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 endpoints: Risk 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.

Anti-inflammatory disease-modifying treatment and short-term disability progression in SPMS / Lorscheider, Johannes; Jokubaitis, Vilija G.; Spelman, Tim; Izquierdo, Guillermo; Lugaresi, Alessandra; Havrdova, Eva; Horakova, Dana; Trojano, Maria; Duquette, Pierre; Girard, Marc; Prat, Alexandre; Grand'Maison, 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. - In: NEUROLOGY. - ISSN 0028-3878. - 89:10(2017), pp. 1050-1059. [10.1212/WNL.0000000000004330]

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

Granella, Franco;
2017

Abstract

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 endpoints: Risk 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.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11381/2844429
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