Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?
disease-modifying drugs
multiple sclerosis
off-label
regulatory issue
rituximab
Journal
Frontiers in immunology
ISSN: 1664-3224
Titre abrégé: Front Immunol
Pays: Switzerland
ID NLM: 101560960
Informations de publication
Date de publication:
2021
2021
Historique:
received:
31
01
2021
accepted:
15
06
2021
entrez:
23
7
2021
pubmed:
24
7
2021
medline:
15
10
2021
Statut:
epublish
Résumé
Despite the availability of a lot of effective disease-modifying drugs, multiple sclerosis (MS) (in particular the progressive forms) still represents an important unmet medical need, because of issues in terms of effectiveness, duration of response, safety, and patient compliance. An increasing body of evidence from randomized clinical trials and real-world data suggest that rituximab is a highly effective alternative in both relapsing and progressive MS, with a low discontinuation rate, related to a good benefit/risk profile, and a good compliance. To date, the use of rituximab in patients with multiple sclerosis is not in accordance with the authorized product information (off-label use). However, the use of this medicine is widespread in several countries, and in some cases, it is the most commonly used disease-modifying drug for MS subtypes. This use could be officially recognized by national regulatory authorities, according to specific procedures, to ensure equal access for patients to a safe and effective option.
Identifiants
pubmed: 34295328
doi: 10.3389/fimmu.2021.661882
pmc: PMC8290177
doi:
Substances chimiques
Rituximab
4F4X42SYQ6
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
661882Informations de copyright
Copyright © 2021 Brancati, Gozzo, Longo, Vitale and Drago.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Références
Expert Rev Neurother. 2015 Apr;15(4):339-46
pubmed: 25800129
Mult Scler Relat Disord. 2019 May;30:176-186
pubmed: 30785074
J Immunol. 2009 Jul 1;183(1):749-58
pubmed: 19535640
Blood. 2003 Jan 15;101(2):466-8
pubmed: 12393404
Autoimmun Rev. 2019 May;18(5):542-548
pubmed: 30844555
Mult Scler J Exp Transl Clin. 2020 Oct 12;6(4):2055217320964505
pubmed: 33110619
Nat Rev Dis Primers. 2018 Nov 8;4(1):43
pubmed: 30410033
CNS Drugs. 2011 Jun 1;25(6):491-502
pubmed: 21649449
Cells. 2018 Dec 28;8(1):
pubmed: 30597851
Mult Scler. 2017 Aug;23(9):1249-1257
pubmed: 27780912
J Neurol. 2018 Jul;265(7):1690-1697
pubmed: 29785523
J Neuroimmunol. 2006 Nov;180(1-2):63-70
pubmed: 16904756
Neurology. 1999 Nov 10;53(8):1698-704
pubmed: 10563615
Ann Neurol. 2008 Mar;63(3):395-400
pubmed: 18383069
Mult Scler Relat Disord. 2020 Aug;43:102210
pubmed: 32485634
Neurol Sci. 2018 May;39(5):965-966
pubmed: 29302813
Neurology. 2016 Jul 12;87(2):141-7
pubmed: 27316241
J Drug Assess. 2020 Jan 23;9(1):20-36
pubmed: 32128285
Nat Rev Neurol. 2020 Jan;16(1):56-62
pubmed: 31649335
Mult Scler. 2021 Jul;27(8):1230-1239
pubmed: 32840408
Mult Scler. 2016 Aug;22(2 Suppl):34-46
pubmed: 27465614
Nat Rev Immunol. 2015 Sep 15;15(9):545-58
pubmed: 26250739
J Neurol. 2019 Mar;266(3):726-734
pubmed: 30661133
Clin Rheumatol. 2019 Nov;38(11):2977-2994
pubmed: 31367943
Rev Neurosci. 2017 Nov 27;28(8):845-860
pubmed: 28787275
Neurology. 2018 Apr 24;90(17):777-788
pubmed: 29686116
Neurol Sci. 2020 Oct;41(10):2939-2945
pubmed: 32350672
PLoS One. 2018 Jan 8;13(1):e0190425
pubmed: 29309416
Eur J Neurol. 2019 Aug;26(8):1060-1067
pubmed: 30762259
Lancet Neurol. 2020 Dec;19(12):998-1009
pubmed: 33129442
Expert Opin Drug Saf. 2020 Sep;19(9):1069-1094
pubmed: 32799563
CA Cancer J Clin. 2020 Jan;70(1):7-30
pubmed: 31912902
Ann Clin Transl Neurol. 2020 Sep;7(9):1477-1487
pubmed: 32767531
Medicine (Baltimore). 2019 Aug;98(34):e15415
pubmed: 31441835
N Engl J Med. 2008 Feb 14;358(7):676-88
pubmed: 18272891
J Med Econ. 2013;16(5):639-47
pubmed: 23425293
Neurol Neuroimmunol Neuroinflamm. 2018 Sep 13;5(6):e498
pubmed: 30258855
J Neuroinflammation. 2016 Jun 27;13(1):164
pubmed: 27349895
