1. Risankizumab was associated with a significantly greater improvement in the primary endpoint of ≥90% reduction of the Psoriasis Area and Severity Index (PASI) score than ustekinumab.
2. Risankizumab was also associated with a significantly higher proportion of patients that experienced 100% reduction in the PASI score than ustekinumab.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Plaque psoriasis is a chronic inflammatory skin disease characterized by raised red patches on the skin covered with scale. There is evidence that suggests the proinflammatory cytokine interleukin-23 (IL-23) has a strong influence on the pathogenesis of psoriasis, and so this phase 2 trial was conducted to compare two anti-IL-23 humanized monoclonal antibodies that are used in the management of plaque psoriasis.
Patients in this trial were randomized in a 1:1:1:1 ratio to receive one of three doses of risankizumab or ustekinumab. For the primary end point of ≥90% reduction in the PASI score from baseline, risankizumab was shown to be superior to ustekinumab. For the secondary endpoint of percentage of patients who experienced 100% reduction in PASI score, risankizumab was also shown to be superior to ustekinumab. These findings are compelling as they were derived from a head-to-head comparison of two anti-IL-23 humanized monoclonal antibodies, however as this was a phase 2 trial, the small study population limited the robust assessment of treatment and side effects.
Relevant Reading: The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing
In-Depth [prospective cohort]: In this 48-week, multicenter, randomized, dose-ranging phase 2 trial, 166 patients were randomized in a 1:1:1:1 ratio to receive one of three doses of risankizumab or ustekinumab. Risankizumab (90 and 180 mg, pooled) was superior to ustekinumab with regard to the primary endpoint at week 12 (77% vs. 40%, p < 0.001). The percentages of patients who experienced 100% reduction in the baseline PASI score were 41% in the 90-mg risankizumab group and 48% in the 180-mg risankizumab group (p < 0.001 for both), versus 18% in the ustekinumab group.
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