Anti-CD20 therapies and pregnancy in neuroimmunologic disorders

Kümpfel, Tania; Thiel, Sandra; Meinl, Ingrid; Ciplea, Andrea I.; Bayas, Antonios; Hoffmann, F.; Oy, Ulrich Hofstadt-van; Hoshi, Muna; Kluge, Jakob; Ringelstein, Marius; Aktaş, Orhan; Stoppe, Muriel; Walter, Annette O.; Weber, Martin; Ayzenberg, Ilya; Hellwig, Kerstin

doi:10.1212/nxi.0000000000000913

Cited by 59 publications

(61 citation statements)

References 37 publications

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“…These results suggest a prolonged protective effect on MS disease activity of rituximab, which can encompass pregnancy and postpartum period, without the high risk of disease reactivation or rebound described with natalizumab withdrawal before pregnancy (111). In line with these data, a German cohort study (112), analyzing 88 pregnancies from 81 women with neuroimmune diseases (including MS and NMOSDs) treated with anti-CD20 mAbs in the year before conception, showed a good control of disease activity during pregnancy and postpartum, with no major safety concerns (with the exception of two congenital abnormalities reported in women exposed to ocrelizumab during pregnancy) and with pregnancy outcomes within the range expected for the general population. An interesting case series about 11 pregnancies in 10 women (7 with MS and 3 with NMOSDs) treated with rituximab within 6 months of conception, seems to confirm these safety and efficacy findings: indeed, all completed pregnancies resulted in term live births of healthy newborns, no maternal relapses occurred before/during pregnancy and only one was observed in the post-partum (113).…”

Section: Special Populationsupporting

confidence: 69%

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?

et al. 2021

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Despite the availability of a lot of effective disease-modifying drugs, multiple sclerosis (MS) (in particular the progressive forms) still represents an important unmet medical need, because of issues in terms of effectiveness, duration of response, safety, and patient compliance. An increasing body of evidence from randomized clinical trials and real-world data suggest that rituximab is a highly effective alternative in both relapsing and progressive MS, with a low discontinuation rate, related to a good benefit/risk profile, and a good compliance. To date, the use of rituximab in patients with multiple sclerosis is not in accordance with the authorized product information (off-label use). However, the use of this medicine is widespread in several countries, and in some cases, it is the most commonly used disease-modifying drug for MS subtypes. This use could be officially recognized by national regulatory authorities, according to specific procedures, to ensure equal access for patients to a safe and effective option.

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Section: Special Populationsupporting

confidence: 69%

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?

et al. 2021

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“…In addition, it was demonstrated that a treatment with ocrelizumab or rituximab prior to conception might be an interesting option for women with RRMS or NMOSD for controlling disease activity during pregnancy and postpartum. 35 …”

Section: Resultsmentioning

confidence: 99%

“…Since then, data acquisition was improved and adapted and women with neuromyelitis optica spectrum disorders (NMOSD) 35 were included, as well as questionnaires to measure the Expanded Disability Status Scale (EDSS) 36 and developmental delays. 37 The follow-up period was also extended to up to 6 years for live births and up to 6 months for miscarriages.…”

Section: Introductionmentioning

confidence: 99%

The German Multiple Sclerosis and Pregnancy Registry: rationale, objective, design, and first results

Thiel

Ciplea

Gold

et al. 2021

Ther Adv Neurol Disord

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Objectives: Multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD) predominantly affect women of reproductive age. During the last few decades many disease-modifying therapies (DMTs) have been approved. It is therefore important to provide epidemiological structures for the collection of safety information on exposed pregnancies. Data on disease activity after withdrawal of DMTs are in high demand especially as severe relapses have been described after ceasing highly effective DMTs. Although breastfeeding is recommended, it is still unclear if the early reintroduction, especially of highly effective DMTs, has a beneficial effect on postpartum relapse risk or a combination of both, however safety data are lacking. Methods: The German MS and Pregnancy Registry (DMSKW) is a nationwide, observational, cohort study of pregnant women with MS or NMOSD, founded in 2006. As the study procedure has undergone important adaptation in recent years, described here is the updated methodology including data source and acquisition as well as variables collected within the DMSKW. Results: As of December 2020, the DMSKW database comprises 2579 pregnancies, 2568 with MS and 11 with NMOSD. Women are enrolled at a median gestational week of 11 (range: 0.02–42.1), have a median postpartum follow up of 1.2 years (range: 0–9.2) with 76% of all pregnancies being exposed to a DMT, mostly in the first trimester. Spontaneous abortion and preterm birth occurred in 7% and 10%, respectively; 19% of all women suffered from at least one relapse during pregnancy, with a minimum of 6% during the third trimester of pregnancy. Conclusion: The DMSKW is a valuable structure in providing safety data on drug exposure during pregnancy and lactation in combination with information on disease activity up to 6 years postpartum. This article will be the reference for describing the methods of future publications from the DMSKW.

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“…Herein, it was shown that PRA could be prevented without rituximab reinfusion during pregnancy in women with NMOSD treated with rituximab before pregnancy. To date, pregnancy outcomes in 16 patients with NMOSD treated with rituximab before pregnancy have been reported [31‐35]. Because the biological effect of B cell depletion can be maintained several months after elimination of the drug [36], rituximab can offer unique advantages preparing for pregnancy.…”

Section: Discussionmentioning

confidence: 99%

Outcome of pregnancies after onset of the neuromyelitis optica spectrum disorder

Kim

Huh

Jang

et al. 2020

Euro J of Neurology

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Background and purpose Data on the pregnancy outcome of neuromyelitis optica spectrum disorder (NMOSD) remain limited, especially for woman who had received immunosuppressive treatment before becoming pregnant. The aim was to evaluate the outcome of pregnancy amongst patients with NMOSD who attempted to become pregnant after NMOSD onset and to identify risk factors that predict pregnancy‐related attack. Methods Medical records from 29 patients who attempted to become pregnant after NMOSD onset were retrospectively evaluated and the patients were interviewed for pregnancy outcomes. Pregnancy‐related attack was defined as an attack that occurred during pregnancy or within 1 year of delivery. Results Amongst the 29 patients, 26 had 33 pregnancies after NMOSD symptom onset. The 33 pregnancies after NMOSD onset resulted in 24 live births (healthy neonates except one with low birth weight), six miscarriages and three elective abortions. Pregnancy‐related attack occurred in nine (75%) of 12 pregnancies before initiation of immunosuppressive therapy, but in only five (24%) of 21 pregnancies after initiation of immunosuppressive therapy (P = 0.009). Multivariable analysis indicated that pregnancy‐related attack was negatively associated with pregnancy after initiation of rituximab (odds ratio 0.048, 95% confidence interval 0.004–0.546). Conclusion Successful pregnancy without maternal and neonatal complications may be feasible in patients with NMOSD. Rituximab treatment before pregnancy might help to prevent pregnancy‐related attack in patients with NMOSD.

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Anti-CD20 therapies and pregnancy in neuroimmunologic disorders

Cited by 59 publications

References 37 publications

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?

The German Multiple Sclerosis and Pregnancy Registry: rationale, objective, design, and first results

Outcome of pregnancies after onset of the neuromyelitis optica spectrum disorder

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