ArticleInternational journal of rheumatic diseases2025
Pharmacovigilance Pregnancy Data in a Population of Japanese Patients With Chronic Inflammatory Disease Exposed to Certolizumab Pegol.
Article in International journal of rheumatic diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
aimUncontrolled 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).
methodsData 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.
resultsAmong 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.
conclusionThe safety profile of CZP in pregnant Japanese women was consistent with published global data.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.