Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development

Matro, Rebecca; Martin, Christopher F.; Wolf, Douglas C.; Shah, Samir A.; M, Uma

doi:10.1053/j.gastro.2018.05.040

Cited by 130 publications

(110 citation statements)

References 29 publications

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“…We conditionally recommend treatment with azathioprine/6‐mercaptopurine, calcineurin inhibitors, NSAIDs and the non–TNF inhibitor biologic agents (anakinra, rituximab, belimumab, abatacept, tocilizumab, secukinumab, and ustekinumab) as compatible with breastfeeding ( ).…”

Section: Results/recommendationsmentioning

confidence: 99%

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

Sammaritano

Bermas

Chakravarty

et al. 2020

Arthritis & Rheumatology

456

520

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Objective To develop an evidence‐based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancy assessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD). Methods We conducted a systematic review of evidence relating to contraception, ART, fertility preservation, HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process to determine final recommendations and grade their strength (conditional or strong). Good practice statements were agreed upon when indirect evidence was sufficiently compelling that a formal vote was unnecessary. Results This American College of Rheumatology guideline provides 12 ungraded good practice statements and 131 graded recommendations for reproductive health care in RMD patients. These recommendations are intended to guide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti‐Ro/SSA and/or anti‐La/SSB antibodies. Recommendations and good practice statements support several guiding principles: use of safe and effective contraception to prevent unplanned pregnancy, pre‐pregnancy counseling to encourage conception during periods of disease quiescence and while receiving pregnancy‐compatible medications, and ongoing physician‐patient discussion with obstetrics/gynecology collaboration for all reproductive health issues, given the overall low level of available evidence that relates specifically to RMD. Conclusion This guideline provides evidence‐based recommendations developed and reviewed by panels of experts and RMD patients. Many recommendations are conditional, reflecting a lack of data or low‐level data. We intend that this guideline be used to inform a shared decision‐making process between patients and their physicians on issues related to reproductive health that incorporates patients’ values, preferences, and comorbidities.

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Section: Results/recommendationsmentioning

confidence: 99%

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

Sammaritano

Bermas

Chakravarty

et al. 2020

Arthritis & Rheumatology

456

520

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“…We detected very low levels of NTZ in breast milk similar to previous reports. 3,4,20 A tool to assess the safety of a certain drug exposure via breast milk is the RID. 13 It is calculated by dividing the absolute infant dose (concentration in breast milk multiplied by daily milk intake [150 mL/kg]) by the maternal dose.…”

Section: Discussionmentioning

confidence: 99%

Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder

Ciplea

Langer‐Gould

Vries

et al. 2020

Neurol Neuroimmunol Neuroinflamm

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ObjectiveTo assess possible adverse effects on breastfed infants of mothers receiving monoclonal antibodies (MAbs) during pregnancy and/or lactation.MethodsWe identified 23 patients from the German Multiple Sclerosis and Pregnancy Registry (DMSKW) who received MAbs (17 natalizumab and 6 anti-CD20) during lactation. Thirteen were already exposed to natalizumab during the third trimester of pregnancy, and 1 received ocrelizumab during pregnancy. Data were obtained from standardized, telephone-administered questionnaires completed by the mother during pregnancy and at 1, 3, 6, and 12 months postpartum. Natalizumab concentration in mother’s milk was analyzed in 3 patients and natalizumab serum concentration in 2 of these patients and their breastfed infants.ResultsWe did not observe a negative impact on infant health and development attributable to breast milk exposure after a median follow-up of 1 year. Infants exposed to natalizumab during the third trimester had a lower birth weight and more hospitalizations in the first year of life. The concentration of natalizumab in breast milk and serum of infants was low; B cells normal in infants breastfed under anti-CD20.ConclusionMore data on the effect of Mab exposure during pregnancy are needed. Otherwise, our data suggest that treatment with natalizumab, ocrelizumab, or rituximab during lactation might be safe for breastfed infants.

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“…While further studies are needed on the impact of uncontrolled inflammation on milk concentrations, and on the intraluminal activity of the small quantities ingested by the infant, at this time, there is no indication of harm from breastfeeding on biologic therapies. 110 3. The practice of "pumping and dumping" is neither necessary nor likely to be effective for most IBD drugs and should be discouraged.…”

Section: Inflammatory Bowel Disease Medication Safety In Lactationmentioning

confidence: 99%

Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group

Robinson²,

et al. 2019

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Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development

Cited by 130 publications

References 29 publications

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder

Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group

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