New anti-inflammatory drugs! Lilly mirikizumab treatment of moderate severe plaque-type psoriasis Phase III: better than Novartis Cosentyx (good) !

July 18, 2020 // Eli Lilly has announced the positive results of a new anti-inflammatory drug mirikizumab treatment for moderate-to-severe plaque psoriasis PHASE III OASIS-2The results showed that mirikizumab reached the primary and all critical secondary endpoints in week 16 (superiority) compared to placebosIn addition, mirikizumab reached all key secondary endpoints in week 16 (non-ineffectiveness) and 52nd week (superiority) compared to Novartis's anti-inflammatory drug Cosentyx (Chinese product name: good, generic name: secukinumab, CukchiU sing-iw, commonly known as "Sukin sing-sing) in Week 16 (non-ineffectiveness) and 52nd week (superiority) to achieve all the critical secondary endpoints, including the 52nd week of complete removal of skin damageMirikizumab is a human-derived IgG4 monoclonal antibody that targets il-23 p19 sub-bases and is currently being developed for a variety of immune diseases, including plaque-type psoriasis, ulcerative colitis and Crohn's disease"The results of this study are very promising for psoriasis patients around the world," said Patrik Johnson, senior vice president and president of Lilly BiopharmaceuticalsWe look forward to bringing mirikizumab to market to provide patients with an additional treatment option that has the potential to provide the efficacy of complete or almost complete removal of skin damage (as measured by PASI 90 and PASI 100) with a sustained effect over a 52-week period"OASIS-2 is a multicenter, randomized, double-blind, placebo-controlled Phase III study that compared the efficacy and safety of patients with moderate-to-severe plaque dandruff in the treatment of mirikizumab, placebo, and CosentyxIn the study, 1465 patients were randomly divided into the following induction and maintenance treatments at a ratio of 4:4:4:1: (a) Mirikizumab treatment group 1: 0, 4, 8, 12 weeks respectively (250mg), from 16th Weekly start every 8 weeks (Q8W, 250mg) ;(b) mirikizumab treatment group 2: 0, 4, 8, 12 weeks respectively administered (dose 250mg), from week 16 Q8W 125 mg dose; (c) Cosentyx treatment group: 0, 1, 2, 3, 4 weeks, once (300mg), once every 4 weeks from week 4 (Q4W, 300mg) ;(d) placebo group: 0, 4, 4, A placebo was given once in 8 and 12 weeks, mirikizumab (Q4W, 250mg) was given every 4 weeks in the 16th to 32nd week, and then every 8 weeks mirikizumab (Q8W, 250mg)All treatments are administered by subcutaneous injectionThe main endpoints of the study included: The 16th week of treatment, the proportion of patients with an overall rating (sPGA) score (0,1) and at least 2 points improvement compared to placebo, the area and severity index of psoriasis (PASI) improved by at least 90% (PASI 90) compared to the baselineCompared to Cosentyx, the assessment of similar endpoints as a key secondary endpoint is assessed in week 16Other secondary endpoints include the proportion of patients with at least 75% (PASI 75) and 100% (PASI 100) in the area and severity index (PASI) improved from the baseline compared to placeboCompared to Cosentyx, the key secondary endpoints for week 52 include the proportion of patients with a sPGA score of (0,1) with a minimum improvement of 2 points, and the proportion of patients with at least 90% (PASI 90) and 100% (PASI 100) improved compared to the baselineThe results showed that the study reached the primary and all critical secondary endpoints, and all the statistical analyses of the comparison were p 0.001, including the non-disadvantageeffect of Cosentyx in the 16th week of treatmentThe specific efficacy data are shown belowIn this study, the safety analysis results were consistent with previously disclosed mirikizumab results and the known safety results of other drugs in the IL23 p19 categoryThe most common adverse events in the treatment period (to 16 weeks) were nasopharyngitis and upper respiratory tract infections, and the induction period (to 52 weeks) was nasopharyngitis, upper respiratory tract infection, headache, back pain and joint pain The rate of severe adverse events in each treatment group during the induction period (-lt;2.5%) and the induction period and the induction period (up to 52 weeks) (up to 6%) was comparable The full results of the OASIS-2 study will be presented at a future medical conference A Phase III clinical trial of mirikizumab for the treatment of inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), is under way, with limited treatment options in this area and current under-service in patients After being suspended from the group due to the COVID-19 pandemic, these studies have resumed the admission of patients Lilly expects to publish induction data from the UC III study in the spring of 2021 and the top-line results for CD III studies in 2022 () Source: Lilly's Mirikizumab Superior to Cosentyx? (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis.