In the study, 149 patients with moderate-to-severe genital psoriasis were randomized to receive Taltz (80 mg every two weeks, following a 160-mg starting dose) or placebo. The impact of genital psoriasis on sexual activity was measured at 12 weeks by pre-specified patient-reported outcomes, including the Genital Psoriasis Sexual Impact Scale (GPSIS), which is composed of the Sexual Activity Avoidance (Avoidance) and Impact of Sexual Activity on Genital Psoriasis Symptoms (Impact) subscales. Patient-reported outcomes were also measured by the Sexual Frequency Questionnaire (SFQ) item 2, evaluating the impact of genital psoriasis on the frequency of sexual activity, and the Dermatology Life Quality Index (DLQI) item 9, evaluating the impact of skin symptoms on sexual difficulties.
At 12 weeks, patients reported the following outcomes: DLQI Item 9 0/1: 92.0 per cent of patients treated with Taltz compared to 56.8 per cent of patients treated with placebo (p < 0.001) reported no (0) or little (1) sexual difficulties caused by skin symptoms. SFQ Item 2 0/1: 78.4 per cent of patients treated with Taltz compared to 21.4 per cent of patients treated with placebo (p < 0.001) reported the frequency of sexual activity was either never (0) or rarely (1) limited by genital psoriasis.
GPSIS-Avoidance 1/2: 76.7 per cent of patients treated with Taltz compared to 25.7 per cent of patients treated with placebo (p < 0.001) reported never (1) or rarely (2) avoiding sexual activity due to genital psoriasis. GPSIS-Impact 1/2: 85.7 per cent of patients treated with Taltz compared to 52.9 per cent of patients treated with placebo (p=0.062) reported worsening of genital psoriasis symptoms during or after sexual activity was very low/none at all (1) or low (2).
Eli lilly presents positive results from phase 3b trial of taltz to treat genital psoriasis at aad meeting