TY - JOUR
T1 - Anti-inflammatory disease-modifying treatment and short-term disability progression in SPMS
AU - Lorscheider, Johannes
AU - Jokubaitis, Vilija G.
AU - Spelman, Tim
AU - Izquierdo, Guillermo
AU - Lugaresi, Alessandra
AU - Havrdova, Eva
AU - Horakova, Dana
AU - Trojano, Maria
AU - Duquette, Pierre
AU - Girard, Marc
AU - Prat, Alexandre
AU - Grand'Maison, Francois
AU - Grammond, Pierre
AU - Pucci, Eugenio
AU - Boz, Cavit
AU - Sola, Patrizia
AU - Ferraro, Diana
AU - Spitaleri, Daniele
AU - Lechner-Scott, Jeanette
AU - Terzi, Murat
AU - Van Pesch, Vincent
AU - Iuliano, Gerardo
AU - Bergamaschi, Roberto
AU - Ramo-Tello, Cristina
AU - Granella, Franco
AU - Oreja-Guevara, Celia
AU - Butzkueven, Helmut
AU - Hupperts, Raymond
AU - Kalincik, Tomas
AU - MSBase Study Group
PY - 2017/9/5
Y1 - 2017/9/5
N2 - 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 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, beta=20.05, 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.
AB - 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 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, beta=20.05, 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.
KW - REMITTING MULTIPLE-SCLEROSIS
KW - DOUBLE-BLIND
KW - GLATIRAMER ACETATE
KW - TREATMENT TRIALS
KW - MS
KW - MULTICENTER
KW - INTERFERON-BETA-1A
KW - FINGOLIMOD
KW - SWITCH
U2 - 10.1212/WNL.0000000000004330
DO - 10.1212/WNL.0000000000004330
M3 - Article
C2 - 28794248
SN - 0028-3878
VL - 89
SP - 1050
EP - 1059
JO - Neurology
JF - Neurology
IS - 10
ER -