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The Food and Drug Administration (FDA) has approved updated labeling for Taltz (ixekizumab; Eli Lilly) to include data on psoriasis involving the genital area.
The approval was based on data from a randomized, placebo-controlled trial that included 149 adults with plaque psoriasis who had a minimum body surface area (BSA) involvement of 1%, a static Physician Global Assessment (sPGA) score of ≥3 (moderate psoriasis), a sPGA of Genitalia score of ≥3 (moderate psoriasis involving the genital area), who failed to respond to or were intolerant of at least one topical therapy used for the treatment of psoriasis affecting the genital area, and who were candidates for phototherapy and/or systemic therapy.
Patients received an initial dose of Taltz 160mg followed by 80mg every 2 weeks, or placebo, for 12 weeks. Results showed that 73% (N=55) of the Taltz-treated group had a sPGA of Genitalia score of 0 (clear) or 1 (minimal) compared with 8% (N=6) in the placebo group. Additionally, 73% (N=55) of the Taltz-treated group had a sPGA score of 0 or 1 compared with 3% (N=2) in the placebo group.
Genital itch scores (as measured by the Genital Psoriasis Symptoms Scale [GPSS] Itch numeric rating scale [NRS]) were also reduced in the treatment group, with 55% (N=31) of patients having a ≥4 point improvement vs 6% (N=3) for placebo. In addition, 78% of Taltz-treated patients scored 0 (never) or 1 (rarely) on the Sexual Frequency Questionnaire (which measures the impact of psoriasis on frequency of sexual activity) compared with 21% in the placebo group.
“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.”
Taltz, a humanized interleukin-17A antagonist, is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and for active psoriatic arthritis. It is available in 80mg single-dose prefilled autoinjectors or 80mg single-dose prefilled syringes.
For more information visit Lilly.com.
