SUMMARY

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Please refer to the local labeling for additional information on TREMFYA and pregnancy.
• Pregnancy outcomes from cases of maternal exposure to TREMFYA from the Janssen Global Safety Database were summarized through July 12, 2025.¹
• In moderate to severe plaque psoriasis (PsO), data from 24 pregnant women exposed to TREMFYA in the clinical development program as well as pregnancy outcomes of women enrolled in the Psoriasis Longitudinal Assessment Registry (PSOLAR) and a World Health Organization (WHO) pharmacovigilance study, are also summarized below.^2-5
• The Organization of Teratology Information Specialists (OTIS) is a non-profit professional scientific organization comprised of experts in the field of assessing and evaluating risks to pregnancy and breastfeeding outcomes from medications and other exposures. OTIS and its information service, MotherToBaby, provide evidence-based information to parents, health professionals, and the general public. Currently, MotherToBaby is enrolling pregnant women in a registry-based study examining the use of TREMFYA to treat PsO or psoriatic arthritis during pregnancy. North American (United States and Canada) patients should be encouraged to enroll by visiting https://mothertobaby.org/ongoing-study/tremfya-guselkumab or by calling 1-877-311-8972.^6,7

BACKGROUND

• In TREMFYA clinical studies, pregnant females and females who intend to become pregnant were excluded from participation.³
• Patients who enrolled in TREMFYA clinical studies were instructed to use highly effective methods of contraception during the study period.³
• If patients became pregnant, TREMFYA was discontinued.³

Pooled Analysis Across All Approved Indications

Mahadevan et al (2026)¹ reported pregnancy outcomes from cases of maternal exposure to TREMFYA from the Janssen Global Safety Database through July 12, 2025.

Results

• Overall, 1126 pregnancy outcomes (including known or unknown or ongoing pregnancies outcomes, twins [n=2], triplets [n=1], and women with 2 pregnancies [n=4]) from 1118 maternal TREMFYA exposure cases were reported.
• The analysis reviews the 400 pregnancy events with known outcomes (396 cases). Of these, 120 pregnancy outcomes were reported prospectively, and 280 were reported retrospectively.
  • Maternal age: mean, 32 years
  • The therapeutic indications for TREMFYA exposure during pregnancy were: psoriatic disease, n=289 (73.0%); other/not reported, n=79 (19.9%); Crohn’s disease, n=15 (3.8%); ulcerative colitis, n=10 (2.5%); and healthy subjects, n=3 (0.8%).
• Maternal exposure (N=400) to TREMFYA occurred during the following periods:
  • Before conception (≤3 months prior to confirmed pregnancy): n=43 (10.8%)
  • During the first trimester: n=140 (35.0%)
  • After the first trimester only: n=2 (0.5%)
  • Throughout pregnancy: n=18 (4.5%)
  • Not reported: n=197 (49.2%)
  • ≤3 months before conception: n=43 (10.8%)
• Rates of live births, spontaneous abortions, elective terminations, and congenital anomalies in women exposed to TREMFYA were comparable with those in the general population. See Table: Rates of Pregnancy Outcomes for TREMFYA-Treated Patients Compared to the General US Population.

• Pregnancy outcomes also included:
  • Elective termination with fetal defects: n=1 (0.25%)
  • Ectopic pregnancy: n=10 (2.5%)
  • Stillbirth without fetal defects: n=4 (1.0%)
  • Unspecified abortion with fetal defects: n=1 (0.25%).
• For pregnancy outcomes, see Table: Pregnancy Outcomes for Prospective and Retrospective Cases by Reported Timing of Maternal Exposure to TREMFYA.
  

Clinical Data in moderate to severe plaque psoriasis

Pharmacovigilance Study

Jeong et al (2025)² utilized the World Health Organization (WHO) global pharmacovigilance database to assess the risk of pregnancy-related adverse outcomes with biologics used for PsO (including a comparison between TREMFYA and tumor necrosis factor [TNF]-α inhibitors).

