دورية أكاديمية
أعرض في EDS

Response to ibudilast treatment according to progressive multiple sclerosis disease phenotype.

التفاصيل البيبلوغرافية
العنوان: Response to ibudilast treatment according to progressive multiple sclerosis disease phenotype.
المؤلفون: Goodman AD; Department of Neurology, University of Rochester, Rochester, New York, USA., Fedler JK; University of Iowa, Iowa City, Iowa, USA., Yankey J; University of Iowa, Iowa City, Iowa, USA., Klingner EA; University of Iowa, Iowa City, Iowa, USA., Ecklund DJ; University of Iowa, Iowa City, Iowa, USA., Goebel CV; Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio, USA., Bermel RA; Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio, USA., Chase M; Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA., Coffey CS; University of Iowa, Iowa City, Iowa, USA., Klawiter EC; Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA., Naismith RT; Department of Neurology, Washington University, St Louis, Missouri, USA., Fox RJ; Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio, USA.
مؤلفون مشاركون: SPRINT-MS Investigators
المصدر: Annals of clinical and translational neurology [Ann Clin Transl Neurol] 2021 Jan; Vol. 8 (1), pp. 111-118. Date of Electronic Publication: 2021 Jan 18.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Wiley Periodicals, Inc on behalf of American Neurological Association Country of Publication: United States NLM ID: 101623278 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2328-9503 (Electronic) Linking ISSN: 23289503 NLM ISO Abbreviation: Ann Clin Transl Neurol Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [Hoboken, NJ] : Wiley Periodicals, Inc on behalf of American Neurological Association, [2014]-
مواضيع طبية MeSH: Atrophy/*pathology , Brain/*pathology , Multiple Sclerosis, Chronic Progressive/*drug therapy , Multiple Sclerosis, Chronic Progressive/*pathology , Phosphodiesterase Inhibitors/*therapeutic use , Pyridines/*therapeutic use, Adult ; Brain/drug effects ; Female ; Humans ; Male ; Middle Aged
مستخلص: Objective: Determine whether a treatment effect of ibudilast on brain atrophy rate differs between participants with primary (PPMS) and secondary (SPMS) progressive multiple sclerosis.
Background: Progressive forms of MS are both associated with continuous disability progression. Whether PPMS and SPMS differ in treatment response remains unknown.
Design/methods: SPRINT-MS was a randomized, placebo-controlled 96-week phase 2 trial in both PPMS (n = 134) and SPMS (n = 121) patients. The effect of PPMS and SPMS phenotype on the rate of change of brain atrophy measured by brain parenchymal fraction (BPF) was examined by fitting a three-way interaction linear-mixed model. Adjustment for differences in baseline demographics, disease measures, and brain size was explored.
Results: Analysis showed that there was a three-way interaction between the time, treatment effect, and disease phenotype (P < 0.06). After further inspection, the overall treatment effect was primarily driven by patients with PPMS (P < 0.01), and not by patients with SPMS (P = 0.97). This difference may have been due to faster brain atrophy progression seen in the PPMS placebo group compared to SPMS placebo (P < 0.02). Although backward selection (P < 0.05) retained age, T2 lesion volume, RNFL, and longitudinal diffusivity as significant baseline covariates in the linear-mixed model, the adjusted overall treatment effect was still driven by PPMS (P < 0.01).
Interpretation: The previously reported overall treatment effect of ibudilast on worsening of brain atrophy in progressive MS appears to be driven by patients with PPMS that may be, in part, because of the faster atrophy progression rates seen in the placebo-treated group.
(© 2021 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association.)
References: Neurology. 2021 Jan 26;96(4):e491-e500. (PMID: 33268562)
Lancet. 2014 Jun 28;383(9936):2213-21. (PMID: 24655729)
J Comput Assist Tomogr. 2001 May-Jun;25(3):466-75. (PMID: 11351200)
J Magn Reson Imaging. 2010 Aug;32(2):489-92. (PMID: 20677282)
Neurology. 2014 Jul 15;83(3):278-86. (PMID: 24871874)
Lancet Neurol. 2015 Feb;14(2):183-93. (PMID: 25772897)
N Engl J Med. 2018 Aug 30;379(9):846-855. (PMID: 30157388)
Lancet. 2016 Mar 12;387(10023):1075-1084. (PMID: 26827074)
Contemp Clin Trials. 2016 Sep;50:166-77. (PMID: 27521810)
N Engl J Med. 2017 Jan 19;376(3):209-220. (PMID: 28002688)
Neurology. 2010 Mar 30;74(13):1033-40. (PMID: 20200338)
Ann Neurol. 2018 Feb;83(2):210-222. (PMID: 29331092)
Lancet Neurol. 2015 Feb;14(2):208-23. (PMID: 25772899)
Lancet. 2018 Mar 31;391(10127):1263-1273. (PMID: 29576505)
معلومات مُعتمدة: U01 NS077179 United States NS NINDS NIH HHS; U24 NS107156 United States NS NINDS NIH HHS; U01 NS077352 United States NS NINDS NIH HHS; U24 NS107182 United States NS NINDS NIH HHS; U01NS082329 International National Institute of Neurological Disorders and Stroke (NINDS); U24 NS107205 United States NS NINDS NIH HHS
المشرفين على المادة: 0 (Phosphodiesterase Inhibitors)
0 (Pyridines)
M0TTH61XC5 (ibudilast)
تواريخ الأحداث: Date Created: 20210118 Date Completed: 20211008 Latest Revision: 20211008
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC7818089
DOI: 10.1002/acn3.51251
PMID: 33460301
قاعدة البيانات: MEDLINE
الوصف
تدمد:2328-9503
DOI:10.1002/acn3.51251