ArticleDrug safety2016
Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis.
Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 8 of them syntheses that pooled it.
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
62 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- 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
- EULAR points to consider for the management of difficult-to-treat rheumatoid arthritis.Annals of the rheumatic diseases · 2022Guideline
- Pooled it
- Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement.Annals of the rheumatic diseases · 2021Guideline
- Pooled it
- The effect of paternal exposure to immunosuppressive drugs on sexual function, reproductive hormones, fertility, pregnancy and offspring outcomes: a systematic review.Human reproduction update · 2020Pooled it
- Diagnostic and therapeutic guidelines for plaque psoriasis - Brazilian Society of Dermatology.Anais brasileiros de dermatologia · 2019Guideline
- Tofacitinib exposure across 2 pregnancies in alopecia universalis: Case report and literature review of Janus kinase inhibitors in pregnancy.JAAD case reports · 2026Article
- Management of Pregnancy in Women with Inflammatory Bowel Disease: Positioning Janus Kinase Inhibitors Within Current Evidence.Current issues in molecular biology · 2026Review
- Updated review of Janus kinase inhibitors for the management of inflammatory bowel disease.World journal of gastrointestinal pharmacology and therapeutics · 2026Review
- Inconsistent medication recommendations for immune-mediated inflammatory diseases across pregnancy, lactation, and paternal preconception: a guideline-based review.Frontiers in pharmacology · 2026Review
- A clinical care pathway for managing pregnancy in patients with inflammatory arthritis.Clinical rheumatology · 2026Review
- Janus Kinase Inhibitors During Pregnancy and Adverse Drug Reactions: A Pharmacovigilance Disproportionality Analysis in VigiBase.Clinical and translational science · 2025Article
- Palmoplantar Pustulosis during Pregnancy Was Successfully Treated with Tofacitinib: A Case Report.Skin appendage disorders · 2025Article
- Pregnancy Outcomes of Targeted Synthetic Disease-Modifying Antirheumatic Drugs Among Patients With Autoimmune Diseases: A Scoping Review.Arthritis care & research · 2025Article
- Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports.Drug safety · 2024Article
- [Janus kinase inhibitors for skin disorders].Dermatologie (Heidelberg, Germany) · 2024Article
- Risk Assessment and Optimization for Pregnancy in Patients with Rheumatic Diseases.Diagnostics (Basel, Switzerland) · 2024Review
- Tofacitinib as a Rescue Therapy for Ulcerative Colitis in Pregnancy.Inflammatory bowel diseases · 2024Article
2 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), and is being investigated for the treatment of psoriasis. Both conditions can present in women of child-bearing potential, but pregnancy was an exclusion and discontinuation criterion in tofacitinib randomized controlled trials (RCTs) because of the unknown effects of tofacitinib on mother and child. Tofacitinib is a small molecule that has the potential to cross the placenta.
objectiveThe objective was to report outcomes of pregnancy cases identified through April 2014 from tofacitinib RA/psoriasis RCTs, RA post-approval non-interventional studies, and spontaneous adverse-event reporting.
methodsPregnancy outcomes were categorized as follows: healthy newborn, medical termination, fetal death, congenital malformation, spontaneous abortion, or pending/lost to follow-up.
resultsOut of 9815 patients, 1821 female patients of child-bearing age were enrolled in the RA/psoriasis RCTs; 47 women became pregnant, including 33 who received tofacitinib monotherapy, 13 who received combination therapy with methotrexate (RA patients only), and one patient whose therapy was still blinded. No fetal deaths were reported. One congenital pulmonary valve stenosis (monotherapy, n = 1), seven spontaneous abortions (monotherapy, n = 4; combination therapy, n = 3), and eight medical terminations (monotherapy, n = 4; combination therapy, n = 3; blinded therapy, n = 1) were identified. Remaining cases reported healthy newborns (n = 25) or were pending/lost to follow-up (n = 6). Forty-four cases of paternal exposure to tofacitinib were reported (monotherapy, n = 43; combination therapy, n = 1), including five spontaneous abortions (monotherapy, n = 4; combination therapy, n = 1), 23 healthy newborns, and 16 pending/lost to follow-up.
conclusionsThe pregnancy outcomes reported in this small number of RA/psoriasis patients appear similar to those observed in the general population and in patients treated with biologic therapies for inflammatory diseases. However, definitive conclusions cannot be drawn, and pregnancy outcomes in patients receiving tofacitinib will continue to be monitored.
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