Alexa B Kimball, Martin M Okun, David A Williams, Alice B Gottlieb, Kim A Papp, Christos C Zouboulis, April W Armstrong, Francisco Kerdel, Michael H Gold, Seth B Forman, Neil J Korman, Evangelos J Giamarellos-Bourboulis, Jeffrey J Crowley, Charles Lynde, Ziad Reguiai, Errol-Prospero Prens, Eihab Alwawi, Nael M Mostafa, Brett Pinsky, Murali Sundaram, Yihua Gu, Dawn M Carlson, Gregor B E Jemec
BACKGROUND: Hidradenitis suppurativa is a painful, chronic inflammatory skin disease with few options for effective treatment. In a phase 2 trial, adalimumab, an antibody against tumor necrosis factor α, showed efficacy against hidradenitis suppurativa. METHODS: PIONEER I and II were similarly designed, phase 3 multicenter trials of adalimumab for hidradenitis suppurativa, with two double-blind, placebo-controlled periods. In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg of adalimumab weekly or matching placebo for 12 weeks...
August 4, 2016: New England Journal of Medicine