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. 2020 Dec 17;8(1):e913.
doi: 10.1212/NXI.0000000000000913. Print 2021 Jan.

Anti-CD20 therapies and pregnancy in neuroimmunologic disorders: A cohort study from Germany

Tania Kümpfel  1 , Sandra Thiel  1 , Ingrid Meinl  1 , Andrea I Ciplea  1 , Antonios Bayas  1 , Frank Hoffmann  1 , Ulrich Hofstadt-van Oy  1 , Muna Hoshi  1 , Jakob Kluge  1 , Marius Ringelstein  1 , Orhan Aktas  1 , Muriel Stoppe  1 , Annette Walter  1 , Martin S Weber  1 , Ilya Ayzenberg  1 , Kerstin Hellwig  2
Affiliations

Anti-CD20 therapies and pregnancy in neuroimmunologic disorders: A cohort study from Germany

Tania Kümpfel et al. Neurol Neuroimmunol Neuroinflamm. .

Abstract

Objective: To report pregnancy outcomes and disease activity (DA) in women with MS, neuromyelitis optica spectrum disorders (NMOSDs), and other neuroimmunologic diseases (ONID) after treatment with rituximab (RTX)/ocrelizumab (OCR) 12 months before or during pregnancy.

Methods: Data were collected in the German MS and pregnancy registry and centers from the Neuromyelitis Optica Study Group. Sixty-eight known outcomes of 88 pregnancies from 81 women (64 MS, 10 NMOSD, and 7 ONID) were included and stratified in 3 exposure groups: >6M-group = RTX/OCR >6 but ≤12 months before the last menstrual period (LMP) (n = 8); <6M group = RTX/OCR <6 months before the LMP (n = 47); preg group = RTX/OCR after the LMP (n = 13).

Results: Pregnancy outcomes were similar between groups, but significantly more preterm births (9.8% vs 45%) occurred after exposure during pregnancy. Overall, 2 major congenital abnormalities (3.3%), both in the preg group, were observed. Three women had severe infections during pregnancy. All women with MS (35) and 12/13 women with NMOSD, RTX/OCR exposure before the LMP and known pregnancy outcomes after gestational week 22 were relapse free during pregnancy. Five of 29 (17.2%) women with relapsing-remitting MS (RRMS) and 1 of 12 (8.3%) with NMOSD and at least 6 months postpartum follow-up experienced a relapse postpartum. Duration of RTX/OCR and early retreatment but not detection of B-cells were possible predictors for postpartum relapses in patients with RRMS/NMOSD.

Conclusions: Although RTX/OCR might be an interesting option for women with RRMS/NMOSD who plan to become pregnant to control DA, more data on pregnancy outcomes and rare risks are needed.

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Figures

Figure
Figure. Flowchart of the pregnancies enrolled in the study
*ONID included in this cohort: 1 myasthenia gravis, 1 autoimmune myositis, 1 neurosarcoidosis, 1 MOG disease, 1 CRION, 2 NMDA-Ab encephalitis. CRION = chronic relapsing inflammatory optic neuropathy; DMSKW = German MS and pregnancy registry (Deutsches Multiple Sklerose und Kinderwunsch Register); DMT = disease-modifying therapy; GW = gestational week; mAb = monoclonal antibody; MOG = myelin oligodendrocyte glycoprotein; NEMOS = Neuromyelitis Optica Study Group; NMOSD = neuromyelitis optica spectrum disorder; ONID = other neuroimmunologic diseases; PPMS = primary progressive MS; RRMS = relapsing-remitting MS; SPMS = secondary progressive MS
See this image and copyright information in PMC

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