SUMMARY

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding the use of STELARA during pregnancy.
• Pregnancy outcome data in women exposed to STELARA are summarized below from clinical trials, prospective cohort studies, retrospective cohort studies, registries, and spontaneous reports, with a studied population of ≥100 in patients with psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), or ulcerative colitis (UC).^1-9

CLINICAL DATA - PsO, PsA, Inflammatory Bowel Disease

Mahadevan et al (2022)¹ described confirmed pregnancy cases and outcomes in patients within the Janssen Global Medical Safety database who received STELARA for the treatment of PsO, PsA, CD, or UC.

Study Design/Methods

• The dataset included individual patient cases within the Janssen safety database through August 2020.
• Pregnancies had maternal exposure to STELARA confirmed by a health care professional and reported outcomes in approved indications (PsO, PsA, CD, or UC) any time during confirmed pregnancy or within 3 months prior to confirmed pregnancy.
• The analysis focused on prospective reported pregnancies and did not include outcomes in neonates exposed via lactation.

Results

• A total of 681 cases of maternal exposure (408 prospective) to STELARA during pregnancy or within 3 months prior to pregnancy were identified:
  • The average maternal age was 31 years.
  • Sources for reported pregnancies were: noninterventional clinical studies (57.6%), spontaneous reports (32.2%), and interventional clinical trials (10.3%).
  • Reporting regions included Europe (47.7%), North America (41.4%), Asia & Pacific (7.8%), Middle East (1.8%), and South America (1.3%).
• Of the 681 cases, STELARA was used for an approved indication in 621 cases (382 prospective): PsO (55.2%), CD (31.4%), UC (2.4%), and PsA (1.6%). Summary of pregnancy outcomes for STELARA-treated patients for all approved indications is noted in Table: Summary of Pregnancy Outcomes in Patients Exposed to STELARA for Approved Indications (All and Prospective Cases).
• Use of concomitant nonbiologic medications for PsO, PsA, CD, and UC (8.2%) and analgesics (28.9%) were also reported among pregnant women.

• Among all cases of patients exposed to STELARA treatment, the rates of live birth, live birth with major congenital anomaly, elective/induced abortion, and spontaneous abortion were 71.7%, 2.5%, 8.1%, and 18.4% compared with 62.9%, 3.0%, 19.4%, and 17.9% in the general population, respectively.
• For the 408 prospective pregnancies, 420 pregnancy outcomes were reported. Summary of prospective pregnancy outcomes in women exposed to STELARA by disease indication is noted in Table: Summary of Pregnancy Outcomes in Women Exposed to STELARA, by Disease Indication, Prospective Cases With Known Outcomes (N=420).

• Across all indications, similar rates of live births were observed in women receiving STELARA 45 mg or STELARA 90 mg. Summary of pregnancy outcomes by dose across all indications is noted in Table: Summary of Pregnancy Outcomes in Women Exposed to STELARA, by Dose, Prospective Cases With Known Outcomes.

• Of the 420 prospectively reported pregnancies, 91.2% (383/420) were exposed to STELARA at least during trimester 1 of pregnancy (ie, during trimester 1, trimester 1-2, or trimester 1-3) regardless of indications.
• A total of 69 women with prospective reported pregnancies were exposed to STELARA through pregnancy, of which 1 resulted in a spontaneous abortion, 59 resulted in live births without congenital anomaly, and 9 resulted in live birth with congenital anomaly.
• Major congenital anomaly was reported in 17 pregnancies (18 pregnancy outcomes), all of which were reported following exposure to STELARA during the first trimester. Heart-related defects were the most prevalent major congenital anomalies, including:
  • Atrial septal defects (27.8%; 5/18)
  • Fenestrated atrial septum (5.6%; 1/18)
  • Septal defect interatrial (5.6%; 1/18)
  • Ventricular septal defects (22.2%; 4/18)

Gorodensky et al (2021)² conducted a retrospective cohort study to compare the risk of serious infections in offspring exposed to STELARA, vedolizumab (VDZ), anti-tumor necrosis factor (TNF) agents, and immunosuppressives compared to offspring unexposed to these agents during pregnancy among women with PsO, PsA, and/or inflammatory bowel disease (IBD) from January 2011 to December 2018.

Study Design/Methods

• Data was collected using the United States (US) MarketScan database (employment insurance database); drug exposure was defined as ≥1 filled prescription or infusion procedure code during pregnancy.
• Serious infections were evaluated in offspring within the first year of life using any single inpatient infection code.

