B-cell-depleting, anti-CD20 monoclonal antibodies (mAbs) such as ocrelizumab may be safe when used before or during the first trimester of pregnancy and/or during lactation, a new study suggested. Anti-CD20 mAbs do not seem to have a depleting effect on the physiological B-cell development in exposed infants. Exposure in the second or third trimester can lead to B-cell depletion.
Data on the reduction of B cells in newborns after different exposure windows of anti-CD20 mAbs before or during pregnancy or breastfeeding are extremely scarce. As a result, anti-CD20 mAbs have a very conservative label regarding pregnancy, which is impractical in daily practice and increases the risk of disease progression in the mother.
Prospective data, presented by Dr Carolin Schwake (Ruhr-University Bochum, Germany), included results from 44 infants (22 girls and 22 boys) who were exposed to anti-CD20 mAbs before or during pregnancy and the lactation period, or only during lactation. B-cell counts and adverse effects of the 44 infants were analysed .
Results indicated that 41 infants were exposed before or during pregnancy (33 to ocrelizumab and 6 to rituximab) and during lactation (1 to rituximab and to 3 ocrelizumab). The average time interval between anti-CD20 mAbs exposure and the last menstrual period was 49.6 days if administered before pregnancy (n=33) and 44 days if administered during pregnancy (n=8). B-cell analysis of the newborns was done on average 19 days postpartum. Mean postnatal B-cell values were within the normal range (782.6 ± 440.7/µL; 15.9 ± 6.8%). In 2 cases, ocrelizumab exposure in the second and third trimesters of pregnancy resulted in complete B-cell depletion, but complete repopulation was seen after 2 months of follow-up. There were no congenital malformations or severe infections during the first year of life. In 3 cases, exposure was limited to lactation (1 ocrelizumab, 2 ofatumumab). This had no effect on the B-cell count of the infants (1,121.7 ± 50.5/µL).
Dr Schwake concluded that active attempts of conception can be planned shortly after infusion/injection of anti-CD20 mAbs. In the second or third trimester, these drugs can cross the placenta and result in B-cell depletion in the infant. During this period, exposure should therefore be monitored and live vaccines postponed.
- Schwake C. Effects of anti-CD20 therapies on infant health and physiological B-cell development if administered before or during pregnancy and/or lactation. Abstract O036, ECTRIMS 2022, Amsterdam, 26–28 October, the Netherlands.
Copyright ©2022 Medicom Medical Publishers
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Table of Contents: ECTRIMS 2022
Letter from the Editor
ECTRIMS 2022 Highlights Podcast
Diagnosis and Prediction of Disease Course
A case for including optic nerve lesions in the McDonald criteria
Cerebrospinal fluid kappa-free light chains for MS diagnosis
Early, non-disabling relapses increase disability accumulation
Physical impairment is present before perceived MS onset
Chronic active MS lesions respond poorly to anti-CD20 antibodies
Treatment: Trials & Strategies
Dimethyl fumarate reduces the risk of a first clinical event in RIS
How and when to make a timely switch to high-efficacy DMT
Comparing real-world effectiveness of DMTs
Study fails to show non-inferiority of rituximab to ocrelizumab
Autologous haematopoietic stem cell transplantation versus DMTs
Stem cell transplantation not superior to natalizumab in progressive MS
Efficacy of DMTs fades away in secondary progressive MS
Smartphone tapping can help detect progressive MS
Early treatment with DMT effective in paediatric-onset MS
Fingolimod in paediatric MS: results of up to 6 years
Switching treatment after initial platform injectable DMT: real-world data
Pregnancy and infant outcomes in women receiving ocrelizumab
New safety data of anti-CD20 mAbs around pregnancy
MS activity and pregnancy outcomes after long-term use of natalizumab
Ravulizumab significantly reduced relapses in AQP4+ NMOSD
NMOSD patients are cognitively impaired regardless of serostatus
Evidence-based consensus on pregnancy in NMOSD
COVID-19 and MS: lessons learned thus far
Ocrelizumab and fingolimod increase the risk of COVID-19 and of worse outcomes
Humoral and cellular immune responses after SARS-CoV-2 vaccination
Re-myelination strategies in MS still pose many unanswered questions
MS associated with a broader Epstein-Barr virus specific T-cell receptor repertoire
Cognitive rehab and mindfulness reduce cognitive complaints in MS
Age and EDSS are risk factors for severe COVID-19
“Expanded Disability Status Scale 0 is not normal”