PMID- 37245349 OWN - NLM STAT- MEDLINE DCOM- 20230619 LR - 20230619 IS - 2211-0356 (Electronic) IS - 2211-0348 (Linking) VI - 75 DP - 2023 Jul TI - Safety evaluations of offspring breastfed by mothers receiving glatiramer acetate for relapsing multiple sclerosis. PG - 104771 LID - S2211-0348(23)00273-0 [pii] LID - 10.1016/j.msard.2023.104771 [doi] AB - BACKGROUND: Although the relapse risk is increased after birth in women with relapsing multiple sclerosis (RMS), only a very few disease-modifying therapies (DMTs) are approved during breastfeeding. Glatiramer acetate (GA, Copaxone(R)) is one of three DMTs that can be used in breastfeeding. The real-world safety of Copaxone(R) in Offsprings of Breastfeeding and treated RMS pAtients (COBRA) study demonstrated that offspring parameters (hospitalisations, antibiotic use, developmental delays, growth parameters) were similar between offspring breastfed by mothers taking GA or no DMT (control) during breastfeeding. COBRA data analyses were extended to provide further safety data on the impact of maternal GA treatment during breastfeeding on offspring. METHODS: COBRA was a non-interventional, retrospective study using German Multiple Sclerosis and Pregnancy Registry data. Participants had RMS, gave birth and had GA or no DMT during breastfeeding. Offspring total adverse events (AEs), non-serious AEs (NAEs) and serious AEs (SAEs) up to 18 months postpartum were assessed. Reasons for offspring hospitalisations and antibiotic treatments were explored. RESULTS: Baseline maternal demographics and disease characteristics were similar between cohorts. Each cohort had 60 offspring. Numbers of offspring AEs were comparable between cohorts; total AEs: 82 (GA) vs 83 (control); NAEs: 59 vs 61; SAEs: 23 vs 22. AEs in both cohorts were diverse with no specific patterns. Duration of GA-exposed breastfeeding was 6 to >574 days for offspring with any AE. For all-cause hospitalisations, 11 offspring had 12 hospitalisations (GA cohort) and 12 control offspring had 16 hospitalisations. Most common reason for hospitalisation was infection: 5/12 (41.7%; GA) vs 4/16 (25.0%, control). Two out of 12 (16.7%) hospitalisations due to infection occurred during GA-exposed breastfeeding; the others occurred 70, 192 and 257 days after discontinuation of GA-exposed breastfeeding. Median (range) duration of GA-exposed breastfeeding was 110 (56 to >/=285) days for offspring hospitalised for infections and 137 (88-396) days for those hospitalised for other reasons. Nine offspring had 13 antibiotic treatments (GA cohort) and nine control offspring had 10 treatments. Ten out of 13 (76.9%) antibiotic treatments occurred during GA-exposed breastfeeding, of which four were primarily due to double kidney with reflux. Other antibiotic treatments occurred 193, 229 and 257 days after discontinuation of GA-exposed breastfeeding. CONCLUSIONS: GA treatment of mothers with RMS during breastfeeding did not increase AEs, hospitalisations or antibiotic use in their offspring versus control offspring. These data support previous COBRA data that the benefit of maternal RMS treatment with GA during breastfeeding outweighs the potential, apparently low risk of untoward events, in their breastfed offspring. CI - Copyright (c) 2023 The Authors. Published by Elsevier B.V. All rights reserved. FAU - Ciplea, Andrea I AU - Ciplea AI AD - Department of Neurology, St Josef Hospital, Katholisches Klinikum Bochum gGmbH, Ruhr University Bochum, Bochum, Germany. FAU - Kurzeja, Anna AU - Kurzeja A AD - European Medical Affairs, Teva Pharmaceuticals Europe B.V., Amsterdam, the Netherlands. FAU - Thiel, Sandra AU - Thiel S AD - Department of Neurology, St Josef Hospital, Katholisches Klinikum Bochum gGmbH, Ruhr University Bochum, Bochum, Germany. FAU - Haben, Sabrina AU - Haben S AD - Department of Neurology, St Josef Hospital, Katholisches Klinikum Bochum gGmbH, Ruhr University Bochum, Bochum, Germany. FAU - Adamus, Evelyn AU - Adamus E AD - Department of Neurology, St Josef Hospital, Katholisches Klinikum Bochum gGmbH, Ruhr University Bochum, Bochum, Germany. FAU - Hellwig, Kerstin AU - Hellwig K AD - Department of Neurology, St Josef Hospital, Katholisches Klinikum Bochum gGmbH, Ruhr University Bochum, Bochum, Germany. Electronic address: kerstin.hellwig@rub.de. LA - eng PT - Journal Article DEP - 20230522 PL - Netherlands TA - Mult Scler Relat Disord JT - Multiple sclerosis and related disorders JID - 101580247 RN - 5M691HL4BO (Glatiramer Acetate) RN - 0 (Immunosuppressive Agents) SB - IM MH - Pregnancy MH - Humans MH - Female MH - Glatiramer Acetate/adverse effects MH - *Multiple Sclerosis/chemically induced MH - Breast Feeding MH - Immunosuppressive Agents/adverse effects MH - Retrospective Studies MH - *Multiple Sclerosis, Relapsing-Remitting/drug therapy/chemically induced MH - Mothers MH - Recurrence OTO - NOTNLM OT - Breastfeeding OT - Disease-modifying therapies OT - Glatiramer acetate OT - Offspring safety OT - Relapsing-remitting multiple sclerosis COIS- Declaration of Competing Interest Andrea I Ciplea has received speaker honoraria from Bayer HealthCare, Biogen GmbH, and Teva, as well as sponsorship for congress participation and travel grants from Teva. Anna Kurzeja is an employee of Teva Pharmaceuticals Europe B.V. Sandra Thiel has received speaker honoraria from Bayer HealthCare and Biogen GmbH, as well as payment for manuscript writing from HEXAL AG. Sabrina Haben has nothing to disclose. Evelyn Adamus has nothing to disclose. K Hellwig has received travel grants from Biogen, Novartis and Merck, and received speaker and research honoraria from Biogen Idec Germany, Teva, Sanofi Genzyme, Novartis, Bayer Health-Care, Merck Serono and Roche. EDAT- 2023/05/29 00:42 MHDA- 2023/06/19 13:09 CRDT- 2023/05/28 18:04 PHST- 2023/02/22 00:00 [received] PHST- 2023/05/05 00:00 [revised] PHST- 2023/05/21 00:00 [accepted] PHST- 2023/06/19 13:09 [medline] PHST- 2023/05/29 00:42 [pubmed] PHST- 2023/05/28 18:04 [entrez] AID - S2211-0348(23)00273-0 [pii] AID - 10.1016/j.msard.2023.104771 [doi] PST - ppublish SO - Mult Scler Relat Disord. 2023 Jul;75:104771. doi: 10.1016/j.msard.2023.104771. Epub 2023 May 22.