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

Bruce Strober, Craig Leonardi, Kim A. Papp, Ulrich Mrowietz, Mamitaro Ohtsuki, Robert Bissonnette, Laura K. Ferris, Carle Paul, Mark Lebwohl, Daniel K. Braun, Lotus Mallbris, Stefan Wilhelm, Wen Xu, Anders Ljungberg, Nayan Acharya, Kristian Reich

Research output: Contribution to journalArticlepeer-review

100 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)432-440.e17
JournalJournal of the American Academy of Dermatology
Volume76
Issue number3
DOIs
StatePublished - 1 Mar 2017

Keywords

  • adverse events
  • etanercept
  • integrated analysis
  • interleukin-17A
  • ixekizumab
  • psoriasis
  • safety

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