Efficacy and safety of ixekizumab over 4 years of open-label treatment in a phase 2 study in chronic plaque psoriasis - 16/07/18
, Kenneth Gordon, MD b, Alexandra B. Kimball, MD c, Mark Lebwohl, MD d, Andrew Blauvelt, MD e, Craig Leonardi, MD f, Daniel Braun, MD, PhD g, Missy McKean-Matthews, MS h, Russel Burge, PhD g, Gregory Cameron, PhD gAbstract |
Background |
Ixekizumab has demonstrated improvement in patients with moderate-to-severe psoriasis by selectively targeting interleukin-17A, which is a proinflammatory cytokine that is important in the pathogenesis of psoriasis.
Objective |
To report 4-year efficacy and safety results from the open-label extension (OLE) of this phase 2 trial.
Methods |
Analysis was by last observation carried forward. Patients received ixekizumab, 120 mg, and then 80 mg subcutaneously once every 4 weeks.
Results |
Of the patients who completed the randomized placebo-controlled trial, 93% entered the OLE. A 75% reduction in the Psoriasis Area Severity Index score was reported in 82% of patients at week 208 of the OLE. A static Physician's Global Assessment score of 0 or 1 was reported in 64% of patients, and a score of 0 was reported in 45% at week 208. Patients' Dermatology Life Quality Index and Itch Visual Analog Scale scores decreased when compared with baseline. Improvements were observed in other efficacy and health outcome measures. Serious adverse events were observed in 16.7% of patients, and 87% had 1 or more treatment-emergent adverse events. Three patients had serious infections. One patient reported 2 major cardiovascular events.
Limitations |
The study was unblinded and lacked a placebo or active comparator.
Conclusions |
Efficacy was shown to be maintained for up to 4 years of ixekizumab treatment.
Le texte complet de cet article est disponible en PDF.Key words : 4 years, interleukin 17, ixekizumab, long-term, open-label, psoriasis
Abbreviations used : BCC, DLQI, HADS, IBD, IL, LOCF, MACE, NAPSI, OLE, PASI, PatGA, PMRU, PsA, PSSI, RCT, SAE, SD, sPGA, TEAE, VAS
Plan
| Funding sources: Supported by Eli Lilly and Company. |
|
| Disclosure: Dr Zachariae has consulting relationships with and/or is an investigator for and/or has received grants or honoraria from Eli Lilly and Company, Janssen Cilag, Novartis Pharmaceutical Corp, AbbVie, Takeda, Amgen Inc, MSD, LEO Pharmaceuticals, Almirall, and Regeneron. Dr Gordon has consulting relationships with AbbVie, Amgen Inc, Celgene, Eli Lilly and Company, Janssen Pharmaceuticals, Inc, Novartis Pharmaceutical Corp, Pfizer Inc, Dermira, and Boehringer Ingelheim and has received grants from AbbVie, Amgen Inc, Celgene, and Janssen Pharmaceuticals, Inc. Dr Kimball has consulting relationships with and/or received honoraria and/or funding from AbbVie, Dermira, Eli Lilly and Company, Merck and Company, Inc, Novartis Pharmaceutical Corp, and Janssen Pharmaceuticals, Inc. Dr Lebwohl is an employee of the Mount Sinai Medical Center and has received funding from Amgen Inc, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen Biotech, Kadmon, LEO Pharmaceuticals, Medimmune, Novartis Pharmaceutical Corp, Pfizer Inc, Sun Pharmaceuticals, and Valeant. Dr Blauvelt has consulting or investigator relationships with AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Inc., Eli Lilly and Company, Genentech/Roche, GlaxoSmithKline, Janssen, Leo, Meiji, Merck Sharp & Dohme, Novartis Pharmaceutical Corp, Pfizer, Purdue Pharma, Regeneron, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac. Dr Leonardi has received honoraria or other funding from AbbVie, Amgen Inc, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly and Company, Janssen Pharmaceuticals, Inc, Leo Pharma Inc, Novartis Pharmaceutical Corp, Pfizer Inc, Sandoz (a Novartis company), UCB, Actavis, Coherus Biosciences, Corrona Inc, Galderma Laboratories, LP, Glenmark Generics Inc, Novella, Stiefel (a GlaxoSmithKline company), and Warner Chilcott. Dr Braun is an employee and minor shareholder of Eli Lilly and Company. Ms McKean-Matthews is an employee of Syneos Health. Dr Burge is an employee and minor shareholder of Eli Lilly and Company. Dr Cameron is an employee and minor shareholder of Eli Lilly and Company. |
Vol 79 - N° 2
P. 294 - août 2018 Retour au numéro
Article précédent
- Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3 randomized controlled trials
- Linda Stein Gold, Mark G. Lebwohl, Jeffrey L. Sugarman, David M. Pariser, Tina Lin, Gina Martin, Radhakrishnan Pillai, Robert Israel, Tage Ramakrishna
- 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)
- Alice B. Gottlieb, Andrew Blauvelt, Diamant Thaçi, Craig L. Leonardi, Yves Poulin, Janice Drew, Luke Peterson, Catherine Arendt, Daniel Burge, Kristian Reich
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?