Clin Neuropharmacol. 2016 Jul-Aug;39(4):178-81
pubmed: 27046661
Cochrane Database Syst Rev. 2012 Dec 12;12:CD006921
pubmed: 23235634
Mult Scler J Exp Transl Clin. 2016 Oct 9;2:2055217316672100
pubmed: 28607739
J Immunol Res. 2018 Nov 12;2018:9084759
pubmed: 30539030
JAMA Neurol. 2018 Mar 1;75(3):320-327
pubmed: 29309484
Clin Transl Immunology. 2018 May 31;7(6):e1018
pubmed: 29881546
Sci Transl Med. 2015 Oct 21;7(310):310ra166
pubmed: 26491076
Acta Neurol Scand. 2020 Jun;141(6):491-499
pubmed: 31990978
Autoimmun Rev. 2020 Aug;19(8):102585
pubmed: 32531469
Cell. 2018 Sep 20;175(1):85-100.e23
pubmed: 30173916
Lancet Neurol. 2015 Feb;14(2):183-93
pubmed: 25772897
J Neurol. 2018 May;265(5):1115-1122
pubmed: 29511864
Mult Scler. 2021 Apr;27(4):585-592
pubmed: 32180508
Neurol Neuroimmunol Neuroinflamm. 2020 Apr 9;7(4):
pubmed: 32273482
Eur Neurol. 2003;49(3):137-41
pubmed: 12646755
Neurol Neuroimmunol Neuroinflamm. 2020 Dec 17;8(1):
pubmed: 33334856
Acta Neurol Scand. 2021 Feb;143(2):178-187
pubmed: 32897569
Neurol Ther. 2015 Dec;4(2):147-57
pubmed: 26647006
Brain Sci. 2020 Oct 20;10(10):
pubmed: 33092190
Acta Neurol Scand. 2018 Oct;138(4):327-331
pubmed: 29797711
Ann Clin Transl Neurol. 2020 Sep;7(9):1466-1476
pubmed: 32767538
Mult Scler. 2020 Oct;26(12):1519-1531
pubmed: 31573386
Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5):
pubmed: 32503093
Mult Scler. 2018 Jul;24(8):1087-1095
pubmed: 28649912
Mult Scler. 2018 Feb;24(2):96-120
pubmed: 29353550
Br J Haematol. 2019 Mar;184(5):858-861
pubmed: 29527657
Sci Transl Med. 2019 May 1;11(490):
pubmed: 31043571
Mult Scler. 2021 Jun;27(7):1066-1076
pubmed: 32820687
Autoimmun Rev. 2013 Mar;12(5):543-53
pubmed: 23051633
Mult Scler J Exp Transl Clin. 2022 Jan 05;8(1):20552173211069359
pubmed: 35024160
Neurology. 2010 Jun 8;74(23):1860-7
pubmed: 20530322
MAbs. 2013 Jan-Feb;5(1):22-33
pubmed: 23211638
Mult Scler. 2020 Dec;26(14):1964-1965
pubmed: 32552363
Ann Neurol. 2016 Jun;79(6):950-8
pubmed: 27038238
Science. 2002 Apr 12;296(5566):346-9
pubmed: 11923495
Mult Scler Relat Disord. 2019 Jan;27:324-326
pubmed: 30471585
Nature. 2004 Jan 22;427(6972):355-60
pubmed: 14737169
N Engl J Med. 2018 Jan 11;378(2):169-180
pubmed: 29320652
J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):909-14
pubmed: 23431079
Arch Med Res. 2014 Nov;45(8):687-97
pubmed: 25431839
Case Rep Womens Health. 2019 Nov 20;25:e00162
pubmed: 31867224
Ann Neurol. 2021 Apr;89(4):780-789
pubmed: 33480077
J Rheumatol. 2015 Oct;42(10):1761-6
pubmed: 26276965
Mult Scler. 2018 Aug;24(9):1224-1233
pubmed: 28762877
N Engl J Med. 2017 Jan 19;376(3):209-220
pubmed: 28002688
J Exp Med. 2012 May 7;209(5):1001-10
pubmed: 22547654
J Neuroimmunol. 2020 Oct 15;347:577317
pubmed: 32731048
PLoS One. 2018 May 14;13(5):e0197415
pubmed: 29758075
N Engl J Med. 2017 Jan 19;376(3):221-234
pubmed: 28002679
Front Pharmacol. 2020 Sep 25;11:588132
pubmed: 33101042
Neurol Neuroimmunol Neuroinflamm. 2020 Oct 21;7(6):
pubmed: 33087582
Mult Scler Relat Disord. 2019 Nov;36:101402
pubmed: 31542710
Biomed Pharmacother. 2019 Jan;109:2415-2426
pubmed: 30551501
Neurol Neuroimmunol Neuroinflamm. 2018 Mar 19;5(3):e453
pubmed: 29564373
JAMA Neurol. 2019 Mar 1;76(3):274-281
pubmed: 30615019
Front Immunol. 2018 May 07;9:834
pubmed: 29867923
Drugs. 2020 Jun;80(8):841-848
pubmed: 32385738
Mult Scler. 2019 May;25(6):828-836
pubmed: 29722639
Ann Clin Transl Neurol. 2016 Feb 01;3(3):166-79
pubmed: 27042677
J Immunol. 2017 Apr 15;198(8):3245-3254
pubmed: 28275140
Neurology. 2016 Nov 15;87(20):2074-2081
pubmed: 27760868
Mult Scler. 2021 Apr;27(5):790-794
pubmed: 32749910
Neurology. 2019 Feb 12;92(7):e723-e732
pubmed: 30635477
Neuropsychiatr Dis Treat. 2015 May 18;11:1221-9
pubmed: 26056453
Ann Neurol. 2015 Nov;78(5):710-21
pubmed: 26239536
Ann Neurol. 2009 Oct;66(4):460-71
pubmed: 19847908
Cold Spring Harb Perspect Med. 2018 Apr 2;8(4):
pubmed: 29358315
Mult Scler Relat Disord. 2020 Oct;45:102398
pubmed: 32707531
Mult Scler Relat Disord. 2020 May;40:101980
pubmed: 32066031