Certolizumab pegol for the treatment of patients with moderate-to-severe chronic plaque psoriasis: pooled analysis of week 16 data from three randomized controlled trials

Journal of the European Academy of Dermatology and Venereology : JEADV
Andrew BlauveltA B Gottlieb

Abstract

Certolizumab pegol, an Fc-free, PEGylated, anti-tumour necrosis factor (TNF) biologic, has demonstrated favourable results in three ongoing, phase 3, randomized, double-blinded, placebo-controlled trials in adults with psoriasis. Data were pooled from the ongoing trials to investigate efficacy in selected subgroups and add precision to estimates of treatment effects during the initial 16 weeks of treatment. In each trial, patients ≥18 years with moderate-to-severe chronic plaque psoriasis for ≥6 months were randomized to receive certolizumab 400 mg, certolizumab 200 mg or placebo every 2 weeks for 16 weeks. Coprimary endpoints for the pooled analysis were responder rates at Week 16, defined as ≥75% reduction in psoriasis area and severity index (PASI 75) and physician global assessment (PGA) of 0/1 ('clear'/'almost clear' with ≥2-category improvement). Safety was assessed by treatment-emergent adverse events. A total of 850 patients treated with certolizumab 400 mg (N = 342), certolizumab 200 mg (N = 351) or placebo (N = 157) were included in the pooled analysis. At Week 16, PASI 75 and PGA 0/1 responder rates were 80.1% and 63.7% in the certolizumab 400 mg group, 74.5% and 54.6% in the certolizumab 200 mg group, and 7.5% and 2...Continue Reading

References

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Citations

Jan 10, 2020·The Cochrane Database of Systematic Reviews·Emilie SbidianLaurence Le Cleach
Jan 10, 2020·Expert Review of Clinical Immunology·Maria EspositoMaria Concetta Fargnoli
Jan 31, 2020·Indian Journal of Dermatology, Venereology and Leprology·Sayanta Thakur, Sandeep Lahiry
Apr 10, 2019·The Journal of Dermatological Treatment·Francesco CarubbiMaria Concetta Fargnoli
Mar 25, 2020·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Arnold Lee, Lesley J Scott
Oct 15, 2020·International Journal of Molecular Sciences·Michio Tokuyama, Tomotaka Mabuchi
Jun 19, 2019·Annales de dermatologie et de vénéréologie·J Charles, UNKNOWN Groupe de recherche sur le psoriasis de la Société française de dermatologie
Apr 20, 2021·The Cochrane Database of Systematic Reviews·Emilie SbidianLaurence Le Cleach
Aug 4, 2021·The Journal of Allergy and Clinical Immunology·Lam C TsoiJohann E Gudjonsson
Jul 1, 2021·Journal of the European Academy of Dermatology and Venereology : JEADV·R B WarrenA Blauvelt

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NCT02326298
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NCT02346240

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