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

Johannes Lorscheider, Vilija G. Jokubaitis, Tim Spelman, Guillermo Izquierdo, Alessandra Lugaresi, Eva Havrdova, Dana Horakova, Maria Trojano, Pierre Duquette, Marc Girard, Alexandre Prat, Francois Grand'Maison, Pierre Grammond, Eugenio Pucci, Cavit Boz, Patrizia Sola, Diana Ferraro, Daniele Spitaleri, Jeanette Lechner-Scott, Murat TerziVincent Van Pesch, Gerardo Iuliano, Roberto Bergamaschi, Cristina Ramo-Tello, Franco Granella, Celia Oreja-Guevara, Helmut Butzkueven, Raymond Hupperts, Tomas Kalincik*, MSBase Study Group

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)1050-1059
Number of pages10
JournalNeurology
Volume89
Issue number10
DOIs
Publication statusPublished - 5 Sept 2017

Keywords

  • REMITTING MULTIPLE-SCLEROSIS
  • DOUBLE-BLIND
  • GLATIRAMER ACETATE
  • TREATMENT TRIALS
  • MS
  • MULTICENTER
  • INTERFERON-BETA-1A
  • FINGOLIMOD
  • SWITCH

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