Results

• Included in this analysis were 16,115 offspring born to 7612 women with PsO/PsA, 8315 women with IBD, and 188 women with PsO/PsA and IBD.
• Among 52 offspring exposed to STELARA, 3.8% reported serious infections (95% confidence interval [CI], 0.4-13.9).
• The risk for serious infections in offspring exposed to STELARA compared to offspring unexposed to any drug is reported below:
  • STELARA: odds ratio (OR) 1.6, 0.4-6.8

CLINICAL DATA - PsO, PsA or cD

Mahadevan et al (2018)³ described pregnancy outcomes in women exposed to STELARA from solicited reports, spontaneous reports, clinical trials/registries, and literature sources in patients with PsO, PsA, or CD.

Study Design/Methods

• The study reported pregnancies during maternal use of STELARA from the company safety database through June 30, 2017, including prospective cases (pregnancy outcome not known when first reported) and retrospective cases (pregnancy outcome known when first reported).
  • Maternal use of STELARA was either during pregnancy or within 2 months prior to conception and with a known pregnancy outcome.

Results

• A total of 206 maternal pregnancies were eligible to be analyzed (130 prospective, 76 retrospective), which included 164 patients with PsO, 36 patients with CD, and 6 patients with PsA, including an average maternal age of 30.3 years.
• Of these reported cases, 43.2% were from solicited reports, 27.1% from spontaneous reports, 23.3% from clinical trials/registries, and 6.3% from literature sources.
• The pregnancy outcomes are detailed in Table: Pregnancy Outcomes for Cases Reporting Maternal Exposure to STELARA With Known Outcomes Cumulatively Through June 30, 2017.
• Of the 9 pregnancies with reported congenital anomalies, 7 pregnancies were from spontaneous reports and 2 pregnancies were from registries. Also, of these cases, a single case may report more than 1 congenital anomaly or birth defect which included: ankyloglossia congenital, aortic stenosis, atrial septal defect, atrioventricular septal defect, cardiac hemangioma benign, cleft palate, congenital absence of cranial vault, congenital absence of 1 kidney, congenital cyst, craniosynostosis, Fallot's tetralogy, multiple hemangioma, right aortic arch, trisomy 21, vascular malformation, ventricular septal defect.
• The spontaneous abortions reported were associated with older maternal age (mean age: 33.2 years).

CLINICAL DATA - PsO

Kimball et al (2021)⁴ reported pregnancy outcomes of women with moderate to severe PsO enrolled in the Psoriasis Longitudinal Assessment Registry (PSOLAR).

Study Design/Methods

• PSOLAR is a multicenter, disease-based, observational registry evaluating long-term safety and clinical outcomes for patients receiving or eligible to receive treatment for PsO with biologics and/or conventional systemic therapies.
• Pregnancy data were considered based on exposure to STELARA, infliximab or golimumab, other biologics, or nonbiologics within the prenatal period (ie, ≤1 year before birth or ≤6 months before spontaneous abortion) or outside the prenatal period (ie, exposure at any other time).

Results

• As of August 23, 2019, 5456 of 12,090 (45.1%) patients enrolled in PSOLAR were female.
• 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.
• Of 298 pregnancies, there were 244 births (81.9%; including 1 stillbirth), 41 (13.8%) spontaneous abortions, and 13 (4.4%) elective terminations.
• 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 STELARA 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 STELARA
    26 days before birth.^4,10
  • 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 STELARA therapy; she discontinued treatment at that time and gave birth more than 7 months later.^4,10
• 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, and 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.
• Pregnancy outcomes are shown in Table: Pregnancy Outcomes by Time of Exposure to STELARA.

CLINICAL DATA – IBD

Post hoc Analysis

Abraham et al (2022)⁵ reported pregnancy outcomes from IBD clinical trials including data from 5 and 2 years of treatment in CD and UC, respectively.

