Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

Study Overview
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Brief Summary
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This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

Official Title
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Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Tofacitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of 18 years old or above Patients with confirmed diagnosis of moderate to severe ulcerative colitis Patients for whom gastroenterologist decides to initiate treatment with tofacitinib as per the French SmPC Patients informed about the study procedures and receiving an information letter signed by the investigator Exclusion Criteria: Patients who have already received tofacitinib treatment before baseline Patients that fulfill any of the contrindications according to the latest version of the SmPC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed tofacitinib<br>Patients with a confirmed diagnosis of moderate to severe ulcerative colitis initiating tofacitinib as per the French summary of product characteristics (SmPC). | Drug: Tofacitinib<br>* Observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with clinical benefit 2 years after initiation of tofacitinib treatment. | The definition of clinical benefit is independent of the discontinuation or not of tofacitinib treatment during the observation period. Clinical benefit at 2 years is defined as a modified partial Mayo Score of 0 or 1 with rectal bleeding subscore of 0 and stool frequency subscore of 0 or 1 -Patients who died or who had a colectomy or used another biologic/anti-JAK/immunosuppressant will be considered to be non-responders, as well as patients who used: More than one oral or topical corticosteroid with systemic effects for UC for more than three months during the first 18 months Oral corticosteroids for UC, between 18 and 24 months (whatever the duration of treatment), | Week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with clinical benefit of tofacitinib at 2 years, for those still receiving tofacitinib at 2 years. |  | week 104 | 
| Predictors of the clinical benefit at 2 years identified from the available baseline data |  | Week 104 | 
| Proportion of patients in clinical remission and still receiving tofacitinib | Clinical remission is defined as partial Mayo score (PMS) <2 | Week 52 | 
| Proportion of patients in clinical remission without corticosteroids (oral or topical with systemic effects for UC) at 1 year |  | Week 52 | 
| Proportion of patients with short-term clinical response for patients still treated with tofacitinib | Clinical response is defined as a reduction in partial Mayo score ≥ 3 points and ≥ 30% with respect to baseline, with a concomitant reduction in rectal bleeding sub-score ≥ 1 point (absolute sub-score of 0 or 1). | Approximately week 8 and 16 | 
| Proportion of patients with biological response during the observation period | Biological response is defined as 50% reduction in the initial value of CRP or Fecal Calprotectine (FCP) | Week 104 | 
| Proportion of patients with mucosal healing during the observation period | Mucosal healing is defined as endoscopic subscore of 0 or 1 | Week 52 | 
| Proportion of patients in sustained clinical remission | Clinical remission is defined as partial Mayo score (PMS) <2 at 52 and 104 weeks | Week 52 and 104 | 
| Time to loss of response to tofacitinib treatment in patients after dose reduction to 5 mg BID at the end of induction | The clinical loss of response is defined by a recrudescence of the symptoms that lead to a systemic therapeutic intervention (return to previous dose of tofacitinib or corticosteroid therapy, or an immunosuppressant or biologic/other anti-JAK) | Week 8, 16, 24, 72, 52 and 104 | 
| Proportion of patients with extraintestinal manifestations at each visit |  | Week 8, 16, 24, 72, 52, 104 | 
| Proportion of patients with a colectomy during study follow-up and time of occurrence |  | Week 8, 16, 24, 72,52 and 104 | 
| Characteristics of patients and UC, on the basis of all the data collected at baseline |  | Week 104 | 
| Description of the changes in the rectal bleeding and stool frequency subscores during the first 2 weeks after initiation of tofacitinib therapy | (self-assessment by patients) | 14 weeks | 
| Change in patient quality-of-life evaluated from the SIBDQ questionnaire between baseline and 1 year, baseline and 2 years, and between 1 and 2 years |  | Week 52, Week 52 to week 104 and week 104 | 
| Change in adherence to tofacitinib treatment during each visit | Using MARS questionnaire | Week 8, 16, 24, 72, 52, 104 | 
| Proportion of patients with serious and non-serious adverse events. |  | Week 8, 16, 24,72,52 and 104 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Tofacitinib, France, Real world data