New psoriasis drug! Skyrizi head to head phase III study efficacy beat Novartis cosentyx!

January 15, 2020 / BIOON / -- abbvie recently announced that the head to head phase III study (nct03478787) to evaluate skyrizi (risankizumab) and Novartis cosentix (secukinumab) in the treatment of plaque psoriasis reached the primary end point and all secondary end points This is a multicenter, randomized, open label, efficacy evaluator blinded, positive drug control study It was carried out in adult patients with moderate to severe plaque psoriasis suitable for systematic treatment The safety and effectiveness of skyrizi and cosentyx were compared In the study, patients were randomly assigned in a 1:1 ratio: (1) skyrizi (n = 164), 150 mg (subcutaneous injection, 2 doses of 75 mg), 75 mg subcutaneously at baseline, 4 weeks later, and every 12 weeks thereafter; (2) cosentyx (n = 163), 300 mg (subcutaneous injection, 2 doses of 150 mg), 150 mg subcutaneously at baseline, 1, 2, 3 and 4 weeks later and every 4 weeks thereafter 。 The study had two primary endpoints (pasi90: non inferiority at week 16, superiority at week 52) and three secondary endpoints (pasi100 at week 52, SPGA 0 / 1 at week 52, PASI75 at week 52) All patients were assessed for safety The results showed that the clearance rate of skin lesions in skyrizi group was significantly higher than that in cosentyx group, reaching the main end point of pasi90 (psoriasis area and severity index improved by at least 90% compared with the baseline) at the 52nd week The specific data were as follows: the proportion of patients who achieved pasi90 at the 52nd week of treatment was 87% in skyrizi group and 57% in cosentityx group (P < 0.001) The study also reached the primary non inferiority end point of pasi90 at week 16: the proportion of patients who achieved pasi90 at week 16 was 74% in skyrizi group and 66% in cosentyx group In addition, skyrizi also showed superiority (P < 0.001) in all secondary endpoints (including pasi100, PASI75, SPGA 0 / 1 at week 52) compared with cosentyx Existing security data show that skyrizi's security is consistent with the results of previous reports, and no new security signals have been observed within 52 weeks The incidence of adverse events (AE) was comparable between skyrizi and cosentix The most common AES are nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhea The incidence of serious adverse events was 5.5% in skyrizi group and 3.7% in cosentyx group The incidence of adverse events in skyrizi group and cosentix group was 1.2% and 4.9% respectively There was no death in both groups Psoriasis is the most common autoimmune disease, which is characterized by over activation of the immune system and extensive inflammation, resulting in pain and itchy plaques anywhere on the skin In addition, psoriasis patients also experience significant emotional, psychological and social burdens, which may lead to skin pain and itching, and seriously affect their quality of life Michael Severino, MD, vice chairman and President of abbvie, said: "in this study, skyrizi showed a higher efficacy in helping patients achieve and maintain a high level of skin lesions clearance at week 52 compared to cosentix Head to head research data like this is essential to help patients and their doctors make informed treatment decisions We are pleased to add these results to the growing evidence supporting skyrizi as a differentiated treatment option for patients with psoriasis " The active component of skyrizi is risankizumab, which is a monoclonal antibody drug It selectively blocks the immune inflammatory medium IL-23 (IL-23) by targeting the il-23p19 subunit IL-23 is a kind of cytokine and is considered to play a key role in many chronic immune diseases Risankizumab was originally developed by the German pharmaceutical company, bringer Ingelheim (BI) In February 2016, ebwi paid a $600 million advance payment to obtain the global commercialization right 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 is in phase III clinical treatment for Crohn's disease and psoriatic arthritis In addition, Abercrombie is also evaluating skyrizi in the treatment of ulcerative colitis and other inflammatory and immunological diseases Skyrizi is entering a very crowded market, and it will compete with a number of drugs, including Novartis cosentix and ilaris, Lilly's taltz, Valeant's siliq, Johnson & Johnson's tremfya, sun pharmaceutical's ilumya, etc Among these drugs, tremfya and ilumya are also biotherapeutics that selectively target IL-23 However, despite all these competitors, the industry is still very optimistic about skyrizi's business prospects Evaluatepharma, a pharmaceutical market research firm, previously predicted that the drug's annual sales would reach $2.2 billion in 2024 Cosentix is the first all human monoclonal antibody drug specifically targeting to inhibit IL-17A It can selectively target to block the activity of circulating IL-17A, reduce the activity of the immune system and improve the symptoms of the disease It is revealed that IL-17A plays an important role in the immune response of various autoimmune diseases, including psoriatic arthritis (PSA), plaque psoriasis (PSO), ankylosing spondylitis (as) Cosentix was approved to be on the market in January 2015, and has been approved for three indications (PSO, PSA, as) Cosentix has five years of continuous efficacy and safety data in three major indications, and more than 250000 patients worldwide have been treated with the drug In China, cosentix (kesenting ®) was approved on April 1, 2019 for the treatment of adult patients with moderate to severe plaque psoriasis who meet the indications of systematic therapy or phototherapy It is worth mentioning that cosentyx is also the first approved psoriasis biological preparation in the list of the first batch of clinically urgent overseas new drugs released by the drug review center of the State Drug Administration in 2018 On May 20, 2019, Novartis Pharmaceutical (China) announced that cosentix (kesantang ®) officially began to supply in China, bringing a new treatment scheme for the majority of Chinese patients with moderate and severe psoriasis In 2018, cosentix's global sales reached $2.837 billion, an increase of 37% over 2017 Evaluatepharma, a pharmaceutical market research organization, predicts that cosentyx will become one of the key products to promote the future growth of Novartis With the steady increase of indications, cosentyx's sales will grow steadily in the next few years, and the global sales are expected to reach 5.5 billion US dollars in 2024 Original source: new head to head phase 3 data show skyrizi Gamma (risankizumab) Superior to Cosentyx® (secukinumab) Across Primary and All Ranked Secondary Endpoints in Adults with Moderate to Severe Plaque Psoriasis at 52 Weeks