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.
• Three retrospective studies assessing the efficacy of intravenous (IV) re-induction with STELARA during maintenance therapy in ulcerative colitis (UC) are summarized below.^1-3
• The phase 3 clinical trial program of STELARA in the treatment of UC did not evaluate re-induction with IV infusion during maintenance therapy.⁴

Clinical data

Retrospective Studies

Lierop et al (2025)¹ assessed the efficacy of dose escalation, including IV re-induction in adult patients with moderate to severe UC who received ≥1 IV induction dose of STELARA through a multicenter retrospective cohort study.

• The primary efficacy outcome was corticosteroid-free clinical remission.
  • Remission was defined as partial Mayo score (PMS) of ≤2. A minimum amount of time for corticosteroid discontinuation was not specified.
• Key secondary efficacy outcomes were assessed:
  • Clinical remission
  • Biochemical remission (C-reactive protein [CRP] <8 mg/L and/or fecal calprotectin [FCP] <250 µg/g)
  • Endoscopic remission (Mayo endoscopic score ≤1 with score ranging from 0 to 3)
• Of the 81 patients who underwent first dose escalation, 7 (8.6%) patients were IV re-induced.
  • Second and third dose escalations occurred in 27 and 2 patients; of which, 13 (48.1%) and 2 (100%) were re-induced, respectively.
• Data specific to patients who required IV re-induction is not reported. For the proportion of patients who achieved the corticosteroid-free clinical remission and other secondary outcomes, see Table: Patients Achieving Efficacy Outcomes at Follow-Up.

• Drug-related adverse events resulting in discontinuation of STELARA in patients who were dose escalated included persistent nausea and migraines with probable relation to STELARA injections (1/81).
• Three patients who were dose escalated underwent UC-related surgery during follow-up.

Muir et al (2024)² assessed the efficacy of IV re-induction with STELARA to maintain drug persistence through a retrospective interventional study in patients with UC.

• Data was collected from patients who received STELARA over 5 years. To determine the efficacy of STELARA, biochemical and endoscopic data were collected.
• Patients who required IV re-induction were analyzed.
  • Of the 61 patients with UC, 24 received re-induction doses. The average time of re-induction from initiation of STELARA was 16.3 months.
    • Data specific to UC patients who required IV re-induction were not reported. Of the 87 patients who received IV re-induction (including those with CD), 63% showed improvement in disease control.

Iborra et al (2023)³ conducted an observational, multicenter study to determine the efficacy of STELARA in patients with refractory UC, including those requiring IV re-induction with STELARA.

• PMS, CRP and FCP levels were recorded at baseline and at 8, 24, and 52 weeks, and at 18 and 24 months.
• There were 108 patients included in this analysis:
  • Dosing interval reduction was required in 58 (54%) patients, of whom 76% were reduced to every 4 weeks and 24% to every 6 weeks after a median of 22.3 (11.6-41.2) weeks.
  • Intravenous re-induction was required in 20/58 (18.5%) patients after a median of 27.7 (6.64-56.3) weeks.
  • Three patients required maintenance therapy with IV administration.
• Data specific to patients who required IV re-induction is not reported in this abstract. For the proportion of patients who achieved clinical remission and normal FCP or CRP in the overall study population, please see Table: Efficacy Outcomes in Patients Receiving STELARA.

• Of the 17 patients who had an endoscopy prior to and after treatment with STELARA, 6 were in remission and 3 had mild activity.
• Adverse events were reported in 5 patients; 12 were hospitalized and 9 required surgery.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 25 August 2025.