Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT) - 16/07/18
, Andrew Blauvelt, MD, MBA b, Carle Paul, MD, PhD c, Howard Sofen, MD d, Jolanta Węgłowska, MD e, Vincent Piguet, MD f, g, Daniel Burge, MD h, Robert Rolleri, PharmD i, Janice Drew, MPH h, Luke Peterson, MS i, Matthias Augustin, MD jAbstract |
Background |
Phase 2 psoriasis studies with the Fc-free, PEGylated, anti–tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.
Objective |
Assess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis.
Methods |
Patients were randomized 3:3:1:3 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice weekly for 12 weeks. Certolizumab-treated patients achieving a ≥75% reduction in Psoriasis Area and Severity Index (PASI) at week 16 from baseline PASI were rerandomized to certolizumab or placebo for 32 weeks. The primary endpoint was responder rate (≥75% reduction in PASI from baseline PASI) versus placebo (primary analysis) and etanercept (secondary analysis) at week 12; secondary endpoints included responder rates on various measures versus placebo at weeks 12, 16, and 48. Safety was assessed by treatment-emergent adverse events.
Results |
All endpoints were significantly greater for certolizumab versus placebo with the greatest response seen with 400 mg. Certolizumab 400 mg was superior to and 200 mg was noninferior to etanercept. Adverse events were consistent with the anti–tumor necrosis factor class of drugs.
Limitations |
Etanercept was administered by unblinded study staff or self-administered, but efficacy assessments were performed by a blinded assessor.
Conclusion |
Both certolizumab regimens improved psoriasis symptoms, with a greater response seen with the higher dose. No new safety signals were observed.
Le texte complet de cet article est disponible en PDF.Key words : anti-TNF, anti–tumor necrosis factor, certolizumab pegol, chronic plaque psoriasis, CIMPACT, etanercept, phase 3 trial
Abbreviations used : CZP, FcRn, PASI, PASI 50, PASI 75, PASI 90, PGA, PGA 0/1, TEAE, TNF
Plan
| Funding sources: Supported by Dermira Inc and UCB Inc. UCB is the regulatory sponsor of certolizumab pegol in psoriasis. |
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| Conflicts of interest: Dr Lebwohl is an employee of Mount Sinai which receives research funds from AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, Leo Pharmaceutucals, Medimmune/Astra Zeneca, Novartis, Pfizer, Sciderm, UCB, Valeant, and ViDac; and is a consultant for Allergan, Aqua, Boehringer-Ingelheim, LEO Pharma, Menlo, and Promius. Dr Blauvelt has received honoraria or fees for consulting, serving as a clinical investigator, and/or speaking for AbbVie, Aclaris, Allergan, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dermavant, Dermira Inc, Eli Lilly and Company, Genentech/Roche, GSK, Janssen, LEO Pharma, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB, Valeant, and Vidac. Dr Paul is a consultant and investigator for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen/Johnson & Johnson, LEO Pharma, Novartis, Pierre Fabre, Pfizer, and Sanofi/Regeneron. Dr Sofen has received honoraria or fees for consulting, serving as a clinical investigator, and/or speaking for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira Inc, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharma, UCB, and Valeant. Dr Węgłowska is an investigator and/or speaker for Amgen, Celgene, Coherus, Dermira Inc, Eli Lilly and Company, Galderma, Janssen, LEO Pharma, Merck, Pfizer, Regeneron, Sandoz, and UCB. Dr Piguet has received honoraria or fees for consulting and/or speaking for AbbVie, Almirall, Celgene, Janssen, Novartis, and Pfizer; and has received departmental support for Cardiff University from AbbVie, Almirall, Alliance, Beiersdorf UK Ltd, Biotest, Celgene, Dermal, Eli Lilly, Galderma, Genus Pharma, GlobeMicro, Janssen-Celag, LaRoche-Posay, L'Oreal, LEO Pharma, Meda, MSD, Novartis, Pfizer, Sinclair Pharma, Spirit, Stiefel, Samumed, Thornton Ross, TyPham, and UCB. Dr Augustin has received honoraria or fees for consulting and/or speaking for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly and Company, GSK, Hexal, Janssen-Cilag, LEO Pharma, Medac, Merck, MSD, Mundipharma, Novartis, Pfizer, Sandoz, UCB BioSciences Inc, and Xenoport. Ms Drew and Dr Burge have received stock options from Dermira Inc. Mr Peterson owns stock in UCB Inc. Dr Rolleri has received stock options from UCB Inc. |
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| Previously presented: These data have been previously presented in part at 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; and the 76th Annual Meeting of the American Academy of Dermatology in San Deigo, California, February 16-20, 2018. |
Vol 79 - N° 2
P. 266 - août 2018 Retour au numéro
Article précédent
- Stage IV melanoma of unknown primary: A population-based study in the United States from 1973 to 2014
- Jeffrey F. Scott, Ruzica Z. Conic, Cheryl L. Thompson, Meg R. Gerstenblith, Jeremy S. Bordeaux
- Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial
- Kim A. Papp, Joseph F. Merola, Alice B. Gottlieb, Christopher E.M. Griffiths, Nancy Cross, Luke Peterson, Christopher Cioffi, Andrew Blauvelt
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