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
ISSN: 01909622





JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Editorial
MOSBY-ELSEVIER, 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA, Estados Unidos America
Tipo de documento: Article
Volumen: 80 Número: 1
Páginas: 70
WOS Id: 000452985600020
ID de PubMed: 29969700
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