Cladribine vs other drugs in MS: Merging randomized trial with real-life data.
Adult
Cladribine
/ administration & dosage
Databases, Factual
Datasets as Topic
Disease Progression
Female
Humans
Immunologic Factors
/ administration & dosage
Male
Middle Aged
Multicenter Studies as Topic
Multiple Sclerosis, Relapsing-Remitting
/ drug therapy
Observational Studies as Topic
Outcome Assessment, Health Care
Randomized Controlled Trials as Topic
Retrospective Studies
Severity of Illness Index
Journal
Neurology(R) neuroimmunology & neuroinflammation
ISSN: 2332-7812
Titre abrégé: Neurol Neuroimmunol Neuroinflamm
Pays: United States
ID NLM: 101636388
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
27
05
2020
accepted:
16
07
2020
entrez:
18
8
2020
pubmed:
18
8
2020
medline:
5
10
2021
Statut:
epublish
Résumé
Cladribine tablets were tested against placebo in randomized controlled trials (RCTs). In this study, the effectiveness of cladribine vs other approved drugs in patients with relapsing-remitting MS (RRMS) was compared by matching RCT to observational data. Data from the pivotal trial assessing cladribine tablets vs placebo (CLARITY) were propensity score matched to data from the Italian multicenter database i-MuST. This database included 3,150 patients diagnosed between 2010 and 2018 at 24 Italian MS centers who started a disease-modifying drug. The annualized relapse rate (ARR) over 2 years from treatment start and the 24-week confirmed disability progression were compared between patients treated with cladribine and other approved drugs (interferon, glatiramer acetate, fingolimod, natalizumab, and dimethyl fumarate), with comparisons with placebo as a reference. Treatment effects were estimated by the inverse probability weighting negative binomial regression model for ARR and Cox model for disability progression. The treatment effect has also been evaluated according to baseline disease activity. All weighted baseline characteristics were well balanced between groups. All drugs tested had an effect vs placebo close to that detected in the RCT. Patients treated with cladribine had a significantly lower ARR compared with interferon (relapse ratio [RR] = 0.48; In patients with RRMS, cladribine tablets showed lower ARR compared with matched patients who started interferon, glatiramer acetate, or dimethyl fumarate; was similar to fingolimod; and was higher than natalizumab. The beneficial effect of cladribine tablets was generally amplified in the subgroup of patients with high disease activity. This study provides Class III evidence that for patients with RRMS, cladribine-treated patients had lower ARR compared with interferon, glatiramer acetate, or dimethyl fumarate; similar ARR compared with fingolimod; and higher ARR compared with natalizumab.
Identifiants
pubmed: 32801167
pii: 7/6/e878
doi: 10.1212/NXI.0000000000000878
pmc: PMC7641098
pii:
doi:
Substances chimiques
Immunologic Factors
0
Cladribine
47M74X9YT5
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
Références
J Clin Epidemiol. 2001 Apr;54(4):387-98
pubmed: 11297888
Lancet. 2018 Apr 21;391(10130):1622-1636
pubmed: 29576504
J Neurol. 2009 Mar;256(3):405-15
pubmed: 19308305
Ann Neurol. 2011 Feb;69(2):292-302
pubmed: 21387374
Curr Med Res Opin. 2018 Aug;34(8):1361-1371
pubmed: 29149804
Mult Scler. 2018 Oct;24(12):1594-1604
pubmed: 28870107
Mult Scler Relat Disord. 2016 Sep;9:23-30
pubmed: 27645339
Mult Scler. 2019 Aug;25(9):1263-1272
pubmed: 30044207
Mult Scler. 2018 Oct;24(12):1617-1626
pubmed: 28857680
CNS Drugs. 2018 Sep;32(9):813-826
pubmed: 30014314
J Clin Med Res. 2018 Feb;10(2):88-105
pubmed: 29317954
Mult Scler Relat Disord. 2019 May;30:176-186
pubmed: 30785074
Neurology. 1983 Nov;33(11):1444-52
pubmed: 6685237
Am J Epidemiol. 2008 Sep 15;168(6):656-64
pubmed: 18682488
Ann Neurol. 2001 Jul;50(1):121-7
pubmed: 11456302
Nat Rev Neurol. 2017 Feb;13(2):105-118
pubmed: 28084327
N Engl J Med. 2010 Feb 4;362(5):416-26
pubmed: 20089960
Multivariate Behav Res. 2011 May;46(3):399-424
pubmed: 21818162
Stat Med. 2015 Dec 10;34(28):3661-79
pubmed: 26238958