Long‐term safety profile of ixekizumab in patients with moderate‐to‐severe plaque psoriasis: an integrated analysis from 11 clinical trials

• Published in: Journal of the European Academy of Dermatology and Venereology 2019-02, Vol.33 (2), p.333-339
• Main Authors: Langley, R.G., Kimball, A.B., Nak, H., Xu, W., Pangallo, B., Osuntokun, O.O., Agada, N., Reich, K.
• Format: Article
• Language: English
• Subjects: Adult; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Clinical Trials as Topic; Controlled Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Injections, Subcutaneous; Japan; Male; Middle Aged; Patient Safety; Psoriasis - drug therapy; Psoriasis - pathology; Risk Assessment; Severity of Illness Index; Time Factors; Treatment Outcome
• ISSN: 0926-9959; 1468-3083
• DOI: 10.1111/jdv.15242

Background Psoriasis in many patients is a chronic and recalcitrant disease that requires long‐term treatment, reinforcing the importance of long‐term safety data. Ixekizumab, a high‐affinity monoclonal antibody that selectively targets interleukin (IL)‐17A, is approved for treating patients with moderate‐to‐severe plaque psoriasis. Objective To determine long‐term safety of ixekizumab in psoriasis. Methods Integrated safety data are presented from 12‐week induction period, 12–60‐week maintenance period, and from all ixekizumab‐treated patients from 11 clinical studies. Exposure‐adjusted incidence rates (IRs) per 100 patient‐years are reported. Results Overall, 5689 patients accounted for 12 061.5 patient‐years of ixekizumab exposure from 11 studies. Over 156 weeks, a total of 83.9% (n = 4775) of patients reported treatment‐emergent adverse events (AEs). Most opportunistic infections (IR [95% confidence interval; CI] 1.8 [1.6, 2.1]) reported were mucocutaneous candidiasis. The IR (95% CI) for oral Candida infection was 0.9 (0.8, 1.1). There was no trend of increase in IR of AEs of special interest. Serious AEs were reported in 11.8% of patients; death occurred in 0.4% (n = 23) of patients. Conclusion The 3‐year, long‐term maintenance treatment with ixekizumab did not show any new safety signals in patients with moderate‐to‐severe plaque psoriasis.