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

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

Author information

1
Department of Dermatology, University of Connecticut Health Center and Probity Medical Research, Farmington, Connecticut. Electronic address: strober@uchc.edu.
2
Central Dermatology PC, St Louis, Missouri.
3
K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.
4
Psoriasis-Center, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.
5
Jichi Medical University, Shimotsuke, Tochigi, Japan.
6
Innovaderm Research, Montreal, Canada.
7
Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
8
Dermatology, Paul Sabatier University, Toulouse, France.
9
Icahn School of Medicine at Mount Sinai, New York, New York.
10
Eli Lilly and Company, Indianapolis, Indiana.
11
Dermatologikum Hamburg and SCIderm, Hamburg, Germany.

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.

KEYWORDS:

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

PMID:
27889292
DOI:
10.1016/j.jaad.2016.09.026
[Indexed for MEDLINE]
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