For patients who have active multiple sclerosis (MS) despite using injectable immunomodulators, switching to the oral immunomodulator fingolimod yields fewer relapses and less disability than does switching to a different injectable immunomodulator, according to a report published in the April issue of JAMA Neurology.
To compare MS outcomes using different treatment regimens, researchers used information from the MSBase registry, which collects observational data on the disorder as part of routine patient care. For this study, the investigators retrospectively analyzed data entered between 1996 and 2014 for 527 patients with MS who had breakthrough disease while receiving injectable immunomodulators (typically an interferon beta or glatiramer acetate preparation) and who switched to either oral fingolimod (148 patients) or a different interferon beta or glatiramer agent (379 patients) up to 12 months after on-treatment clinical disease activity.
The two groups were propensity matched for baseline clinical and demographic variables, including patient age, area of residence, disease duration, total number of previous treatments, disability score, number of relapses, and previous medications. The groups were followed for a median of 13 months (range, three to 80 months) after switching therapies, said Anna He, MBBS, a neurologist at Royal Melbourne Hospital in Australia, and her associates. Head-to-head analyses of relapse and disability outcomes used paired, weighted, negative binomial models or frailty proportional hazards models adjusted for MRI variables.
Patients who switched to fingolimod had a lower mean annualized relapse rate, compared with the other patients (0.31 vs 0.42). The fingolimod group had a decreased risk of relapse (hazard ratio [HR], 0.74), compared with patients who switched to a different injectable therapy. Patients who switched to fingolimod also had a 47% decreased risk of progression of disability. In addition, the fingolimod group had a markedly increased likelihood of disability regression (HR, 2.0). Furthermore, the rate of continuing on the new treatment at two years was higher with fingolimod (82.5%) than with a different injectable (73.2%), said Dr. He and her associates.
“Although analyses of observational data do not serve as a substitute for trial data, our study provides real-world evidence, representative of clinical practice in tertiary MS centers, to support clinical decision-making that is highly relevant to the management of active MS,” said the investigators.
—Mary Ann Moon