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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.