Disability progression markers over 6-12 years in interferon-β-treated multiple sclerosis patients

Abstract

Objective: To investigate the association between activity during interferon-beta (IFNβ) therapy and disability outcomes in patients with relapsing-remitting multiple sclerosis (RRMS).

Methods: A longitudinal study based on two previously described cohorts of IFNβ-treated RRMS patients was conducted. Patients were classified according to clinical activity after 2 years (clinical cohort) or to clinical and radiological activity after 1 year (magnetic resonance imaging (MRI) cohort). Multivariate Cox models were calculated for early disease activity predicting long-term disability.

Results: A total of 516 patients from two different cohorts were included in the analyses. Persistent clinical disease activity during the first 2 years of therapy predicted severe long-term disability (clinical cohort). In the MRI cohort, modified Rio score and no or minimal evidence of disease activity (NEDA/MEDA) did not identify patients with risk of Expanded Disability Status Scale (EDSS) worsening. However, a Rio score ≥ 2 (hazard ratio (HR): 3.3, 95% confidence interval (CI): 1.7-6.4); ≥3 new T2 lesions (HR: 2.9, 95% CI: 1.5-5.6); or ≥2 Gd-enhancing lesions (HR: 2.1, 95% CI: 1.1-4) were able to identify patients with EDSS worsening.

Conclusion: Although early activity during IFNβ therapy is associated with poor long-term outcomes, minimal degree of activity does not seem to be predictive of EDSS worsening over 6.7-year mean follow-up.

Keywords: MRI; Multiple sclerosis; disability; interferon-beta; outcome measurement; treatment response.