Study Design/Methods

• A case-noncase disproportionality analysis was performed to evaluate associations between adverse maternal, fetal, and neonatal outcomes and systemic PsO treatments vs TNFα inhibitors and certolizumab pegol in pregnant individuals, using global reports from 1968-2024 across Africa, the Americas, Southeast Asia, Europe, the Eastern Mediterranean, and the Western Pacific.
• Systemic PsO treatments assessed included TNFα inhibitors (etanercept; infliximab; adalimumab; certolizumab pegol), the interleukin [IL]-12/23 inhibitor ustekinumab, IL17 inhibitors (secukinumab; brodalumab; ixekizumab; bimekizumab), and IL23 inhibitors (TREMFYA; tildrakizumab; risankizumab).
• The analysis used data from VigiBase, a global pharmacovigilance database maintained by the Uppsala Monitoring Centre.
• Pregnancy-related reactions were classified using Medical Dictionary for Regulatory Activities (MedDRA) categories, including system organ classes (pregnancy, puerperium, and perinatal conditions), high-level group terms (HLGTs; fetal/neonatal investigations; neonatal/perinatal conditions; neonatal respiratory disorders), and high-level terms (HLTs; exposures associated with pregnancy/delivery/lactation; fetal or obstetric therapeutic procedures; induced abortions).

Results

• A total of 6518 reports of pregnancy-related adverse outcomes associated with the biologics of interest were extracted. Among these, 214 pregnancies were exposed to TREMFYA, with 18 reports including pregnancyrelated adverse outcomes.
• A total of 26,257 pregnancies were exposed to TNFα inhibitors (etanercept, n=3809; infliximab, n=5875; adalimumab, n=10,641; certolizumab pegol, n=5932). Pregnancyrelated adverse outcomes were reported for etanercept (n=634), infliximab (n=619), adalimumab (n=1337), and certolizumab pegol (n=469).
• For reporting odds ratios (RORs) of adverse maternal, fetal, and neonatal outcomes with TREMFYA vs TNFα inhibitors, see Table: RORs of Adverse Maternal, Fetal, and Newborn Outcomes with Exposure to TREMFYA vs TNF-α inhibitors.

TREMFYA Clinical Development Program

Kimball et al (2020)³ reported the pregnancy outcomes of women exposed to TREMFYA in the clinical development program.

Study Design/Methods

• Pregnancy cases reported from female participants (maternal pregnancy) across all indications in the clinical development program for TREMFYA with suspected exposure during any time of pregnancy or within 3 months prior to conceptions were reviewed.
• The dataset included unblinded medically confirmed individual patient cases within the Global Medical Safety global safety database through 12 July 2019.

Results

• A total of 24 maternal pregnancies were reported (Table: Characteristics of Cases Reporting Maternal Pregnancy for TREMFYA-Treated Patients in the Clinical Development Program).
  • Suspected exposure to TREMFYA occurred during the first trimester in all pregnancies.

• A summary of pregnancy outcomes is noted in Table: Pregnancy Outcomes for TREMFYA-Treated Patients Across All Indications in the Clinical Trials and Real-World Development Program.

• The mean age of the female participants with the 7 live birth cases was 32.3 years. The mean±standard deviation (SD) gestational age was 40.1±0.8 weeks (n=7), the mean±SD 5-minute APGAR was 9.7±0.6 (n=3), and the mean±SD birth weight was 7.8±1.0 pounds (n=5). No congenital anomalies were reported in the 7 live birth cases.
• Among the 2 spontaneous abortion cases, 1 case involved a 38-year-old female who had a history of 2 elective/induced abortions, and no risk factors were reported in the other case (26-year-old female). Both women participated in a clinical study of TREMFYA as healthy patients.
• The ages of the female participants with elective/induced abortion were 26 and 38 years old.
• One case reporting abortion missed, (unspecified) concerned a 31-year-old female with a medical history of 1 other spontaneous abortion. No other risk factors were reported.

