Rituximab, MS, and pregnancy

Smith, Jessica; Hellwig, Kerstin; Fink, Katharina; Lyell, Deirdre J.; Piehl, Fredrik; Langer‐Gould, Annette

doi:10.1212/nxi.0000000000000734

Cited by 67 publications

(68 citation statements)

References 38 publications

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“…Although the overall risk of PB was similar to other studies, 2,24 we found a higher risk for PB (45%) and lower birth weight when anti-CD20 mAb was given during pregnancy. This might be partially related to the underlying disease and/or concomitant autoimmune diseases, 25 especially in NMOSD, to the previous DMT exposure and/or other concomitant medication with steroids, and deserves further investigation.…”

Section: Discussionsupporting

confidence: 89%

“…14,15 Anti-CD20 mAbs could be an interesting option as in contrast to other drugs, no rebound has been reported so far. 2,16 Therefore, the objective of this cohort study was to investigate the safety of RTX/ocrelizumab (OCR) during the last 12 months before or during pregnancy in women with neuroimmunologic diseases and to assess DA in a subcohort of women with RRMS or NMOSDs.…”

mentioning

confidence: 99%

“…Only limited (<200) data on pregnancy outcomes after anti-CD20 monoclonal antibodies (mAbs) exposure—mainly focusing on rituximab (RTX)—in women with neuroimmunologic diseases have been published. 1 – 3 Because of the fear of potential fetal B-cell depletion, the label is conservative and recommends to discontinue anti-CD20 mAbs at least 6 (US Food and Drug Administration) to 12 months (European Medicine Agency) before planned conception.…”

mentioning

confidence: 99%

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Anti-CD20 therapies and pregnancy in neuroimmunologic disorders

Kümpfel

Thiel

Meinl

et al. 2021

Neurol Neuroimmunol Neuroinflamm

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ObjectiveTo 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.MethodsData 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).ResultsPregnancy 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.ConclusionsAlthough 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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Section: Discussionsupporting

confidence: 89%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Anti-CD20 therapies and pregnancy in neuroimmunologic disorders

Kümpfel

Thiel

Meinl

et al. 2021

Neurol Neuroimmunol Neuroinflamm

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“… 25 Thus, our study provides evidence and supports that RTX may be the preferred choice of therapy for women with MS considering pregnancy. A few studies provide further assurance, as they concluded that there have been no major safety concerns associated with RTX use during pregnancy 16 , 26 ; however, these were based on a small number of women, and future studies focused on safety, such as risk of malformation or stillbirth, should be conducted to confirm findings.…”

Section: Discussionmentioning

confidence: 99%

Disease activity in pregnancy and postpartum in women with MS who suspended rituximab and natalizumab

Razaz

Piehl

Frisell

et al. 2020

Neurol Neuroimmunol Neuroinflamm

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ObjectiveTo evaluate risks of disease reactivity during pregnancy and postpartum following rituximab (RTX) and natalizumab (NTZ) suspension in women with MS.MethodsAn observational cohort study of all women with MS disease onset before childbirth between 2006 and 2017. Women were identified through the Swedish MS Registry, a nationwide clinical register, with substratification into 3 groups: women who suspended RTX and NTZ within 6 months before conception and women who were not treated with any disease-modifying treatment (DMT) within 1 year of conception. The primary outcome was the annualized relapse rate (ARR) during pregnancy and 1 year postpartum.ResultsWe identified 2,386 women with MS onset before a live birth; of these, 76 women suspended RTX and 53 suspended NTZ, and 457 were untreated within 1 year before conception. In all women, regardless of the treatment type, the ARR declined from 0.05–0.04 prepregnancy to 0.03–0.02 during pregnancy, returning to prepregnancy rates at 3–6 months (0.05) postpartum. In the suspended cohort, 76% (98/129) of women resumed a DMT after delivery. The relapse rate 1 year postpartum was significantly higher in the suspended NTZ women compared with the suspended RTX women (adjusted rate ratio [aRR] 7.65, 95% CI 2.47–23.6) and was lower in the suspended RTX women compared with the untreated women (aRR 0.21, 95% CI 0.08–0.61).ConclusionDisease reactivity during the postpartum period was lower among women with MS who suspended RTX before pregnancy, relative to those who suspended NTZ and untreated women. These findings suggest that RTX may exert long-acting effects on MS disease activity that encompass pregnancy and postpartum periods.Classification of evidenceThis study provides Class IV evidence that in patients with MS who were on treatment before pregnancy, RTX reduces clinical disease activity compared with NTZ in the postpartum period.

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“…A study of 74 pregnancies in Kaiser Permanente patients with MS showed no increase in adverse perinatal outcomes over expected population rates. [ 14 ]. The largest dataset available comes from the rituximab global drug safety database maintained by Biogen Idec/Genentech/Roche [ 2 ].…”

Section: Discussionmentioning

confidence: 99%

Pregnancy outcomes following maternal treatment with rituximab prior to or during pregnancy: a case series

Perrotta

Kiernan

Bandoli

et al. 2021

Rheumatology Advances in Practice

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Objective Rituximab is a CD20-directed cytolytic antibody used for non-Hodgkin lymphoma, chronic lymphocytic leukaemia and RA, and off label for JIA, multiple sclerosis and lupus. Owing to concerns about infant B cell depletion, the manufacturer recommends avoidance of rituximab throughout pregnancy and for 12 months before conception. The aim of this study was to add to the limited data on pregnancy outcomes in women with exposure to rituximab. Methods Data were obtained from MotherToBaby Pregnancy Studies. Participants were enrolled prospectively into this observational study between 2007 and 2019. Pregnancy exposure and outcome data were collected from medical records, telephone interviews and dysmorphology examinations. The outcomes examined included spontaneous abortion, stillbirth, premature delivery, pregnancy complications, major and minor anomalies, small for gestational age, neonatal complications and serious infections. Results We classified 19 women with exposure to rituximab into three groups. Group A included three women who received rituximab during pregnancy. Group B included three women who received their last infusion before conception but had assumed pregnancy exposure owing to the long half-life of the drug. Group C included 13 women who used rituximab in the 2 years before pregnancy, with the last infusion given no sooner than five half-lives before conception. Three children had a major structural defect. Preterm delivery occurred in two pregnancies, and two infants were small for gestational age on birth weight. No cases of B cell depletion were reported. Conclusion No pattern of major structural anomalies or other adverse outcomes was reported in this case series.

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Rituximab, MS, and pregnancy

Cited by 67 publications

References 38 publications

Anti-CD20 therapies and pregnancy in neuroimmunologic disorders

Anti-CD20 therapies and pregnancy in neuroimmunologic disorders

Disease activity in pregnancy and postpartum in women with MS who suspended rituximab and natalizumab

Pregnancy outcomes following maternal treatment with rituximab prior to or during pregnancy: a case series

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