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

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Published:1st Jan 2019
Author: Paul C, Griffiths CEM, van de Kerkhof PCM, Puig L, Dutronc Y, Henneges C et al.
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Ref.:J Am Acad Dermatol. 2019 Jan;80(1):70-79.e3.
Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study

Biologics targeting interleukin (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, versus 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 approved labels. After one year, efficacy was assessed via improvements in Psoriasis Area and Severity Index (PASI; 90% improvement=PASI 90), and static physician global assessment (sPGA) responses of (0) or (0,1), counting drop-outs as non-responders. Safety analyses included treatment-emergent adverse events (TEAEs).

Results: At Week 52, significantly more ixekizumab-treated patients (p<0.01) reported PASI 90 (104, 76.5%), sPGA (0) (72, 52.9%), and sPGA (0,1) (110, 82.1%) responses, compared to ustekinumab-treated patients (PASI 90: 98, 59.0%; sPGA (0): 60, 36.1%; sPGA (0,1): 108, 65.1%). TEAE, serious AEs, and discontinuation rates were not different between the treatment groups. Injection site reactions occurred more frequently in the ixekizumab treatment group (IXE: 22, 16.3%, UST: 2, 1.2%; p<0.001).

Limitations: This study was not designed to compare safety endpoints related to rare events.

Conclusions: Ixekizumab showed superior efficacy and comparable safety outcomes versus ustekinumab through 52 weeks of treatment.

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