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.

Treatment response score to glatiramer acetate or interferon beta-1a / Bovis, Francesca; Kalincik, Tomas; Lublin, Fred; Cutter, Gary; Malpas, Charles; Horakova, Dana; Kubala Havrdova, Eva; 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; Cartechini, Elisabetta; Petersen, Thor; Altintas, Ayse; Soysal, Aysun; Ramo-Tello, Cristina; Mccombe, Pamela; Turkoglu, Recai; Butzkueven, Helmut; Wolinsky, Jerry S.; Solaro, Claudio; Pia Sormani, Maria. - In: NEUROLOGY. - ISSN 0028-3878. - 96:2(2021), pp. e214-e227. [10.1212/wnl.0000000000010991]

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

Diana Ferraro;
2021

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.
2021
6-ott-2020
96
2
e214
e227
Treatment response score to glatiramer acetate or interferon beta-1a / Bovis, Francesca; Kalincik, Tomas; Lublin, Fred; Cutter, Gary; Malpas, Charles; Horakova, Dana; Kubala Havrdova, Eva; 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; Cartechini, Elisabetta; Petersen, Thor; Altintas, Ayse; Soysal, Aysun; Ramo-Tello, Cristina; Mccombe, Pamela; Turkoglu, Recai; Butzkueven, Helmut; Wolinsky, Jerry S.; Solaro, Claudio; Pia Sormani, Maria. - In: NEUROLOGY. - ISSN 0028-3878. - 96:2(2021), pp. e214-e227. [10.1212/wnl.0000000000010991]
Bovis, Francesca; Kalincik, Tomas; Lublin, Fred; Cutter, Gary; Malpas, Charles; Horakova, Dana; Kubala Havrdova, Eva; Trojano, Maria; Prat, Alexandre;...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1221922
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