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 on dosage and administration for STELARA.
• The phase 3 clinical trial program of STELARA in the treatment of ulcerative colitis (UC) did not evaluate the use of intravenous (IV) formulation as maintenance treatment.¹
• Retrospective studies describing the use of STELARA IV infusion during maintenance treatment in UC are summarized below.^2-6

clinical data

Retrospective Studies

Argüelles-Arias et al (2025)² conducted an observational, retrospective study evaluating the effectiveness and safety of STELARA IV maintenance therapy in patients with inflammatory bowel disease (IBD) who had a partial response or complete loss of response to STELARA subcutaneous (SC) maintenance therapy.

• Of patients who received STELARA IV maintenance therapy, 59 were followed through 12 weeks and 30 patients through 52 weeks.
• The primary endpoint was clinical remission at weeks 12 and 52, (partial Mayo score [pMS] ≤2).
• After a median duration of 25 months on SC maintenance treatment, patients were switched to STELARA IV maintenance treatment.
  • A total of 52.5% (31/59) of patients were escalated to 130 mg IV q4w, 11.9% (7/59) to 130 mg IV every 6 weeks, and 18.6% (11/59) of patients to 130 mg IV every 8 weeks.
• Overall, clinical remission was achieved by 47.5% at week 12 and 64.3% at week 52.
  • Of these patients in remission at week 52, 89% were steroid-free.
• Among the patients with UC (N=9), median pMS at baseline was 8.5 (interquartile ratio [IQR], 6.5-9) and was reduced to 5.5 (IQR, 4.3-6) after 12 weeks of STELARA IV maintenance therapy and 3 (IQR, 2-4.8) at week 52 (P=0.017).
  • Among patients with UC, 5.1% and 10.7% achieved clinical remission after 12 and 52 weeks of STELARA IV maintenance therapy, P<0.01.
• Median fecal calprotectin (FCP) levels decreased from baseline (800.2 µg/g) to 12 and 52 weeks (520 µg/g and 220 µg/g, respectively; P<0.001).
• Median serum C-reactive protein (CRP) levels decreased from baseline (7.1 mg/L) to 12 and 52 weeks (4 mg/L and 3 mg/L, respectively; P<0.001).
• At the end of follow-up, 96.6% of patients maintained IV maintenance treatment.
• No adverse events (AEs) were reported during the study.

Pesantes et al (2025)³  conducted a single-center, retrospective, observational study to assess STELARA IV maintenance therapy in patients with a partial or loss of response to STELARA SC maintenance therapy.

• Patients received STELARA IV maintenance therapy of 130 mg every 4 weeks.
• The primary endpoint was clinical remission, defined as a partial Mayo score [pMS] ≤2.
• Of the 25 patients included in this study, 7 had UC.
• In UC, clinical remission was not statistically significant at week 12 or at the end of follow-up:
  • Baseline: 22.22%
  • Week 12: 22.22%
  • End of follow-up: 55.56%
• At week 12 and at the end of follow-up, pMS significantly reduced:
  • Baseline: 5.11 (standard deviation [SD]: 2.71)
  • Week 12: 3.67 (SD: 2.18), P=0.026
  • End of follow-up: 2.78 (SD: 2.44), P=0.0407
• FCP did not significantly decrease from baseline at weeks 12 and the end of follow-up:
  • Baseline: 1900.4 µg/g (539, 2690)
  • Week 12: 1580.95 µg/g (1006.8, 2111.2)
  • End of follow-up: 1689.3 µg/g (1006.8, 2192.7)
• FCP biochemical remission was not significant at 12 weeks nor at the end of follow-up (defined as FCP<250 µg/g):
  • Baseline: 4.35%
  • Week 12: 18.18%
  • End of follow-up: 17.39%
• CRP significantly decreased at the end of follow-up from baseline:
  • Baseline: 5.8 mg/L (2, 11.5)
  • Week 12: 3.8 mg/L (2.1, 10.9)
  • End of follow-up: 3.6 mg/L (1.65, 7.85), P=0.0075
• CRP biochemical remission was not significant at 12 weeks nor at the end of follow-up (defined as CRP<5 mg/L)
  • Baseline: 40%
  • Week 12: 56.52%
  • End of follow-up: 62.50%
• Adverse events [AEs] were reported in 3 patients (arthralgias, asthenia) resulting in the discontinuation of STELARA in one patient.

