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.
• Phase 3 clinical trials for STELARA in Crohn’s disease (CD) did not evaluate intravenous (IV) maintenance dosing.¹
• Retrospective studies and a case series describing the use of STELARA IV infusion during maintenance therapy in CD are summarized below.^2-10

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, (Harvey-Bradshaw Index [HBI] of ≤4).
• 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 CD (N=50), median HBI at baseline was 9 (interquartile ratio [IQR], 6-12) and was reduced to 5 (IQR, 4-7) after 12 weeks of STELARA IV maintenance therapy and 4 (IQR, 3-6) at week 52 (P<0.001).
  • Among patients with CD, 42.4% and 53.6% 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.

Lopez-Saez et al 2025³ assessed the efficacy of IV STELARA as maintenance therapy in adult patients with a loss of response to SC therapy in a single-center study.

• Twenty-three patients with CD were included; the mean age was 40.5±13.9 years.
• Patients were given IV maintenance therapy (130 mg IV every 4 weeks) with STELARA following an IV weight-based re-induction dose.
  • Among the 23 patients who were re-induced and switched to STELARA IV maintenance therapy, 39% (9 patients) were previously on STELARA SC every 8 weeks and 61% (14 patients) were previously on STELARA SC every 4 weeks maintenance therapy.
  • The mean time between the start of STELARA and switching to IV maintenance was 1.4±1.3 years.
• At weeks 8 and 16, 23 patients were available for follow-up:
  • Week 8: 73.9% achieved clinical response and 47.8% achieved clinical remission
  • Week 16: 60.9% achieved clinical response and 39.1% achieved clinical remission
• At 12 months, 12 patients were available for follow-up:
  • 83.3% achieved clinical response and 66.7% achieved clinical remission
• Adverse events (recurring respiratory infections) were reported in 2 patients.

Pesantes et al (2025)⁴  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 HBI ≤4.
• Of the 25 patients included in this study, 16 had CD.
• For CD, clinical remission was statistically significant at week 12 and at the end of follow-up:
  • Baseline: 37.5%
  • Week 12: 81.25%, P=0.0156
  • End of follow-up: 75%, P=0.0312
• 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)⁵  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 (HBI ≤4) with biochemical (FCP
  250 µg/g and CRP <5 mg/L) and/or endoscopic response (50% reduction from baseline in the simple endoscopic score for Crohn’s disease [SES-CD] at week 12.
• A total of 22 patients were included, 19 had CD and 3 had ulcerative colitis (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, 7 patients with CD achieved clinical remission.
• At weeks 12 and 52, the median HBI decreased from baseline:
  • Baseline: 6 points
  • Week 12 and 52: 3 and 2 points, respectively (P<0.001 for both)
• FCP and CRP did not significantly decrease from baseline to week 12:
  • Median FCP at baseline: 624 µg/g (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)⁶ 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 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 mean 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.

Hermida Pérez et al (2023)⁷ conducted a retrospective study evaluating the efficacy and safety of STELARA IV maintenance therapy as a rescue strategy in patients with CD.

• A total of 12 adult patients with CD who were nonresponders or had a loss of response to standard therapy with STELARA and received ≥2 consecutive STELARA IV doses as a rescue strategy were included.
• Clinical remission was defined as an HBI score of <5 without steroids.
• Clinical response was defined as a ≥2-point decrease in HBI.
• Overall, 75% of patients started STELARA IV maintenance therapy, after previous SC treatment, at doses of 390 mg (50%), 260 mg (42%), and 130 mg (8%).
• The initial infusion interval was 8, 6, and 4 weeks in 67%, 8%, and 25% of patients, respectively, which was shortened in 25% of patients.
• Mean follow-up duration was 117.1 weeks, and mean therapy survival duration was 105.9 weeks.
• Summary of clinical response and remission and median basal FCP and CRP levels through 52 weeks of STELARA IV maintenance therapy are presented in Table: Efficacy of STELARA IV Maintenance Therapy through 52 Weeks.

• After 52 weeks of STELARA IV maintenance therapy, 17% of patients were de-escalated to STELARA SC therapy.
• No severe AEs were reported, and 25% of patients had mild AEs that did not require hospital admission or therapy withdrawal.

Garcia-Alvarado et al (2022)⁸ conducted a retrospective study to evaluate 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% of patients received STELARA 90 mg SC q6w, and 68.4% of patients received STELARA 90 mg SC q4w.
• Three 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, 0.13-11.69) 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 therapy.

