Use of STELARA in Adult Patients with Proctitis

SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• The use of STELARA in adult patients with proctitis has been reported in 2 retrospective studies, a registry-based study, and a case report.^1-4

CLINICAL DATA

Retrospective Studies

D’Amico et al (2026)¹ conducted a multicenter, retrospective study to evaluate the effectiveness and safety of biologics and small molecules in adult patients with moderately to severely active ulcerative proctitis. Results specific to STELARA are reported below.

Study Design/Methods

• The study included adult patients who received advanced therapies for ulcerative proctitis between 2000 and 2025, with ≥12 weeks of follow-up.
• The primary outcome was steroid-free clinical remission (SF-CR) at week 12 (defined as a partial Mayo score [pMS] ≤2, including a rectal bleeding score of 0, and a stool frequency subscore of ≤1, without corticosteroid therapy for 12 consecutive weeks).

Results

• Of the 114 patients included, 24 patients (21.1%) were receiving STELARA.
• At week 12, the pMS decreased significantly (P<0.001; 95% confidence interval [CI],
  0.97-0.99; n=108), with a significant improvement in bowel urgency (P<0.001; 95% CI, 0.75-0.94; n=56).
• Overall, SF-CR was achieved by 59.6% (68/114) of patients at week 12.
  • Of 24 patients treated with STELARA, 12 patients (50%) achieved SF-CR at week 12.

Dalal et al (2025)² conducted a retrospective cohort study to evaluate the effectiveness and safety of first-line advanced therapies in adult patients with ulcerative proctitis through 1 year of treatment.

Study Design/Methods

• The study included adult patients who received advanced therapies for ulcerative proctitis between January 1, 2014, and June 1, 2023, within the Mass General Brigham health system.
• Advanced therapies included vedolizumab, antitumor necrosis factor alpha agents (adalimumab, infliximab, golimumab), anti-interleukin 12/23 agents (STELARA), Janus kinase inhibitors (tofacitinib), and sphingosine 1-phosphate receptor modulators (ozanimod).
• Ulcerative proctitis diagnosis was confirmed through endoscopic reports documenting inflammation ≤15 cm from the anal verge.
• The primary outcome was SF-CR at 52±4 weeks after advanced therapy initiation for ulcerative proctitis, defined by Simple Clinical Colitis Activity Index (SCCAI) ≤2 or provider global assessment in the absence of SCCAI.
• The secondary outcome was treatment persistence at 52 weeks. Results specific to STELARA are described below.

Results

Baseline Characteristics

• Of 72 patients with ulcerative proctitis, 3 (4%) received treatment with STELARA.
• The median age at initiation was 41 years (interquartile range, 30-52 years).
• At baseline, 64% of patients had moderate to severe disease activity, as indicated by an MES of 2 or 3.
• The median baseline SCCAI score was 4.

Outcomes at Week 52

• At week 52, SF-CR was achieved in 100% (3/3) of patients treated with STELARA.
• Treatment persistence at 52 weeks was observed in 67% (2/3) of patients treated with STELARA.
• Baseline topical therapies were successfully discontinued in 100% (1/1) of patients treated with STELARA for whom data were available.

Safety

• One patient treated with STELARA reported nausea/vomiting.
• No deaths or colectomies were reported through 1 year of follow-up.

Registry-Based Study

Ferreiro-Iglesias et al (2024)³ conducted a registry-based cohort study to clinically characterize adult patients with ulcerative proctitis, identify complications associated with refractory ulcerative proctitis, and identify the need for immunosuppressive therapies (PROCU study).

Study Design/Methods

• The study utilized data from the ENEIDA registry, a prospectively maintained database compiled by the Spanish Working Group in Crohn’s and Colitis (GETECCU).
• Adult patients diagnosed with ulcerative proctitis were identified from the ENEIDA registry.
• Ulcerative proctitis was defined according to the Montreal classification and European Crohn's and Colitis Organisation guidelines.
• Refractory ulcerative proctitis was defined as an active ulcerative proctitis unresponsive to topical and oral 5-aminosalicylic acid (ASA) combined with topical and/or oral corticosteroids.
• Clinical remission was defined as complete cessation of rectal bleeding and bowel urgency, along with normalization of stool frequency.
• Clinical response was defined as improvement without symptom resolution. Results specific to STELARA are described below.

Results

Baseline Characteristics

• A total of 6281 patients with ulcerative proctitis were identified, representing 18.1% of the registry population, of whom 691 (11%) patients were refractory to 5-ASA and corticosteroids and required immunosuppressants.
• The mean ± standard deviation age was 53.0±15 years, with a mean disease duration of 12.0±9 years.
• A total of 6 (0.9%) patients received STELARA, all of whom had failed at least one prior antitumor necrosis factor therapy.

Clinical Response

• Long-term SF-CR was achieved in 67% (4/6) of patients treated with STELARA.

Case Report

Dalal et al (2021)⁴ reported the case of a 27-year-old female with pan-ulcerative colitis after primary nonresponse to infliximab and vedolizumab.

• The patient presented with complaints of diarrhea, hematochezia, and abdominal cramps for several weeks.
• She was initially treated with 5-ASA and azathioprine, which did not control her symptoms.
• She was switched to infliximab 5 mg/kg every 8 weeks (Q8W). However, after several months of treatment, a colonoscopy revealed persistent, moderate proctitis. Despite an infliximab dose escalation, the patient had moderate inflammation in the intestines as seen on follow-up colonoscopies.
• The patient was subsequently treated with vedolizumab, oral budesonide, and azathioprine due to persistent symptoms. After 3 months of combination therapy with azathioprine and vedolizumab, a colonoscopy revealed mild proctitis and moderate inflammation in the intestines.
• She transitioned to a partial elemental diet, which did not improve her symptoms or mucosal inflammation.
• STELARA therapy was initiated on a standard weight-based infusion followed by subcutaneous (SC) maintenance dosing Q8W. After 3 months of treatment, the patient achieved clinical remission.
  • After 12 months of maintenance therapy, colonoscopy findings were consistent with endoscopic remission (no mucosal inflammation, except for erythema and granularity in 2 small patches in the right colon).
  • At 22 months of follow-up, the patient continued to be in clinical remission while receiving maintenance therapy of STELARA SC Q8W.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 03 June 2026.