Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study
Por:
Paul, C, Griffiths, CEM, van de Kerkhof, PCM, Puig, L, Dutronc, Y, Henneges, C, Dossenbach, M, Hollister, K, Reich, K
Publicada:
1 ene 2019
Resumen:
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.
Filiaciones:
Paul, C:
Paul Sabatier Univ, CHU, Dept Dermatol, Toulouse, France
Griffiths, CEM:
Univ Manchester, Dermatol Ctr, Salford Royal Hosp, Manchester Acad Hlth Sci Ctr, Manchester, Lancs, England
van de Kerkhof, PCM:
Radboud Univ Nijmegen, Med Ctr, Dept Dermatol, Nijmegen, Netherlands
Puig, L:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Barcelona, Spain
Dutronc, Y:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Henneges, C:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Dossenbach, M:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Hollister, K:
Eli Lilly & Co, Indianapolis, IN 46285 USA
Reich, K:
Dermatologikum Berlin, Berlin, Germany
Georg August Univ Gottingen, Gottingen, Germany
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