Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study.
Fingolimod
Multiple sclerosis
Natalizumab
Ocrelizumab
Switch
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
received:
14
12
2021
accepted:
24
12
2021
revised:
23
12
2021
pubmed:
5
1
2022
medline:
24
5
2022
entrez:
4
1
2022
Statut:
ppublish
Résumé
Exit strategy after natalizumab cessation in multiple sclerosis (MS) is a crucial point because the risk of disease reactivation is high during this period. The objective of this observational study was to compare ocrelizumab to fingolimod after natalizumab cessation in patients with relapsing-remitting multiple sclerosis (RRMS). All RRMS patients starting fingolimod or ocrelizumab within 6 weeks after natalizumab cessation were included. The primary endpoint was the annualized relapse rate (ARR) at 1 year. We included 54 patients receiving fingolimod and 48 patients receiving ocrelizumab after natalizumab cessation. In multivariate analysis, ARR at 1 year was significantly lower in the ocrelizumab group than in the fingolimod group (0.12 ± 0.39 versus 0.41 ± 0.71, p = 0.026), i.e. a 70.7% lower relapse rate. The cumulative probability of relapses at 1 year was 31.5% (17/54 patients) with fingolimod and 10.4% (5/48 patients) with ocrelizumab, corresponding to a hazard ratio of 3.4 (95% confidence interval: 1.1-11, p = 0.04). Our results suggest ocrelizumab is potentially a better exit strategy than fingolimod after natalizumab cessation.
Sections du résumé
BACKGROUND
BACKGROUND
Exit strategy after natalizumab cessation in multiple sclerosis (MS) is a crucial point because the risk of disease reactivation is high during this period. The objective of this observational study was to compare ocrelizumab to fingolimod after natalizumab cessation in patients with relapsing-remitting multiple sclerosis (RRMS).
METHODS
METHODS
All RRMS patients starting fingolimod or ocrelizumab within 6 weeks after natalizumab cessation were included. The primary endpoint was the annualized relapse rate (ARR) at 1 year.
RESULTS
RESULTS
We included 54 patients receiving fingolimod and 48 patients receiving ocrelizumab after natalizumab cessation. In multivariate analysis, ARR at 1 year was significantly lower in the ocrelizumab group than in the fingolimod group (0.12 ± 0.39 versus 0.41 ± 0.71, p = 0.026), i.e. a 70.7% lower relapse rate. The cumulative probability of relapses at 1 year was 31.5% (17/54 patients) with fingolimod and 10.4% (5/48 patients) with ocrelizumab, corresponding to a hazard ratio of 3.4 (95% confidence interval: 1.1-11, p = 0.04).
CONCLUSIONS
CONCLUSIONS
Our results suggest ocrelizumab is potentially a better exit strategy than fingolimod after natalizumab cessation.
Identifiants
pubmed: 34982200
doi: 10.1007/s00415-021-10950-7
pii: 10.1007/s00415-021-10950-7
pmc: PMC8725429
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Immunologic Factors
0
Immunosuppressive Agents
0
Natalizumab
0
ocrelizumab
A10SJL62JY
Fingolimod Hydrochloride
G926EC510T
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
3295-3300Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
Références
Bigaut K, Fabacher T, Kremer L et al (2021) Long-term effect of natalizumab in patients with RRMS: TYSTEN cohort. Mult Scler 27:729–741. https://doi.org/10.1177/1352458520936239
doi: 10.1177/1352458520936239
pubmed: 32643521
Iaffaldano P, Lucisano G, Pozzilli C et al (2015) Fingolimod versus interferon beta/glatiramer acetate after natalizumab suspension in multiple sclerosis. Brain 138:3275–3286. https://doi.org/10.1093/brain/awv260
doi: 10.1093/brain/awv260
pubmed: 26362907
Cohen M, Maillart E, Tourbah A et al (2014) Switching from natalizumab to fingolimod in multiple sclerosis: a French prospective study. JAMA Neurol 71:436–441. https://doi.org/10.1001/jamaneurol.2013.6240
doi: 10.1001/jamaneurol.2013.6240
pubmed: 24566807
Confavreux C, Compston DA, Hommes OR et al (1992) EDMUS, a European database for multiple sclerosis. J Neurol Neurosurg Psychiatry 55:671–676. https://doi.org/10.1136/jnnp.55.8.671
doi: 10.1136/jnnp.55.8.671
pubmed: 1527537
pmcid: 489202
Medistica (2020) pvalue.io, a graphic user interface to the R statistical analysis software for scientific medical publications. Available on: https://www.pvalue.io
Alping P, Frisell T, Novakova L et al (2016) Rituximab versus fingolimod after natalizumab in multiple sclerosis patients. Ann Neurol 79:950–958. https://doi.org/10.1002/ana.24651
doi: 10.1002/ana.24651
pubmed: 27038238
Ellwardt E, Rolfes L, Klein J et al (2020) Ocrelizumab initiation in patients with MS: a multicenter observational study. Neurol Neuroimmunol Neuroinflamm. https://doi.org/10.1212/NXI.0000000000000719
doi: 10.1212/NXI.0000000000000719
pubmed: 32273482
pmcid: 7176249
Genovese MC, Kaine JL, Lowenstein MB et al (2008) Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum 58:2652–2661. https://doi.org/10.1002/art.23732
doi: 10.1002/art.23732
pubmed: 18759293
Mandala S, Hajdu R, Bergstrom J et al (2002) Alteration of lymphocyte trafficking by sphingosine-1-phosphate receptor agonists. Science 296:346–349. https://doi.org/10.1126/science.1070238
doi: 10.1126/science.1070238
pubmed: 11923495
Levin SN, Ezuma C, Levine L et al (2020) Switching from natalizumab to ocrelizumab in patients with multiple sclerosis. Mult Scler 26:1964–1965. https://doi.org/10.1177/1352458520927631
doi: 10.1177/1352458520927631
pubmed: 32552363