Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2) - 16/07/18
, Andrew Blauvelt, MD, MBA b, Diamant Thaçi, MD c, Craig L. Leonardi, MD d, e, Yves Poulin, MD f, Janice Drew, MPH g, Luke Peterson, MS h, Catherine Arendt, MD, PharmD i, Daniel Burge, MD g, Kristian Reich, MD j, kAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : anti-TNF, anti–tumor necrosis factor, certolizumab pegol, chronic plaque psoriasis, CIMPASI-1, CIMPASI-2, phase 3 trial
Abbreviations used : CZP, DLQI, FcRn, PASI, PASI 50, PASI 50-75, PASI 75, PASI 90, PGA, TEAE, TNF
Plan
| Funding sources: Supported by Dermira Inc and UCB Inc. |
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| Conflicts of interest: Dr Gottlieb has consulted and/or received other fees from Janssen Inc, Celgene Corp, Bristol-Myers Squibb Co, Beiersdorf Inc, AbbVie, UCB, Novartis, Incyte, Eli Lilly, Reddy Labs, Valeant, Dermira Inc, Allergan, and Sun Pharmaceutical Industries; and has received research or educational grants (paid to Tufts Medical Center) from Janssen Incyte, Lilly, Novartis, Allergan, and LEO Pharma. Dr Blauvelt has received honoraria or fees for consulting, being a clinical investigator, and/or speaker for AbbVie, Aclaris, Allergan, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dermavant, Dermira Inc, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Janssen, LEO Pharma, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac. Dr Leonardi has received fees or honoraria for consulting, speaking, or serving on the advisory board for AbbVie, Actavis, Amgen, Boehringer Ingelheim Pharma, Celgene, Coherus, Corrona, Dermira Inc, Eli Lilly, Galderma, Glenmark, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sandoz, Stiefel, UCB Pharma, Vitae, and Wyeth. Dr Poulin has received research grants as an investigator for AbbVie, Baxter, Boehringer Ingelheim Pharma, Celgene, Centocor/Janssen, Eli Lilly, EMD Serono, GlaxoSmithKline, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Takeda, and UCB Pharma; and has received honoraria speaking for AbbVie, Celgene, Janssen, Eli Lilly, LEO Pharma, Novartis, Regeneron, and Sanofi Genzyme. Dr Reich has received speaker's fees or honoraria from and/or served on the advisory board for AbbVie, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Eli Lilly, Medac, Merck Sharp & Dohme, Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB Pharma, and Xenoport. Dr Thaçi has received research support from AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Dignity, Eli Lilly, Forward-Pharma, GlaxoSmithKline, LEO Pharma, Janssen-Cilag, Maruho, Merck Sharp & Dohme, Mitsubishi Pharma, Novartis, Pfizer, Roche, Regeneron, and Sandoz; received honoraria from AbbVie, Biogen, Celgene, Janssen, LEO Pharma, Pfizer, Roche-Possay, Novartis, and Mundipharma; served as a consultant for AbbVie, Biogen, Celgene, Dignity, Galapagos, Maruho, Mitsubishi, Novartis, Pfizer, and Xenoport; and sat on the scientific advisory boards for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, GlaxoSmithKline, LEO Pharma, Pfizer, Novartis, Janssen, Mundipharma, and Sandoz. Ms Drew and Dr Burge have received stock options from Dermira Inc. Mr Peterson owns stock in UCB Inc. Dr Arendt owns stock in and has received stock options from UCB Inc. |
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| Previously presented: These data have been previously presented in part at the 75th Annual Meeting of the American Academy of Dermatology in Orlando, Florida, March 3-7, 2017; the 13th Annual Maui Derm for Dermatologists in Maui, Hawaii, March 20-24, 2017; the Dermatology Education Foundation Essential Resource Meeting in Las Vegas, Nevada, July 20-23, 2017; the 26th Annual Congress of the European Academy of Dermatology and Venereology in Geneva, Switzerland, September 13-17, 2017; the 36th Annual Fall Clinical Dermatology Conference in Las Vegas, Nevada, October 12-15, 2017; the 8th Triennial International Congress on Psoriasis: From Gene to Clinic in London, United Kingdom, November 30-December 2, 2017; the 13th Annual Winter Clinical Dermatology Conference in Maui, Hawaii, January 12-17, 2018; the 14th Annual Maui Derm for Dermatologists in Maui, Hawaii, January 28-February 1, 2018; and the 76th Annual Meeting of the American Academy of Dermatology in San Diego, California, February 16-20, 2018. |
Vol 79 - N° 2
P. 302 - août 2018 Retour au numéro
Article précédent
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