Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

• Ozanimod (Drug): According to the product label
• Azathioprine (Drug): According to the product label

Primary outcomes

• Proportion of participants achieving steroid-free symptomatic remission [Week 12; Weeks 24 and 52]

Secondary outcomes

• Oral steroid dose prescribed [Week 12; Weeks 24 and 52]
• Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation [Weeks 24 and 52]
• Steroid-free maintenance period duration [Up to Week 52]
• Time to achieving steroid-free status [Up to Week 52]
• Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs) [Up to Week 52]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Participants with Ulcerative Colitis (UC) provided written consent to participate in the study
* Participants who are aged ≥ 18 years at the earlier date of either initiation of treatment with ozanimod or azathioprine or obtaining consent
* Starting dose of oral steroid ≥ 30 mg/day (prednisolone equivalent)
* Administration of ozanimod or azathioprine started after oral steroid administration, and ozanimod or azathioprine administered concomitantly with steroids (excluding patients who started oral steroids and ozanimod or azathioprine on the same day)
* In the ozanimod group, patients with notable clinical symptoms due to the primary disease (rectal bleeding subscore ≥ 1 point or total PRO2 score ≥ 2 points) remained at the start of ozanimod administration
* In the azathioprine group, patients who started azathioprine treatment after February 2019

Exclusion Criteria:

* Participants with symptoms of UC with no change or increase in Patient-Reported Outcome 2 (PRO2) from the time of initiating oral steroid administration after 2 weeks of administration of ≥ 30 mg/day (prednisolone equivalent) of oral steroids
* Participants with complications requiring continued steroid use (excluding topically acting steroids for inhalation or topical application)
* Participants who participated in other clinical studies involving interventions during the observation period
* Participants judged to be inappropriate for enrollment in this study by the investigator at each participating study site

• Bristol Myers Squibb, Study director, Bristol-Myers Squibb