https://orcid.org/0000-0002-8549-4999
Lay Summary
The infliximab biosimilar CT-P13 is used for the treatment of ulcerative colitis. We report for the first time the serum drug levels and long-term health status of the child of a patient treated with CT-P13 throughout her pregnancy.
Introduction
Pregnancy in patients with clinically active ulcerative colitis (UC) is associated with risks,1 and it is recommended for UC patients who conceive to continue their medication.2
Clinical studies of CT-P13, an infliximab (IFX) biosimilar, have excluded pregnant women; therefore the safety profile during pregnancy can only be extrapolated from that of IFX. We report a case where CT-P13 was maintained for a patient throughout her pregnancy, and describe for the first time the serum CT-P13 levels of the child born, as well as the lack of significant adverse events up to the age of five.
Case Report
A 27-year old female was diagnosed with left-sided ulcerative colitis at the age of 11. Her UC was well-controlled on intravenous IFX (5 mg/kg), which was changed to CT-P13 just 11 months prior to conception, as per policy of the hospital. While in remission, she conceived and opted to continue on CT-P13 during her pregnancy after joint decision-making with the IBD provider. Infusions of CT-P13 were given at 5 weeks’, 12 weeks’, and 31 weeks’ gestation. The third infusion was given later than scheduled due to hospitalization at 20 weeks’ gestation for threatened preterm labor. A healthy male infant weighing 3258 g was born at 39 weeks’ gestation by vaginal delivery with vacuum extraction. Apgar scores were 8 and 9. She chose to breast-feed the child while continuing on treatment with CT-P13. She was in clinical remission throughout her pregnancy.
With consent from the mother, drug levels were measured after birth in the mother and child, using a commercial assay (SHIKARI Q-INFLIXI, Matriks Biotek, Turkey).3 The ratio of cord blood to maternal drug concentration at birth was 2.74. The serum CT-P13 level of the infant was measured regularly (Figure 1), showing a marginally detectable drug level at week 40 which was undetectable by week 47. Apart from a mild bronchial asthma which is under control, the child has remained healthy throughout the first 5 years of life with no episodes of severe infection. The child received all the recommended routine immunizations, apart from the rotavirus vaccine. The Bacille Calmette-Guérin (BCG) vaccine was given at 1 year, after confirming that serum level of CT-P13 was undetectable.
Infliximab biosimilar levels in the mother and child over time from the time of birth. Results on the graph show the cord blood level for week 0 in the child, whereas serum levels are shown for the rest of the time points.
Discussion
It is known that IFX readily crosses the placenta in the third trimester of pregnancy and that the drug level stays detected in the infant’s serum up to 12 months after birth.4–6 Although our report is limited to a single case, our results were comparable with previous reports regarding IFX. Similar cautions should be exercised as with IFX regarding the timing of live vaccinations. Our case highlights the safety and importance of maintaining remission of UC throughout pregnancy by continuing therapy.
Abbreviations
Author Contributions
A.K.: study concept and design, interpretation of data, analysis of data, drafting of manuscript; T.F.: study concept and design, acquisition of data, drafting of manuscript; R.M.: acquisition of data, critical revision of the manuscript for important intellectual content; Y.S.: acquisition of data, critical revision of the manuscript for important intellectual content; T.Y.: acquisition of data, critical revision of the manuscript for important intellectual content; R.O.: study concept and design, critical revision of the manuscript for important intellectual content.
Funding
This study was supported with the measurement of CT-P13 by Nippon Kayaku Co. Ltd., who markets the drug. The authors have received no personal funding for this work.
Conflicts of Interest
The corresponding author confirms on behalf of all authors that there have been no involvements that might raise the question of bias in the work reported or in the conclusions, implications, or opinions stated.
Data Availability
The data underlying this article are available within the article.