Study Design/Methods

• Reported pregnancies with maternal STELARA exposure (typical STELARA terminal half-life: ~3 weeks) were analyzed from data in 4 CD and 1 UC clinical trials:
  • CD¹¹:
    • Phase 2 clinical trial: CERTIFI (n=526)
    • Phase 3 clinical trial: UNITI-1 (n=769)
    • Phase 3 clinical trial: UNITI-2 (n=640)
    • Phase 3 clinical trial: IM-UNITI maintenance: (n=1281)
  • UC¹¹:
    • Phase 3 clinical trial: UNIFI induction (n=961)
    • Phase 3 clinical trial: UNIFI maintenance (n=783)

Results

• Of 1289 women in the 2020 IBD dataset who received ≥1 dose of STELARA, 39 maternal pregnancies (28 and 11 pregnancies in patients with CD and UC, respectively) with outcomes were reported. In all cases, STELARA treatment was discontinued upon the report of pregnancy.
• The median duration of STELARA therapy prior to pregnancy was 63.7 weeks and the median maternal age was 28 years (range, 18-42).
• Of the 39 reported pregnancies, there were 26 (66.7%) live births without congenital abnormalities (normal newborns; NNs¹¹), 8 (20.5%) spontaneous abortions, and 5 (12.8%) elective abortions. All spontaneous abortions occurred within the first trimester. There were no congenital anomalies or stillbirths reported in the IBD pregnancy cohort.
• Pregnancy outcomes in STELARA-treated patients were compared to the US general population in Table: Pregnancy Outcomes Among Patients With Crohn’s Disease or Ulcerative Colitis Treated With STELARA vs the US General Population.

• Among patients with NNs, there was 1 report of a single episode of transient hypoglycemia that was treated with an oral supplement.¹¹
• Overall, in patients with IBD, the median gestational age (>37 weeks is full term) in NNs was 38.4 (range, 33.1-40.1) weeks (n=22), the median 1 minute-APGAR (score range, 0-10) was 9.0 (range, 8.0-10.0) (n=12), the median 5 minute-APGAR was 10.0 (range, 8.0-10.0) (n=12), and the median birthweight (<5 pounds is underweight) was 7.1 (range, 5.3-9.2) (n=23).
• For NNs characteristics by disease state, see Table: APGAR Scores and Characteristics of Normal Newborns in Crohn’s Disease and Ulcerative Colitis.

• For neonatal outcomes along with baseline characteristics, in the STELARA-treated CD and UC pregnancy cohort, see Table: Neonatal Outcomes in the STELARA-treated Crohn’s Disease and Ulcerative Colitis Pregnancy Cohort.

• Baseline Crohn’s Disease Activity Index (CDAI) scores and partial Mayo scores were similar for patients with NN, elective abortions, spontaneous abortions and were representative of patients with moderate to severe CD and UC.
  • In patients with CD, the median CDAI score at the visit prior to pregnancy was 88.5 (n=28; range, -11 to 321, clinical remission defined as CDAI <150).
  • In patients with UC, the median partial Mayo score at the visit prior to pregnancy was 1.0 (n=11; range, 1-4, clinical remission defined as partial Mayo score 0 or 1).

Prospective Cohort Studies

Avni-Biron et al (2022)⁶ conducted a multicenter, prospective cohort study in Israel to assess maternal, pregnancy, and neonatal outcomes in patients with IBD treated with STELARA.

Study Design/Methods

• Women with IBD who received STELARA during conception and pregnancy between 2019-2021 were included in the analysis.
• Outcomes were compared to 2 control groups: patients receiving anti-TNF treatment and patients receiving conventional treatment (including non-STELARA/non-anti-TNF treatment [thiopurines or mesalazine] or no treatment).
• STLELARA-treated patients were matched to controls in a 1:2 ratio due to insufficient women meeting the predetermined set of matching criteria, based on age, body mass index, and number of prior pregnancies.
• Newborns were followed up for 12 months.

Results

• Included in this analysis were 129 pregnant women who received:
  • STELARA (n=27)
  • Anti-TNF treatment (n=52)
  • Conventional treatment (n=50)
• Of these, 96.9% of women had CD.
• Patients who received STELARA had a median disease duration of 11 years (IQR, 8.00-15.00).
• Disease activity at conception was reported in 16 (59.3%) patients receiving STELARA.
• The median duration of treatment prior to conception among patients who received STELARA was 12 months (IQR, 5.75-18.25).
• Of the 27 patients receiving STELARA, 92.5% (25/27) continued treatment throughout the third trimester.
  • One patient with active disease at conception decided to stop STELARA during the first trimester. At 17 gestational weeks, this patient had a spontaneous abortion.
  • One patient who was in clinical remission stopped STELARA treatment during the second trimester. No exacerbation occurred during the remainder of the pregnancy.
• Compared to the control groups, STELARA-treated patients had significantly higher rate of active disease during the first and third trimester (P=0.001 and P=0.008, respectively).
• Maternal outcomes and neonatal outcomes were comparable between treatment groups as noted in Table: Pregnancy and Neonatal Outcomes by Treatment Cohort.

