Ixekizumab (IXE), an interleukin 17A (IL-17A) antagonist used for the treatment of psoriasis, is associated with a low overall rate of urinary tract infections (UTIs) and does not increase the rate of UTIs in comparison with control, etanercept, or ustekinumab. This is according to integrated safety analysis data published in the Journal of the American Academy of Dermatology.
The integrated analysis included 6091 patients with psoriasis, representing 17,499 person-years, who were treated with IXE in 14 clinical trials. Across these patients treated with IXE, there were treatment-emergent adverse events (TEAEs) for upper UTI in 23 patients (incidence rate per 100 person-years [IR], 0.1; 95% CI, 0.1-0.2), lower UTI in 424 patients (IR, 2.4; 95% CI, 2.2-2.7), and prostatitis in 12 patients (IR, 0.1; 95% CI, 0.0-0.1).
There were no significant differences in IXE, placebo, etanercept, and ustekinumab in terms of UTI rates. In patients with upper UTIs that were considered serious (n=14); approximately 85.7% (n=12) of these patients had a history of UTI and/or predisposing factors. In addition, 64.3% (n=9) of patients were categories with obesity, and another 64.3% were >50 years of age.
Limitations of this integrated safety analysis included the short sampling period of 466 person-years, as well as the inclusion of studies featuring patients with known risk factors to UTI development, which may reduce the generalizability of the findings.
The researchers emphasized that it may be important to consider predisposing risk factors for UTI “when evaluating infection rates in psoriasis patients, and when judging the suitability of anti-IL-17 agents or any other biologic for patients with psoriasis.”
Disclosure: This clinical trial was supported by Eli Lilly and Company. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Smith SD, Conrad C, Ramharter M, et al. Integrated safety analysis: frequency of urinary tract infections in patients with psoriasis treated with ixekizumab [published online February 21, 2020]. J Am Acad Dermatol. doi:10.1016/j.jaad.2020.02.045