echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > Novartis Sujin monoto-resin is FDA-approved for the treatment of mid-axis spinal arthritis.

    Novartis Sujin monoto-resin is FDA-approved for the treatment of mid-axis spinal arthritis.

    • Last Update: 2020-08-01
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Cosentyx's approved nr-axSpA indicationisis is based on positive data from Stage 3 Clinical PREVENT (NCT02696031), which is the largest biological agent study to date in patients with nr-axSpA.
    PREVENT is a two-year randomized, double-blind, placebo-controlled study designed to assess cosentyx's efficacy and safety in active nr-axSpA patients.
    study included 555 adult nr-axSpA patients (pre-45, visual simulation scale (VAS) upper spinal pain score rating of 40/100, Bath severe spinal disease activity index (BASDAI) 4), these patients received at least two different nonsteroidal anti-inflammatory drugs (NSAID) 4 weeks before the start of the study, may have previously received TNF inhibitors (no more than one), but not more than one response.
    501 (90%) of the 555 patients had not previously received biotherapy.
    patients were divided into 3 groups and received: Cosentyx 150mg of loaded dose (induced: 150mg subcutaneous injection, treatment for 4 weeks per week; maintenance: 150mg, once per month), Cosentyx 150mg unloaded dose (150mg subcutaneous injection, once per month), placebo (induced: subcutaneous injection, treatment once per week for 4 weeks; maintenance: once a month). the main endpoint of
    is weeks 16 and 52, and the proportion of patients treated with Cosentyx for ASAS40 remission in primary TNF treatment.
    secondary endpoints include changes in BASDAI over time and aggressive scores of aggressive spina bifida with CHANGEs in CRP (ASDAS-ARP).
    results showed that Cosentyx reached the primary endpoint compared to the placebo group, achieving a statistically significant improvement in the symptoms and signs of nr-axSpA, and at least 40 percent improvement in ASAS40 responses in patients with primary chemotherapy at the 52st week.
    AxSpA is a long-term inflammatory disease characterized by chronic inflammatory back pain, including aggressive spina bifida (AS) and nr-axSpA, the former joint damage that is usually visible on X-rays and the latter not visible.
    however, the two diseases have similar symptom burdens, including nighttime pain, morning stiffness, fatigue and loss of function, which can have a significant impact on quality of life if left untreated.
    about 1.7 million patients with nr-axSpA in the top five EU countries and the United States.
    However, due to inadequate diagnosis, the disease has been delayed by more than 7 years or more on average.
    Cosentyx is the world's first and only specific target to inhibit interleukin-17A (IL-17A) all-human monoclonal antibody drug, approved by the FDA in 2015, and is now listed in more than 80 countries, including the European Union and the United States, including psoriasis arthritis (PsA), plaque-type psoriasis (PSO), AS and nr-axpA.
    Source: Novartis Cosentyx® Receives FDA for new oed to treat non-radiographic axial spondyloarthritis.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.