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. 2025 Jan;28(1):e70048.
doi: 10.1111/1756-185X.70048.

Pharmacovigilance Pregnancy Data in a Population of Japanese Patients With Chronic Inflammatory Disease Exposed to Certolizumab Pegol

Mikako Goto  1 , Shigeru Saito  2 , Angela E Scheuerle  3 , Shinya Yasuda  4 , Niamh Houston  5 , Thomas Kumke  6 , Bernard Lauwerys  7 , Atsuko Murashima  1
Affiliations

Pharmacovigilance Pregnancy Data in a Population of Japanese Patients With Chronic Inflammatory Disease Exposed to Certolizumab Pegol

Mikako Goto et al. Int J Rheum Dis. 2025 Jan.

Abstract

Aim: Uncontrolled chronic inflammatory diseases (CIDs) before, during, and after pregnancy, as well as some CID medications, can increase the risk of impaired fertility in addition to adverse maternal/pregnancy outcomes in women of childbearing age. We report pregnancy outcomes from prospectively reported pregnancies in Japanese women treated with certolizumab pegol (CZP).

Methods: Data from July 2001 to November 2020 on CZP-exposed pregnancies from the CZP Pharmacovigilance safety database were reviewed. Pregnancy outcomes analyzed included live birth, ectopic pregnancy, abortion (miscarriage or medically indicated/elective), and stillbirth. Congenital anomalies (major and minor), preterm delivery, and low birth weight were also examined.

Results: Among 149 prospective pregnancies with maternal CZP exposure and known outcomes identified in Japanese women, 111/149 (74.5%) involved at least first-trimester exposure and 53/149 (35.6%) were exposed in all trimesters; 135/149 (90.6%) live births, 12/149 (8.1%) abortions (11 miscarriages, one elective termination), 2/149 (1.3%) stillbirths, no ectopic pregnancies reported. One (0.7%) infant, whose mother had first-trimester exposure, manifested a minor congenital anomaly (accessory auricle). There were no major congenital anomalies. Among live births, 3/135 (2.2%) were preterm and 10/135 (7.4%) had low birth weight.

Conclusion: The safety profile of CZP in pregnant Japanese women was consistent with published global data.

Keywords: Certolizumab pegol; Japanese patients; TNFi; congenital anomalies; pregnancy outcomes.

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Conflict of interest statement

M.G.: None. S.S.: Received speaker fees from UCB and Astellas Pharma Inc. A.E.S.: Received consultancy fees from Antiretroviral Pregnancy Registry, Harmony Biosciences, IQVIA, PPD, Sanofi‐Genzyme, Syneos, UCB, and ViiV. S.Y.: Employee of UCB. N.H., T.K., and B.L.: Employees and shareholders of UCB. A.M.: Received research grants from Asahi Kasei Pharma Corporation and Chugai Pharmaceutical Co. Ltd. and speaking fees from Asahi Kasei Pharma Corporation, Astellas Pharma Inc., Chugai Pharmaceutical Co. Ltd., and UCB.

Figures

FIGURE 1
FIGURE 1
Reports of pregnancies with CZP exposure identified in the CZP Pharmacovigilance safety database. aThe higher number of outcomes compared with pregnancies in the global population is due to a number of non‐singleton births. 1. Clowse M, et al. Ther Adv Musculoskel Dis 2022;14:1–18. CZP: Certolizumab pegol.
FIGURE 2
FIGURE 2
Known pregnancy outcomes of prospectively reported pregnancies with maternal CZP exposure. Data are reported as % (n). aTerminations included elective abortions and there were no medically indicated abortions reported; bThere were no ectopic pregnancies reported in CZP‐exposed pregnancies in Japanese women. 1. Clowse M, et al. Ther Adv Musculoskel Dis 2022;14:1–18. CZP: Certolizumab pegol.
FIGURE 3
FIGURE 3
Graphical abstract. CID, Chronic inflammatory disease; CZP, Certolizumab pegol.
See this image and copyright information in PMC

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