Mirikizumab beats secukinumab in phase 3 plaque psoriasis study

Data from an investigational treatment demonstrated the superiority of mirikizumab (Eli Lilly) vs secukinumab (Cosentyx, Novartis) as a treatment for moderate-to-severe plaque psoriasis, according to a press release from manufacturer Eli Lilly.

Mirikizumab, an investigational IgG4 monoclonal antibody designed to bind to the p19-subunit of interleukin-23 (IL-23), met all primary and secondary endpoints at week 16 (superiority) and all secondary endpoints vs secukinumab at weeks 16 (non-inferiority) and 52 (superiority) in the Oasis-2 study.

The phase 3 multicenter, double-blind, placebo-controlled, randomized clinical trial compared the safety and efficacy of mirikizumab to placebo and secukinumab, a monoclonal antibody that targets inhibition of IL-17A.

Oasis-2 enrolled 1,465 patients with moderate-to-severe plaque psoriasis, who were randomized in a 4:4:4:1 ratio to one of the following treatment arms:

a) mirikizumab 250 mg at weeks 0, 4, 8, 12 then followed by 250 mg every 8 weeks (Q8W) beginning at week 16;

b) mirikizumab 250 mg at weeks 0, 4, 8, 12 followed by 125 mg Q8W beginning at week 16;

c) secukinumab 300 mg at weeks 0, 1, 2, 3, 4, followed by 300 mg every 4 weeks (Q4W) beginning at week 4;

d) placebo at weeks 0, 4, 8, 12, followed by mirikizumab 250 mg starting at week 16 through week 32 followed by Q8W.

Primary endpoints of the study included the proportion of patients achieving a Static Physician's Global Assessment (sPGA) score of 0 or 1 with a minimum of a 2-point improvement, as well as the proportion of patients who achieve at least a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 vs placebo.

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Secondary endpoints included the proportion of patients who achieved a minimum of PASI 75 and PASI100 at week 16 vs placebo. At week 52, the proportion of patients with sPGA of 0 or 1 with a minimum of a 2-point improvement, and the proportion of patients who achieved at least PASI 90 and PASI 100 from baseline vs secukinumab.

Results of the study show at week 16, 79.7% of patients who received mirikizumab (250 mg Q4W) achieved an sPGA score of 0 or 1 compared with 76.3% of patients who received secukinumab and 6.3% who received placebo; at week 52, 83.3% of patients who received mirikizumab 250 mg Q4W/250 mg Q8W achieved sPGA 0 or 1 vs 83.1% who received mirikizumab 250 mg Q4W/125 mg Q8W and 68.5% who received secukinumab per label.

The proportion of patients who achieved PASI 90 at week 16 was 74.4% of those treated with mirikizumab (250 mg Q4W) vs 72.8% of patients treated with secukinumab and 6.3% of those treated with placebo. At week 52, 82.4% of patients treated with mirikizumab 250 mg Q4W/250 mg Q8W achieved PASI 90 compared with 81.4% of those treated with mirikizumab 250 mg Q4W/125 mg Q8W and 69.4% of those treated with secukinumab.

Thirty-seven percent of patients treated with mirikizumab (250 mg Q4W) achieved PASI 100 by week 16 (37.7%) vs 36.6% of those treated with secukinumab and 1.8% of those treated with placebo. At week 52, 58.8% of patients treated with mirikizumab 250 mg Q4W/250 mg Q8W patients reached PASI 100 compared with 53.9% of those treated with mirikizumab 250 mg Q4W/125 mg Q8W and 42.9% of those treated with secukinumab.

"We are pleased with the positive results observed in the mirikizumab psoriasis development program (OASIS). Mirikizumab has the potential to be a meaningful treatment option for people living with psoriasis," says Andrew Blauvelt, M.D., M.B.A., president of Oregon Medical Research Center and a lead investigator in the OASIS program. "The data builds on our understanding of IL-23 inhibition in psoriasis and possible future applications."

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Oasis-2 showed the safety profile was consistent with previous trial results with the most common treatment-emergent adverse events (≥5%) occurring during the induction period (up to week 16) being nasopharyngitis and upper respiratory infection. During the combined maintenance and induction period (up to week 52), upper respiratory infection, nasopharyngitis, back pain, headache and arthralgia were the most common treatment-emergent adverse events.

"The results from this study are promising to people around the world who are burdened by psoriasis, and Lilly is grateful to the patients, providers and investigators for advancing science to benefit patients with immunologic conditions," says Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines. "We look forward to bringing mirikizumab to market to provide patients with an additional treatment option that has the potential to provide near complete or complete skin clearance as measured by PASI 90 and PASI 100, with sustained results at 52 weeks."

Currently, Lilly is planning on releasing full results of the OASIS-2 clinical trial at future congresses.

References:

1. Lilly's Mirikizumab Superior to Cosentyx® (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis. (2020, July 17). Retrieved August 25, 2020, from https://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-superior-cosentyxr-secukinumab-phase-3-study