Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:76

Article; Proceedings Paper

Strober, Bruce¹  Leonardi, Craig²  Papp, Kim A.³  Mrowietz, Ulrich⁴  Ohtsuki, Mamitaro⁵  Bissonnette, Robert⁶  Ferris, Laura K.⁷  Paul, Carle⁸  Braun, Daniel K.^9,10  Mallbris, Lotus¹⁰  Wilhelm, Stefan¹⁰  Xu, Wen¹⁰  Ljungberg, Anders¹⁰  Acharya, Nayan¹⁰  Reich, Kristian¹¹ 

[1] Univ Connecticut, Hlth Ctr & Prob Med Res, Dept Dermatol, 21 South Rd,Second Floor, Farmington, CT 06032 USA

[2] Cent Dermatol PC, St Louis, MO USA

[3] K Papp Clin Res & Prob Med Res, Waterloo, ON, Canada

[4] Univ Med Ctr Schleswig Holstein, Psoriasis Ctr, Campus Kiel, Kiel, Germany

[5] Jichi Med Univ, Shimotsuke, Tochigi, Japan

[6] Innovaderm Res, Montreal, PQ, Canada

[7] Univ Pittsburgh, Med Ctr, Dept Dermatol, Pittsburgh, PA 15260 USA

[8] Paul Sabatier Univ, Dermatol, Toulouse, France

[9] Icahn Sch Med Mt Sinai, New York, NY 10029 USA

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

[11] Dermatol Hamburg & SCIderm, Hamburg, Germany

关键词: adverse events;    etanercept;    integrated analysis;    interleukin-17A;    ixekizumab;    psoriasis;    safety;   

DOI  :  10.1016/j.jaad.2016.09.026

来源: Elsevier

【 摘 要 】

Background: Safety of biologics is important when treating patients with psoriasis. Objective: We sought to determine the safety of ixekizumab in psoriasis. Methods: Integrated safety data are presented from a 12-week induction period, a 12- to 60-week maintenance period, and from all ixekizumab-treated patients from 7 clinical trials. Exposure-adjusted incidence rates (IRs) per 100 patient-years are reported. Results: Overall, 4209 patients received ixekizumab (total exposure: 6480 patient-years). During the induction period, the IRs of patients experiencing 1 or more treatment-emergent adverse event (AE) were 251 and 236 among ixekizumab-and etanercept-treated patients, respectively, and for serious AEs was 8.3 in both groups. During maintenance, for ixekizumab, the IRs of treatment-emergent AEs and serious AEs were 100.4 and 7.8, respectively. Among all ixekizumab-treated patients from 7 trials, the IR of Candida infections was 2.5. The IRs of treatment-emergent AEs of special interest (including serious infections, malignancies, major adverse cardiovascular events) were comparable for ixekizumab and etanercept during the induction period. Limitations: Additional long-term data are required. Conclusion: Ixekizumab had an acceptable safety profile with no unexpected safety findings during ixekizumab maintenance in psoriasis.

【 授权许可】

Free