This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.

Study Overview
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Brief Summary
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The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.

Official Title
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Retrospective Non-interventional Multicenter Patient Chart Data Study on Tofacitinib Realworld Experience in Ulcerative Colitis in Finland (FinTofUC)

Conditions
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Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Xeljanz (tofacitinib) usage for ulcerative colitis Diagnosis of ulcerative colitis (ICD-10: K51.0, K51.1, K51.2, K51.3, K51.5, K51.8, K51.9) between January 2010 and December 2021 (incident or prevalent). Exclusion Criteria: Age < 18 years at the start of tofacitinib use Use of tofacitinib before reimbursement (1.3.2019) < 8 weeks of treatment with tofacitinib at the start of data mining History of panproctocolectomy, IPAA or ileostomy.

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 treated with Tofacitinib<br>Patients treated with tofacitinib for ulcerative colitis in Finland. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant demographics at tofacitinib treatment initiation | Age, gender, weight, height, smoking status, body mass index (BMI), treating hospital | Baseline | 
| Disease characteristics at tofacitinib treatment initiation | Age at diagnosis, duration of disease and extent of colonic involvement according to the Montreal classification: E1 (ulcerative proctitis), E2 (left sided, distal colitis), E3 (pancolitis) | Baseline | 
| Disease severity at tofacitinib treatment initiation | Assessed by Mayo score and fecal calprotectin (f-calprotectin) | Baseline | 
| Laboratory results for biochemical inflammatory markers at tofacitinib treatment initiation | Plasma C-reactive protein (P-CRP), blood thrombocytes (B-thromb), plasma albumin (P-alb), blood leukocytes (B-leuk), blood lymphocytes (B-ly), blood neutrophiles (B-neutr), blood hemoglobin (B-hb) and f-calprotectin | Baseline | 
| Endoscopic findings including histology at tofacitinib treatment initiation |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who are taking tofacitinib |  | Weeks 8, 16, 24, 52 | 
| Rate of clinical remission based on full Mayo score | A clinical remission is defined as a full Mayo score of ≤2 points with no individual sub score exceeding 1 point, with rectal bleeding sub-score of 0 | Weeks 8, 16, 24, 52 | 
| Rate of clinical remission based on partial Mayo score | A clinical remission is defined as a partial Mayo score <2 points with rectal bleeding sub-score of 0 | Weeks 8, 16, 24, 52 | 
| Rate of clinical response based on full Mayo score | A clinical response is defined as a full Mayo score decrease of ≥3 points and a decrease of ≥30% from baseline, with a decrease of ≥1 point on the rectal bleeding sub score or an absolute rectal bleeding score of ≤1 | Weeks 8, 16, 24, 52 | 
| Rate of clinical response based on partial Mayo score | A clinical response is defined as a partial Mayo score decrease of ≥2 points and reduction of at least 25% in partial Mayo score from baseline with an accompanying decrease in rectal bleeding sub score of ≥1 point or absolute rectal bleeding sub score of ≤1 | Weeks 8, 16, 24, 52 | 
| Proportion of participants in steroid-free clinical remission | Steroid-free clinical remission is defined by full or partial Mayo who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit | Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching clinical response based on full Mayo score | A clinical response is defined as a full Mayo score decrease of ≥3 points and a decrease of ≥30% from baseline, with a decrease of ≥1 point on the rectal bleeding sub score or an absolute rectal bleeding score of ≤1. | Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching clinical response based on partial Mayo score | A clinical response is defined as a partial Mayo score decrease of ≥2 points and reduction of at least 25% in partial Mayo score from baseline with an accompanying decrease in rectal bleeding sub score of ≥1 point or absolute rectal bleeding sub score of ≤1 | Weeks 8, 16, 24, 52 | 
| Time to response as assessed by a decrease based on full Mayo score. |  | Weeks 8, 16, 24, 52 | 
| Time to response as assessed by a decrease based on partial Mayo score. |  | Weeks 8, 16, 24, 52 | 
| Proportion of participants that had f-calprotectin above 250 mg/kg |  | Baseline | 
| Change from baseline in fecal calprotectin |  | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching f-calprotectin below 250 mg/kg of those with active disease based on f-calprotectin at baseline | Active disease defined as fecal calprotectin (f-calprotectin) >250mg/kg. | Weeks 8, 16, 24, 52 | 
| Proportion of participants in sustained remission (full Mayo score) |  | Week 8 to week 16, 24 and 52 | 
| Proportion of participants in sustained remission (full Mayo score) |  | Week 16 to week 24 and 52 | 