Hashmi et al (2022)⁹ evaluated the safety and effectiveness of STELARA reinduction and IV maintenance therapy in patients with refractory CD at a single-center Veteran Affairs medical center.

• A total of 4 patients with refractory CD were included. Each patient received STELARA IV induction.
• All patients had loss of response or inadequate response (objectively measured via CRP, FCP, endoscopy, and radiography) upon transitioning to STELARA SC maintenance therapy. Ustekinumab trough levels remained subtherapeutic (<4.5 µg/dL) with ongoing active disease despite dose optimization to q4w.
• These patients were then switched to weight-based STELARA IV maintenance dosing q4w, and disease activity was reassessed after 3 months.
  • All patients achieved endoscopic and/or radiographic remission with therapeutic drug troughs (not reported).
  • No AEs were reported during the study.

Case Series

Masood et al (2023)¹⁰ conducted a case series to evaluate the efficacy of STELARA IV maintenance therapy in 6 patients with CD who were switched to STELARA IV every 12 weeks (q12w) for maintenance, due to reasons unrelated to treatment effect, after receiving at least 1 IV induction dose. Patients weighing between 55 kg and 85 kg received a 390 mg IV maintenance dose, whereas those weighing above 85 kg received a 520 mg IV maintenance dose.

• Patient 1 was a 69-year-old male (61 kg) with perianal and ileal CD previously treated with mesalamine and infliximab with secondary loss of response.
  • The patient received STELARA SC therapy for 149 weeks and was subsequently switched to STELARA IV maintenance therapy (completed 60 weeks of IV therapy to date).
  • The patient remained in endoscopic and clinical remission while receiving STELARA IV maintenance therapy.
  • After 30 weeks of treatment, the patient experienced diarrheal symptoms, which resolved following 10 days of treatment with rifaximin.
• Patient 2 was a 66-year-old female (89 kg) with CD affecting the ascending colon and ileum. She was previously treated with infliximab without any loss of response but was later switched to certolizumab (which resulted in primary nonresponse) and STELARA to manage enteropathic arthritis.
  • The patient received STELARA SC therapy for 30 weeks and was subsequently switched to 30 weeks of STELARA IV maintenance therapy.
  • The patient has maintained clinical remission while on STELARA IV maintenance therapy but has not undergone follow-up endoscopy at the time of this report.
• Patient 3 was a 74-year-old male (69 kg) with rectal and perianal CD previously treated with mesalamine.
  • The patient received STELARA SC therapy for 145 weeks and was subsequently switched to 56 weeks of STELARA IV maintenance therapy.
  • The patient remained in clinical remission, with a decrease in the HBI score from 3 to 1. Furthermore, endoscopic remission was confirmed on colonoscopy.
• Patient 4 was a 69-year-old female (80 kg) who had undergone partial colectomy with an end-to-side ileocolonic anastomosis. She then developed CD affecting the ileum and ileocolonic anastomosis and had received treatment with mesalamine, prednisone, and budesonide.
  • The patient received STELARA SC therapy for 91 weeks and was subsequently switched to 39 weeks of STELARA IV maintenance therapy.
  • The patient remained in clinical remission, with a decrease in the HBI score from 5 to 0; however, she has not undergone follow-up endoscopy since starting STELARA IV maintenance therapy.
  • At the 22-week follow-up, the STELARA IV dosing was adjusted to every 10 weeks (from q12w) due to reappearance of urgency and diarrhea symptoms at the 10-week mark.
  • Following dose adjustment, the patient has remained in clinical remission with drug levels at 8 µg/mL and over 10 µg/mL at 12 and 22 weeks, respectively.
• Patient 5 was a 70-year-old male (74.8 kg) with CD affecting the ileum and colon following a small bowel and ileocolic resection with an end-to-side ileocolonic anastomosis; he was previously treated with mesalamine.
  • The patient received STELARA SC therapy for 55 weeks and subsequently completed 41 weeks of STELARA IV maintenance therapy.
  • The patient has maintained clinical remission while on STELARA IV maintenance therapy but has not undergone follow-up endoscopy.
• Patient 6 was a 79-year-old male (69.9 kg) with ileal CD previously treated with sulfasalazine.
  • The patient received STELARA SC therapy for 158 weeks and STELARA IV therapy for 38 weeks.
  • The patient has maintained clinical remission but has not undergone follow-up endoscopy.

Details about the patients’ laboratory values and endoscopic and clinical scoring, respectively, are summarized in Table: Laboratory Values Before and After STELARA IV Therapy and Table: Endoscopic and Clinical Scoring Before and After STELARA IV Therapy.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 19 September 2025.