Author(s): Gottlieb A, Menter A, Armstrong A, Ocampo C, Gu Y, Teixeira HD
BACKGROUND: Hidradenitis Suppurativa (HS), also known as acne inversa, is a painful, chronic, debilitating, inflammatory skin disease and has shown response to anti-TNF-α therapy. Efficacy and safety of the anti-TNF-α agent, adalimumab, was assessed in a post hoc analysis of women from the first 16 weeks of a phase 2 study of men and women with HS.
METHODS: Patients with moderate-to-severe HS in at least 2 body areas, unresponsive or intolerant to oral antibiotics for treatment of their HS, and with no previous anti-TNF-a or systemic non-biologic treatment, were randomized 1:1:1 to 40 mg adalimumab-weekly or every-other-week, or placebo. Efficacy was analyzed post hoc for women from the intent-to-treat population (ITT Population). Efficacy was analyzed for the primary endpoint Hidradenitis Suppurativa Physicians Global Response Clinical Response (HS-PGA Clinical Response), Hidradenitis Suppurativa Clinical Response (HiSCR, defined as a ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline), and a pain endpoint, represented by 30% reduction measured by visual analog scale (VAS30).
RESULTS: At week 16, a higher percentage of women randomized to adalimumab-weekly vs. every-other-week or placebo achieved treatment response measured by HS-PGA (19.4% vs. 7.9% or 5.6%; P>.05), by HiSCR (51.6% vs. 24.2% or 27.6%; P>.05), and achieved VAS30 (50.0% vs. 34.3%; P>.05 or 21.2% P<.05; significant for adalimumab-weekly vs. placebo). Four women had serious adverse events (anemia, benign neoplasm, pneumonia, and suicide attempt). There were no fatalities. Women had a similarly acceptable safety profile as the overall study population.
CONCLUSION: In this subpopulation of women with moderate-to-severe HS, a greater proportion achieved reduction in HS severity and pain with adalimumab 40 mg weekly dosing compared with every-other-week or placebo. No new safety signals were identified.
J Drugs Dermatol. 2016;15(10):1192-1196.
Dermatology Journal and/or Publisher
Journal Name: Journal of drugs in dermatology : JDD
Journal Abbreviation: J Drugs Dermatol
Journal Date Published: 2016-10-14
National Center for Biotechnology Information
Article Source: http://www.ncbi.nlm.nih.gov/pubmed/27741335
Lasted Revision: 2017-04-26
Abstract Source: National Center for Biotechnology Information, U.S. National Library of Medicine Abstract Query for Hidradenitis suppurativa (HS).