PSOLAR Registry Study

Kimball et al (2020, 2021)^4,5 reported pregnancy outcomes of women with moderate to severe PsO enrolled in the PSOLAR study.

Study Design/Methods

• PSOLAR is a multicenter, disease-based, observational study evaluating long-term safety and clinical outcomes of patients receiving (or eligible to receive) treatment for PsO with biologics and/or conventional systemic agents.
• All pregnancy data for this registry study were considered based on exposure to ustekinumab, infliximab (not including biosimilars) or golimumab/golimumab intravenous (IV), other biologic (eg, predominantly etanercept and adalimumab but could also include secukinumab, risankizumab, alefacept, efalizumab, tildrakizumab, brodalumab, and ixekizumab) within, or outside of, the prenatal period. TREMFYA was handled in a separate PSOLAR protocol amendment and therefore was either categorized as an other biologic or other sponsor biologic depending on the analysis
  • Within the prenatal period: exposure to agent within 1 year prior to birth or within 6 months prior to spontaneous abortion
  • Outside the prenatal period: exposure to agent at any other time outside the above parameters

Results

• As of August 2019, 5456 of 12,090 (45.1%) patients enrolled in PSOLAR were female.⁵
• A total of 2224 women (12,929 patient-years of follow-up) were of childbearing age (18-45 years).
• In PSOLAR, the general fertility rate was 18.9/1000 annually in women 18-45 years of age.
• Available data for 298 pregnancies in 220 patients (median duration of enrollment, 7.2 [range, 3.3-8.0] years per patient) were summarized: 159 patients with 1 pregnancy, 48 patients with 2 pregnancies, 10 patients with 3 pregnancies, and 3 patients with 4 or 5 pregnancies.
• Clinical characteristics of the pregnancy cohort and the females of childbearing age cohort are noted in Table: Demographic and Clinical Characteristics in the Pregnancy Cohort and in All Women of Childbearing Age in PSOLAR.

• Of 298 pregnancies, there were 244 births (81.9%; including 1 stillbirth), 41 (13.8%) spontaneous abortions, and 13 (4.4%) elective terminations.⁵
  • No elective terminations were known to derive from a congenital anomaly or other medical issue.
• Most live births (90.9%; 221/243) were full term and 9.1% (22/243) were premature.
• Among the live births, 2 congenital anomalies were reported; both occurred in women who had received ustekinumab during the prenatal period.
  • One premature newborn (gestational age of 36 weeks) with a posterior cleft palate required hospitalization for 16 days. The infant also had a left coronal craniosynostosis. The mother of the infant received her last dose of ustekinumab
    26 days before birth.
  • A full-term newborn was born with nonketotic hyperglycinemia requiring tube feeding, ventilation, and hospitalization for 3 weeks. The mother of the infant realized she was pregnant approximately 10 months after starting ustekinumab therapy; treatment was discontinued at that time and gave birth more than 7 months later.
• A total of 10 infants had neonatal adverse events (3 respiratory issues [2 related to prematurity and 1 to aspiration pneumonia], 2 preterm deliveries related to pre-eclampsia, and 1 each of the following: ABO blood type mismatch, low birth weight due to early delivery [1 of 2 infants in a twin birth], opioid withdrawal, hyperemesis, and hypoglycemia).
• A total of 252 pregnancies occurred in women who were exposed to biologic therapy before or during pregnancy, 168 of which had exposure during the prenatal period.
• A total of 46 pregnancies occurred in women who were never exposed to biologic therapy but may have received another systemic therapy or phototherapy before or during pregnancy.
• The pregnancy outcomes are detailed in Table: Pregnancy Outcomes by Maternal Age Group and Pregnancy Outcomes by Time of Exposure to Biologics and Non-biologics through August 2018 and Pregnancy Outcomes by Time of Exposure to Biologic and Nonbiologic Therapies through August 2019.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 20 January 2026.