The U.S. Food and Drug Administration (FDA), a vast government bureaucracy, employs about 17,500 people and had a budget of $5.7 billion in 2019. Yet even with its enormous resources, the FDA these days relies more and more on patients to…
News
Poor mental health, not having a full-time job, spending fewer years in school, and having comorbidities such as hypertension or diabetes all contribute to failure to respond to initial treatment with TNF-alpha inhibitors among people with axial spondyloarthritis (axSpA), according to a real-world study. The study, “Predicting…
The gleaming new Dutch headquarters of the European Medicines Agency (EMA), fronting Domenico Scarlattilaan in Amsterdam’s suburban Zuidas business district, finally opened for business last month — just over two years after the European Union decided to relocate the EMA to the Netherlands in the wake of Brexit.
Variations in the LTA gene can alter a person’s risk of developing ankylosing spondylitis (AS), a new study suggests. The study, “Associations of lymphotoxin-a (LTA) rs909253 A/G gene polymorphism, plasma level and risk of ankylosing spondylitis in a Chinese Han population,” was published in the journal…
Early Low Blood Levels of Humira and Antibodies Against It Predict Therapy’s Failure, Study Says
Low levels of Humira (adalimumab) early in the course of treatment and the presence of neutralizing autoantibodies in the blood of people with ankylosing spondylitis (AS) are associated with failure to respond to this treatment, a study says. The study, “Early adalimumab and anti-adalimumab antibody…
People with ankylosing spondylitis (AS) are almost three times more likely to develop obstructive sleep apnea (OSA) than healthy individuals, a population-based study in Taiwan shows. The risk is higher in middle-aged patients and those diagnosed more recently. The study, “Ankylosing Spondylitis Is Associated With Risk of…
Treatment with Cosentyx (secukinumab) continues to be safe and to ease symptoms in people with active ankylosing spondylitis (AS) through three years of use, new data from a Phase 3 trial show. The three-year data were reported in a study, titled “Secukinumab 150/300…
People with ankylosing spondylitis (AS) have an altered composition of microorganisms in their gut, leading to more bacteria that play a role in inflammation and AS progression, a new study reports. The study, “Metagenomic profiling of the pro-inflammatory gut microbiota in ankylosing spondylitis,” was published in the…
Health Canada has approved Cimzia (certolizumab pegol) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-axSpA). The medication is used to treat nr-axSpA patients with evidence of active inflammation, as indicated by magnetic resonance imaging and/or levels of the blood marker C-reactive…
Qletli, a biosimilar to Humira (adalimumab), is now available in China for the treatment of three autoimmune diseases, including ankylosing spondylitis (AS). The medication is also approved for the treatment of rheumatoid arthritis and plaque psoriasis. With its approval by China’s National Medical Products Administration (NMPA)…
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