New anti-inflammatory drugs! Novartis Cosentyx (Can Be Good) Treatment of Mid-Axis Spinal Arthritis (axSpA) early, long-lasting significant improvement of symptoms/signs!
Last Update: 2020-06-17
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, June 07, 2020 //Bio ValleyBIOON/ --Novartisrecently announced the anti-inflammatory drug Cosentyx (Chinese commodity name: Ko-san, generic name: secukinumab, Treasury Chiyu sepsis, commonly known as "Sukin sepsis") therapeutic active radiology negative mid-axis spinal arthritis (nr-axSpA) adult patient Phase III PREVENT study (NCT02696031) complete 52-week resultsPREVENT is the largest study to date to evaluate a biological agent for the treatment of nr-axSpAPreviously released data showed that Cosentyx showed clinically significant results in the third week of treatment, reaching the primary endpoint of the International Society for Spinal Arthritis Assessment improvement of 40% (ASAS40) in the 16th week of treatmentnew data show that during the 52-week period of treatment, Cosentyx significantly and continuously improved the symptoms and signs of nr-axSpAThese data reinforce the substantial and sustainable benefits of Cosentyx in the entire disease spectrum (AS and nr-axSpA) of mid-axis spinal arthritis (axSpA)nr-axSpA is a painful and debilitating disease that affects about 1.7 million people in THE EU's TOP5 countries and the United StatesHowever, due to inadequate nr-axSpA diagnosis, the averagediagnosisdelay of more than 7 years, so the actual number may be higherin April this year, Cosentyx was approved for the fourth time in the European Union for the treatment of active nr-axSpA adult patientsthe three pre-approved indications of thethe drug are psoriasis arthritis (PsA), plaque-type psoriasis (PsO), and aggressive spinabitis (AS)currently, Cosentyx's treatment nr-axSpA is also under review in the United States and Japan It is worth mentioning that Cosentyx is the first IL-17A inhibitor approved in Europe for the treatment of nr-axSpA In the U.S., Lilly Taltz received FDA approval earlier this month, becoming the first IL-17A inhibitor to treat nr-axSpA in the U.S market "AxSpA can seriously affect the quality of life
of patients and their ability to perform daily tasks," said Cosentyx, a clinical trial project investigator and professor of rheumatology at Bochum Ruhr University in Germany The PREVENT study demonstrated the effectiveness and safety of Cosentyx's treatment of nr-axSpA, showing early and sustained remission of symptoms and signs of this frequently painful disease "
PREVENT is a randomized, double-blind, placebo study that investigated the efficacy and safety of Patients with Cosentyx's active nr-axSpA treatment The study included 555 active nr-axSpA patients (before the onset age of 45 years of age, the visual simulation scale (VAS) upper spinal pain score of 40/100, Bath strong spinal rhinolytitis disease activity index (BASDAI) 4), these patients before the start of the study received at least 2 different nonsteroidal anti-inflammatory drugs (NSAID) to treat the maximum dose for 4 weeks, may have previously received a maximum dose of TT inhibitors (but not more than one type of t-b 555 patients, 501 (90.3%) had not previously been treated with biotherapy (primary treatment of biological therapy) In the study, patients were divided into three treatment groups: Cosentyx 150mg subcutaneous injection loaded dose (induced: 150mg subcutaneous injection, treatment for 4 weeks per week; maintenance: 150mg, once per month), Cosentyx 150mg subcutaneous injection stake less than a load dose (150mg subcutaneous injection, once per month), and maintenance The primary endpoint was the 16th and 52nd weeks of treatment, and in patients with TNF primary treatment, the proportion of patients who received Cosentyx 150mg was treated to 40% improvement (ASAS40) assessed by the International Society for Spinal Arthritis Secondary endpoints include changes in BASDAI over time and changes in CRP (ASDAS-ARP) activity score for aggressive spina bifida results showed that in the 16th and 52nd weeks of treatment, the study reached the primary endpoint of ASAS40: patients treated with a load dose of Cosentyx 150mg showed a statistically significant and clinically significant reduction in disease activity compared to patients treated with placebo (16th Weekly ASAS40 mitigation rate: 42.2% vs 29.2%, p 0.05; Week 52 ASAS40 Mitigation Rate: 35.4% vs 19.9%, p 0.05) Secondary endpoints also showed significant statistical improvements, including pain, activity, and health-related quality of life Trials have shown lasting mitigation and safety consistent with previous clinical trials No new safety signal scan was detected "With these new data and the recent world's first global approval of Cosentyx for the treatment of nr-axSpA in Europe, we are continuing to build on our leadership in the spectrum of disease sacroonic spinal arthritis," said Eric Hughes, global development director of immunology, liver disease and dermatology at Novartis Cosentyx's 4th Indicationist is a further demonstration of our commitment to reimagining care for more patients "
at the end of April this year, Cosentyx (Cosenty ®) was approved by the State Drug Administration (NMPA) for routine treatment of adult patients with severe spina bifida (AS), which is not effective 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 axial spinal arthritis (axSpA) is a long-term inflammatory disease spectrum characterized by chronic inflammatory back pain The axSpA disease spectrum includes strong direct spina bifida (AS) and radiological-negative mid-axis spinal arthritis (nr-axSpA), which can see joint damage under X-rays and joint damage under X-rays BOTH AS AND Nr-axSpA have similar symptom burdens, including nighttime pain, fatigue, morning stiffness and functional disability If left untreated, axSpA can impair activity, result ingons of working hours and have a significant impact on quality of life Cosentyx is the first human monoclonal antibody drug specifically targeted to inhibit leukerin-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-type psoriasis (PsO), aggressive spinaencephalitis (AS), and 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 (biovalleybioon.com) original source: Novartis PREVENT data show Cosentyx? help patient seily and lasting relief in axial spondyloarthritis
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