Tocilizumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk and infant serum

Saito, Jumpei; Yakuwa, Naho; Kaneko, Kayoko; Takai, Chinatsu; Goto, Mikako; Nakajima, Ken; Yamatani, Akimasa; Murashima, Atsuko

doi:10.1093/rheumatology/kez100

Cited by 33 publications

(42 citation statements)

References 7 publications

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“…No teratogenic effects were observed. In a case series of 50 pregnancies exposed to tocilizumab with known outcomes, 36 resulted in live births, while there were five low-birthweight infants born and one case of neonatal asphyxia [57,58].…”

Section: Interleukin 6 and Interleukin 6 Receptor Inhibitorsmentioning

confidence: 99%

Current Therapeutic Options in the Treatment of Rheumatoid Arthritis

Köhler

Günther

Kaudewitz

et al. 2019

JCM

137

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Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation of the joints. Untreated RA leads to a destruction of joints through the erosion of cartilage and bone. The loss of physical function is the consequence. Early treatment is important to control disease activity and to prevent joint destruction. Nowadays, different classes of drugs with different modes of action are available to control the inflammation and to achieve remission. In this review, we want to discuss differences and similarities of these different drugs.

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Section: Interleukin 6 and Interleukin 6 Receptor Inhibitorsmentioning

confidence: 99%

Current Therapeutic Options in the Treatment of Rheumatoid Arthritis

Köhler

Günther

Kaudewitz

et al. 2019

JCM

137

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“…Three prospective studies evaluated the safety of tocilizumab (TCZ) during pregnancy and breastfeeding for a total of 7 pregnancies in women treated for RA and adult-onset Still disease. [25][26][27] In all 7 women, TCZ was either stopped during the first trimester or continued throughout pregnancy; all resulted in term delivery of healthy infants. Infant serum was collected at delivery in 1 pregnancy with a low, but detectable, TCZ concentration attributed to placental transfer.…”

Section: Tocilizumabmentioning

confidence: 99%

“…Infant serum was collected at delivery in 1 pregnancy with a low, but detectable, TCZ concentration attributed to placental transfer. 25 All 7 mothers breastfed their infants while receiving TCZ postpartum and provided serially sampled breastmilk between 11 hours and up to 34 days postinfusion. TCZ was present at low concentrations in all samples, with the highest reported concentration at 0.215 μg/mL 2.8 days postinfusion.…”

Section: Tocilizumabmentioning

confidence: 99%

“…TCZ was present at low concentrations in all samples, with the highest reported concentration at 0.215 μg/mL 2.8 days postinfusion. 25 Only 2 studies longitudinally followed 3 infants within a range of 6 to 13 months with normal development, routine vaccinations, and no severe infections noted. 25,26 In addition, a retrospective study evaluated TCZ treatment in 61 pregnancies in 53 mothers treated for chronic inflammatory conditions (RA, systematic idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and multicentric Castleman disease) 28 ; 2 mothers breastfed while receiving TCZ postpartum, but further details were not reported.…”

Section: Tocilizumabmentioning

confidence: 99%

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Transfer of monoclonal antibodies into breastmilk in neurologic and non-neurologic diseases

LaHue

Anderson

Krysko

et al. 2020

Neurol Neuroimmunol Neuroinflamm

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ObjectiveTo review currently available data on the transfer of monoclonal antibodies (mAbs) in the breastmilk of women receiving treatment for neurologic and non-neurologic diseases.MethodsWe systematically searched the medical literature for studies referring to 19 selected mAb therapies frequently used in neurologic conditions and “breastmilk,” “breast milk,” “breastfeeding,” or “lactation.” From an initial list of 288 unique references, 29 distinct full-text studies met the eligibility criteria. One additional study was added after the literature search based on expert knowledge of an additional article. These 30 studies were reviewed. These assessed the presence of our selected mAbs in human breastmilk in samples collected from a total of 155 individual women.ResultsDrug concentrations were typically low in breastmilk and tended to peak within 48 hours, although maximum levels could occur up to 14 days from infusion. Most studies did not evaluate the breastmilk to maternal serum drug concentration ratio, but in those evaluating this, the highest ratio was 1:20 for infliximab. Relative infant dose, a metric comparing the infant with maternal drug dose (<10% is generally considered safe), was evaluated for certolizumab (<1%), rituximab (<1%), and natalizumab (maximum of 5.3%; cumulative effects of monthly dosing are anticipated). Importantly, a total of 368 infants were followed for ≥6 months after exposure to breastmilk of mothers treated with mAbs; none experienced reported developmental delay or serious infections.ConclusionsThe current data are reassuring for low mAb drug transfer to breastmilk, but further studies are needed, including of longer-term effects on infant immunity and childhood development.

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“…Hoeltzenbein et al 54 and Saito et al demonstrated that no indication for a substantially increased malformation risk was observed with tocilizumab usage during pregnancy. 55,56 Monoclonal antibodies are actively transported across the placenta during the third trimester. They may affect immune response in the in utero exposed infant as the immunoglobulin (Ig)-G isotype's endogenous immunoglobulins are excreted into human milk.…”

Section: Drug-drug and Drug-disease Interactions In Females With Covimentioning

confidence: 99%

Consensus Scientific Statement on Advisory Working Guidelines and Recommendations for the Female Population in COVID-19 Era by WINCARS

Takkar

Jyotsna

Goyal

et al. 2020

Indian Journal of Cardiovascular Disease in Women WINCARS

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Tocilizumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk and infant serum

Cited by 33 publications

References 7 publications

Current Therapeutic Options in the Treatment of Rheumatoid Arthritis

Current Therapeutic Options in the Treatment of Rheumatoid Arthritis

Transfer of monoclonal antibodies into breastmilk in neurologic and non-neurologic diseases

Consensus Scientific Statement on Advisory Working Guidelines and Recommendations for the Female Population in COVID-19 Era by WINCARS

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