Evidence map›Paper›PMID 31719115›Full record

ArticleNeurology(R) neuroimmunology & neuroinflammation2020

Minimal breast milk transfer of rituximab, a monoclonal antibody used in neurological conditions.

Kristen M Krysko, Sara C LaHue, Annika Anderson, Alice Rutatangwa, William Rowles, Ryan D Schubert, Jacqueline Marcus, Claire S Riley, Carolyn Bevan, Thomas W Hale and 1 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Neurology(R) neuroimmunology & neuroinflammation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
7.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04387110 completednot on this map

Monoclonal Antibodies in Mothers' Milk and Infants: Ocrelizumab in Breastmilk

TypeobservationalSponsorUniversity of California, San FranciscoRan2020 to 2022Enrolled30ConditionsMultiple Sclerosis, Clinically Isolated SyndromeArmsOcrelizumab
NCT06085144 recruitingnot on this mapstarted 2024, after this paper: background citation

Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine

Typeobservational_patient_registrySponsorUniversity of California, San FranciscoRan2024 to 2028Enrolled30ConditionsMigraineArmsGalcanezumab
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Monoclonal insulin autoimmune syndrome in pregnancy and postpartum.Endocrinology, diabetes & metabolism case reports · 2026
    Article
  5. Article
  6. Review
  7. Article
  8. Safety of Drugs in Breastfeeding Women With CKD.Kidney international reports · 2025
    Article
  9. A literature review of drug transport mechanisms during lactation.CPT: pharmacometrics & systems pharmacology · 2024
    Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Safety of breast feeding during rituximab treatment in multiple sclerosis.Journal of neurology, neurosurgery, and psychiatry · 2022
    Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Kristen M KryskoFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.ORCID 0000-0003-0090-597X
Sara C LaHueFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.
Annika AndersonFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.
Alice RutatangwaFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.
William RowlesFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.
Ryan D SchubertFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.ORCID 0000-0002-3132-5831
Jacqueline MarcusFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.
Claire S RileyFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo. riley.bove@ucsf.edu.
Carolyn BevanFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.
Thomas W HaleFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo.
Riley BoveFrom the Department of Neurology (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), University of California, San Francisco; Weill Institute for Neurosciences (K.M.K., S.C.L., A.A., A.R., W.R., R.D.S., R.B.), Department of Neurology, University of California, San Francisco; Department of Neurology (J.M.), Kaiser Permanente, San Francisco; Department of Neurology (C.S.R.), Columbia University, New York, New York; Department of Neurology (C.B.), Northwestern University, Chicago, Illinois; and Department of Pediatrics (T.W.H.), Texas Tech University School of Medicine, Amarillo. riley.bove@ucsf.edu.
Northwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the transfer of rituximab, an anti-CD20 monoclonal antibody widely used for neurologic conditions, into mature breast milk.

methodsBreast milk samples were collected from 9 women with MS who received rituximab 500 or 1,000 mg intravenous once or twice while breastfeeding from November 2017 to April 2019. Serial breast milk samples were collected before infusion and at 8 hours, 24 hours, 7 days, and 18-21 days after rituximab infusion in 4 patients. Five additional patients provided 1-2 samples at various times after rituximab infusion.

resultsThe median average rituximab concentration in mature breast milk was low at 0.063 μg/mL (range 0.046-0.097) in the 4 patients with serial breast milk collection, with an estimated median absolute infant dose of 0.0094 mg/kg/d and a relative infant dose (RID) of 0.08% (range 0.06%-0.10%). Most patients had a maximum concentration at 1-7 days after infusion. The maximum concentration occurred in a woman with a single breast milk sample and was 0.29 μg/mL at 11 days postinfusion, which corresponds with an estimated RID of 0.33%. Rituximab concentration in milk was virtually undetectable by 90 days postinfusion.

conclusionsWe determined minimal transfer of rituximab into mature breast milk. The RID for rituximab was less than 0.4% and well below theoretically acceptable levels of less than 10%. Low oral bioavailability would probably also limit the absorption of rituximab by the newborn. In women with serious autoimmune neurologic conditions, monoclonal antibody therapy may afford an acceptable benefit to risk ratio, supporting both maternal treatment and breastfeeding.

Indexed as

Breast FeedingAdultFeasibility StudiesFemaleHumansImmunologic FactorsInfantMilk, HumanMultiple SclerosisProspective StudiesRituximabImmunologic FactorsRituximab

Identifiers

PMID31719115
PMCPMC6857908
OpenAlexW2988019951

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.