Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:80

Article

Paul, Carle¹  Griffiths, Christopher E. M.²  van de Kerkhof, Peter C. M.³  Puig, Lluis⁴  Dutronc, Yves⁵  Henneges, Carsten⁵  Dossenbach, Martin⁵  Hollister, Kristin⁵  Reich, Kristian^6,7 

[1] Paul Sabatier Univ, CHU, Dept Dermatol, Toulouse, France

[2] Univ Manchester, Dermatol Ctr, Salford Royal Hosp, Manchester Acad Hlth Sci Ctr, Manchester, Lancs, England

[3] Radboud Univ Nijmegen, Med Ctr, Dept Dermatol, Nijmegen, Netherlands

[4] Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Barcelona, Spain

[5] Eli Lilly & Co, Indianapolis, IN 46285 USA

[6] Dermatologikum Berlin, Berlin, Germany

[7] Georg August Univ Gottingen, Gottingen, Germany

关键词: biologic;    clinical trial;    efficacy;    ixekizumab;    IXORA-S;    psoriasis;    safety;    ustekinumab;   

DOI  :  10.1016/j.jaad.2018.06.039

来源: Elsevier

【 摘 要 】

Background: Biologics targeting interleukin 17A (IL-17A) allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile. Objectives: To compare the safety and efficacy of ixekizumab, an IL-17A antagonist, with the safety and efficacy of the IL-12/23 inhibitor ustekinumab through 52 weeks of treatment in the head-to-head trial IXORA-S. Methods: Patients were randomized to ixekizumab (n = 136) or ustekinumab (n = 166) and dosed per the approved labels. After 1 year, efficacy was assessed via improvements in Psoriasis Area and Severity Index (PASI) score (with PASI 90 indicating a 90% or greater improvement from baseline PASI score) and a static Physician's Global Assessment (sPGA) response of either 0 or 0 or 1, with dropouts counted as nonresponders. Safety analyses included treatment-emergent adverse events (AEs). Results: At week 52, significantly more ixekizumab-treated patients (P<.01) reported PASI 90 (104 [76.5%]), an sPGA response of 0 (72 [52.9%]), or an sPGA response of 0 or 1 (110 [82.1%]) responses than did ustekinumab-treated patients (PASI 90, 98 [59.0%]; sPGA response of 0, 60 [36.1%]; and sPGA response of 0 or 1, 108 [65.1%]). Treatment-emergent AEs, serious AEs, and discontinuation rates were not different between the treatment groups. Injection site reactions occurred more frequently in the ixekizumab-treated group (ixekizumab, 22 [16.3%]; ustekinumab, 2 [1.2%]) (P<.001). Limitations: This study was not designed to compare safety end points related to rare events. Conclusions: Compared with ustekinumab, ixekizumab showed superior efficacy and comparable safety outcomes through 52 weeks of treatment.

【 授权许可】

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