Efficacy and Safety of Mirikizumab (LY3074828) in the Treatment of Moderate‐to‐Severe Plaque Psoriasis: Results from a Randomised Phase 2 Study

Abstract

Background and Objectives

Inhibiting the interleukin (IL)‐23 cytokine in patients with psoriasis has demonstrated high levels of skin clearance. In this Phase 2 (AMAF, NCT02899988), multicentre, double‐blind trial, we investigated the efficacy and safety of three dose groups of mirikizumab (LY3074828), a p19‐directed IL‐23 antibody, compared to placebo in patients with moderate‐to‐severe plaque psoriasis.

Methods

Adult patients were randomised 1:1:1:1 to receive placebo (N=52), mirikizumab 30 mg (N=51), 100 mg (N=51), or 300 mg (N=51) subcutaneously at Weeks 0 and 8. The primary objective was to evaluate superiority of mirikizumab to placebo in achieving a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) response at Week 16. Comparisons were done using logistic regression analysis with treatment, geographic region and previous biologic therapy in the model. Missing data were imputed as nonresponse.

Results

Ninety‐seven percent of patients completed the first 16 weeks of Study AMAF. The primary endpoint was met for all mirikizumab dose groups versus placebo, with PASI 90 response rates at Week 16 of 0%, 29.4% (p=0.009), 58.8% (p<0.001) and 66.7% (p<0.001) for patients receiving placebo, mirikizumab 30 mg, 100 mg and 300 mg, respectively. There were 2 (1.3%) serious AEs in mirikizumab‐treated patients compared to 1 (1.9%) placebo‐group patient.

Conclusions

At Week 16, 66.7% of patients treated with mirikizumab 300 mg at 8‐week intervals achieved PASI 90. The percentage of patients reporting at least one treatment‐emergent adverse event was similar among patients treated with placebo or mirikizumab.

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