Ixekizumab Improved Patient-Reported Genital Psoriasis Symptoms and Impact of Symptoms on Sexual Activity vs Placebo in a Randomized, Double-Blind Study

• DOI: 10.1016/j.jsxm.2018.09.004
• Publication Date: 2018-11-09T00:17:10Z
• Authors: Gil Yosipovitch; Peter Foley; Caitriona Ryan; Jennifer C. Cather; Kim A. Meeuwis; Russel Burge; Alison Potts Blea...; Chen-Yen Lin; William Malatestinic; Alice Gottlieb
• Keywords: Ixekizumab; Sex organ

Abstract Introduction Genital psoriasis (GenPs) is common and distressing for patients, but often not discussed with physicians, no previous clinical trials have assessed the effects of biologics specifically on GenPs its associated symptoms. Aim To report results novel patient-reported outcomes (PROs) assessment symptoms sexual impact before after treatment in IXORA-Q study. Methods (NCT02718898) was a phase III, randomized, double-blind, placebo-controlled study ixekizumab (80 mg/2 weeks 160-mg initial dose) vs placebo GenPs. Men women ≥18 years old moderate-to-severe body surface area (BSA) ≥1% were through 12 weeks. Main Outcome Measure using 8-item Psoriasis Symptoms Scale (GPSS), Sexual Frequency Questionnaire (GenPs-SFQ), Impact (GPSIS) (validation data presented supplemental materials), Dermatology Life Quality Index (DLQI) item 9. Results For patients receiving (N = 75) 74), statistically significant improvement seen from week 1 onward (GPSS total individual items, all P < .005). activity avoidance owing to decreased significantly 4 (all <.005), whereas improved at 2–8 0.05). Ixekizumab resulted by limitations frequency (GenPs-SFQ 2). difficulties caused skin (DLQI 9) 2 .001). Clinical Implications Both rapidly BSA ≥1%. Strength & Limitations our knowledge, this first placebo-controlled, double-blinded trial evaluate effect any related The did include an active comparator lack well-established GenPs, period herein relatively short duration. Conclusion These validated PRO measures may aid future studies facilitating discussions their between clinicians.