Modified neonatal B-cell repertoire as a consequence of rituximab administration to a pregnant woman

Martínez-Martínez, Marco Ulises; Baranda-Cándido, Lourdes; González‐Amaro, Roberto; Pérez-Ramírez, Oscar de Jesús; Abud-Mendoza, Carlos

doi:10.1093/rheumatology/kes164

Cited by 17 publications

(14 citation statements)

References 8 publications

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“…In this respect the London Position Statement of the World Congress of Gastroenterology on the Biological Therapy for IBD stated that vaccination of infants exposed to biological therapy in utero should be given according standard schedules, except for live-virus vaccines, which are not recommended if biological agents are detectable in the infant bloodstream (71). Table III summaries the reports of maternal exposure to rituximab either prior to or during pregnancy (16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34). Rituximab has various indications.…”

Section: Anti-tnfαmentioning

confidence: 99%

Are biological drugs safe in pregnancy?

et al. 2015

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The introduction of biological therapies has significantly improved the outcome of inflammatory rheumatic diseases. As most of these diseases affect women and men in childbearing age, some concerns have been voiced as to the safety of these drugs in relation to reproduction and pregnancy. Data from many hundreds of pregnancies in patients affected by inflammatory bowel disease and inflammatory arthritis have suggested that exposure to anti-TNF therapies at conception and/or during pregnancy is not associated with adverse pregnancy outcomes or any increase in congenital abnormalities. However, the exposure to anti-TNFα agents, particularly to monoclonal antibodies, in late pregnancy is associated with high drug levels in the newborn and their long-term effects on children remain unknown. Therefore, limiting the use of anti-TNFα to the first 30 weeks of pregnancy is recommended to reduce fetal exposure. Live-virus vaccines should be given only when levels of anti-TNFα drugs are undetectable in the serum of infants. Studies suggest that many of these drugs do enter breast milk in small amounts, but the extent to which the infant absorbs them is less clear. Limited reports have not suggested adverse pregnancy outcomes in women whose partners were exposed to anti-TNF therapies at the time of conception. Pregnancy data for rituximab, abatacept, anakinra, tocilizumab and belimumab are limited and their use in pregnancy cannot currently be recommended.

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Section: Anti-tnfαmentioning

confidence: 99%

Are biological drugs safe in pregnancy?

et al. 2015

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“…Being large proteinaceous molecules, these drugs are unlikely to survive the passage through the infant's gastrointestinal tract to achieve drug levels of any therapeutic significance (or to cause any adverse effects). Studies involving anti‐TNF agents in breast milk have been singularly reassuring (Table ) …”

Section: Commencing or Continuing Anti‐tnf Agents In Pregnancymentioning

confidence: 99%

“…Transient cytopenias lasting weeks to months; B‐cell depletion for up to 6 months in exposed neonates …”

Section: Commencing or Continuing Anti‐tnf Agents In Pregnancymentioning

confidence: 99%

Biologics in pregnancy – for the obstetrician

Soh

Mackillop

2016

The Obstetric & Gynaecologis

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Key content The authors discuss commencing biologics in pregnancy and the potential side effects. Infection is a particular risk, which may be atypical or present atypically. While there is no evidence of teratogenicity, these drugs cross the placenta and neonatal cord drug levels may exceed those of maternal drug levels. If possible, anti‐tumour necrosis factor (TNF) agents should be discontinued midtrimester but the gestation to which each drug can be used is slightly different. Neonates exposed in utero to anti‐TNF agents beyond the recommended gestation should not be given live attenuated vaccines for the first 6 months of life and any infections promptly treated. Data are lacking on the long‐term effects of biologics on children exposed in utero. However, the benefits of controlling active autoimmune disease in the mother often outweigh the small risk to the exposed infants. Learning objectives To know the biologics most commonly used in pregnancy. To understand the literature regarding safety of the common biologics in pregnancy. To be able to counsel a woman taking a biologic about the potential benefits and risks of taking it at different gestations. To be able to counsel a woman receiving biologics in pregnancy about vaccinations for her baby after birth. Ethical issues Biologic agents are relatively new drugs that are being increasingly used in young women because of their perceived ‘fertility sparing’ benefits despite a lack of high quality evidence. Most women who have been prescribed biologics are often refractory to other treatments, and therefore these agents are required for disease control. The decision to continue or discontinue these drugs in pregnancy, especially late pregnancy, is particularly contentious. The long‐term effect of biologics on infants exposed in utero is not known and the decision to use these drugs has to be balanced against the risk of severe maternal flares.

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“…Le taux de fausse couche spontanée dans cette série était de 21 %. Une lymphopénie B profonde peut cependant être observée chez le nouveau-né et nous ne disposons actuellement pas de données sur le devenir à long terme des enfants exposés au rituximab pendant la vie embryonnaire et foetale et notamment sur le risque d'hypogammaglobulinémie [25]. Ce médicament reste donc déconseillé pendant la grossesse, particulièrement au 3 e trimestre où il exposerait de manière plus importante le nouveau-né au risque de lymphopénie B prolongée ou d'hypogammaglobulinémie.…”

Section: Questions Encore Sans Réponsesunclassified