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

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

(eng) 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.