Sanchez et al (2025)⁴ assessed the efficacy of IV STELARA maintenance therapy in patients who lost response to SC STELARA maintenance therapy in a single-center, observational study.

• The coprimary endpoints were clinical remission (pMS ≤2) with biochemical (FCP
  250 µg/g and CRP <5 mg/L) and/or endoscopic response (reduction in the Mayo endoscopic subscore of ≥1 point) at week 12.
• A total of 22 patients were included, 19 had Crohn’s disease (CD) and 3 had UC.
• Different maintenance regimens of STELARA IV were used; the most frequent regimens were 260 mg every 4 weeks (22.73%) and 380 mg every 6 weeks (18.18%).
• The coprimary endpoint was achieved in 36.36% of patients with either CD or UC.
• At week 12, 2 patients with UC achieved clinical remission.
• At weeks 12 and 52, the median pMS decreased from baseline:
  • Baseline: 5 points
  • Week 12 and 52: 0 (P<0.0001 and P<0.001, respectively)
• FCP and CRP did not significantly decrease from baseline to week 12:
  • Median FCP at baseline: 624 µg/g (interquartile ratio [IQR]: 10-5.390)
    • Median FCP at week 12: 223 µg/g (IQR: 9-8)
  • Mean CRP at baseline: 9 mg/L (IQR: 0.5-185)
    • Mean CRP at week 12: 6 mg/L (IQR 0.5-21.1)

Win et al (2023)⁵ conducted a retrospective study to evaluate the effectiveness of STELARA IV vs STELARA SC as maintenance therapy in adult patients with IBD.

• A total of 51 patients (CD, 88%; UC, 8%; indeterminate colitis, 4%) were included. Of the 43 patients who received STELARA SC maintenance treatment, 8 were switched to STELARA IV maintenance treatment due to lack of response.
• When comparing STELARA IV vs STELARA SC as maintenance therapy, 40% vs 42% of patients showed improvement (confirmed via endoscopy or imaging) and 20% vs 25% of patients showed significant progression, respectively.
• Hospital admission rates during treatment, mean CRP levels, and FCP levels among patients receiving STELARA IV vs SC as maintenance therapy are presented in Table: Recorded Characteristics Among Patients Receiving STELARA IV vs SC as Maintenance Therapy.

Garcia-Alvarado et al (2022)⁶ conducted a retrospective study evaluating the effectiveness of STELARA IV administered at regular intervals (usually, every 4-6 weeks) in patients with CD or UC who had insufficient efficacy or loss of response to STELARA 90 mg SC every 4-6 weeks.

• Data were collected from patients with active CD (n=73) or UC (n=6) defined by HBI or pMS >4 points and/or persistent biomarker elevation (calprotectin >250 μg/g) and/or endoscopic or radiological evidence of disease activity.
• FCP levels before and after initiating STELARA IV were available for 44 patients, and ustekinumab trough levels were available for 48 patients.
• Before STELARA IV was initiated, 31.6% and 68.4% of patients received STELARA 90 mg SC q6w and q4w, respectively.
• Overall, 3.8% of the patients were biologic-naïve and 41.8% had received ≥1 biologic.
• Mean follow-up period after the first STELARA IV dose administration was 13.22 months (IQR, 2-37).
• After 12 weeks of the first STELARA IV dose, 43% of patients achieved clinical remission (HBI <5 or pMS 2). At the end of the follow-up, 59.5% of patients achieved clinical remission.
• FCP levels decreased significantly from baseline to 12 months (612.6 mg/kg vs 384.1 mg/kg; P=0.0002) and at the end of the follow-up (222 mg/kg; P=0.0048).
• Ustekinumab levels at the beginning of STELARA IV administration were 2.6 μg/mL (IQR, 0.1311.69) and significantly increased from baseline (weeks 12-16, 9.09 μg/mL; after 1 year, 10.7 μg/mL; P<0.001 for both).
• At the end of the follow-up, 81% of the patients maintained treatment.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 27 October 2025.