Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden

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• Colitis, Ulcerative 1,492

Colitis, Ulcerative

1,492 studies on the registry are indexed under Colitis, Ulcerative; 400 are open to participants now.

This study's enrollment of 102 is below the median of 157 across 395 observational studies indexed under Colitis, Ulcerative.

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Study population

Groups and cohorts

• Patients prescribed tofacitinib

  Patients with a confirmed diagnosis of ulcerative colitis with confirmed active disease (biomarker or endoscopy) initiating tofacitinib as per the Swedish summary of product characteristics (SmPC).

  Drug: tofacitinib

Interventions

• Drugtofacitinib

  Observational study

Primary outcomes

1. Proportion of Participants in Remission as Measured by Partial Mayo Score

   Clinical Remission is defined as a partial score of \<2 points with 0 points regarding rectal bleeding.

   Time frame: Week 52

Secondary outcomes

1. Proportion of Participants who are taking tofacitinib

   Time frame: Baseline, Weeks 8, 16, 52, 104

2. Proportion of Participants in Clinical Remission Based on Total Mayo Score

   Clinical Remission is defined as a total Mayo score of ≤2 points with no individual subscore exceeding 1 point, with 0 points regarding rectal bleeding.

   Time frame: Weeks 8, 16, 52, and 104

3. Proportion of Participants in Clinical Response Based on Total Mayo Score

   Clinical Response is defined as a total Mayo score decrease of ≥3 points and a decrease of ≥30% from baseline, with a decrease of ≥1 point on the rectal bleeding subscore or an absolute rectal bleeding score of ≤1

   Time frame: Weeks 8, 16, 52, and 104

4. Proportion of Participants in Clinical Remission Based on Partial Mayo Score

   Clinical Remission is defined as a partial Mayo score \<2 points with 0 points regarding rectal bleeding.

   Time frame: Weeks 8, 16, 52 and 104

5. Proportion of Participants in Clinical Response Based on Partial Mayo Score

   Clinical Response is defined as a partial Mayo score decrease of ≥2 points and reduction of at least 25% in partial Mayo (pMayo) score from baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point

   Time frame: Weeks 8, 16, 52 and 104

6. Proportion of Participants in Steroid-Free Clinical Remission

   Steroid-Free Clinical Remission is defined by a total Mayo Score who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit (for all patients and for those treated with corticosteroids at baseline)

   Time frame: Baseline, weeks 8, 16, 52, and 104

7. Change from Baseline in Total Mayo Score

   Time frame: Baseline, Weeks 8, 16, 52, and 104

8. Change From Baseline In Partial Mayo Score

   Time frame: Baseline, Weeks 8, 16, 52 and 104

9. Change From Baseline In Level of Fecal Calprotectin (f-calprotectin)

   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.

   Time frame: Baseline, Weeks 8, 16, 52 and 104

10. Proportion of Responders defined by a Fecal Calprotectin (f-calprotectin) Reduction of ≥50%, ≥75% or ≥90%

    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.

    Time frame: Weeks 8, 16, 52, and 104

11. Change from Baseline of C-Reactive Protein (CRP)

    Time frame: Baseline, Weeks 8, 16, 52, and 104

12. Proportion of Participants In Sustained Remission (Partial Mayo score)

    Time frame: Week 8 To Weeks 16, 52 and 104

13. Proportion of Participants In Sustained Remission (Partial Mayo score)

    Time frame: Week 16 To Weeks 52 and 104

14. Proportion of Participants in Sustained Steroid Free Remission (Partial Mayo Score) (for all patients and for those treated with corticosteroids at baseline)

    Time frame: Weeks 16 through 52 and at Week 104

15. Proportion of Participants in Endoscopic Remission, Mucosal Healing or Endoscopic Response

    Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.

    Time frame: Week 8, 16, 52 and 104

16. Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response

    Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.

    Time frame: Week 8 to Week 16, 52 and 104

17. Proportion of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response

    Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.

    Time frame: Week 16 to 52 and at Week 104

18. Proportion of Participants in Sustained Steroid Free Remission (Partial Mayo Score) (For All Participants and for Those Treated With Corticosteroids at Baseline) and Endoscopic Remission, Mucosal Healing or Endoscopic Response

    Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.

    Time frame: Week 16 to 52 and 104

19. Change From Baseline In Inflammatory Bowel Disease Fatigue (IBD-F) Score

    Time frame: Baseline, Weeks 8, 16, 52 and 104

20. Change From Baseline In EuroQol 5 Dimensions 5 Levels (EQ5D-5L)

    Time frame: Baseline, Weeks 8, 16, 52, and 104

21. Change From Baseline In Short Health Scale (SHS)

    Time frame: Baseline, Weeks 8, 16, 52 and 104

22. Proportion of Participants Who Had a Colectomy

    Time frame: Weeks 8, 16, 52, and 104

23. Comparison of Response and Remission (Partial Mayo Score) Based on the Extent of Ulcerative Colitis According To the Montreal Classification

    Time frame: Weeks 8, 16, 52 and 104

24. Proportion of Participants In Sustained Remission (Total Mayo score)

    Time frame: Week 16 To Weeks 52 and 104

25. Proportion of Participants In Sustained Remission (Total Mayo score)

    Time frame: Week 8 To Weeks 16, 52 and 104

26. Proportion of Participants in Sustained Steroid Free Remission (Total Mayo Score) (For All Participants and for Those Treated With Corticosteroids at Baseline) and Endoscopic Remission, Mucosal Healing or Endoscopic Response

    Endoscopic remission is defined as a subscore of 0. Mucosal healing is defined as a subscore of 0-1. Endoscopic response is defined as a subscore reduction from baseline of ≥1.

