Eli Lilly and Company has announced that patients with moderate-to-severe genital psoriasis treated with Taltz (ixekizumab) reported a greater decrease in the impact of their condition on sexual activity compared to placebo after 12 weeks of treatment. Results from the phase 3b trial presented in an oral presentation at the annual meeting of the American Academy of Dermatology, taking place in San Diego, California.

"Over the course of their disease, up to 63 per cent of psoriasis patients experience genital psoriasis, which can be difficult to treat and can have a significant impact on their sexual health," said Dr. Lotus Mallbris, vice president, immunology platform team leader, product development. "We look forward to fostering a discussion at AAD about the need for healthcare providers to address this important issue affecting people living with psoriasis."

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).

Taltz was superior to placebo as early as week one on the limitations on frequency of sexual activity due to genital psoriasis (p < 0.05), week two for the sexual difficulties caused by skin symptoms (p < 0.001).

"Genital psoriasis can be an uncomfortable and burdensome condition for patients to manage," said Jennifer Clay Cather, M.D., Modern Research Associates, Dallas, Texas. "This condition can have a significant impact on patients' sexual health and experience."

The most common (=4 per cent) adverse events observed in patients treated with Taltz in this study were upper respiratory tract infections, injection-site reactions, headache, oropharyngeal pain and pruritus. The safety outcomes were consistent with the overall safety profile of Taltz.

Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In December 2017, Taltz was also approved for the treatment of adults with active psoriatic arthritis.