Ustekinumab in Ulcerative Colitis: A Real-Life Effectiveness Study Across Multiple Belgian Centers (SULTAN)

Area of Science:

• Gastroenterology
• Immunology
• Pharmacology

Background:

• Ustekinumab (UST) is approved for moderate-to-severe ulcerative colitis (UC) based on UNIFI trial data.
• Real-world evidence on UST effectiveness, especially for histological remission in UC, is limited.
• Assessing UST's real-world utility in refractory UC patients is crucial.

Purpose of the Study:

• To evaluate the real-world effectiveness and safety of ustekinumab (UST) in patients with refractory ulcerative colitis (UC).
• To assess clinical, endoscopic, and histological remission rates with UST treatment.
• To identify predictors of treatment response and failure in UC patients receiving UST.

Main Methods:

• Multicenter, retrospective cohort study of UC patients treated with UST from September 2020 to June 2023.
• Primary endpoint: steroid-free clinical remission at week 16.
• Secondary endpoints: clinical, endoscopic, and histological remission/response; UST drug persistence; safety assessment.

Main Results:

• 34% of patients achieved steroid-free clinical remission by week 16, increasing to 44% by week 52.
• Histological remission rates were 8% at week 16 and 11% by week 52.
• Active smoking, prior vedolizumab non-response, and high baseline Nancy score predicted early UST failure.
• UST drug persistence was 70.8% by week 52, with no new safety signals.

Conclusions:

• Ustekinumab demonstrates acceptable remission rates and high treatment persistence in real-world refractory UC patients.
• UST offers a favorable safety profile for managing moderate-to-severe UC.
• Identifying predictors like smoking status can help optimize UST therapy for UC patients.