Alice B Gottlieb1, Andrew Blauvelt2, Diamant Thaçi3, Craig L Leonardi4, Yves Poulin5, Janice Drew6, Luke Peterson7, Catherine Arendt8, Daniel Burge6, Kristian Reich9. 1. New York Medical College at Metropolitan Hospital, New York, New York. Electronic address: gottlieba@nychhc.org. 2. Oregon Medical Research Center, Portland, Oregon. 3. Comprehensive Centre Inflammation Medicine, University Hospital of Schleswig-Holstein Campus Lübeck, Lübeck, Germany. 4. Central Dermatology, St. Louis, Missouri; Saint Louis University School of Medicine, St. Louis, Missouri. 5. Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada. 6. Dermira, Inc, Menlo Park, California. 7. UCB Pharma, Raleigh, North Carolina. 8. UCB Pharma, Brussels, Belgium. 9. Dermatologikum Hamburg, Hamburg, Germany; SCIderm Research Institute, Hamburg, Germany.
Abstract
BACKGROUND:Certolizumab pegol, the only Fc-free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements suggestive of a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis. OBJECTIVE: Assess certolizumab efficacy and safety versus placebo in phase 3 studies. METHODS:Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks. At week 16, certolizumab-treated patients achieving a 50% reduction in Psoriasis Area and Severity Index continued treatment through week 48. Coprimary endpoints were week 16 responder rates, defined as a 75% reduction in Psoriasis Area and Severity Index and Physician's Global Assessment 0/1 (clear/almost clear) and ≥2-point improvement. Safety was assessed by treatment-emergent adverse events. RESULTS: Week-16 endpoints were significantly greater for both doses of certolizumab versus placebo, and the responses were maintained through week 48. For most measures, improvement was numerically greater for certolizumab 400 mg. No unexpected safety signals were identified. LIMITATION: There was no active comparator. CONCLUSION: Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant and clinically meaningful improvements in moderate-to-severe psoriasis. The 400-mg dose could provide additional clinical benefit. The safety profile was consistent with the therapeutic class.
RCT Entities:
BACKGROUND:Certolizumab pegol, the only Fc-free, PEGylated anti-tumornecrosis factor biologic, demonstrated clinically meaningful improvements suggestive of a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis. OBJECTIVE: Assess certolizumab efficacy and safety versus placebo in phase 3 studies. METHODS:Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks. At week 16, certolizumab-treated patients achieving a 50% reduction in Psoriasis Area and Severity Index continued treatment through week 48. Coprimary endpoints were week 16 responder rates, defined as a 75% reduction in Psoriasis Area and Severity Index and Physician's Global Assessment 0/1 (clear/almost clear) and ≥2-point improvement. Safety was assessed by treatment-emergent adverse events. RESULTS: Week-16 endpoints were significantly greater for both doses of certolizumab versus placebo, and the responses were maintained through week 48. For most measures, improvement was numerically greater for certolizumab 400 mg. No unexpected safety signals were identified. LIMITATION: There was no active comparator. CONCLUSION: Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant and clinically meaningful improvements in moderate-to-severe psoriasis. The 400-mg dose could provide additional clinical benefit. The safety profile was consistent with the therapeutic class.
Authors: April W Armstrong; Ahmed M Soliman; Keith A Betts; Yan Wang; Yawen Gao; Luis Puig; Matthias Augustin Journal: Dermatol Ther (Heidelb) Date: 2021-03-31
Authors: A Blauvelt; C Paul; P van de Kerkhof; R B Warren; A B Gottlieb; R G Langley; F Brock; C Arendt; M Boehnlein; M Lebwohl; K Reich Journal: Br J Dermatol Date: 2020-09-06 Impact factor: 9.302