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Safety and efficacy of adalimumab in patients with moderate to severe hidradenitis suppurativa: Results from first 12 weeks of PIONEER I, a phase 3, randomized, placebo-controlled trial

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Published:30th Apr 2015

Author: <p>Kimball A, Zouboulis CC, Armstrong AW, Korman NJ, Crowley JJ, Lynde C, et al.</p>

Source: Journal of the American Academy of Dermatology

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Ref.:J Am Acad Dermatol.2015;72(5):AB60.

DOI:http://dx.doi.org/10.1016/j.jaad.2015.02.251

Safety and efficacy of adalimumab in patients with moderate to severe hidradenitis suppurativa: Results from first 12 weeks of PIONEER I, a phase 3, randomized, placebo-controlled trial

This multicenter study evaluated safety and efficacy of adalimumab (ADA) in patients (pts) with moderate to severe hidradenitis suppurativa (HS). The 12-wk double-blind, placebo (PBO)-controlled period is reported here. Anti-TNFα-naïve pts diagnosed with HS for = 1 year, with total abscess and inflammatory nodule (AN) count of = 3 and HS lesions in = 2 body areas (Hurley Stage II or III), were randomized 1:1 to ADA (160 mg at wk 0; 80 mg at wk 2; 40 mg weekly from wk 4) or matching PBO. Efficacy was analyzed for all randomized pts (intent-to-treat [ITT]), and safety for all ITT pts who received at least 1 dose of study drug. Nonresponder imputation was used for missing data. The 307 ITT pts (63.8% female, 76.2% white, 20.2% black) had mean age of 37.0 years, mean HS duration of 11.5 years, and median AN count of 11. A significantly higher proportion of pts randomized to ADA achieved the primary efficacy endpoint HiSCR (Hidradenitis Suppurativa Clinical Response defined as = 50% reduction from baseline in AN count with no increase in abscess or draining fistula counts) at wk12; ADA (64/153, 41.8%) vs PBO (40/154, 26.0%; P = .003). Adverse events (AE) reported by >10% of pts were exacerbation of HS (13.2% PBO, 9.2% ADA) and nasopharyngitis (10.5% PBO, 5.9% ADA). Cellulitis was reported by 2 pts for each PBO and ADA. Serious AEs included pyelonephritis (n = 1 ADA) and breast cancer (n = 1 PBO). No deaths occurred. In PIONEER I, a Phase 3 randomized PBO-controlled study of ADA in HS, significantly more pts randomized to ADA achieved HiSCR vs pts randomized to PBO. AEs were comparable to PBO and consistent with the ADA safety profile; no new risks were identified.

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