Subgroups of multiple sclerosis patients with larger treatment benefits: a meta-analysis of randomized trials

• Published in: European journal of neurology Vol. 22; no. 6; pp. 960 - 966
• Main Authors: Signori, A., Schiavetti, I., Gallo, F., Sormani, M. P.
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.06.2015; John Wiley & Sons, Inc
• Subjects: Adult; disability progression; Disease Progression; early treatment; Humans; larger treatment effect; meta-analysis; Middle Aged; Multiple Sclerosis, Relapsing-Remitting - drug therapy; Outcome Assessment (Health Care) - statistics & numerical data; randomized controlled clinical trials; Randomized Controlled Trials as Topic - statistics & numerical data; relapse rate; Severity of Illness Index; subgroup analysis; randomized controlled clinical trials; subgroup analysis; relapse rate; meta-analysis; larger treatment effect; disability progression; early treatment
• ISSN: 1351-5101; 1468-1331
• DOI: 10.1111/ene.12690

Background and purpose No subgroups of patients with higher treatment effects have been clearly detected in multiple sclerosis (MS). The aim of the present work was to evaluate whether there are subgroups of relapsing−remitting MS (RRMS) patients who are more responsive to treatments. Methods All published randomized clinical trials in RRMS reporting a subgroup analysis of treatment effect were collected. Two main outcomes, the annualized relapse rate (ARR) and the disability progression, were studied. The treatment effect in each subgroup was reported as a relative effect (RE), defined as the treatment effect in the subgroup relative to the overall effect. A meta‐analysis was run to compare the RE between subgroups. Results Six trials (6693 RRMS patients) were included. Treatment effects on ARR were significantly higher in younger than in older subjects (RE = 0.83 vs. RE = 1.30, P < 0.001), in patients with than those without gadolinium activity (RE = 0.86 vs. RE = 1.15, P = 0.005) and in patients with lower than in those with higher Expanded Disability Status Scale (RE = 0.96 vs. RE = 1.23, P = 0.02), and on disability progression in younger than in older subjects (RE = 0.82 vs. RE = 1.28, P = 0.017). Conclusions This study formally shows that in RRMS higher treatment effects are associated with characteristics of earlier (lower age and Expanded Disability Status Scale) and more active (higher gadolinium activity) disease.