Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Issue 1 (23rd August 2016)

• Record Type: Journal Article
• Authors: Mease, Philip J; van der Heijde, Désirée; Ritchlin, Christopher T; Okada, Masato; Cuchacovich, Raquel S; Shuler, Catherine L; Lin, Chen-Yen; Braun, Daniel K; Lee, Chin H; Gladman, Dafna D
• Other Names: author non-byline.; Barkham N author non-byline.; Bessette L author non-byline.; Alonso R Blanco author non-byline.; Box EJ author non-byline.; Brooks M author non-byline.; Vargas R Burgos author non-byline.; Chandran V author non-byline.; Dhar R author non-byline.; Nebro A Fernandez author non-byline.; Fleischmann R author non-byline.; Flint K author non-byline.; Forstot J author non-byline.; Villegas F Galvan author non-byline.; Garcia-Fructuoso F author non-byline.; Garmish O author non-byline.; Geneva-Popova M author non-byline.; Geusens P author non-byline.; Gladstein G author non-byline.; Goto H author non-byline.; Griep E author non-byline.; Harrell R author non-byline.; Hou A author non-byline.; Howell M author non-byline.; Kivitz A author non-byline.; Klein S author non-byline.; Kolczewska A author non-byline.; Korkosz M author non-byline.; Montilla D Lopez author non-byline.; Lue C author non-byline.; Makino Y author non-byline.; de la Fuente JL Marenco author non-byline.; Marzo-Ortega H author non-byline.; Miyamura T author non-byline.; Mueller E author non-byline.; Myasoutova L author non-byline.; Sarabia F Navarro author non-byline.; Ostor A author non-byline.; Papp K author non-byline.; Podrazilova L author non-byline.; Pulka G author non-byline.; Raussi E-K author non-byline.; Rosa J author non-byline.; Roussou E author non-byline.; Rychlewska-Hanczewska A author non-byline.; Sada K author non-byline.; Sedova L author non-byline.; Sikes D author non-byline.; Solomon S author non-byline.; Stack M author non-byline.; Stanislavchuk M author non-byline.; Suzuki K author non-byline.; Tahir H author non-byline.; Tälli J author non-byline.; Toncheva A author non-byline.; Turkiewicz A author non-byline.; Valter I author non-byline.; Vladeva S author non-byline.; Wolfe S author non-byline.; Zyablova N author non-byline.;
• Is Part Of: Annals of the rheumatic diseases. Volume 76:Issue 1(2017)
• Page Start: 79
• Page End: 87
• Publication Date: 2016-08-23
• Subjects: DMARDs (biologic) -- Psoriatic Arthritis -- Treatment -- Spondyloarthritis; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2016-209709
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objective: To assess the safety and efficacy of ixekizumab, a monoclonal antibody that inhibits interleukin-17A, in a double-blind phase III trial enrolling patients with active psoriatic arthritis (PsA). Methods: Patients naive to biologic therapy with active PsA were randomised to subcutaneous injections of placebo (N=106), adalimumab 40 mg once every 2 weeks (active reference; N=101), ixekizumab 80 mg once every 2 weeks (IXEQ2W) (N=103), or ixekizumab 80 mg once every 4 weeks (IXEQ4W) (N=107). Both ixekizumab regimens included a 160-mg starting dose. The primary objective was to assess the superiority of IXEQ2W or IXEQ4W versus placebo as measured by the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response at week 24. Results: Significantly more patients treated with ixekizumab achieved an ACR20 response with IXEQ2W (62.1%) or IXEQ4W (57.9%) than placebo (30.2%) (p≤0.001; non-responder imputation method). Disease activity and functional disability were significantly improved with both ixekizumab doses versus placebo at weeks 12 and 24, and there was significantly less progression of structural damage at week 24 (p≤0.01). Clearance of plaque psoriasis was greater with ixekizumab than placebo (p≤0.001). Efficacy results with adalimumab, the active reference arm, showed significant improvements versus placebo. Treatment-emergent adverse events were more frequent with ixekizumab (65.7–66.4%) and adalimumab (64.4%) than placebo (47.2%) (p<0.05). Conclusions: In biologic-naive patients with active PsA, ixekizumab treatment resulted in improvements in disease activity and physical function, as well as in the inhibition of structural damage progression. Overall, adverse events were more frequent in all active groups compared with placebo. Trial registration number: NCT01695239; EudraCT2011-002326-49; Results.