Ocrelizumab treatment for relapsing-remitting multiple sclerosis after a suboptimal response to previous disease-modifying therapy: A nonrandomized controlled trial.
MRI
Multiple sclerosis
disease progression
ocrelizumab
safety
switch
Journal
Multiple sclerosis (Houndmills, Basingstoke, England)
ISSN: 1477-0970
Titre abrégé: Mult Scler
Pays: England
ID NLM: 9509185
Informations de publication
Date de publication:
04 2022
04 2022
Historique:
pubmed:
13
8
2021
medline:
6
4
2022
entrez:
12
8
2021
Statut:
ppublish
Résumé
Many patients with multiple sclerosis (MS) experience suboptimal disease control despite the use of disease-modifying therapy (DMT). To assess the efficacy and safety of ocrelizumab (OCR) in patients with relapsing-remitting MS (RRMS) and suboptimal response to prior DMTs. Patients with RRMS and suboptimal responses (one clinically reported relapse and/or lesion activity) after ⩾ 6 months on another DMT were enrolled. OCR 600 mg was given intravenously every 24 weeks. The primary outcome was no evidence of disease activity (NEDA), defined as the absence of protocol-defined relapse, confirmed disability progression (CDP), T1 Gd-enhancing lesions, and new/enlarging T2 lesions. The intention-to-treat (ITT) population included 608 patients; NEDA was analyzed in a modified ITT (mITT) population ( Consistent efficacy of OCR on clinical and magnetic resonance imaging (MRI) disease activity measures and progression was shown in patients with RRMS and a suboptimal response to prior DMTs; no new safety signals were observed.
Sections du résumé
BACKGROUND
Many patients with multiple sclerosis (MS) experience suboptimal disease control despite the use of disease-modifying therapy (DMT).
OBJECTIVE
To assess the efficacy and safety of ocrelizumab (OCR) in patients with relapsing-remitting MS (RRMS) and suboptimal response to prior DMTs.
METHODS
Patients with RRMS and suboptimal responses (one clinically reported relapse and/or lesion activity) after ⩾ 6 months on another DMT were enrolled. OCR 600 mg was given intravenously every 24 weeks. The primary outcome was no evidence of disease activity (NEDA), defined as the absence of protocol-defined relapse, confirmed disability progression (CDP), T1 Gd-enhancing lesions, and new/enlarging T2 lesions.
RESULTS
The intention-to-treat (ITT) population included 608 patients; NEDA was analyzed in a modified ITT (mITT) population (
CONCLUSION
Consistent efficacy of OCR on clinical and magnetic resonance imaging (MRI) disease activity measures and progression was shown in patients with RRMS and a suboptimal response to prior DMTs; no new safety signals were observed.
Identifiants
pubmed: 34382875
doi: 10.1177/13524585211035740
pmc: PMC8978461
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
ocrelizumab
A10SJL62JY
Types de publication
Controlled Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
790-800Références
Curr Opin Neurol. 2018 Jun;31(3):233-243
pubmed: 29634596
Clinicoecon Outcomes Res. 2017 Apr 28;9:251-260
pubmed: 28496344
Can J Neurol Sci. 2020 Jul;47(4):437-455
pubmed: 32654681
Ann Neurol. 2011 Feb;69(2):292-302
pubmed: 21387374
J Thromb Haemost. 2011 Nov;9(11):2153-8
pubmed: 21920015
Mult Scler Relat Disord. 2015 Jul;4(4):329-33
pubmed: 26195051
Contemp Clin Trials. 2015 Mar;41:69-74
pubmed: 25545026
Mult Scler. 2014 Nov;20(13):1745-52
pubmed: 24842959
J Neurol. 2019 May;266(5):1182-1193
pubmed: 30820738
Continuum (Minneap Minn). 2019 Jun;25(3):715-735
pubmed: 31162313
Ther Adv Neurol Disord. 2016 Jan;9(1):44-52
pubmed: 26788130
Neurology. 2020 Sep 29;95(13):e1854-e1867
pubmed: 32690791
Mult Scler Relat Disord. 2015 Sep;4(5):460-469
pubmed: 26346796
Nat Rev Neurol. 2009 Oct;5(10):553-60
pubmed: 19794514
Patient Prefer Adherence. 2012;6:39-48
pubmed: 22272068
Lancet. 2012 Nov 24;380(9856):1829-39
pubmed: 23122650
Mayo Clin Proc. 2014 Feb;89(2):225-40
pubmed: 24485135
J Neurol Neurosurg Psychiatry. 2014 Sep;85(9):1035-7
pubmed: 24686566
Ther Adv Neurol Disord. 2016 Jul;9(4):250-63
pubmed: 27366231
Ann Neurol. 2013 Jan;73(1):95-103
pubmed: 23378325
N Engl J Med. 2017 Jan 19;376(3):221-234
pubmed: 28002679
Mult Scler. 2019 Aug;25(9):1263-1272
pubmed: 30044207