gms | German Medical Science

43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

Secukinumab is superior to Ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: 16-week results from the CLEAR study

Meeting Abstract

  • Diamant Thaci - Exzellenzzentrum Entzündungsmedizin der Universität zu Lübeck, Dermatologie, Lübeck
  • Andrew Blauvelt - Oregon Medical Research Center, Portland, Oregon, USA
  • Kristian Reich - Dermatologikum Hamburg, Hamburg
  • Tsen-Fang Tsai - National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan
  • Francisco Vanaclocha - Hospital 12 de Octubre, Madrid, Spain
  • Kulli Kingo - Dermatology Clinic, Tartu University, Tartu, Estonia
  • Michael Ziv - Emek Medical Center, Afula, Israel
  • Andreas Pinter - University of Frankfurt, Frankfurt, Germany
  • Sophie Hugot - Novartis Pharma AG, Basel, Switzerland
  • Ruquan You - Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China
  • Marina Milutinovic - Novartis Pharma AG, Basel, Switzerland

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. DocVS.04

doi: 10.3205/15dgrh255, urn:nbn:de:0183-15dgrh2559

Veröffentlicht: 1. September 2015

© 2015 Thaci 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

Introduction: CLEAR is a phase 3b study comparing the efficacy and safety of secukinumab with ustekinumab in moderate to severe plaque psoriasis.

Methods: In this 52-wk, multicenter, double-blind, parallel-group study (NCT02074982), subjects were randomized 1:1 to subcutaneous injection of secukinumab (300 mg) or ustekinumab (dosing per label). Secukinumab was administered at Baseline, Wks 1, 2 and 3, then every 4 wks from Wk 4 to 48. Primary objective: demonstrate the superiority of secukinumab vs. ustekinumab in PASI90 response at Wk 16 (non-responder imputation).

Results: Secukinumab (79.0%; n=334) was superior to ustekinumab (57.6%; n=335) in PASI90 response at Wk 16 (P<0.0001 [logistic regression model]). PASI100 response (clear skin) at Wk 16 was also achieved by a significantly greater proportion of subjects receiving secukinumab (44.3%) than ustekinumab (28.4%) (P<0.0001). Secukinumab was superior to ustekinumab with respect to PASI75 responses at Wk 4: 50.0% vs. 20.6% of subjects, respectively (P<0.0001). Secukinumab’s safety profile was similar to that of ustekinumab and consistent with that seen in secukinumab pivotal phase 3 studies.

Conclusion: Secukinumab treatment – even at early timepoints – has demonstrated superiority to ustekinumab in clearing skin of subjects with moderate to severe psoriasis, with a comparable safety profile.