A new anti-inflammatory drug: Novartis cosentix in the treatment of non radiologic axial spondyloarthroarthritis (NR axspa) phase III research success

November 16, 2019 / BIOON / -- Novartis, a Swiss pharmaceutical giant Novartis recently announced at the 2019 annual meeting of American rheumatology society / Rheumatology Health Professionals Association (ACR / ARP) held in Atlanta the phase III study of the evaluation of the anti-inflammatory drug cosentix (Chinese trade name: keshanting, common name: secukinumab, scuchiumab, commonly known as "sujinumab") in the treatment of non radiologic axial spondyloarthroarthritis (NR axspa) patients Detailed results of NT (nct02696031) Event is an ongoing 2-year, randomized, double-blind, placebo study (2-year extension) to investigate the efficacy and safety of cosentix in the treatment of active NR axspa patients 555 male and female active NR axspa patients were enrolled in the study (onset age before 45 years old, visual analogue scale [VAS] upper spine pain score ≥ 40 / 100, Bath Ankylosing spondylitis disease activity index [BASDAI] ≥ 4) These patients received at least two different non steroidal anti-inflammatory drugs (NSAID) at the highest dose for 4 weeks before the start of the study, and they may have received TNF inhibition previously Preparation (not more than one) but insufficient response Of 555 patients, 501 (90.3%) had not received biotherapy before In the study, patients were divided into three treatment groups: cosentix 150mg subcutaneous injection with loading dose (induction: 150mg subcutaneous injection, once a week for 4 weeks; maintenance: 150mg, once a month), cosentix 150mg subcutaneous injection without loading dose (150mg subcutaneous injection, once a month), placebo (induction: subcutaneous injection, once a week for 4 weeks; maintenance: once a month) The primary end point was the 16th and 52nd weeks of treatment, and the proportion of patients who received cosentix 150mg to achieve asas40 remission was among the first treated patients with TNF Secondary endpoints included changes in BASDAI and CRP (asdas-arp) scores of ankylosing spondylitis activity over time The results showed that at the 16th week of treatment, the study reached the main end point of asas40: compared with placebo treatment, patients treated with cosentix 150mg showed a statistically significant and clinically significant reduction in disease activity (asas40 remission rate: 42.2% vs 29.2%, P < 0.05) There were also statistically significant improvements in secondary endpoints, including pain, activity, and health-related quality of life The trial showed consistent long-term remission and safety with previous clinical trials No new safety signal detected "The event study showed clinically significant results as early as the third week, which lasted for up to a year for patients treated with cosentix," said Atul deodhar, chief investigator of the study, medical professor and director of rheumatology clinic at the University of health and Science in Oregon NR axspa has a debilitating burden of symptoms, and if approved, cosentix will provide an important treatment option for this disease with limited current treatment options " Eric Hughes, head of the international development unit for immunology, Hepatology and dermatology at Novartis, said: "these data reinforce the evidence that cosentix, as an effective treatment, can address the entire axspa spectrum As the largest study ever conducted on NR axspa, event is an example of how we re envision drugs to improve patient outcomes " Axial spondyloarthroarthritis (axspa) is a long-term inflammatory disease spectrum characterized by chronic inflammatory back pain The disease spectrum of axspa includes ankylosing spondylitis (as) and radiographically negative axial spondylitis (NR axspa) The former can see joint injury under X-ray, while the latter can't see joint injury under X-ray Both as and NR axspa have similar symptom burden, including night pain, fatigue, morning stiffness and functional disability If not treated, axspa can damage activity, cause a loss of working hours, and have a significant impact on quality of life Recently, Novartis has submitted to the European Drug Administration (EMA) and plans to submit to the U.S Food and Drug Administration (FDA) a new application for cosentix to treat NR axspa, potentially providing patients with an effective treatment plan to solve the whole disease spectrum of axspa If approved, this would be the fourth indication for cosentyx 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) Cosentyx has 5 years of continuous efficacy and safety data on three major indications, and more than 250 thousand patients worldwide have received 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, this year, Novartis Pharmaceutical (China) announced that cosentix (kesantang ®) officially began to supply throughout the country, 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 Novartis event data show cosentix? Deliveries early relief in axial spondyloarthritis