TY - JOUR
T1 - Treatment response score to glatiramer acetate or interferon beta-1a
AU - Bovis, Francesca
AU - Kalincik, Tomas
AU - Lublin, Fred
AU - Cutter, Gary
AU - Malpas, Charles
AU - Horakova, Dana
AU - Havrdova, Eva Kubala
AU - Trojano, Maria
AU - Prat, Alexandre
AU - Girard, Marc
AU - Duquette, Pierre
AU - Onofrj, Marco
AU - Lugaresi, Alessandra
AU - Izquierdo, Guillermo
AU - Eichau, Sara
AU - Patti, Francesco
AU - Terzi, Murat
AU - Grammond, Pierre
AU - Bergamaschi, Roberto
AU - Sola, Patrizia
AU - Ferraro, Diana
AU - Ozakbas, Serkan
AU - Iuliano, Gerardo
AU - Boz, Cavit
AU - Hupperts, Raymond
AU - Grand'Maison, Francois
AU - Oreja-Guevara, Celia
AU - van Pesch, Vincent
AU - Cartechini, Elisabetta
AU - Petersen, Thor
AU - Altintas, Ayse
AU - Soysal, Aysun
AU - Ramo-Tello, Cristina
AU - McCombe, Pamela
AU - Turkoglu, Recai
AU - Butzkueven, Helmut
AU - Wolinsky, Jerry S
AU - Solaro, Claudio
AU - Sormani, Maria Pia
N1 - © 2020 American Academy of Neurology.
PY - 2021/1/6
Y1 - 2021/1/6
N2 - 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.
AB - 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.
U2 - 10.1212/WNL.0000000000010991
DO - 10.1212/WNL.0000000000010991
M3 - Article
C2 - 33024022
VL - 96
SP - e214-e227
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 2
ER -