FDA Approves Lilly's Taltz for Label Update to Treat Psoriasis Involving the Genital Area

The FDA has approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. Eli Lilly and Company's Taltz is the first treatment FDA approved for moderate-to-severe plaque psoriasis that includes such data in its label. 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.

"It is common for patients with psoriasis to experience symptoms in the genital area at some point during the course of their disease," said Michael Siegel, PhD, senior vice president of research and clinical affairs, National Psoriasis Foundation. "This news is a significant step in providing patients with more options for treating their disease. We encourage patients to talk with their healthcare provider about their symptoms of psoriasis in the genital area."

The label update is based on positive results from the first randomized, double-blind, placebo-controlled study in moderate-to-severe psoriasis involving the genital area. In the study, 149 patients with plaque psoriasis who were candidates for phototherapy or systemic therapy, and who failed to respond to or were intolerant of at least one topical therapy for the treatment of psoriasis affecting the genital area, were treated with Taltz or placebo. Patients were required to have a minimum body surface area involvement of 1 percent, a static Physician Global Assessment (sPGA) score of ≥3 and a sPGA of genitalia score of ≥3.

Taltz demonstrated a significant improvement compared to placebo at 12 weeks in the severity of psoriasis affecting the genital area, as measured by sPGA of genitalia score; overall psoriasis, as measured by sPGA score; genital itch, as measured by the Genital Psoriasis Symptoms Scale (GPSS) Itch numeric rating scale (NRS); and in the patient-perceived impact of psoriasis involving the genital area on frequency of sexual activity, as measured by Sexual Frequency Questionnaire (SFQ) Item 2 (In the past week how often did your psoriasis involving the genital area limit the frequency of your sexual activity?) score.

• sPGA of genitalia score of "0" (clear) or "1" (minimal): 73 percent of patients treated with Taltz compared to 8 percent for placebo
• Overall sPGA score of "0" (clear) or "1" (minimal): 73 percent of patients treated with Taltz compared to 3 percent for placebo
• GPSS Genital Itch (≥4 point improvement): 55 percent of patients treated with Taltz compared to 6 percent for placebo
• SFQ Item 2 score "0" (never) or "1" (rarely): 78 percent of patients treated with Taltz compared to 21 percent for placebo

"Psoriasis involving the genital area can significantly impact patients, yet it's not routinely examined by healthcare providers," said Caitriona Ryan, MD, lead study investigator. "The results from this clinical trial may raise awareness around the topic among healthcare providers."

"The trial results found that the majority of patients treated with Taltz achieved clear or almost clear genital skin at week 12," said Jennifer Clay Cather, MD, Modern Research Associates, Dallas, Texas. "With these data, physicians can recommend Taltz as an effective treatment option for psoriasis in this area."