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Mult Scler. 2018 May 1:1352458518772748. doi: 10.1177/1352458518772748. [Epub ahead of print]

Efficacy of rituximab in refractory RRMS.

Author information

1
Pôle de Neurosciences Cliniques, Service de Neurologie, APHM, Hôpital de la Timone, Marseille, France/CRMBM UMR 7339, CNRS, Aix-Marseille Université, Marseille, France.
2
Service de Neurologie, CHU de Bordeaux, Bordeaux, France; Université de Bordeaux, Bordeaux, France.
3
Service de neurologie-sclérose en plaques, pathologies de la myéline et neuro-inflammation, Hôpital Pierre Wertheimer, Hospices Civils de Lyon, Lyon, France/Fondation Eugène Devic EDMUS contre la Sclérose en Plaques, Bron, France.
4
Departement de Neurologie Centre Expert Sclerose en Plaques, Centre de Reference Leucodystrophies Adultes, CHU de Montpellier, Montpellier, France.
5
Service de neurologie, Hôpital Central, CHU de Nancy, Nancy, France.
6
Service de neurologie, Hôpital Universitaire de la Pitié-Salpêtrière, Assistance publique-Hôpitaux de Paris, Paris, France.
7
Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.
8
Service de neurologie, Hôpital Saint Antoine, Assistance publique-Hôpitaux de Paris, Paris, France.
9
Pôle des neurosciences, Service de neurologie, CHU, hôpital Pierre-Paul Riquet, Toulouse, France/INSERM U1043, Université Toulouse III, Toulouse, France.

Abstract

OBJECTIVE:

To investigate the efficacy of rituximab as rescue therapy in patients with relapsing-remitting multiple sclerosis (RRMS) and persistent disease activity confirmed by magnetic resonance imaging (MRI) despite immunosuppressive disease-modifying therapy (DMT).

METHODS:

In this observational nationwide retrospective multicenter study, we first identified 351 off-label rituximab-treated patients through a cohort of 15,984 RRMS patients. In this group, we identified patients with disease activity prior to rituximab confirmed by MRI (one or more new T2 lesion and/or gadolinium-enhancing lesion) despite immunosuppressive DMT (fingolimod, natalizumab, or mitoxantrone) with a follow-up after rituximab initiation longer than 6 months. Outcome data were collected from the French Observatory of Multiple Sclerosis (OFSEP) register and medical charts.

RESULTS:

A total of 50 patients were identified. Median rituximab treatment duration was 1.1 (0.5-6.4) year. Mean annualized relapse rate significantly decreased from 0.8 during last immunosuppressive DMT to 0.18 after rituximab ( p < 0.0001). While 72% of patients showed gadolinium-enhancing lesions on the last MRI performed during last immunosuppressive DMT, 8% of them showed gadolinium-enhancing lesions on the first MRI performed 6.1 (range 1.4-18.4) months after rituximab ( p < 0.0001).

CONCLUSION:

This study provides level IV evidence that rituximab reduces clinical and MRI disease activity in patients with active RRMS despite immunosuppressive DMT.

KEYWORDS:

Multiple sclerosis; disease-modifying therapies; relapsing/remitting; second-line treatment; treatment response

PMID:
29722639
DOI:
10.1177/1352458518772748

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