Anti-inflammatory disease-modifying treatment and short-term disability progression in SPMS

• Published in: Neurology Vol. 89; no. 10; pp. 1050 - 1059
• Main Authors: Lorscheider, Johannes, Jokubaitis, Vilija G, Spelman, Tim, Izquierdo, Guillermo, Lugaresi, Alessandra, Havrdova, Eva, Horakova, Dana, Trojano, Maria, Duquette, Pierre, Girard, Marc, Prat, Alexandre, GrandʼMaison, François, Grammond, Pierre, Pucci, Eugenio, Boz, Cavit, Sola, Patrizia, Ferraro, Diana, Spitaleri, Daniele, Lechner-Scott, Jeanette, Terzi, Murat, Van Pesch, Vincent, Iuliano, Gerardo, Bergamaschi, Roberto, Ramo-Tello, Cristina, Granella, Franco, Oreja-Guevara, Celia, Butzkueven, Helmut, Kalincik, Tomas
• Format: Journal Article
• Language: English
• Published: United States American Academy of Neurology 05-09-2017; Lippincott Williams & Wilkins
• Subjects: Adult; Anti-Inflammatory Agents - therapeutic use; Area Under Curve; Disability Evaluation; Disease Progression; Female; Follow-Up Studies; Humans; Longitudinal Studies; Magnetic Resonance Imaging; Male; Middle Aged; Multiple Sclerosis, Chronic Progressive - diagnostic imaging; Multiple Sclerosis, Chronic Progressive - drug therapy; Propensity Score; Proportional Hazards Models; Recurrence; Treatment Outcome
• ISSN: 0028-3878; 1526-632X; 1526-632X
• DOI: 10.1212/WNL.0000000000004330

OBJECTIVE:To investigate the effect of disease-modifying treatment on short-term disability outcomes in secondary progressive multiple sclerosis (SPMS).
METHODS:Using MSBase, an international cohort study, we previously validated a highly accurate definition of SPMS. Here, we identified patients in MSBase who were either untreated or treated with a disease-modifying drug when meeting this definition. Propensity score matching was used to select subpopulations with comparable baseline characteristics. Disability outcomes were compared in paired, pairwise-censored analyses adjusted for treatment persistence, visit density, and relapse rates.
RESULTS:Of the 2,381 included patients, 1,378 patients were matchable (treated n = 689, untreated n = 689). Median pairwise-censored follow-up was 2.1 years (quartiles 1.2–3.8 years). No difference in the risk of 6-month sustained disability progression was observed between the groups (hazard ratio [HR] 0.9, 95% confidence interval [CI] 0.7–1.1, p = 0.27). We also did not find differences in any of the secondary endpointsrisk of reaching Expanded Disability Status Scale (EDSS) score ≥7 (HR 0.6, 95% CI 0.4–1.1, p = 0.10), sustained disability reduction (HR 1.0, 95% CI 0.8–1.3, p = 0.79), or change in disability burden (area under the EDSS-time curve, β = −0.05, p = 0.09). Secondary and sensitivity analyses confirmed the results.
CONCLUSIONS:Our pooled analysis of the currently available disease-modifying agents used after conversion to SPMS suggests that, on average, these therapies have no substantial effect on relapse-unrelated disability outcomes measured by the EDSS up to 4 years.
CLASSIFICATION OF EVIDENCE:This study provides Class IV evidence that for patients with SPMS, disease-modifying treatment has no beneficial effect on short-term disability progression.