Measuring treatment response to advance precision medicine for multiple sclerosis

Abstract Objective To assess the independent contributions of clinical measures (relapses, Expanded Disability Status Scale [EDSS] scores, and neuroperformance measures) and nonclinical measures (new brain magnetic resonance imaging [MRI] activity and serum neurofilament light chain [sNfL] levels) f...

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Autores principales:	Peter A. Calabresi, Ludwig Kappos, Gavin Giovannoni, Tatiana Plavina, Irene Koulinska, Michael R. Edwards, Bernd Kieseier, Carl deMoor, Elias S. Sotirchos, Elizabeth Fisher, Richard A. Rudick, Alfred Sandrock
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/fa352fd8745148f48a725597ae0f7a77
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spelling	oai:doaj.org-article:fa352fd8745148f48a725597ae0f7a772021-11-22T11:11:52ZMeasuring treatment response to advance precision medicine for multiple sclerosis2328-950310.1002/acn3.51471https://doaj.org/article/fa352fd8745148f48a725597ae0f7a772021-11-01T00:00:00Zhttps://doi.org/10.1002/acn3.51471https://doaj.org/toc/2328-9503Abstract Objective To assess the independent contributions of clinical measures (relapses, Expanded Disability Status Scale [EDSS] scores, and neuroperformance measures) and nonclinical measures (new brain magnetic resonance imaging [MRI] activity and serum neurofilament light chain [sNfL] levels) for distinguishing natalizumab‐treated from placebo‐treated patients. Methods We conducted post hoc analyses using data from the AFFIRM trial of natalizumab for multiple sclerosis. We used multivariable regression analyses with predictors (EDSS progression, no relapse, new or enlarging MRI activity, brain atrophy, sNfL levels, and neuroperformance worsening) to identify measures that independently discriminated between treatment groups. Results The multivariable model that best distinguished natalizumab from placebo was no new or enlarging T2 or gadolinium‐enhancing activity on MRI (odds ratio; 95% confidence interval: 7.2; 4.7–10.9), year 2 sNfL levels <97.5th percentile (4.1; 2.6–6.2), and no relapses in years 0–2 (2.1; 1.5–3.0). The next best‐fitting model was a two‐component model that included no MRI activity and sNfL levels <97.5th percentile at year 2. There was little difference between the three‐ and two‐component models. Interpretation Nonclinical measures (new MRI activity and sNfL levels) discriminate between treatment and placebo groups similarly to or better than clinical outcomes composites and have implications for patient monitoring.Peter A. CalabresiLudwig KapposGavin GiovannoniTatiana PlavinaIrene KoulinskaMichael R. EdwardsBernd KieseierCarl deMoorElias S. SotirchosElizabeth FisherRichard A. RudickAlfred SandrockWileyarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENAnnals of Clinical and Translational Neurology, Vol 8, Iss 11, Pp 2166-2173 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Peter A. Calabresi Ludwig Kappos Gavin Giovannoni Tatiana Plavina Irene Koulinska Michael R. Edwards Bernd Kieseier Carl deMoor Elias S. Sotirchos Elizabeth Fisher Richard A. Rudick Alfred Sandrock Measuring treatment response to advance precision medicine for multiple sclerosis
description	Abstract Objective To assess the independent contributions of clinical measures (relapses, Expanded Disability Status Scale [EDSS] scores, and neuroperformance measures) and nonclinical measures (new brain magnetic resonance imaging [MRI] activity and serum neurofilament light chain [sNfL] levels) for distinguishing natalizumab‐treated from placebo‐treated patients. Methods We conducted post hoc analyses using data from the AFFIRM trial of natalizumab for multiple sclerosis. We used multivariable regression analyses with predictors (EDSS progression, no relapse, new or enlarging MRI activity, brain atrophy, sNfL levels, and neuroperformance worsening) to identify measures that independently discriminated between treatment groups. Results The multivariable model that best distinguished natalizumab from placebo was no new or enlarging T2 or gadolinium‐enhancing activity on MRI (odds ratio; 95% confidence interval: 7.2; 4.7–10.9), year 2 sNfL levels <97.5th percentile (4.1; 2.6–6.2), and no relapses in years 0–2 (2.1; 1.5–3.0). The next best‐fitting model was a two‐component model that included no MRI activity and sNfL levels <97.5th percentile at year 2. There was little difference between the three‐ and two‐component models. Interpretation Nonclinical measures (new MRI activity and sNfL levels) discriminate between treatment and placebo groups similarly to or better than clinical outcomes composites and have implications for patient monitoring.
format	article
author	Peter A. Calabresi Ludwig Kappos Gavin Giovannoni Tatiana Plavina Irene Koulinska Michael R. Edwards Bernd Kieseier Carl deMoor Elias S. Sotirchos Elizabeth Fisher Richard A. Rudick Alfred Sandrock
author_facet	Peter A. Calabresi Ludwig Kappos Gavin Giovannoni Tatiana Plavina Irene Koulinska Michael R. Edwards Bernd Kieseier Carl deMoor Elias S. Sotirchos Elizabeth Fisher Richard A. Rudick Alfred Sandrock
author_sort	Peter A. Calabresi
title	Measuring treatment response to advance precision medicine for multiple sclerosis
title_short	Measuring treatment response to advance precision medicine for multiple sclerosis
title_full	Measuring treatment response to advance precision medicine for multiple sclerosis
title_fullStr	Measuring treatment response to advance precision medicine for multiple sclerosis
title_full_unstemmed	Measuring treatment response to advance precision medicine for multiple sclerosis
title_sort	measuring treatment response to advance precision medicine for multiple sclerosis
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/fa352fd8745148f48a725597ae0f7a77
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Measuring treatment response to advance precision medicine for multiple sclerosis

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