• Two spontaneous abortions occurred in the STELARA-treated group during the first and second trimester. Both patients had active disease at conception and during pregnancy.
• Maternal complications were reported in 3 patients (2 abortions, 1 premature contractions). These patients were hospitalized for an obstetrical cause.
• Ten patients were reported to have cesarean delivery, and of these, half were due to perianal CD.
• In the STELARA-treated group, 3 neonatal complications were observed: 1 preterm birth, 1 low birth weight, and 1 congenital anomaly (Hirschsprung's disease).
• Two infants were hospitalized from the STELARA-treated group due to Rotavirus infection and respiratory infection.

Mitrova et al (2022)⁷ conducted a prospective, multicenter, observational study which reported maternal, neonatal, and infant safety outcomes of STELARA and VDZ use during pregnancy.

Study Design/Methods

• The study included women with CD or UC who received STELARA or VDZ within 2 months prior to conception or during pregnancy between January 2017 to December 2021 in 15 centers of Czech Republic.
• The control group consisted of pregnant patients with CD or UC exposed to anti-TNF treatment. Outcomes were retrospectively collected at 2 centers in the Czech Republic from 2013-2017 and 2017-2021.
• The treating physician completed 2 questionnaires related to maternal and postnatal outcomes in children ≥6 months of age.

Results

• Of 183 pregnancies, 54 pregnancies were exposed to STELARA, 39 pregnancies to VDZ, and 90 pregnancies to anti-TNF. For baseline characteristics of the studied population, see Table: Select Baseline Patient Demographic and Clinical Characteristics at Time of Conception and During Pregnancy.

• In pregnancies exposed to STELARA, there were 43 (79.9%) live births and 11 (20.4%) led to spontaneous abortions.
• The last administration of STELARA during pregnancy was at median gestational week 33 (range, 18-38).
• Patients continuing treatment through the third trimester included 37 (86%) patients exposed to STELARA. No disease flare-up was observed in either treatment after discontinuation.
• For maternal outcomes with STELARA and anti-TNF treatments, see Table: Maternal Pregnancy-related Complications With STELARA and Anti-TNF Treatments.

• Perinatal complications in:
  • Newborns exposed to STELARA (n=2, 4.7%) included icterus with phototherapy and congenital toxoplasmosis
• Congenital malformation complications in:
  • Newborns exposed to STELARA (n=3, 7.0%) included asymmetric dilatation of brain ventricles, hydrocoele, and Currarino syndrome
• Postnatal infant outcomes (≥6 months after birth) were observed in 20 infants exposed to STELARA were compared to 49 infants in the control group.
  • There was infant allergy and atopy development in the STELARA group (n=3, 15.0%) and the control group (n=10, 20.4%).
  • Abnormal psychomotor development was not observed in any treatment group.
• Postnatal infection infant outcomes (≥12 months after birth) measured for infants aged ≤1 years old were observed in infants exposed to STELARA (n/N=3/17, 17.6%) and the control group (n/N=5/41, 12.2%).

Registries

Meyer et al (2025)⁸ evaluated the safety of STELARA and VDZ with that of anti-TNF agents during pregnancy in patients with IBD from the EPI-MERES Registry.

Study Design/Methods

• EPI-MERES is a French nationwide study that includes all pregnancies that have ended in France since January 1, 2010.
• The dataset included all pregnancies among women with IBD aged 15 to 49 years.
• The study included pregnancies that ended between January 1, 2014, and December 31, 2021, in patients with IBD who were exposed to STELARA, VDZ, or anti-TNF agents (infliximab, adalimumab, or golimumab) during pregnancy.
• Patients were excluded if they had exposure to both STELARA and VDZ or had received methotrexate or tofacitinib.
• Exposure during pregnancy was considered overall and during the following periods:
  • During the first trimester only
  • During the first and second trimesters only
  • During first, second, and third trimesters
• The study assessed the following outcomes:
  • Maternal adverse pregnancy outcomes (spontaneous abortion and elective/medical abortion), congenital abnormalities, serious infections, and malignancies in offspring.
  • Among pregnancies resulting in birth (live or stillbirth), adverse outcomes included the following: scheduled cesarean section, unplanned or emergency cesarean section, stillbirth, preterm birth, very preterm birth, low birth weight, and large birth weight.
  • A serious infection in offspring was defined as a primary diagnosis of an infection requiring hospitalization.

