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 a retrospective study, registry-based study, and a case report.^1-3 

CLINICAL DATA

Retrospective Study

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

Study Design/Methods

• The study included adult patients who received advanced therapies for UP 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).
• UP diagnosis was confirmed through endoscopic reports documenting inflammation ≤15 cm from the anal verge.
• The primary outcome was steroid-free clinical remission (SFCR) at 52±4 weeks after advanced therapy initiation for UP, 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 UP, 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, SFCR 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)² conducted a registry-based cohort study to clinically characterize adult patients with UP, identify complications associated with refractory UP, 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 UP were identified from the ENEIDA registry.
• UP was defined according to the Montreal classification and European Crohn's and Colitis Organisation guidelines.
• Refractory UP was defined as an active UP 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 UP 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 SFCR was achieved in 67% (4/6) of patients treated with STELARA.

Case Report

Dalal et al (2021)³ 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 01 July 2025.