N/A
Completed N=252
This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.
Source: ClinicalTrials.gov NCT05082428 ↗Enrolled (actual)
252
Serious AEs
—
Results posted
Sep 2024
Primary outcomePrimary: Age at the Time of Diagnosis — 31.08 Years
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Age at the Time of Diagnosis |
31.08 | — |
| PRIMARY Duration of Ulcerative Colitis |
7.91 | — |
| PRIMARY Number of Participants With Extent of Colonic Involvement According to the Montreal Classification |
5; 67; 180 | — |
| PRIMARY Mayo Score at Initiation of Tofacitinib |
7.45 | — |
| PRIMARY Partial Mayo Score at Initiation of Tofacitinib |
4.75 | — |
| PRIMARY Number of Participants According to Endoscopic Findings Based on Histology |
NA; NA; 0 | — |
| PRIMARY Number of Participants According to Endoscopic Sub Score Based on Mayo Score |
10; 42; 36 | — |
| SECONDARY Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52 |
91.67; 80.16; 71.03; 54.72 | — |
| SECONDARY Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
5.49; 9.52; 14.66; 20.16 | — |
| SECONDARY Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
28.77; 36.52; 34.91; 33.66 | — |
| SECONDARY Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
32.5; 38.75; 35; 26.09 | — |
| SECONDARY Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
37.44; 44.83; 42.86; 33.33 | — |
| SECONDARY Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
NA; 6.67; 12.93; 19.38 | — |
| SECONDARY Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
10.5; 31.74; 30.17; 31.19 | — |
| SECONDARY Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months |
15.3; 45.8; 56.2; 67.0; 70.5; 72.2 | — |
| SECONDARY Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52 |
29.1; 46.56; 45.5; 37.34 | — |
| SECONDARY Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52 |
20.63; 36.51; 37.04; 32.28 | — |
| SECONDARY Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52 |
12.17; 24.34; 25.93; 23.42 | — |
| SECONDARY Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline |
31; 55; 58; 44 | — |
| SECONDARY Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 With F-Calprotectin Above 250 mg/kg at Baseline |
-594.83; -1100.28; -1291.7; -1393.53 | — |
| SECONDARY Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 8 to Week 16, Week 24, and Week 52 |
100.0; NA; NA | — |
| SECONDARY Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 8 to Week 16, Week 24, and Week 52 |
84.13; 63.49; 50.91 | — |
| SECONDARY Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52 |
90.0; 75.0 | — |
| SECONDARY Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 |
76.19; 64.29 | — |
| SECONDARY Percentage of Participants in Sustained Steroid Free Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52 |
85.71; 71.43 | — |
| SECONDARY Percentage of Participants in Sustained Steroid Free Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 |
72.6; 60.66 | — |
| SECONDARY Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
-1.9; -2.39; -2.63; -2.66 | — |
| SECONDARY Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
-1.62; -2.21; -2.4; -2.43 | — |
| SECONDARY Percentage of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 |
100; 100; 50 | — |
| SECONDARY Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52 |
NA; NA; 6.19; 11.48 | — |
| SECONDARY Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52 |
0; -0.01; -0.02; -0.18 | — |
| SECONDARY Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Full Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 |
NA; NA; NA | — |
| SECONDARY Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Partial Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 |
NA; NA; NA | — |
| SECONDARY Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 |
0; 0; 0; NA; 0; NA | — |
| SECONDARY Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 |
NA; NA; NA; NA; 12; 21 | — |
| SECONDARY Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 |
0; NA; NA; NA; 8; 11 | — |
| SECONDARY Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 |
NA; NA; NA; NA; 20; 24 | — |
| SECONDARY Percentage of Participants With Corticosteroid Tapering at Week 8, Week 16, Week 24 and Week 52 |
NA | — |
| SECONDARY Tapering Rate |
NA | — |
| SECONDARY Corticosteroid Tapering Dose |
NA | — |
| SECONDARY Percentage of Participants With Improvement in Stool Frequency Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 |
38.03; 45.07; 41.78; 32.6 | — |
| SECONDARY Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52 |
-0.62; -0.86; -0.97; -1.01 | — |
| SECONDARY Percentage of Participants With Improvement in Rectal Bleeding Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 |
28.57; 29.49; 28.11; 22.83 | — |
| SECONDARY Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52 |
-0.41; -0.49; -0.47; -0.53 | — |
| SECONDARY Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 |
67.4; 61.63; 57.09; 44.55; 70.29; 63.45 | — |
| SECONDARY Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52 |
-1.06; -1.31; -1.74; -2.36 | — |
| SECONDARY Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 |
0.71; 1.19; 1.11; 3.77; 0.58; 1.18 | — |
| SECONDARY Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 |
-3.31; -4.34; -4.81; -2.34; 0.18; 0.06 | — |
| SECONDARY Percentage of Participants With Extended Tofacitinib Induction Dose at Week 8, Week 16 |
69.71; 36.25 | — |
| SECONDARY Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52 |
75.93; 40.24; 30.28; 17.45 | — |
| SECONDARY Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52 |
183; 101; 76; 37 | — |
| SECONDARY Time to Drug Discontinuation, Colectomy or UC-related Hospitalization |
14.3 | — |
| SECONDARY Number of Previous Treatments |
4.5 | — |
| SECONDARY Number of Participants According to Type of Previous Treatment |
229; 237; 222; 182; 93; 23 | — |
| SECONDARY Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
0; NA; 6; 11 | — |
| SECONDARY Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 |
NA; 36; 32; 32 | — |
| SECONDARY Percentage of Participants That Had f-Calprotectin Above 250 mg/kg at Baseline |
90.5 | — |
| SECONDARY Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 |
-511.55; -955.7; -1092.93; -1179.35 | — |
| SECONDARY Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Full Mayo Score From Week 16 to Week 24 and Week 52 |
NA; NA | — |
| SECONDARY Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 |
63.89; 44.83 | — |
| SECONDARY Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 |
— | — |
| SECONDARY Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Full Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 |
— | — |
| SECONDARY Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline |
126.73; 139.22; 36.49 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05082428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.