Authors of a JAAD study searched published alopecia areata (AA) clinical trials and assessed placebo group regrowth rates (PGRR) across AA clinical trials. The studies were divided into two groups: Patchy AA (or less than 50% scalp involvement) or more than 50% scalp involvement. Ten studies assessed patchy AA PGRR with a pooled PGRR of 6.4% over a period of six weeks to 11 months. Ten severe AA trials were included with a pooled PGRR of 7.2% by 12 to 24 weeks. According to the authors, the findings demonstrate a low net PGRR in AA clinical trials, confirming that patients rarely experience spontaneous regrowth while in the placebo arm of clinical trials.
The potential FDA approval of multiple JAK inhibitors could offer new treatment options for dermatology patients. Read more inDermWorld.
DermWorld Insights and Inquiries: The globalization of monkeypox
Here we go again. I have not thought much about monkeypox (MP) since 2003 when a documented case appeared in a 3-year-old girl from central Wisconsin. Investigations implicated a shipment of 800 small animals from Ghana to Texas as the probable means of entry of the MP virus into the United States. According to Sale et al: “A sick Gambian giant-pouched rat (Cricetomys gambianus) from this shipment was subsequently sold to an Illinois animal vendor where it was kept in close proximity to prairie dogs (a native North American rodent [Cynomys species]). Prairie dogs that became infected were sold to a second animal distributor, and eventually to two pet shops and at a pet swap meet in northern Wisconsin. Additional animals from the Texas shipment, including dormice and rope squirrels, tested positive for monkeypox virus. As of July 2003, 72 cases of human monkeypox were under investigation in Illinois, Indiana, Kansas, Missouri, Ohio, and Wisconsin with 37 cases confirmed through laboratory analysis.”Keep reading!
AADA renews calls for iPLEDGE improvements with IPMG, FDA
Leaders of the AADA iPLEDGE workgroup met with the Isotretinoin Product Manufacturer Group (IPMG) and the FDA on May 18, 2022, to renew demands for changes addressing issues that have plagued the program for years. During the meeting, AADA members outlined how the program’s approach to preventing isotretinoin exposed pregnancy is illogical; impedes access to needed treatment, especially in populations that already experience health care disparities; and exacerbates physician shortage issues by necessitating additional appointments.
The AADA again urged IPMG to:
Remove the monthly physician attestation requirements from iPLEDGE REMS for patients who cannot become pregnant.
Remove the 19-day “lockout” period if a patient misses an initial window period.
Increase transparency and collaboration to facilitate needed improvements.
Throughout the crisis and after, the Academy has also advocated for improvements to the platform, including restoring key features that were removed when the program migrated. At the meeting IPMG shared plans that address these concerns, including reinstating the calendar functionality, enhanced enrollment process, and general prescriber and designee updates. However, IPMG was not able to provide a timetable for implementation, noting the FDA must approve these changes first, which could take up to six months after submission, after which their vendor will need time to implement within the iPLEDGE site. AADA urged IPMG and FDA to expedite this process.
Additionally, advocacy by the AADA with Congress has resulted in language addressing reforms to the administration of REMS programs (including iPLEDGE) in draft legislation that would reauthorize drug and medical device user fees. The language would require public input on REMS program changes in the future. The AADA has noted that lack of input from physicians and patients before implementation of the changes last year contributed significantly to the crisis that ensued. The bill also include language requiring the Government Accountability Office to investigate the scope, impact, and resolution of REMS program vendor changes.
Seeking comments on atopic dermatitis guidelines on topical therapies
The American Academy of Dermatology is requesting feedback from members about its draft clinical practice guidelines of care for the management and treatment of atopic dermatitis in adults with topical therapies. View the draft guidelines and share your comments by May 30.
Guidelines serve as decision-making and educational aids for clinical practice to support and improve quality dermatologic care, and are used as the framework for quality measurement, reimbursement decisions, advocacy efforts, public messaging, and the identification of research gaps. When finalized, these evidence-based guidelines will be submitted for publication in the Journal of the American Academy of Dermatology and will be considered current for five years from the date of publication.
In a Journal of Investigative Dermatologystudy, topical ruxolitinib cream was given to adults with cutaneous lichen planus twice daily for eight weeks. At week four, total body lesion count decreased by an average of 50 lesions. Therapeutic response, defined as more than 50% reduction in modified Composite Assessment of Index Lesion Severity score, was achieved in 83.3% of index treated lesions compared with 33.3% of controls. In this small, open-label study, topical ruxolitinib was found to be an effective treatment for cutaneous lichen planus.
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