The following is a summary of “Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up,” published in the December 2023 issue of Dermatology by Papp, et al.

Psoriasis is a chronic, inflammatory skin condition that often necessitates prolonged treatment. For a study, researchers assessed the long-term safety and efficacy of risankizumab in patients with psoriasis. They evaluated the safety and efficacy of continuous risankizumab treatment over an extended period in adults with moderate-to-severe plaque psoriasis.

The ongoing LIMMitless study, a phase 3, open-label extension study, analyzed the long-term safety and efficacy of risankizumab (150 mg every 12 weeks) in adults with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies. This interim analysis focused on safety monitoring treatment-emergent adverse events (TEAEs) through 304 weeks. Efficacy assessments included the proportion of patients achieving ≥90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90/100), static Physician’s Global Assessment of clear/almost clear (sPGA 0/1), and Dermatology Life Quality Index of no effect on the patient’s life (DLQI 0/1) through 256 weeks.

Among the 897 patients initially randomized to risankizumab in the base studies, 706 were still ongoing at the data cutoff. Rates of TEAEs, TEAEs leading to discontinuation, and TEAEs of safety interest were low. At week 256, 85.1% and 52.3% of patients achieved PASI 90 and PASI 100, respectively. Additionally, 85.8% achieved sPGA 0/1, and 76.4% achieved DLQI 0/1.

Continuous risankizumab treatment for up to 5 years demonstrated high and durable efficacy with a favorable safety profile.

Source: jaad.org/article/S0190-9622(23)02416-7/fulltext