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

J Am Acad Dermatol. 2017 Mar;76(3):432-440.e17. doi: 10.1016/j.jaad.2016.09.026. Epub 2016 Nov 23.


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.

Keywords: adverse events; etanercept; integrated analysis; interleukin-17A; ixekizumab; psoriasis; safety.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Candidiasis / chemically induced
  • Candidiasis / epidemiology*
  • Clinical Trials as Topic
  • Colitis, Ulcerative / chemically induced
  • Colitis, Ulcerative / epidemiology
  • Crohn Disease / chemically induced
  • Crohn Disease / epidemiology
  • Dermatologic Agents / adverse effects*
  • Etanercept / adverse effects*
  • Female
  • Humans
  • Incidence
  • Induction Chemotherapy / adverse effects
  • Maintenance Chemotherapy / adverse effects
  • Male
  • Middle Aged
  • Myocardial Infarction / chemically induced
  • Myocardial Infarction / epidemiology
  • Neoplasms / chemically induced
  • Neoplasms / epidemiology*
  • Psoriasis / drug therapy*
  • Stroke / chemically induced
  • Stroke / epidemiology
  • Time Factors


  • Antibodies, Monoclonal, Humanized
  • Dermatologic Agents
  • ixekizumab
  • Etanercept