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 Sola; Diana 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

doi:10.1212/WNL.0000000000010991

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 journal › Article › peer-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 language	English
Journal	Neurology
DOIs	https://doi.org/10.1212/WNL.0000000000010991
Publication status	E-pub ahead of print - Oct 6 2020

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Bovis, F., Kalincik, T., Lublin, F., Cutter, G., Malpas, C., Horakova, D., Havrdova, E. K., Trojano, M., Prat, A., Girard, M., Duquette, P., Onofrj, M., Lugaresi, A., Izquierdo, G., Eichau, S., Patti, F., Terzi, M., Grammond, P., Bergamaschi, R., ... Sormani, M. P. (2020). Treatment response score to glatiramer acetate or interferon beta-1a. Neurology. https://doi.org/10.1212/WNL.0000000000010991

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; 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.

In: Neurology, 06.10.2020.

Research output: Contribution to journal › Article › peer-review

Bovis, F, Kalincik, T, Lublin, F, Cutter, G, Malpas, C, Horakova, D, Havrdova, EK, Trojano, M, Prat, A, Girard, M, Duquette, P, Onofrj, M, Lugaresi, A, Izquierdo, G, Eichau, S, Patti, F, Terzi, M, Grammond, P, Bergamaschi, R, Sola, P, Ferraro, D, Ozakbas, S, Iuliano, G, Boz, C, Hupperts, R, Grand'Maison, F, Oreja-Guevara, C, van Pesch, V, Cartechini, E, Petersen, T, Altintas, A, Soysal, A, Ramo-Tello, C, McCombe, P, Turkoglu, R, Butzkueven, H, Wolinsky, JS, Solaro, C & Sormani, MP 2020, 'Treatment response score to glatiramer acetate or interferon beta-1a', Neurology. https://doi.org/10.1212/WNL.0000000000010991

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 ; 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. / Treatment response score to glatiramer acetate or interferon beta-1a. In: Neurology. 2020.

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title = "Treatment response score to glatiramer acetate or interferon beta-1a",

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.",

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

note = "{\textcopyright} 2020 American Academy of Neurology.",

year = "2020",

month = oct,

day = "6",

doi = "10.1212/WNL.0000000000010991",

language = "English",

journal = "Neurology",

issn = "0028-3878",

publisher = "Lippincott Williams and Wilkins",

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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

PY - 2020/10/6

Y1 - 2020/10/6

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

JO - Neurology

JF - Neurology

SN - 0028-3878

ER -