Treatment response score to glatiramer acetate or interferon beta-1a

Francesca Bovis, Tomas Kalincik, Fred Lublin, Gary Cutter, Charles Malpas, Dana Horakova, Eva Kubala Havrdova, Maria Trojano, Alexandre Prat, Marc Girard, Pierre Duquette, Marco Onofrj, Alessandra Lugaresi, Guillermo Izquierdo, Sara Eichau, Francesco Patti, Murat Terzi, Pierre Grammond, Roberto Bergamaschi, Patrizia SolaDiana Ferraro, Serkan Ozakbas, Gerardo Iuliano, Cavit Boz, Raymond Hupperts, Francois Grand'Maison, Celia Oreja-Guevara, Vincent van Pesch, Elisabetta Cartechini, Thor Petersen, Ayse Altintas, Aysun Soysal, Cristina Ramo-Tello, Pamela McCombe, Recai Turkoglu, Helmut Butzkueven, Jerry S Wolinsky, Claudio Solaro, Maria Pia Sormani

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVE: To compare the effectiveness of glatiramer acetate (GA) vs intra-muscular Interferon beta-1a (IFNbeta-1a)), we applied a previously published statistical method, aimed at identifying patients' profiles associated with efficacy of treatments.

METHODS: Data from 2 independent multiple sclerosis datasets, a randomized study (the CombiRx trial, evaluating GA vs IFNbeta-1a and an observational cohort extracted from MSBase, were used to build and validate a treatment response score, regressing annualized relapse rates (ARRs) on a set of baseline predictors.

RESULTS: The overall ARR ratio of GA vs IFNbeta-1a in the CombiRx trial was 0.72. The response score (made up of a linear combination of age, sex, relapses in the previous year, disease duration and EDSS) detected differential response of GA vs IFNbeta-1a: in the trial, patients with the largest benefit from GA vs IFNbeta-1a (lower score quartile) had an ARR ratio of 0.40 (95%confidence interval [CI] = 0.25-0.63), those in the 2 middle quartiles of 0.90 (95% CI = 0.61-1.34) and those in the upper quartile of 1.14 (95%CI = 0.59-2.18) (heterogeneity p = 0.012); this result was validated on MSbase, with the corresponding ARR ratios of 0.58 (95% CI = 0.46-0.72), 0.92 (95% CI = 0.77-1.09) and 1.29 (95% CI = 0.97-1.71); heterogeneity p < 0.0001).

CONCLUSIONS: We demonstrate the possibility of a criterion, based on patients' characteristics, to choose whether to treat with GA or IFNbeta-1a. This result, replicated on an independent real-life cohort, may have implications for clinical decisions in everyday clinical practice.

Original languageEnglish
JournalNeurology
DOIs
Publication statusE-pub ahead of print - Oct 6 2020

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