Effects of Ibudilast on MRI Measures in the Phase 2 SPRINT-MS Study.

Aged Female Humans Magnetic Resonance Imaging / methods Male Middle Aged Multiple Sclerosis / diagnostic imaging Phosphodiesterase Inhibitors / therapeutic use Pyridines / therapeutic use Treatment Outcome

Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
26 01 2021
Historique:
received: 08 01 2020
accepted: 04 09 2020
pubmed: 4 12 2020
medline: 10 2 2021
entrez: 3 12 2020
Statut: ppublish

Résumé

To determine whether ibudilast has an effect on brain volume and new lesions in progressive forms of multiple sclerosis (MS). A randomized, placebo-controlled, blinded study evaluated ibudilast at a dose of up to 100 mg over 96 weeks in primary and secondary progressive MS. In this secondary analysis of a previously reported trial, secondary and tertiary endpoints included gray matter atrophy, new or enlarging T2 lesions as measured every 24 weeks, and new T1 hypointensities at 96 weeks. Whole brain atrophy measured by structural image evaluation, using normalization, of atrophy (SIENA) was a sensitivity analysis. A total of 129 participants were assigned to ibudilast and 126 to placebo. New or enlarging T2 lesions were observed in 37.2% on ibudilast and 29.0% on placebo ( Ibudilast treatment was associated with a reduction in gray matter atrophy. Ibudilast treatment was not associated with a reduction in new or enlarging T2 lesions or new T1 lesions. An effect on brain volume contributes to prior data that ibudilast appears to affect markers associated with neurodegenerative processes, but not inflammatory processes. This study provides Class II evidence that for people with MS, ibudilast does not significantly reduce new or enlarging T2 lesions or new T1 lesions.

Identifiants

DOI: 10.1212/WNL.0000000000011314 PMID: 33268562 PMC: PMC7905793
pubmed: 33268562
pii: WNL.0000000000011314
doi: 10.1212/WNL.0000000000011314
pmc: PMC7905793
doi:

Substances chimiques

Phosphodiesterase Inhibitors 0
Pyridines 0
ibudilast M0TTH61XC5

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e491-e500

Subventions

Organisme : NINDS NIH HHS
ID : U01 NS077179
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS082329
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS077352
Pays : United States
Organisme : NINDS NIH HHS
ID : U24 NS107182
Pays : United States
Organisme : NINDS NIH HHS
ID : U24 NS107205
Pays : United States

Investigateurs

Shlomo Shinnar (S)
Daniel Ontaneda (D)
Claire S Riley (CS)
Jai Perumal (J)
Neil Lava (N)
Eric Klawiter (E)
Bruce Cohen (B)
Michael Racke (M)
Vijayshree Yadav (V)
Burk Jubelt (B)
Bianca WeinstockGutman (B)
Patricia Coyle (P)
Pavle Repovic (P)
Khurram Bashir (K)
Michelle Apperson (M)
Barbara Giesser (B)
Aram Zabeti (A)
Augusto Miravalle (A)
Sharon Lynch (S)
Silvia Delgado (S)
Valerie Suski (V)
Andrew Goodman (A)
Angela Flores (A)
Dana DeWitt (D)
Myla Goldman (M)
Harold Moses (H)
Robert Naismith (R)
Qi Peng (Q)
Ken Sakaie (K)
Sachin Jambawalikar (S)
Jonathan P Dyke (JP)
Hiroumi Kitajima (H)
Lawrence Panych (L)
Thomas Witzel (T)
Todd Parrish (T)
Rick Layman (R)
Xiangyu Yang (X)
Seonghwan Yee (S)
Dhaval Shah (D)
Terry Button (T)
Tony Williams (T)
Mike Buonocore (M)
Costin Tanase (C)
Ben Ellingson (B)
Mary GaskillShipley (M)
Ray Morton (R)
Mark Brown (M)
Phil Lee (P)
Pradip Pattany (P)
Hoby Hetherington (H)
Jianhui Zhang (J)
Shijn Varghese (S)
James Lee (J)
John P Mugler (JP)
Ron Price (R)
Betsy Thomas (B)
Mary Welch (M)
Jeremy Liff (J)
Andrew Smith (A)
Rossman Ian (R)
Wendy Vargas (W)
Comana Cioroiu (C)
Nancy Nealon (N)
Diana Vargas (D)
Calli Cook (C)
Moogeh Baharnoori (M)
Haatem Reda (H)
Farrah Mateen (F)
Kevin Patel (K)
Margaret Kay-Stacey (M)
Yasushi Kisanuki (Y)
Alldredge Brett (A)
Christine Bogda (C)
Michele Mass (M)
Edward Kim (E)
Anuradha Duleep (A)
Megan Grosso (M)
Meg Bucello (M)
Nancy McLinkskey (N)
Angeli Mayadev (A)
Qian Peiqing (Q)
William Meador (W)
David Richman (D)
Andrew Dorsch (A)
Kristin Nygren (K)
Ahmed Obeidat (A)
Anastacia Wall (A)
Nancy Hammond (N)
Heather Andersen (H)
Manoj Mittal (M)
Leticia Tornes (L)
Alexis Lizarraga (A)
Islam Zaydan (I)
Megan Hyland (M)
Shanan Munoz (S)
Katy Wright (K)
Gordon Smith (G)
Denise Bruen (D)
James Nicholas Brenton (JN)
Siddharama Pawate (S)
Subramaniam Sriram (S)
Kerry Oddis (K)
Eileen Scheid (E)
William Thayer (W)
Mariana Duodova (M)
Margaret Keller (M)
Jennifer Scott (J)
Mengesha Teshome (M)

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2020 American Academy of Neurology.

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Auteurs

Robert T Naismith (RT)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada. naismithr@wustl.edu.

Robert A Bermel (RA)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Christopher S Coffey (CS)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Andrew D Goodman (AD)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Janel Fedler (J)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Marianne Kearney (M)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Eric C Klawiter (EC)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Kunio Nakamura (K)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.
ORCID: 0000-0002-7833-8138

Sridar Narayanan (S)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Christopher Goebel (C)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Jon Yankey (J)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Elizabeth Klingner (E)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

Robert J Fox (RJ)

From Washington University (R.T.N.), St. Louis, MO; Cleveland Clinic Foundation (R.A.B., K.N., C.G., R.J.F.), OH; University of Iowa (C.S.C., J.F., J.Y., E.K.), Iowa City; University of Rochester (A.D.G.), NY; Massachusetts General Hospital (M.K., E.C.K.), Harvard Medical School, Boston; McConnell Brain Imaging Centre (S.N.), Montreal Neurological Institute, McGill University; and NeuroRx Research (S.N.), Montreal, Canada.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Effects of Ibudilast on MRI Measures in the...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Effects of Ibudilast on MRI Measures in the...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Imagerie par résonance magnétique › Effects of Ibudilast on MRI Measures in the...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Effects of Ibudilast on MRI Measures in the...
questionsmedicales.fr › Maladies du système immunitaire › Maladies auto-immunes › Maladies auto-immunes du système nerveux › Maladies démyélinisantes auto-immunes du SNC › Sclérose en plaques › Effects of Ibudilast on MRI Measures in the...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Mécanismes moléculaires de l'action pharmacologique › Antienzymes › Inhibiteurs de la phosphodiestérase › Effects of Ibudilast on MRI Measures in the...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Pyridines › Effects of Ibudilast on MRI Measures in the...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Effects of Ibudilast on MRI Measures in the...