Results from a phase 3 study of mirikizumab showed the IL-23 inhibitor significantly improved symptoms of moderate-to-severe plaque psoriasis, although the developer has since declined to pursue regulatory approval for the potential treatment, according to recent research published in the British Journal of Dermatology.
Andrew Blauvelt, MD, MBA, board-certified dermatologist and president of the Oregon Medical Research Center, Portland, and colleagues evaluated mirikizumab in the double-blinded, randomized, placebo-controlled, phase 3 OASIS-1 trial where 531 patients with moderate-to-severe plaque psoriasis were randomized to receive subcutaneous mirikizumab (250 mg) every 4 weeks or placebo. Participants in the trial were mean 46.3 years old, had a disease duration of 17.6 years, and a Psoriasis Area and Severity Index (PASI) score of 22.6 at baseline.
At 16 weeks, the researchers assessed which patients achieved an improvement in static Physician’s Global Assessment (sPGA) of 2 points or greater and 90% improvement in PASI (PASI90) as co-primary endpoints. The secondary endpoints were PASI75, PASI100, and proportion of patients with less than 1% of body surface area with psoriasis. A subset of patients who responded to mirikizumab during the induction period were further randomized to receive either mirikizumab at a dose of 125 mg or 250 mg every 8 weeks or placebo for up to 52 weeks in a maintenance period.
There was a significantly greater response to mirikizumab compared with placebo at 16 weeks (69.3% vs 6.5%; P < .001), and PASI90 scores were also significantly higher among patients receiving mirikizumab compared with placebo (64.3% vs 6.5%; P < .001). Regarding secondary outcomes, more patients receiving mirikizumab than patients in the placebo group achieved PASI75 (82.5% vs 9.3%; P < .001) and PASI100 (32.4% vs 0.9%; P < .001).
Of the 91 patients in the mirikizumab group who went on to receive placebo during the maintenance period for up to 52 weeks, 18.7% achieved PASI90, 9.9% achieved PASI100, and 17.6% had an sPGA of 0 or 1 (P < .001). For patients who received mirikizumab up to 16 weeks and continued mirikizumab at a dose of 125 mg every 8 weeks, 85.6% achieved PASI90, 58.9% achieved PASI100, and 85.6% had an sPGA of 0 or 1 (P < .001). Among the patients who started on mirikizumab 250 mg every 4 weeks and moved to mirikizumab 250 mg every 8 weeks, 84.6% of patients achieved PASI90, 60.4% achieved PASI100, and 82.4% had an sPGA of 0 or 1 (P < .001).
There were no new safety signals with mirikizumab, and there were no deaths in either group.
“These results are aligned with other clinical trials in patients with plaque psoriasis that also assessed time to loss of response after withdrawal from IL-23 inhibitors,” Blauvelt and colleagues wrote.
While the results of the trial are positive, Eli Lilly notably made the decision in April 2021 to not submit mirikizumab for approval as a treatment for psoriasis “in any geography,” according to an announcement in a press release, focusing instead on evaluating mirikizumab as a potential treatment for ulcerative colitis and Crohn’s disease.
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Disclosures: Authors declared financial ties to drugmakers. See full study for details. This study was funded by Eli Lilly.
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