Skin-Sights from September 2024
Welcome to this week's edition of Dermatology Times' LinkedIn newsletter!
As September wraps up, we're reflecting on a month rich with advancements in dermatology. Key expert insights highlighted the importance of innovative treatment approaches, while recent clearances and approvals have set the stage for more effective therapies in skin health.
If you have questions, suggestions, or would like to contribute to a future edition, please contact us via LinkedIn or via email at [email protected] .
?? Expert Insights from the Month
Explore clinical insights from: Henry W. Lim , MD; Arash Mostaghimi, MD, MPA, MPH ; Kilian Eyerich, MD, PhD; Graham Heap , MBBS, PhD; Aaron S. Farberg, MD ; and more.
?? Clearances, Approvals, and Updates
The US FDA approved 礼来 's lebrikizumab-lbkz (Ebglyss) for the treatment of moderate to severe atopic dermatitis in individuals aged 12 years and older. The drug is intended for patients whose AD is not adequately controlled with topical therapies. Approval is based on positive data from the ADvocate 1, ADvocate 2, and ADhere clinical trials, showing significant improvement in skin clarity and itch relief at 16 weeks.
The US FDA approved 优时比 's bimekizumab-bkzx (Bimzelx) for adults with active psoriatic arthritis. Already approved for moderate to severe plaque psoriasis, the drug is now also cleared for non-radiographic axial spondyloarthritis and ankylosing spondylitis. The approval for PsA is based on positive results from the BE OPTIMAL and BE COMPLETE phase 3 trials, showing significant improvements in patients’ clinical responses compared to placebo.
?? Big Studies and Big Data
领英推荐
LEO Pharma presented new data on chronic hand eczema at the European Society of Contact Dermatitis Congress in Dresden. The findings stem from the multinational CHECK study involving over 60,000 participants from Canada and Europe, and the RWEAL study, which included nearly 2,000 patients. The CHECK study found that 5.6% of participants self-reported CHE in the past year, with 1 in 5 attributing it to occupational factors.
Regeneron and Sanofi announced that their phase 3 LIBERTY-CUPID Study C trial for dupilumab (Dupixent) in chronic spontaneous urticaria met its primary and secondary endpoints. In the trial, 30% of patients treated with dupilumab achieved a complete response compared to 18% on placebo. Dupilumab also significantly reduced itch and urticaria activity scores.
?? Market and Pharma News
The US FDA granted Fast Track Designation to Innovent Biologics ' IBI363, a PD-1/IL-2α bispecific antibody fusion protein therapy, for patients with unresectable, advanced, or metastatic melanoma. Early results from trials showed promising efficacy, with a 29.7% overall response rate in melanoma patients and good safety in broader phase 1 studies.
Organon announced its acquisition of Dermavant Sciences, an Organon company and its product, tapinarof cream 1% (Vtama), for up to $1.2 billion. Tapinarof is a non-steroidal topical cream approved for plaque psoriasis, with an FDA decision for atopic dermatitis expected by late 2024. Organon aims to expand its dermatology portfolio and further its mission to enhance women's health.
?? Strides for Skin Health Equity
Following the US FDA approval of lebrikizumab (Ebglyss) for moderate-to-severe atopic dermatitis, interim results from the ADmirable phase 3b study highlighted the drug's effectiveness in patients with skin of color. Presented at the Maui Derm NP+PA Fall conference, the study showed that 68% of participants reached EASI 75 at week 16.
A study found that preclinical medical students performed similarly in diagnosing dermatological conditions in both White patients and those with skin of color. Second-year students demonstrated better diagnostic skills overall, especially with conditions on White skin, while first-year students showed less accuracy. Although students were more confident diagnosing conditions on White skin, they acknowledged the need for increased exposure to dermatological education focused on skin of color.
Thank you for reading!