| Proportion of participants in sustained remission (partial Mayo score) |  | Week 8 to week 16, 24 and 52 | 
| Proportion of participants in sustained remission (partial Mayo score) |  | Week 16 to week 24 and 52 | 
| Proportion of participants in sustained steroid free remission (full Mayo score) (for all patients and for those treated with corticosteroids at baseline). |  | Week 16 to 24 and 52 | 
| Proportion of participants in sustained steroid free remission (partial Mayo score) (for all patients and for those treated with corticosteroids at baseline). |  | Week 16 to 24 and 52 | 
| Change in full Mayo score |  | Baseline, Weeks 8, 16, 24, 52 | 
| Change in partial Mayo score |  | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants in sustained endoscopic remission, mucosal healing or endoscopic response | Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1. | Baseline, Week 8 to week 16, 24 and 52 | 
| Proportion of participants in physician assessed histological remission determined as inactive disease, or normal histology, and change from baseline in histology assessment | Active disease is defined as an endoscopic Mayo sub-score of ≥2 or fecal-calprotectin (f-calprotectin) >250mg/kg. Histology is assessed as subscore 0= normal histology, 1= inactive disease and 2 = active disease. | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants in sustained steroid free remission (partial Mayo score) (for all patients and for those treated with corticosteroids at baseline) and endoscopic remission, mucosal healing or endoscopic response | Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1. | Baseline, Week 8 to week 16, 24 and 52 | 
| Proportion of participants in sustained steroid free remission (full Mayo score) (for all patients and for those treated with corticosteroids at baseline) and endoscopic remission, mucosal healing or endoscopic response | Endoscopic remission is defined as a sub score = 0. Mucosal healing is defined as a sub score 0-1. Endoscopic response is defined as a sub score reduction from baseline of ≥1. | Baseline, Week 8 to week 16, 24 and 52 | 
| Comparison of response and remission (full Mayo score) based on the extent of colonic involvement according to the Montreal classification |  | Baseline, Weeks 8, 16, 24, 52 | 
| Comparison of response and remission (partial Mayo score) based on the extent of colonic involvement according to the Montreal classification |  | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants with corticosteroid tapering and their tapering rates and doses |  | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants with improvement in stool frequency and change from baseline in stool frequency sub score | Improvement in stool frequency defined as sub score improvement of 1 or more points | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of patients with improvement in rectal bleeding and change from baseline in rectal bleeding sub score | Improvement inrectal bleeding defined as sub score improvement of 1 or more points | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching normal plasma C-reactive protein (P-CRP) levels and change from baseline | Normal P-CRP levels defined as below 4mg/L | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching normal blood hemoglobin (B-hb) levels and change from baseline | Normal B-hb levels defined as men=134-167 g/L, women=117-155 g/L | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching normal blood leukocyte (B-leuk) levels and change from baseline | Normal B-leuk levels defined as 3.4-8.2 x 109/L | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching normal blood thrombocytes (B-Thromb) levels and change from baseline | Normal B-Thromb levels defined as 150-360 x 109/L | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching normal blood lymphocyte (B-ly) levels and change from baseline | Normal B-ly levels defined as 1.3-3.6 x 109/L | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching normal blood neutrophile (B-neutr) levels and change from baseline | Normal B-neutr levels defined as 1.5-6.7 x 109/L | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants reaching normal plasma albumin (P-alb) levels and change from baseline | Normal P-alb levels defined as 18-39 years=36-48 g/L, 40-69 years=36-45 g/L, 70 years and over=34-45 g/L | Baseline, Weeks 8, 16, 24, 52 | 
| Proportion of participants with extended tofacitinib induction dose | Participants with induction dose after 8 weeks | Baseline, Weeks 8, 16, 24, 52 | 
| Real-world dosing of tofacitinib |  | Baseline, Weeks 8, 16, 24, 52 | 
| Survival without drug discontinuation, colectomy or UC-related hospitalization |  | Baseline, Weeks 8, 16, 24, 52 | 
| To Assess Treatment Lines Prior to Tofacitinib Treatment. | Number and type of previous UC treatments. | Baseline | 
| Proportion of responders defined by a fecal calprotectin (f-calprotectin) reduction of ≥50%, ≥75% or ≥90% compared to baseline | Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. | Baseline, Weeks 8, 16, 24, 52 |