Use of STELARA in Combination with Immunomodulators, 5-ASAs, and Corticosteroids in Ulcerative Colitis: UNIFI Clinical Trial Program

SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to your local labeling for relevant information on the use of STELARA in combination with immunomodulators, 5-aminosalicylates (5-ASAs), and corticosteroids in ulcerative colitis (UC).
• Analysis of remission rates and other outcomes for STELARA vs placebo based on concomitant UC therapy from the phase 3, randomized UNIFI induction (8-week) and maintenance (44-week) studies and the open-label long-term extension (LTE) in adult patients with moderately to severely active UC are presented below.^1-6
• Additionally, pharmacokinetic analyses of data from the 52-week UNIFI induction and maintenance studies demonstrated that serum ustekinumab concentrations were not affected by concomitant immunomodulator therapy (azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]).⁷

CLINICAL DATA

Phase 3 Randomized Clinical Trial Program (UNIFI)

• A phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial program (UNIFI) evaluated the efficacy and safety of STELARA therapy in adult patients with moderately to severely active UC. The program consisted of 2 studies: an 8-week intravenous (IV) induction study and a 44-week subcutaneous (SC) maintenance study.^1-3
• Patients enrolled had demonstrated an inadequate response to or failed to tolerate a biologic (ie, tumor necrosis factor [TNF] blocker and/or vedolizumab), corticosteroids, and/or 6-MP or AZA therapy.¹
• During the induction study (8 weeks in duration, N=961), patients were randomized 1:1:1 at week 0 (baseline) to receive a single IV induction dose of STELARA 130 mg or a dose approximating STELARA 6 mg/kg (~6 mg/kg): 260 mg IV (weight ≤55 kg), 390 mg IV (weight >55 kg but ≤85 kg), or 520 mg IV (weight >85 kg) or IV placebo.^1,2
• Patients who demonstrated a clinical response to STELARA IV induction treatment at week 8 (and those who did not have a response to IV placebo who then received an induction dose of STELARA ~6 mg/kg IV at week 8 and had a response at week 16) were eligible to enter the 44-week maintenance study (N=523) and were randomized 1:1:1 to receive STELARA 90 mg SC every 8 weeks (q8w), STELARA 90 mg SC every 12 weeks (q12w), or SC placebo.^1,3
• Stable doses of immunomodulators (ie, AZA, 6-MP, or MTX) and oral 5-ASAs were maintained from baseline of the induction study through week 44 of the maintenance study. Oral corticosteroids were maintained at a stable dose during the induction study and tapered when patients entered the maintenance study.^1,4
• At baseline of the induction study, the proportions of patients receiving the following concomitant UC medications were:²
  • Corticosteroids: 51.8%
  • Immunomodulators: 28.2%
  • Aminosalicylates: 68.7%
• At baseline of the maintenance study, the proportions of patients receiving the following UC medications were:³
  • Corticosteroids: 51.1%
  • Immunomodulators: 25.9%
  • Aminosalicylates: 70.7%
• Remission rates during induction and maintenance therapy for STELARA vs placebo based on baseline concomitant UC therapy status are noted in Table: Proportion of Patients in Clinical Remission at Week 8 by Baseline Concomitant UC Therapy Status and Table: Proportion of Patients in Clinical Remission at Week 44 by Baseline Concomitant UC Therapy Status.⁴

• Of the 284 patients randomized to STELARA and treated in the open-label LTE, 139 patients were receiving corticosteroids at maintenance baseline. Of these patients, 79.1% (110 patients) were not receiving corticosteroids at week 200.⁵
• For symptomatic remission rates at weeks 44 and 200, see Table: Proportion of Patients in Symptomatic Remission and Corticosteroid-Sparing Effects at Weeks 44 and 200.⁵

Disease Clearance Among Patients Receiving Concomitant Therapy  

• Danese et al (2025)⁶ conducted post-hoc analyses to evaluate achievement of disease clearance and the association of achieving disease clearance after induction with long-term outcomes.
• Disease clearance was characterized by the achievement of both symptomatic remission and histologic and endoscopic mucosal improvement (HEMI).
  • Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
  • HEMI consisted of histologic improvements (<5% neutrophils in the epithelium, no crypt destruction, and no erosions, ulcerations, or granulations) and endoscopic improvement (Mayo endoscopic subscore of 0 or 1).
• Among 316 evaluable patients responded to STELARA IV induction treatment who were randomized to STELARA maintenance treatment and participated in the long-term extension, at Maintenance Week 0, 79 patients achieved disease clearance, 142 achieved symptomatic remission without HEMI, and 82 achieved neither symptomatic remission nor HEMI.
• For demographic information related to the proportions of patients receiving conventional therapies (eg, corticosteroids, immunomodulators, or 5-ASAs) at Maintenance Week 0 by disease clearance status, see Table: Proportion of Patients Receiving Conventional Therapies by Disease Clearance Status at Maintenance Week 0 Among Patients Randomized to STELARA Maintenance Therapy

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 May 2026.

Summarized in this response are relevant data with a focus on the use of STELARA in combination with immunomodulators, 5-ASAs, and corticosteroids from the phase 3 pivotal clinical trial program, including the open-label LTE in the treatment of UC.