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Efficacy of rituximab in refractory RRMS.

Authors :: Durozard P
Maarouf A
Boutiere C
Ruet A
Brochet B
Vukusic S
Carra-Dalliere C
Labauge P
Mathey G
Debouverie M
Papeix C
Maillart E
Lubetzki C
Bensa C
Gout O
Giannesini C
Stankoff B
Ciron J
Brassat D
Pelletier J
Rico Lamy A
Audoin B
Source :: Multiple sclerosis (Houndmills, Basingstoke, England) [Mult Scler] 2019 May; Vol. 25 (6), pp. 828-836. Date of Electronic Publication: 2018 May 03.
Publication Year :: 2019
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).<br />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.<br />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).<br />Conclusion: This study provides level IV evidence that rituximab reduces clinical and MRI disease activity in patients with active RRMS despite immunosuppressive DMT.