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45. Kongress der Deutschen Gesellschaft für Rheumatologie, 31. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 27. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

06.09. - 09.09.2017, Stuttgart

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Fifty two-week efficacy and safety results from SPIRIT-P1: A Phase 3 study of ixekizumab in patients with active psoriatic arthritis

Meeting Abstract

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  • Philip Mease - Department of Rheumatology, Swedish Medical Center, and University of Washington, Seattle, WA, USA
  • M Okada - St Luke’s International Hospital, Tokyo, Japan
  • M Kishimoto - St Luke’s International Hospital, Tokyo, Japan
  • Catherine Shuler - Eli Lilly and Company, Indianapolis, USA
  • H Carlier - Eli Lilly and Company, Indianapolis, USA
  • Chen-Yen Lin - Eli Lilly and Company, Indianapolis, USA
  • J Mou - Eli Lilly and Company, Indianapolis, United Sates
  • Susan Moriarty - 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. 45. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 31. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 27. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Stuttgart, 06.-09.09.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. DocRA.22

doi: 10.3205/17dgrh185, urn:nbn:de:0183-17dgrh1852

Veröffentlicht: 4. September 2017

© 2017 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: The efficacy and safety of ixekizumab were evaluated in patients with active PsA.

Methods: Patients (N=417) were randomized to ixekizumab 80mg once every 4 (IXEQ4W) or 2 (IXEQ2W) weeks (160mg starting dose included), 40mg adalimumab, or placebo during the double-blind treatment period (DBTP: weeks 0–24). 381 patients entered the extension period (EP: weeks 24–52): at week 16 or 24, patients from the adalimumab or placebo groups were re-randomized to IXEQ4W or IXEQ2W.

Results: Results are presented for the EP population who received IXEQ4W or IXEQ2W since baseline (IXEQ4W/IXEQ4W and IXEQ2W/IXEQ2W). The EP was completed by 304 patients. Response rates at week 52 for the groups, respectively, were: ACR 20/50/70: 69.1/54.6/39.2%, 68.8/53.1/39.6%; PASI 75/90/100: 78.8/66.7/56.1%, 81.8/78.2/67.3%; static PGA score of (0 or 1)/(0): 81.3/60.4%, 78.4/62.2%. For the IXEQ4W/IXEQ4W and IXEQ2W/IXEQ2W groups, respectively, changes from baseline to week 52 were -13.5 and -9.3 for percent BSA involvement of psoriasis and -16.5 and -21.6 for NAPSI. Most adverse events (AEs) were mild or moderate; serious AEs occurred in 4 patients.

Conclusion: Ixekizumab demonstrated improvements in signs and symptoms of PsA with a safety profile that was consistent in the EP and DBTP.