The past year has been an extraordinary time in drug approvals in medical dermatology, especially the approval of treatments that impact patients with skin of color, according to Dr. Andrew F. Alexis, co-chair of Skin of Color Update. Next Steps in Derm, in partnership with Skin of Color Update, interviewed Dr. Alexis, who is also vice-chair for diversity and inclusion for the Weill Cornell Medical College Department of Dermatology. Watch as he highlights a few of the recently approved topical, biologic and oral therapies. Learn how these new treatments address conditions that disproportionately affect and burden patients with skin of color. Plus hear Dr. Alexis’s take on what’s to come in the drug pipeline.
Further Reading
If you want to read more about new drug approvals in medical dermatology, check out the following articles published in the Journal of Drugs in Dermatology:
ABSTRACT
Background: Patients with atopic dermatitis (AD) need safe and effective topical treatments.
Objective: To assess safety and efficacy of roflumilast cream in patients with mild to moderate AD.
Methods: In this phase 2, proof of concept trial, patients (N=136) aged ≥12 years with AD were randomized to once-daily roflumilast cream 0.15%, roflumilast cream 0.05%, or vehicle cream for 4 weeks. Absolute change from baseline in Eczema Area and Severity Index (EASI) score at week 4 (primary endpoint), percentage change and responder rates, Validated Investigator Global Assessment-AD (vIGA-AD), and safety were assessed.
Results: At week 4, mean absolute changes in EASI were -6.4 (P=0.097 vs vehicle), -6.0 (P=0.356), and -4.8 with roflumilast 0.15%, roflumilast 0.05%, and vehicle, respectively. Significant improvements were observed for percentage change from baseline in EASI, patients reaching 75% improvement in EASI, and patients achieving vIGA-AD score of “clear” or “almost clear.” Treatment-related adverse events (AEs) occurred in 2 (2.2%) patients receiving roflumilast (mild rash and moderate application site pain). Only 1 (1.1%) patient receiving roflumilast discontinued study/drug due to an AE.
Limitations: Small number of patients.
Conclusions: Results support additional larger clinical trials of roflumilast cream to assess its potential as a once-daily, nonsteroidal topical AD treatment. ClinicalTrials.gov identifier NCT03916081
A Review of the Current Landscape of Hidradenitis Suppurativa Treatment Development
ABSTRACT
Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by recurrent nodules and abscesses leading to subsequent scarring and tunnel formation. Despite being a fairly common disease with a significant impact on quality of life, only one drug, adalimumab, is currently US Food and Drug Administration (FDA)-approved for treating HS. However, there are many clinical trials underway to address this gap in care for patients with HS.
Methods: All clinical trials related to HS as of 10/03/2022 were reviewed via clinicaltrials.gov. Studies on topical or systemic medical therapies were included and available results reported if they were ongoing or completed within 6 months prior to the search.
Results: Over 30 drugs with at least 20 different mechanisms of action are currently in development for the treatment of HS. While many of these are in phase 2 trials, several are undergoing phase 3 trials and will likely become viable treatment options in the next 5 years.
Conclusions: Following years of limited treatment options for HS, drug development has accelerated significantly, forecasting more treatment possibilities and better disease control for many patients.
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