Results

• Of 8207 pregnancies, 464 were exposed to STELARA; these were matched with 1856 pregnancies exposed to anti-TNF agents after propensity score matching.
• Among 299 pregnancies with birth exposed to STELARA, 97.7% were exposed during the first trimester, 72.9% during the second trimester, and 40.8% during the third trimester.
• Among the 2062 pregnancies not ending in births, 165 were exposed to STELARA.

Outcomes After Exposure to STELARA and Anti-TNF Agents

• The median age at pregnancy onset was 30 years (interquartile range [IQR], 26-33), and 92% of patients were diagnosed with CD for a median of 8.6 years (IQR, 5.4-12.3). For details, see Table: Select Maternal, IBD, and Pregnancy Characteristics According to Drug Exposure During Pregnancy in Propensity-Matched Groups.

• Exposure to STELARA when compared to anti-TNF agents was not associated with the risk of abortion, either spontaneous (adjusted hazard ratio [aHR], 0.88; 95% CI, 0.54-1.42) or elective/medical (aHR, 1.07; 95% CI, 0.87-1.31).
• Among pregnancies ending in births, those exposed to STELARA had an increased risk of small-for-gestational-age birth (aHR, 1.45; 95% CI, 1.03-2.06) but not of cesarean section, stillbirth, and preterm birth as compared with pregnancies exposed to anti-TNF agents; see Table: Pregnancy Outcomes According to Drug Exposure During Pregnancy Among Pregnancies With Birth.

• Among live births, 291 vs 1142 children were exposed in utero to STELARA vs anti-TNF agents.
• The risk of serious infections was similar between children exposed to STELARA and anti-TNF agents.
  • First year of life: aHR, 1.01; 95% CI, 0.69-1.48; with no association between drug exposure and any site or type of serious infection
  • Second to fifth year of life: aHR, 0.96; 95% CI, 0.40-2.30
• Among children exposed to STELARA during the first trimester, 5 cases of congenital abnormalities were reported as follows:
  • Hydrocephaly, n=1
  • Atrial septal defect, n=1
  • Tetralogy of Fallot, n=1
  • Hydronephrosis, n=1
  • Polydactyly, n=1
• During the first trimester, exposure to STELARA was not associated with an increased rate of congenital abnormalities when compared with exposure to anti-TNF agents (adjusted risk ratio, 1.73; 95% CI, 0.60-4.93).

Chugh et al (2024)⁹ assessed maternal and fetal outcomes of STELARA and VDZ exposed pregnancies in patients with IBD from the Pregnancy Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) registry.

Study Design/Methods

• The PIANO registry is a multicenter, prospective, observational study which included pregnant women with singleton pregnancies and a diagnosis of IBD.
• The observed treatment groups included STELARA, VDZ, anti-TNFs, immunomodulators, and combination with anti-TNFs and immunomodulators. All treatment groups were compared to no exposure to biologics/immunomodulators.
• Questionnaires were administered to patients at study intake, each subsequent trimester, delivery, and at 4, 9, and 12 months after birth.
• Infections were categorized as serious infections (requiring hospitalization) or nonserious infections (any reported infection without hospitalization).

Results

• There were 1669 completed pregnancies with 1610 live births.
• Maternal mean age was 32.1±4.6 years at delivery.
• For pregnancy-related complications from the PIANO registry, see Table: Pregnancy-related Complications by Drug Exposure in Completed Pregnancies-PIANO Registry.

• Overall and nonserious infection rates in the first 4 months were similar across all treatments. Serious infant infection rates were comparable across all treatment groups at birth, 4 months or within the first year. For overall rates of infection, see Table: Infant Infection Rates During the First 12 Months of Life.
• Nonserious infections included upper respiratory and diarrheal illnesses. None of which required hospitalization or the use of antibiotics.
• Overall infections were lower at 12 months of life in patients exposed to STELARA (20%, P=0.02).

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 11 March 2025.

Pregnancy outcome data in women exposed to STELARA are summarized in this response from clinical trials, prospective cohort studies, retrospective cohort studies, registries, and spontaneous reports, with a studied population of ≥100 in patients with PsO, PsA, CD, or UC.

Data on maternal and infant ustekinumab concentrations in women receiving STELARA during pregnancy are not summarized in this response.