ArticleArthritis & rheumatology (Hoboken, N.J.)2018
Pregnancy Outcomes After Exposure to Certolizumab Pegol: Updated Results From a Pharmacovigilance Safety Database.
Article in Arthritis & rheumatology (Hoboken, N.J.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04569890 (Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China), which is not on this map. Cited by 78 papers, 5 of them syntheses that pooled it.
What it found
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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.
Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China
Who cites it
78 citing papers in PubMed, 5 syntheses or guidelines pooled it, 177 citations in OpenAlex.
- Australasian hidradenitis suppurativa management guidelines.The Australasian journal of dermatology · 2025Guideline
- British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.Rheumatology (Oxford, England) · 2023Guideline
- Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: A systematic review and meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2022Pooled it
- Adverse Pregnancy Outcomes Following Exposure to Biologics in Women With Crohn's Disease: A Systematic Review and Meta-Analysis.Frontiers in medicine · 2021Pooled it
- Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review.Drugs · 2020Pooled it
- Certolizumab pegol to prevent adverse pregnancy outcomes in patients with antiphospholipid syndrome and lupus anticoagulant (IMPACT): results of a prospective, single-arm, open-label, phase 2 trial.Annals of the rheumatic diseases · 2025Trial
- Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial.Journal of the European Academy of Dermatology and Venereology : JEADV · 2021Trial
- Hidradenitis Suppurativa from Preconception to Lactation: Clinical Treatment Decision-Making Review.Dermatology and therapy · 2026Review
- The Role of Complement and CD4 T Cells in Preeclampsia and Offspring Neurodevelopment.Current opinion in physiology · 2026Article
- Pharmacokinetics of Certolizumab Pegol in Pregnancy: Results from the Open-Label CHERISH Study.Rheumatology and therapy · 2026Article
- Phenotype- and phase-directed immune interpretation in recurrent implantation failure and pregnancy loss: an integrative framework.Frontiers in reproductive health · 2026Review
- Immune profiling-informed immunomodulation associated with gestational extension in early-onset preeclampsia with monochorionic twins: a case report.Frontiers in immunology · 2026Article
- A real-world pharmacovigilance study of Certolizumab pegol based on FAERS database.Scientific reports · 2025Article
- Hidradenitis Suppurativa Treatment During Pregnancy and Lactation: Navigating Challenges.International journal of dermatology · 2025Review
- Progress in APS pregnancy: Results from the IMPACT trial.Seminars in arthritis and rheumatism · 2025Article
- A Guide to the Management of Hidradenitis Suppurativa in Pregnancy and Lactation.American journal of clinical dermatology · 2025Review
- Communication and Therapy Planning for Patients of Reproductive Age Under Immunomodulatory Treatments for Psoriasis or Psoriatic Arthritis-Survey of the German National Psoriasis Registry PsoBest.Healthcare (Basel, Switzerland) · 2025Article
- Management of psoriasis in women 18 to 45 years of age in Australia and Japan: insights from patient and dermatologist surveys.International journal of women's dermatology · 2025Article
- Certolizumab pegol in severe hidradenitis suppurativa in pregnancy: A case report.SAGE open medical case reports · 2025Article
- Biologics Use for Psoriasis during Pregnancy and Its Related Adverse Outcomes in Pregnant Women and Newborns: Findings from WHO Pharmacovigilance Study.International archives of allergy and immunology · 2025Article
18 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 8 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveAnti-tumor necrosis factor (anti-TNF) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti-TNF agents are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF agent approved for the treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This analysis was undertaken to evaluate pregnancy outcomes in women receiving CZP, especially those exposed during early pregnancy.
methodsProspective and retrospective data on maternal CZP exposure were extracted from the UCB Pharma safety database through March 6, 2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. The numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained.
resultsOf 1,137 prospectively reported pregnancies with maternal exposure to CZP, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred in 367 (81.2%) of 452 pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred in 201 (44.5%) of 452 pregnancies.
conclusionThis analysis represents the largest cohort of pregnant women exposed to an anti-TNF agent for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP.
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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.