Fingolimod Significantly Improves Quality of Life in Pediatric MS
The phase 3 PARADIGMS trial involving 215 pediatric patients demonstrated superior efficacy for fingolimod over interferon beta-1a.
|The following article is part of conference coverage from the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from ECTRIMS 2018.|
For pediatric patients with multiple sclerosis (MS), treatment with fingolimod is linked to significant improvements in all patient-reported measures of quality of life compared with treatment with interferon β-1a, according to research presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, held October 10-12, 2018, in Berlin, Germany.
In the double-blind, phase 3 PARADIGMS trial, 215 pediatric patients taking fingolimod for up to 2 years were shown to have reduced annualized relapse rates by 81.9%, reduced annualized rates of new or newly enlarged T2 lesions by 52.6%, and the number of T1 gadolinium-enhancing lesions reduced by 66% when compared with patients taking interferon β-1a.
The current study's objective was to compare the quality of life effects of these two medications using the Pediatric Quality of Life (PedsQL) inventory. Summary statistics of change from baseline PedsQL scores as reported by patients or parents to scores reported at the end of the trial were pre-planned, and researchers performed a posthoc analysis for inferential testing on between-group differences. The change from baseline in Psychosocial Health Summary, Physical Health Summary, and Total Scale scores were compared using a parametric analysis of covariance model (ANCOVA) adjusted by treatment, pubertal status, region, and the corresponding baseline score.
Significant improvements in PedsQL parent- and patient-reported Psychosocial Health Summary, Physical Health Summary, and Total Scale scores were seen in patients treated with fingolimod compared with interferon β-1a, who showed consistent worsening. These improvements in quality of life as reported by both patients and parents were confirmed by posthoc inferential statistical analysis (all P & LT; 0.05).
Study investigators concluded that "[c]onsistent with the primary efficacy results, treatment with fingolimod versus IFN β-1a was associated with a significant improvement in all measures of health-related quality of life as reported by the patients, and in Total score and Physical Health score as reported by their parents."
Disclosures: Study funding was provided by Novartis Pharma AG, Basel, Switzerland.
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Krupp L, Banwell B, Chitnis T, et al. Effect of fingolimod on quality of life in paediatric MS: results of the phase 3 PARADIGMS Study. Presented at: 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis 2018. October 10-12, 2018; Berlin, Germany. Poster 949.