, or speaker honoraria from various sources.

Source: Keller K et al. Int J Cardiol. 2021 Sep 1. doi: 10.1016/j.ijcard.2021.08.042.

Key clinical point: Psoriasis was associated with an unfavorable cardiovascular and venous thromboembolism (VTE) risk profile in patients with pulmonary embolism (PE) but lower in-hospital mortality.

Major finding: Despite patients with PE and psoriasis being younger than those without psoriasis (median age, 68 years vs 72 years; P < .001), those with psoriasis showed a higher prevalence of VTE and traditional cardiovascular risk factors such as obesity, essential arterial hypertension, hyperlipidemia, and diabetes mellitus (all P < .001) but lower in-hospital mortality (11.1% vs 16.0%; P < .001).

Study details: The study evaluated 1,076,384 hospitalized patients with PE, of which 3,145 (0.3%) patients also had psoriasis.

Disclosures: No specific funding was disclosed for the study. JMG disclosed being an editor for a few journals, co-patent holder of resiquimod for treating cutaneous T cell lymphoma, and Board Director for the International Psoriasis Council. Some of the authors declared receiving consultation fees, research grants, or speaker honoraria from various sources.

Source: Keller K et al. Int J Cardiol. 2021 Sep 1. doi: 10.1016/j.ijcard.2021.08.042.