    Time frame: Week 16 to 52 and 104

27. Proportion of Participants in Sustained Steroid Free Remission (Total Mayo Score) (for all patients and for those treated with corticosteroids at baseline)

    Time frame: Weeks 16 through 52 and at Week 104

28. Comparison of Response and Remission (Total Mayo Score) Based on the Extent of Ulcerative Colitis According To the Montreal Classification

    Time frame: Weeks 8, 16, 52 and 104

29. Proportion of Participants in Steroid-Free Clinical Remission

    Steroid-Free Clinical Remission is defined by a partial Mayo Score who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit (for all patients and for those treated with corticosteroids at baseline)

    Time frame: Baseline, weeks 8, 16, 52, and 104

30. Proportion of participants reaching f-calprotectin below 250 mg/kg of those that had f-calprotectin above 250 mg/kg at 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.

    Time frame: Baseline, week 8, 16, 52 and 104

31. Portion of participants with dose change of tofacitinib

    Time frame: Week 8, 16, 52 and 104

32. Portion of participants with a termination of tofacitinib

    Time frame: Week 8, 16, 52 and 104

33. Portion of participants with dose and dose changes of tofacitinib and corticosteroids

    Time frame: Week 8, 16, 52 and 104

34. Proportion of particpants with changes in rectal bleeding and stool frequency

    Proportion of patients with improvement in rectal bleeding and stool frequency with a change in baseline sub score 1

    Time frame: Baseline, Week 2

35. Proportion of participants with changes in EQ5D and SHS

    Time frame: Baseline, Week 2

36. Proportion of particpants with rectal bleeding and stool frequency sub score indicative of mild disease

    Time frame: Baseline, Week 2

37. Proportion of participants with stool frequency and rectal bleeding subscore of 0

    Time frame: Baseline, Week 2

38. Proportion of participants with mild abdominal pain

    Time frame: Baseline, week 2, 8, 16, 52 and 104

39. Proportion of participants with no abdominal pain

    Time frame: Baseline, week 2, 8, 16, 52 and 104

40. Proportion of participants with no bowel urgency

    Time frame: Baseline, Weeks 2, 8, 16, 52 and 104.

41. Proportion of participants with reduction of ≥ 1 point from baseline rectal bleeding and stool frequency sub score

    Time frame: Baseline, Week 2

42. Proportion of patients achieving symptomatic remission

    Symptomatic remission is defined as a total sum of 0 of the to Mayo sub-scores stool frequency(SF) and rectal bleeding (RB)

    Time frame: Baseline, weeks 2, 8, 16, 52 and 104.

43. Proportion of patients achieving symptomatic remission stratified on steroid use at baseline or not.

    Time frame: Baseline, weeks 2, 8, 16, 52 and 104

44. Proportion of patients achieving symptomatic response

    Symptomatic response is defined as a decrease of at least 50% of the sum of the Mayo-sub-scores stool frequency (SF) and rectal bleeding (RB).

    Time frame: Baseline, weeks 2, 8, 16, 52 and 104

45. Proportion of patients achieving symptomatic response stratified on steroid use at baseline

    Time frame: Baseline, weeks 2, 8, 16, 52 and 104

46. Proportion of patients in steroid-free clinical remission (pMayo and full Mayo score)stratified based on steroid use at baseline or not.

    Steroid-Free Clinical Remission is defined by a partial Mayo Score who did not require any corticosteroid treatment during the period ≥4 weeks prior to the visit (for all patients and for those treated with corticosteroids at baseline)

    Time frame: Baseline, weeks 8, 16, 52 and 104

47. Change from baseline in bowel urgency (as measured by SCCAI)

    SCCAI is the Simple Clinical Colitis Activity Index bowel urgency sub-score used to assess the bowel urgency.

    Time frame: Weeks 2, 8, 16, 52 and 104

Publications

• Nyberg L, Halfvarson J, Soderling J, Olen O, Strid H, Hedin CRH, Jonsdottir SB, Hjortswang H, Jaghult S, Cappelleri JC, Henrohn D, Seddighzadeh M, Marsal J, Grip O; SWIBREG ODEN Study Group. Prospective observational study of tofacitinib in ulcerative colitis - analysis of clinical data, fatigue and health-related quality of life during the induction phase. Ther Adv Gastroenterol. 2025 Jun 16;18:17562848251343427. doi: 10.1177/17562848251343427. eCollection 2025. PubMed 40535533 ↗

Related links

• To obtain contact information for a study center near you, click here. ↗

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.