Durability of no evidence of disease activity-3 (NEDA-3) in patients receiving cladribine tablets: The CLARITY extension study.
CLARITY Extension
Cladribine tablets
bridging interval
no evidence of disease activity
randomized trial
relapsing-remitting multiple sclerosis
treatment durability
Journal
Multiple sclerosis (Houndmills, Basingstoke, England)
ISSN: 1477-0970
Titre abrégé: Mult Scler
Pays: England
ID NLM: 9509185
Informations de publication
Date de publication:
07 2022
07 2022
Historique:
pubmed:
13
10
2021
medline:
14
6
2022
entrez:
12
10
2021
Statut:
ppublish
Résumé
No evidence of disease activity (NEDA-3) is a patient-centric outcome increasingly used as the goal of multiple sclerosis treatment. Determine treatment durability of cladribine tablets beyond 2 years considering the variable bridging interval of 0.1-116.0 weeks between CLARITY and CLARITY Extension. Between CLARITY and CLARITY Extension, patients transitioned from cladribine tablets 3.5 mg/kg to placebo (CP3.5 group, The 2-year NEDA-3 in CLARITY Extension (encompassing both years of CLARITY Extension) was 29.6% in the CP3.5 group and 32.8% in the CC7.0 group. There was no evidence that treatment effect differed with varying bridging intervals. For patients in the CP3.5 group with a bridging interval of ⩽48 weeks, 1 year NEDA-3 (the first year of CLARITY Extension) was 44.4% (28/63) compared with 31.4% (11/35) in patients with a bridging interval of >48 weeks. Treatment with cladribine tablets in CLARITY, followed by either placebo or cladribine tablets in CLARITY Extension, produced sustained benefits for NEDA-3 and its constituent elements for a follow up period up to 6 years from CLARITY baseline.
Sections du résumé
BACKGROUND
No evidence of disease activity (NEDA-3) is a patient-centric outcome increasingly used as the goal of multiple sclerosis treatment.
OBJECTIVE
Determine treatment durability of cladribine tablets beyond 2 years considering the variable bridging interval of 0.1-116.0 weeks between CLARITY and CLARITY Extension.
METHODS
Between CLARITY and CLARITY Extension, patients transitioned from cladribine tablets 3.5 mg/kg to placebo (CP3.5 group,
RESULTS
The 2-year NEDA-3 in CLARITY Extension (encompassing both years of CLARITY Extension) was 29.6% in the CP3.5 group and 32.8% in the CC7.0 group. There was no evidence that treatment effect differed with varying bridging intervals. For patients in the CP3.5 group with a bridging interval of ⩽48 weeks, 1 year NEDA-3 (the first year of CLARITY Extension) was 44.4% (28/63) compared with 31.4% (11/35) in patients with a bridging interval of >48 weeks.
CONCLUSION
Treatment with cladribine tablets in CLARITY, followed by either placebo or cladribine tablets in CLARITY Extension, produced sustained benefits for NEDA-3 and its constituent elements for a follow up period up to 6 years from CLARITY baseline.
Identifiants
pubmed: 34634968
doi: 10.1177/13524585211049392
pmc: PMC9189728
doi:
Substances chimiques
Immunosuppressive Agents
0
Tablets
0
Cladribine
47M74X9YT5
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1219-1228Commentaires et corrections
Type : CommentIn
Références
Neurology. 2017 Sep 12;89(11):1107-1116
pubmed: 28835401
JAMA Neurol. 2014 Mar;71(3):269-70
pubmed: 24395449
Lancet Neurol. 2009 Mar;8(3):254-60
pubmed: 19201654
CNS Drugs. 2020 Dec;34(12):1275-1286
pubmed: 33226562
N Engl J Med. 2010 Feb 4;362(5):416-26
pubmed: 20089960
Mult Scler Relat Disord. 2013 Apr;2(2):65-7
pubmed: 25877624
Mult Scler. 2018 Oct;24(12):1594-1604
pubmed: 28870107
Mult Scler Relat Disord. 2012 Jan;1(1):6-7
pubmed: 25876444
Ther Adv Neurol Disord. 2020 Jun 24;13:1756286420935019
pubmed: 32636933
Ther Adv Neurol Disord. 2018 Jan 23;11:1756285617753365
pubmed: 29399054
Ther Adv Neurol Disord. 2015 Jan;8(1):3-13
pubmed: 25584069
Mult Scler. 2016 Sep;22(10):1297-305
pubmed: 26585439
Mult Scler Relat Disord. 2015 Jul;4(4):329-33
pubmed: 26195051
Neurotherapeutics. 2017 Oct;14(4):874-887
pubmed: 29168160
Neurology. 2017 Sep 12;89(11):1117-1126
pubmed: 28835403
Lancet Neurol. 2011 Apr;10(4):329-37
pubmed: 21397565