Related Experiment Video
Updated: Jan 16, 2026
05:13
Preclinical Model of Prenatal Delta-9-Tetrahydrocannabinol Exposure to Assess Its Impact on Neurodevelopmental Outcomes
Published on: February 28, 2025
613
Pregnancy Outcomes After Maternal or Paternal Exposure to Tofacitinib Across Clinical Programs
Uma Mahadevan1, María Chaparro2, Michelle Segovia3
1Colitis and Crohn's Disease Center, University of California San Francisco, San Francisco, California, USA.
The American Journal of Gastroenterology
|September 26, 2025
Summary
Pregnancy outcomes following tofacitinib exposure in patients with immune-mediated diseases were evaluated. Tofacitinib exposure during pregnancy did not show increased adverse outcomes compared to the general population.
Area of Science:
- Rheumatology
- Pharmacovigilance
- Reproductive Health
Background:
- This analysis reports updated pregnancy outcomes following tofacitinib exposure in patients diagnosed with immune-mediated diseases.
- Tofacitinib is a Janus kinase (JAK) inhibitor used to treat various autoimmune conditions.
Purpose of the Study:
- To evaluate pregnancy and neonatal outcomes in patients exposed to tofacitinib.
- To assess the safety profile of tofacitinib during pregnancy for both maternal and paternal exposure.
Main Methods:
- Pregnancy and partner pregnancy cases involving tofacitinib exposure were identified from interventional studies.
- Data were collected from the Pfizer safety database up to March 2023.
Main Results:
- A total of 184 pregnancies were reported, including 85 maternal and 99 paternal exposure events.
- Maternal exposure resulted in 46 healthy newborns, 12 medical terminations, 1 fetal death, 1 congenital malformation, 14 spontaneous abortions, and 11 pending outcomes.
- Paternal exposure resulted in 67 healthy newborns, 1 fetal death, 9 spontaneous abortions, and 22 pending outcomes.
Conclusions:
- Pregnancy outcomes following maternal or paternal tofacitinib exposure were comparable to those observed in the general population.
- Tofacitinib should be used with caution during pregnancy and only when clearly indicated.
Related Concept Videos
01:07Teratogenicity
4.0K
The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
4.0K
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
492
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
492
01:23Upper Respiratory Drugs: Antitussives, Expectorants, and Mucolytics
972
Respiratory symptoms, such as congestion and cough, commonly accompany respiratory tract conditions. Various medications, such as antitussives, expectorants, and mucolytics, play crucial roles in providing relief.
Antitussives include codeine, dextromethorphan (Robitussin), and benzonatate (Tessalon). Codeine and dextromethorphan exert their effects centrally by suppressing the cough reflex center in the medulla. Benzonatate operates peripherally within the respiratory tract by...
Antitussives include codeine, dextromethorphan (Robitussin), and benzonatate (Tessalon). Codeine and dextromethorphan exert their effects centrally by suppressing the cough reflex center in the medulla. Benzonatate operates peripherally within the respiratory tract by...
972
01:29Therapeutic Drug Monitoring: Affecting Factors
201
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
201
01:25Mutagenicity and Carcinogenicity
1.9K
Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
1.9K
01:16TGF - β Signaling Pathway
10.5K
The TGF-β signaling pathway regulates cell growth, differentiation, adhesion, motility, and development. TGF-β ligands that induce TGF-β signaling are synthesized in their latent form. Several proteases or cell surface receptors such as integrins act upon the latent form, releasing the active ligand. There are three types of mammalian TGF-βs: (TGF-β1, TGF-β2, and TGF-β3) that bind as homodimers or heterodimers to TGF-β receptors. The TGF-β receptors...
10.5K