gms | German Medical Science

44. Kongress der Deutschen Gesellschaft für Rheumatologie, 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

31.08. - 03.09.2016, Frankfurt am Main

A Double-blind Phase 3 Study of Efficacy and Safety of Ixekizumab, Adalimumab, and Placebo in Patients Naïve to Biologic Disease modifying Antirheumatic Drugs with Psoriatic Arthritis

Meeting Abstract

  • Philip Mease - Department of Rheumatology, Swedish Medical Center, and University of Washington, Seattle, WA, USA
  • Desiree van der Heijde - Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
  • Christopher Ritchlin - Allergy, Immunology, & Rheumatology Division, University of Rochester Medical Center, Rochester, New York, USA
  • Raquel Cuchacovich - Eli Lilly and Company, and Department of Medicine, Rheumatology Division, Indiana University School of Medicine, Indianapolis, USA
  • Catherine Shuler - Eli Lilly and Company, Indianapolis, USA
  • Chen-Yen Lin - Eli Lilly and Company, Indianapolis, USA
  • Harold Vangerow - Eli Lilly and Company, Indianapolis, USA
  • Suvajit Samanta - Eli Lilly and Company, Indianapolis, USA
  • Chin Lee - Eli Lilly and Company, Indianapolis, USA
  • Dafna Gladman - Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, Canada
  • Monika Kurzawa - Lilly Deutschland GmbH, Bad Homburg, Germany

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Frankfurt am Main, 31.08.-03.09.2016. Düsseldorf: German Medical Science GMS Publishing House; 2016. DocRA.44

doi: 10.3205/16dgrh215, urn:nbn:de:0183-16dgrh2157

Veröffentlicht: 29. August 2016

© 2016 Mease et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Background: Ixekizumab (IXE) is an anti-IL-17A monoclonal antibody under investigation for PsA treatment.

Methods: 417 biologic disease modifying antirheumatic drug (bDMARD)-naive patients with active psoriatic arthritis (PsA) were randomized to placebo (PBO; N=106), adalimumab (ADA) 40mg Q2W (N=101), or IXE 80mg Q2W (N=103) or Q4W (N=107) after an initial 160mg dose. Endpoints included ACR20 response at 24 weeks (primary), ACR50/70, PASI75/90/100, DAS28-CRP, LDI-B, LEI, and HAQ-DI (12 and 24 weeks), and mTSS (16 and 24 weeks).

Results: 382 patients completed 24 weeks: 30.2%, 57.4%, 62.1% and 57.9% of PBO-, ADA-, IXE Q2W- and IXE Q4W patients, respectively, had ACR20 responses. At 12 (ACR70 not eligible for comparison) and 24 weeks, a higher percentage of IXE Q2W/IXE Q4W- than PBO patients achieved ACR20/50/70 and PASI75/90/100 responses (p≤.001).IXE groups experienced greater reductions than PBO in LDI-B (p≤.025) and LEI (Week 12 Q2W only; p≤.05) (Table). DAS28-CRP and HAQ-DI scores improved, and both IXE doses inhibited radiographic progression of joint structural damage (mTSS) (p≤.025 vs PBO). 24-week treatment-emergent adverse events (TEAE) incidence was higher (p≤.025) with IXE and ADA vs PBO. Discontinuation due to TEAE was similar across groups. No deaths occurred.

Conclusion: IXE patients showed greater disease marker improvement than PBO and no unexpected safety findings were observed in bDMARD-naive patients with PsA.