Placental Transfer of Canakinumab in a Patient with Muckle-Wells Syndrome

Egawa, Makiko; Imai, Kohsuke; Mori, Masaaki; Matsuda, Naoyuki

doi:10.1007/s10875-017-0389-3

Cited by 19 publications

(12 citation statements)

References 8 publications

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“…In rodents, passive immunity of the neonate via protective IgG is delivered via the placenta as well as through breast milk. However, the situation in humans is clearly in favour of the transplacental pathway [ 7 , 12 ], as shown by therapeutic serum levels of IgG monoclonal antibodies such as canakinumab, infliximab or adalimumab in neonates after in-utero exposure during late gestation [ 13 – 15 ]. Fetal exposure can be reduced by avoiding the biologic drug during the third trimester, or even beyond gestational week 20, as in our patient with MWS.…”

Section: Discussionmentioning

confidence: 99%

Rituximab and Canakinumab Use During Lactation: No Detectable Serum Levels in Breastfed Infants

et al. 2021

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Introduction: In breastfeeding patients with chronic inflammatory rheumatic diseases, a postpartum flare may require the use of biologics. However, data on the safety of biologics during lactation are scarce, potentially impeding the decision-making process. Case series: We report two cases of women in whom treatment with a monoclonal IgG antibody (rituximab or canakinumab) was indicated during the lactation period. In both cases, breastfeeding was continued, and drug levels in the mother's serum, in serial breast milk samples and in the infant's serum were measured. Both rituximab and canakinumab showed minimal drug concentrations in breast milk and no detectable levels in the infants' sera. Conclusion:The lack of detectable levels of rituximab and canakinumab in the sera of breastfed infants reflects the poor oral bioavailability of these biologics and helps to promote their use in breastfeeding patients.

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Section: Discussionmentioning

confidence: 99%

Rituximab and Canakinumab Use During Lactation: No Detectable Serum Levels in Breastfed Infants

et al. 2021

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“…The data for Canakinumab are even more sparse. One case report measured its transplacental transfer and found a cord blood to maternal blood ratio of 2.11 [ 78 ] which needs to be further studied.…”

Section: Discussionmentioning

confidence: 99%

“…In the exposed pregnancies included in this review, the indications for treatment were CAPS (34.1%), Familial Mediterranean Fever (FMF-33%), and AOSD/SJIA (20.4%). There is only one report, to our knowledge, of CAPS during pregnancy treated with medication other than those targeting the IL-1 system [ 78 ]. This study reported a rate of miscarriage of 30% as compared to 10% for CAPS-patients treated with Anakinra [ 78 ].…”

Section: Discussionmentioning

confidence: 99%

A Systematic Review of the Safety of Blocking the IL-1 System in Human Pregnancy

Brien

Gaudreault

Hughes

et al. 2021

JCM

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Blockade of the interleukin-1 (IL-1) pathway has been used therapeutically in several inflammatory diseases including arthritis and cryopyrin-associated periodic syndrome (CAPS). These conditions frequently affect women of childbearing age and continued usage of IL-1 specific treatments throughout pregnancy has been reported. IL-1 is involved in pregnancy complications and its blockade could have therapeutic potential. We systematically reviewed all reported cases of IL-1 blockade in human pregnancy to assess safety and perinatal outcomes. We searched several databases to find reports of specific blockade of the IL-1 pathway at any stage of pregnancy, excluding broad spectrum or non-specific anti-inflammatory intervention. Our literature search generated 2439 references of which 22 studies included, following extensive review. From these, 88 different pregnancies were assessed. Most (64.8%) resulted in healthy term deliveries without any obstetrical/neonatal complications. Including pregnancy exposed to Anakinra or Canakinumab, 12 (15.0%) resulted in preterm birth and one stillbirth occurred. Regarding neonatal complications, 2 cases of renal agenesis (2.5%) were observed, and 6 infants were diagnosed with CAPS (7.5%). In conclusion, this systematic review describes that IL-1 blockade during pregnancy is not associated with increased adverse perinatal outcomes, considering that treated women all presented an inflammatory disease associated with elevated risk of pregnancy complications.

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“…Only a retrospective cohort study (Youngstein et al, 2017) and a case report (Egawa et al, 2017) provided data on the use of canakinumab during pregnancy (Table 2); in total, data were available for nine pregnancies; of these, eight completed pregnancies resulted in the normal development of the fetus; only 1 miscarriage in Cogan Syndrome patient was found.…”

Section: Data On the Use Of Anti-il1 Drugs During Pregnancymentioning

confidence: 99%

Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review

et al. 2021

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The published experience with biologics in childbearing age with autoimmune and inflammatory diseases mainly deals with the use of TNFα inhibitors (TNFα-i). Limited data are available for biologics targeting other cytokines or immunocompetent cells, especially for the inflammasome targeted therapy including IL-1 inhibitors and colchicine. We conducted a nested case-control study by using the US Food and Drug Administration Adverse Event Reporting System database aimed at quantifying the association between the use of IL-1 inhibitors/colchicine in pregnant women and the occurrence of maternal/fetal adverse effects. The reporting odds ratio was used as a measure of disproportional reporting. From the total cohort (40,033 pregnant women), we retrieved 7,620 reports related to neonatal AEs, 2,889 to fetal disorders, 8,364 to abortion, 8,787 to congenital disorders, and 7,937 to labor/delivery complications. Inflammasome-targeted drugs did not present any disproportionate reporting for all these clusters of AEs. TNFα-i confirmed their safety during pregnancy with aROR < 1 for all clusters of AEs except for labor complications. Finally, we performed a systematic review of the current literature. Data from the eligible studies (12 observational studies and 6 case reports; yielding a total of 2,075 patients) were reassuring. We found no major safety issues on malformations risk of inflammasome targeted therapies in pregnancy. However, due to limited data, the routine use of these agents should be considered in pregnancy only if risk benefit assessment justifies the potential risk to the fetus.

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Placental Transfer of Canakinumab in a Patient with Muckle-Wells Syndrome

Cited by 19 publications

References 8 publications

Rituximab and Canakinumab Use During Lactation: No Detectable Serum Levels in Breastfed Infants

Rituximab and Canakinumab Use During Lactation: No Detectable Serum Levels in Breastfed Infants

A Systematic Review of the Safety of Blocking the IL-1 System in Human Pregnancy

Inflammasome Targeted Therapy in Pregnancy: New Insights From an Analysis of Real-World Data From the FAERS Database and a Systematic Review

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