Adalimumab Treatment in Women With Moderate-to-Severe Hidradenitis Suppurativa from the Placebo-Controlled Portion of a Phase 2, Randomized, Double-Blind Study
October 2016 | Volume 15 | Issue 10 | Original Article | 1192 | Copyright © October 2016
Alice Gottlieb MD PhD,a Alan Menter MD,b April Armstrong MD,c Christopher Ocampo MD,d Yihua Gu MS,d and Henrique D. Teixeira PhDd
aDepartment of Dermatology, New York Medical College, Valhalla, NY bBaylor Research Institute, Dallas, TX cUniversity of Colorado, Denver, CO dAbbVie Inc., North Chicago, IL
Abstract
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.
INTRODUCTION
Hidradenitis Suppurativa (HS), also known as acne inversa, is a painful, chronic, debilitating, inflammatory skin disease that commonly presents after puberty.1 HS affects approximately 1% of the population, and women are affected approximately 2 to 5 times more commonly than men.1 The various comorbidities associated with HS include obesity2-5 and hormonal influences occurring from puberty to menopause in women.4 Immunological abnormalities of the hair follicle, including follicular occlusion, likely play a role in the etiology of the disease.2,6 Elevated levels of the inflammatory cytokine, tumor necrosis factor (TNF)-α,7 are seen in blood and HS tissues of patients with HS.6,8,9Adalimumab (Humira®), a fully human, IgG1 monoclonal antibody specific for TNF-α, is currently the only approved medical treatment for HS, and is also approved for the treatment of moderate-to-severe psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, adult and juvenile Crohn’s disease, and ulcerative colitis. Other available treatments are based on case reports and case series studies.9,10,11 Off-label treatments include antibiotics, corticosteroids, oral contraceptives, cyclosporine, systemic retinoids, metformin and TNF-α inhibitors other than adalimumab.12 For advanced HS, surgical intervention is frequently utilized.12,13As HS is more common in women,14 the objective of this analysis was to determine post hoc the efficacy and safety of adalimumab therapy in a subgroup of women patients from the initial 16-week, randomized, double-blinded, placebo-controlled portion of a 52-week, phase 2 study of patients with moderate to severe HS, a study that identified adalimumab as the first systemic therapy to demonstrate significant
