Baseline disability, age, and multiple sclerosis (MS) disease duration may help predict 6-month confirmed disability progression in patients with relapsing-remitting MS, according to a post-hoc analysis of the TRANSFORMS trial (ClinicalTrials.gov: NCT00340834).
The results of the 36-month follow-up study were presented at the 2017 Consortium of Multiple Sclerosis Centers Annual Meeting, May 24-27 in New Orleans.
TRANSFORMS was a 12-month, double-blind, randomized, phase 3 study of fingolimod 0.5 mg/d vs intramuscular inferferon beta-1a in patients with relapsing-remitting MS. In the extension study, patients who received interferon beta-1a were switched to fingolimod. In the current study, the team of investigators, led by Aaron Boster, MD, of Ohio State University in Columbus, sought to assess the ability of clinical parameters at baseline through month 12 to predict MS relapse and disease progression in months 12 through 24 and 12 through 48.
A total of 1292 patients were included in the TRANSFORMS study (month [M] 12-24=973; M12-48=778). In both the short and long term, relapse was predicted by a combined clinical occurrence of at least 1 gadolinium-enhancing lesion or at least 2 T2 lesions and at least 1 confirmed relapse (M12-24: odds ratio [OR] 2.776; 95% CI, 1.649-4.674, P <.0001; M12-48: OR 3.703; 95% CI, 2.158-6.356, P <.0001) or the number of confirmed relapses from baseline to month 12 (M12-24: OR 2.24; 95% CI, 1.751-2.866, P <.0001; M12-48: OR 2.297, 95% CI 1.753-3.009, P < .0001).
Factors that predicted 6-month confirmed disability progression in months 12-48 were baseline Expanded Disability Status Scale score (OR 1.44; 95% CI, 1.244-1.668, P <.0001), MS disease duration (OR 1.045; 95% CI, 1.009-1.082, P =.0131), and age (OR 1.033; 95% CI, 1.010-1.057, P =.005).
The results, the investigators concluded, “suggest that early use of high-efficacy treatment may help control disease worsening.”
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Disclosures: The study was supported by Novartis. Drs Boster, Repovic, Meng, Meier, Boulos, Sprenger, and Barkhof report multiple relationships with industry. See the abstract for a full list of disclosures.
Boster A, Repovic P, Meng X, et al. Short- and long-term predictors of relapses or disability worsening in patients with multiple sclerosis in the phase 3 TRANSFORMS study. Presented at: 2017 Consortium of Multiple Sclerosis Centers Annual Meeting. May 24-27, 2017; New Orleans, LA. Abstract DX56.