New psoriasis drug! AbbVie Skyrizi head-to-head Phase III efficacy beat Novartis Cosentyx (good ness): Peel damage completely cleared more!

June 13, 2020 /PRNewswire/ -- AbbVie recently released new data from the Psoriasis Head-to-Head IIIb IMMerge Study (NCT03478787) at the American Society of Dermatology (AAD) online meetingThe study was conducted in adult patients with moderate to severe plaque-type psoriasis, comparing the IL-23 inhibitor Skyrizi (risankizumab) with Novartis IL-17A inhibitor Cosentyx (Chinese commodity name: good, generic name: secukinumab, skuchiyu monotomodrine, commonly known as "Sukin sing)The results showed that Skyrizi outperformed Cosentyx in terms of skin loss removal rates during the 52nd week of treatmentThe specific data were: During the 52nd week of treatment, 66% of patients in the Skyrizi group achieved complete removal of skin loss - psoriasis area and severity index (PASI) was 100% of skin loss removal rate (PASI 100), compared with 40% in the Cosentyx treatment group, with a statistically significant difference in data (p.001)IMMerge is a multicenter, random, open label, efficacy evaluator blind method, and positive drug control study, which was conducted in adult patients with moderate to severe plaque psoriasis suitable for systematic treatment, comparing the safety and effectiveness of Skyrizi with CosentyxIn the study, patients were randomly assigned at a ratio of 1:1: (1) Skyrizi (n-164), dose 150 mg (subcutaneous injection, 2 doses of 75 mg), 2 doses of 75 mg at baseline, 4 weeks later, and every 12 weeks after; (2) Cosentyx (n-163), dose 300 mg (subcutaneous injection, 2 doses of 150 mg), 2 doses of 150 mg at baseline, 1 week, 2 weeks, 3 weeks and 4 weeks later and then every 4 weeksThe study had two main endpoints (the psoriasis area and severity index improved by at least 90% over the baseline (PASI90) and three secondary endpoints (PASI100, 52nd week, PGA 0/1, 52nd week PASI75)Conduct a safety assessment for all patientsIn January, AbbVie published the study's top-line results, showing that Skyrizi and Cosentyx reached the main end point of week 16 non-ineffectiveness and 52nd week superiority in paSI90In addition, Skyrizi and Cosentyx show edimen over all secondary endpoints (including Week 52 PASI100, PASI75, sPGA 0/1) and show superiority (p.001)The main endpoint results showed a higher rate of skin loss removal in the Skyrizi group than in the Cosentyx group: (1) the proportion of patients with PASI90 achieved in the 16th week of treatment, 74% in the Skyrizi group and 66% in the Cosentyx group(2) The proportion of patients with PASI90 achieved in the 52nd week of treatment was 87% in the Skyrizi group and 57% in the Cosentyx group (p 0.001)Secondary endpoint results showed that in the 52nd week of treatment, the Skyrizi group achieved a significantly higher percentage of patients with a static doctor's overall assessment (sPGA) score for complete or almost complete removal of skin damage (sPGA 0/1) (88% vs 58%, p 0.001)Existing security data indicate that Skyrizi's security is consistent with previously reported findings and no new safety signals were observed for 52 weeksThe incidence of adverse events (AEs) in Skyrizi and Cosentyx is comparableThe most common AE is nasopharyngitis, upper respiratory tract infections, headaches, joint pain and diarrheaThe incidence of severe adverse events in the Skyrizi group and the Cosentyx group was 5.5% and 3.7%, respectively The rates of adverse events in the Skyrizi and Cosentyx groups, which led to drug discontinuation in the study, were 1.2% and 4.9%, respectively No patients died in either treatment group Psoriasis is the most common autoimmune disease characterized by overactivation of the immune system and widespread inflammation, which causes painful, itchy patches anywhere on the skin In addition, psoriasis patients experience significant emotional, psychological, and social burdens that can cause pain and itching in the skin and seriously affect their quality of life "In this study, Skyrizi showed greater efficacy in helping patients achieve and maintain high levels of skin loss removal at week 52 than Cosentyx," said Dr Michael Severino, Vice President and President of AbbVie Head-to-head research data like this is critical to helping patients and their doctors make informed treatment decisions We are pleased to add these results to the growing body of evidence supporting Skyrizi as a differentiated treatment option for psoriasis patients Dr Richard B Warren, lead investigator at IMMerge research and professor and honorary consultant dermatologist at the Salford Royal NHS Foundation Trust at the University of Manchester, said: "I have seen first-hand how achieving and maintaining a complete removal of skin damage can have an incredible positive impact on the lives of psoriasis patients These new data are critical because they emphasize that the complete removal of skin loss is a realistic treatment goal for psoriasis patients "Skyrizi's active drug ingredient is risankizumab, a monoclonal antibody drug that selectively blocks the immune inflammatory medium leukocyte interleukin-23 (IL-23) selectively targeted at IL-23p19, a cytokine that is considered to play a key role in many chronic immune diseases Risankizumab was originally developed by German drugmaker Boehringer Ingerheim (BI), and AbbVie paid a $600 million advance payment in February 2016 to secure the global commercialization rights of risankizumab In 2019, Skyrizi was approved in the United States and the European Union for the treatment of adult patients with moderate to severe plaque psoriasis At present, Skyrizi treats Crohn's disease and psoriasis arthritis are in Phase III clinical In addition, AbbVie is evaluating Skyrizi for other inflammatory and immunological diseases such as ulcerative colitis Skyrizi is entering a very crowded market where the drug will compete with a number of drugs, including Novartis Cosentyx and Ilaris, Lilly's Taltz, Valeant's Siliq, Johnson and Johnson's Tremfya, Sun Pharma's Ilumya, and more Among these drugs, Tremfya and Ilumya are also selectively targeted for il-23 biological therapy However, despite all these competitors, the industry remains bullish on Skyrizi's business prospects Evaluate Pharma, a pharmaceutical market research firm, had previously forecast annual sales of $2.2 billion in 2024 Cosentyx is the first human monoclonal antibody drug specifically targeted to inhibit interleukin-17A (IL-17A), selectively targeting the activity of the circulating IL-17A, reducing immune system activity and improving disease symptoms Studies have revealed that IL-17A plays an important role in driving the body's immune response to a variety of autoimmune diseases, including psoriasis arthritis (PsA), plaque psycosinsis (PsO), aggressive spina encephalitis (AS), and radiological-negative mid-axis spinal arthritis (nr-axSpA) Cosentyx was approved for listing in January 2015 and has now been approved for four indications (PsO, PsA, AS, nr-axSpA) Cosentyx has five years of continuous efficacy and safety data on the top three indications, with more than 300,000 patients worldwide receiving the drug In China, at the end of April, Cosentyx (®) was approved by the State Drug Administration (NMPA) for routine treatment of adult patients with ineffective aggressive scoliosis (AS) This is the second indication that can be approved in China following the approval of the ® in March 2019 for the treatment of moderate to severe plaque psyritus (PsO), and the first and only interlemic inhibitor approved for the treatment of aggressive spina bifida (AS) in the country In 2019, Cosentyx's global sales reached $3.551 billion, up 28% from 2018 Evaluate Pharma, a pharmaceutical market research firm, predicts that Cosentyx will be one of the key products driving Novartis's future growth, and that Cosentyx's sales will climb steadily in the coming years as the indications steadily increase (BioValleyBioon.com) Original source: AbbVie Presents New Late-Breaking Data Show SKYRIZI ® (risankizumab-rzaa) The Ssuperior Ssuperior of The Complete Skin S Clearance Versus COsentyX ® (secukinumab) at 52 Weeks