Efficacy and safety of mirikizumab (LY3074828) in the treatment of moderate‐to‐severe plaque psoriasis: results from a randomized phase II study

• Published in: British journal of dermatology (1951) Vol. 181; no. 1; pp. 88 - 95
• Main Authors: Reich, K., Rich, P., Maari, C., Bissonnette, R., Leonardi, C., Menter, A., Igarashi, A., Klekotka, P., Patel, D., Li, J., Tuttle, J., Morgan‐Cox, M., Edson‐Heredia, E., Friedrich, S., Papp, K.
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01-07-2019
• Subjects: Psoriasis; Skin
• ISSN: 0007-0963; 1365-2133
• DOI: 10.1111/bjd.17628

Summary
Background
Inhibiting interleukin (IL)‐23 in patients with psoriasis has demonstrated high levels of skin clearance.
Objectives
To investigate, in a phase II (AMAF; NCT02899988), multicentre, double‐blind trial, the efficacy and safety of three doses of mirikizumab (LY3074828), a p19‐directed IL‐23 antibody, vs. placebo in patients with moderate‐to‐severe plaque psoriasis.
Methods
Adult patients were randomized 1 : 1 : 1 : 1 to receive placebo (n = 52), mirikizumab 30 mg (n = 51), mirikizumab 100 mg (n = 51) or mirikizumab 300 mg (n = 51) subcutaneously at weeks 0 and 8. The primary objective was to evaluate the superiority of mirikizumab over 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, geographical region and previous biological therapy in the model. Missing data were imputed as nonresponses.
Results
Ninety‐seven per cent of patients completed the first 16 weeks of the study. The primary end point was met for all mirikizumab dose groups vs. placebo, with PASI 90 response rates at week 16 of 0%, 29% (P = 0·009), 59% (P < 0·001) and 67% (P < 0·001) for patients receiving placebo, and mirikizumab 30 mg, 100 mg and 300 mg, respectively. There were two (1%) serious adverse events in mirikizumab‐treated patients vs. one (2%) in a placebo‐group patient.
Conclusions
At week 16, 67% 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.
What's already known about this topic?
Interleukin (IL)‐23 is a key cytokine in the pathogenesis of psoriasis.
Inhibiting IL‐23 has shown great promise for psoriasis therapy in clinical trials.
What does this study add?
In this phase II trial of mirikizumab – a p19‐directed IL‐23 antibody – we evaluated three dose regimens of mirikizumab vs. placebo. There was significantly higher efficacy in patients treated with mirikizumab vs. placebo and comparable safety profiles.
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