AMSTERDAM – Patient complaints of psoriasis-related sexual difficulties decreased significantly in response to treatment with the investigational biologic agent ixekizumab in a phase 2 dose-ranging study.
Sexual problems attributed by psoriasis patients to their skin condition are a common, underappreciated, and understudied problem. Most physicians simply don’t ask. But when they do, as was done formally in this study, it turned out that at baseline roughly one-third of the 142 participating subjects with moderate to severe chronic plaque psoriasis reported some degree of sexual problems they believed due specifically to their skin disease, Dr. Lyn Guenther reported at the annual congress of the European Academy of Dermatology and Venereology.
That rate dropped precipitously and in dose-dependent fashion in response to subcutaneous therapy with ixekizumab, a super-potent psoriasis medication directed against interleukin 17A, according to Dr. Guenther, professor of dermatology at the University of Western Ontario, London.
The study entailed double-blind randomization of the 142 participants to subcutaneous injections of ixekizumab at 10, 25, 75, or 150 mg or placebo at 0, 2, 4, 8, 12, and 16 weeks. The standard primary outcome -- the proportion of patients with a PASI 75 improvement at 12 weeks -- has previously been reported as highly positive (N. Engl. J. Med. 2012;366:1190-9).
For her secondary analysis of psoriasis-related sexual difficulties and their response to treatment, Dr. Guenther used as her metric the patients’ response to item 9 on the Dermatology Life Quality Index, which all subjects completed at weeks 0, 8, and 16. Item 9 asks the extent to which the responder’s skin “caused any sexual difficulties” during the past week. The options range from 0 (none at all) to 3 (very much). She categorized a response of 1 or more as evidence of sexual difficulties. And because of the relatively small sample size in this study, she lumped together as the low-dose therapy group those patients assigned to ixekizumab at 10 or 25 mg, with the high-dose group being comprised of patients on 75 or