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Observational Study
. 2022 Jun;269(6):3295-3300.
doi: 10.1007/s00415-021-10950-7. Epub 2022 Jan 4.

Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study

Kévin Bigaut  1   2   3 , Laurent Kremer  4   5   6 , Thibaut Fabacher  7 , Guido Ahle  8 , Mathilde Goudot  9 , Marie Fleury  4   6 , Claude Gaultier  8 , Sylvie Courtois  9 , Nicolas Collongues  4   5   6 , Jérôme de Seze  4   5   6
Affiliations
Observational Study

Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study

Kévin Bigaut et al. J Neurol. 2022 Jun.

Abstract

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: 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: 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: Our results suggest ocrelizumab is potentially a better exit strategy than fingolimod after natalizumab cessation.

Keywords: Fingolimod; Multiple sclerosis; Natalizumab; Ocrelizumab; Switch.

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Conflict of interest statement

LK, TF, MF, CG, and NC declare that they have no conflict of interest. KB and JDS report fees as consultant or for presentations in partnership with Biogen, Roche, Novartis and BMS/Celgene. MG reports fees as consultant or for presentations in partnership with Biogen. GA reports grant travel in partnership with Biogen, Novartis, Roche, Sanofi, Abbvie, and Pfizer. SC reports fees for presentations in partnership with Biogen, and Novartis.

Figures

Fig. 1
Fig. 1
Flowchart of the study
Fig. 2
Fig. 2
Relapse rate at 1 year, Kaplan–Meier curves, and days between fingolimod or ocrelizumab initiation and relapses for each patient. A Relapse rate at 1 year in both groups. Analysis was performed using a multivariate logistic regression adjusted for age, disease duration, sex, initial EDSS, number of relapses the year before natalizumab cessation, the time with natalizumab, washout period, and the presence of infratentorial lesions on brain MRI. B Kaplan–Meier curves of the occurrence of relapse in both groups. Analysis was performed using a Cox model. C Days between fingolimod or ocrelizumab initiation and relapses for each patient. Relapses occurred in 17/54 (31.5%) patients with fingolimod and 5/48 (10.4%) patients with ocrelizumab. HR  hazard ratio, 95% CI = 95% confidence interval. *Ocrelizumab as reference
See this image and copyright information in PMC

References

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