Eli Lilly recently announced positive results from the Phase III OASIS-2 study evaluating mirikizumab, a novel anti-inflammatory agent, for the treatment of moderate-to-severe plaque psoriasis. The results demonstrated that mirikizumab met the primary endpoint and all key secondary endpoints at Week 16 (superiority) compared with placebo. Furthermore, mirikizumab met all key secondary endpoints compared with Novartis’ anti-inflammatory drug Cosentyx (Chinese brand name: Keshanting; generic name: secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority), including superiority in complete skin clearance at Week 52.
Mirikizumab is a humanized IgG4 monoclonal antibody that targets and binds to the p19 subunit of IL-23. This drug is currently under development for the treatment of various immune-mediated diseases, including plaque psoriasis, ulcerative colitis, and Crohn's disease.
Patrik Jonsson, Senior Vice President and President of Eli Lilly and Company, stated, “The results of this study are very promising for psoriasis patients worldwide. We look forward to bringing mirikizumab to market, providing patients with an additional treatment option that has the potential to achieve complete or almost complete skin clearance (as measured by PASI 90 and PASI 100), with sustained efficacy over a 52-week period.”
OASIS-2 is a multicenter, randomized, double-blind, placebo-controlled Phase III study comparing the efficacy and safety of mirikizumab, placebo, and Cosentyx in patients with moderate-to-severe plaque psoriasis. In this study, 1,465 patients were randomized in a 4:4:4:1 ratio to the following induction and maintenance treatment regimens: (a) Mirikizumab Treatment Group 1: administered once at Weeks 0, 4, 8, and 12 (250 mg each), followed by every 8 weeks (Q8W, 250 mg) starting from Week 16; (b) Mirikizumab Treatment Group 2: administered once at Weeks 0, 4, 8, and 12 (250 mg each), followed by Q8W dosing at 125 mg starting from Week 16; (c) Cosentyx Treatment Group: administered once at Weeks 0, 1, 2, 3, and 4 (300 mg each), followed by every 4 weeks (Q4W, 300 mg) starting from Week 4; (d) Placebo Group: administered placebo once at Weeks 0, 4, 8, and 12, followed by mirikizumab every 4 weeks (Q4W, 250 mg) from Weeks 16 to 32, and thereafter mirikizumab every 8 weeks (Q8W, 250 mg). All treatments were administered via subcutaneous injection.
In this study, the primary endpoints included: at Week 16 of treatment, the proportion of patients achieving a static Physician’s Global Assessment (sPGA) score of (0,1) with an improvement of at least 2 points compared with placebo, and the proportion of patients achieving at least a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90). Similar endpoints assessed at Week 16 versus Cosentyx served as key secondary endpoints. Other secondary endpoints included: at Week 16 of treatment, the proportion of patients achieving at least a 75% (PASI 75) and 100% (PASI 100) improvement from baseline in PASI compared with placebo. Key secondary endpoints at Week 52 versus Cosentyx included the proportion of patients achieving an sPGA score of (0,1) with an improvement of at least 2 points, as well as the proportion of patients achieving at least a 90% (PASI 90) and 100% (PASI 100) improvement from baseline in PASI.
The results demonstrated that the study met its primary endpoint and all key secondary endpoints, with all comparative statistical analyses yielding p-values < 0.001, including non-inferiority versus Cosentyx at Week 16 of treatment. The specific efficacy data are presented below.
In this study, the safety analysis results were consistent with previously disclosed results for mirikizumab and the known safety profiles of other drugs in the IL-23 p19 class. During the induction period (up to 16 weeks), the most common treatment-emergent adverse events (≥5%) were nasopharyngitis and upper respiratory tract infection; during the combined induction and maintenance periods (up to 52 weeks), they were nasopharyngitis, upper respiratory tract infection, headache, back pain, and arthralgia. The incidence rates of serious adverse events were comparable across treatment groups during the induction period (<2.5%) and the combined induction and maintenance periods (up to 52 weeks) (<6%).
The full results of the OASIS-2 study will be presented at upcoming medical conferences. Phase 3 clinical trials of mirikizumab for the treatment of inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), are ongoing in this therapeutic area with limited options and where patients are currently underserved. Patient enrollment in these studies has resumed following a pause due to the COVID-19 pandemic. Eli Lilly expects to report induction data from the UC Phase 3 study in spring 2021 and topline results from the CD Phase 3 study in 2022.
Original Source: Is Lilly’s Mirikizumab Superior to Cosentyx® (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis?
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