Eli Lilly’s anti-IL-23 antibody beat placebo at clearing psoriasis symptoms in a phase 3 study, teeing up regulatory filings across the globe. But that’s not all—the drug also outshone Novartis’ blockbuster Cosentyx in the same study.
The 1,465-patient study tested two regimens of the drug, mirikizumab, against placebo and Cosentyx, finding that mirikizumab outdid placebo on three measures in patients with moderate to severe plaque psoriasis. After 16 weeks of treatment, three-quarters of mirikizumab patients had a 90% reduction in symptoms compared to just 6% of placebo patients, as measured by the Psoriasis Area and Severity Index (PASI), which accounts for the severity and extent of a patient’s psoriasis. Some patients logged a 100% reduction in their PASI score: 38% in the mirikizumab group and 2% in the placebo group. And nearly 80% of patients who got Lilly’s drug achieved clear or almost clear skin, as measured by the Static Physician’s Global Assessment, a visual assessment of psoriasis, compared to 6% of placebo patients.
In addition to meeting the study’s primary endpoints, mirikizumab also outperformed Cosentyx on all three measures after one year of treatment. These data include numbers for patients who had started the study on placebo, but were transitioned to mirikizumab after week 16.
More than 80% of patients taking mirikizumab logged a 90% reduction in their PASI score, compared to 69% of patients on Cosentyx, while more than half of mirikizumab patients saw a 100% reduction in symptoms, compared to 43% of Cosentyx patients.
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"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," said Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines, in a statement. "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."
The most common side effects were upper respiratory infections, like the common cold, headache, back pain and joint pain. Eli Lilly will unveil the full data at future medical meetings.
While Cosentyx inhibits IL-17A to treat psoriasis and other autoimmune diseases, mirikizumab blocks a different interleukin, IL-23. Lilly is testing mirikizumab in ulcerative colitis and Crohn’s disease, with top-line data for those phase 3 studies expected in 2021 and 2022, respectively.
"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," said the study's lead investigator, Andrew Blauvelt, M.D., president of Oregon Medical Research Center, in the statement. "The data builds on our understanding of IL-23 inhibition in psoriasis and possible future applications."