Vedolizumab →Ustekinumab - Standard DosageJAK Inhibitor
Vedolizumab: UC patients treated with vedolizumab
Ustekinumab - Standard Dosage: UC patients treated with ustekinumab
JAK Inhibitor: UC patients treated with JAK inhibitors
Study summary
The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;
* Age ≥ 18 years-old;
* Capability of expressing informed consent;
* Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;
* Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;
* Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and/or golimumab);
* No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;
* At least 1 follow-up visit after baseline
Exclusion Criteria:
* Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
* Age \< 18 years-old;
* Incapability of expressing informed consent;
* Acute severe UC requiring hospitalization at baseline;
* No previous exposure to anti-TNFα therapies;
* Previous treatment with target therapies other than anti-TNF-α for UC before baseline;
* Ustekinumab or JAK inhibitors induction with a non-standard posology for UC.
Primary outcome measure(s)
Clinical and endoscopic effectiveness of the three treatments — 12 months Rates of steroid-free clinical remission and endoscopic remission
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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