PARADIGMS study of Gilenya for pediatric multiple sclerosis patients is published in NEJM.- Novartis
Novartis announced that The New England Journal of Medicine (NEJM) has published full results from the landmark Phase III Gilenya (fingolimod) PARADIGMS study , the first-ever controlled, randomized study specifically designed for children and adolescents (aged 10 to 17) with relapsing forms of MS (RMS). Children and adolescents with MS experience more frequent and often more severe relapses than those seen in adults with MS. The negative effect of relapses on movement, memory and thinking prevents patients from enjoying their childhood and adolescent years to the full, often leaving them feeling isolated and anxious.
PARADIGMS met the primary endpoint of significantly reducing the rate of relapses when compared to interferon beta-1a intramuscular injections over a period of up to two years. The study also met several secondary clinical and imaging endpoints. Results from PARADIGMS show that, compared to interferon beta-1a, Gilenya:� Significantly reduced relapse rates by 82% (p<0.001) and delayed the time to first relapse; an estimated 85.7% of patients treated with gilenya were relapse-free at 24 months, versus 38.8% of patients treated with interferon beta-1a (p><0.001)� significantly reduced the number of new or newly enlarged t2 lesions up to 24 months by 53% (p><0.001). also, it significantly reduced the average number of gadolinium enhancing t1 (gd+) lesions per scan at 24 months by 66.0% (p><0.001). the number and volume of lesions are associated with increased relapse rates and disability progression � in additional analyses, significantly reduced the annualized rate of brain volume loss (brain shrinkage) by 40%. the safety profile of gilenya in this study was overall consistent with that seen in previous clinical trials in adults.>0.001).>0.001).>0.001)�>0.001)>
Gilenya is a well-established treatment for MS in the adult population, having been used to treat more than 255,000 patients in both clinical trials and the post-marketing setting, with approximately 566,000 years of patient experience.
See-"Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis"- Tanuja Chitnis, M.D., Douglas L. Arnold, M.D., Brenda Banwell, M.D.,et al.-September 13, 2018. N Engl J Med 2018; 379:1017-1027 DOI: 10.1056/NEJMoa1800149.
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