Retrospective Non-interventional Multicenter Patient Chart Data Study on Tofacitinib Realworld Experience in Ulcerative Colitis in Finland (FinTofUC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Age at the Time of Diagnosis
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Age at the Time of Diagnosis
Time Frame: At diagnosis (anytime between Jan 2010 and Dec-2021, approximately 12 years (from data collected and analyzed retrospectively over 5 months)
Participant's age at the time of ulcerative colitis diagnosis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.
Duration of Ulcerative Colitis
Time Frame: At index (from data collected and analyzed retrospectively over 5 months)
Duration of ulcerative colitis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.
Number of Participants With Extent of Colonic Involvement According to the Montreal Classification
Time Frame: At index (from data collected and analyzed retrospectively over 5 months)
Montreal classification was used to classify UC based on extent of inflammation. Three subgroups of UC were: E1= ulcerative proctitis: involvement limited to rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided, distal colitis: involvement limited to portion of colorectum distal to splenic flexure and E3= extensive UC (pancolitis): involvement extends proximal to the splenic flexure. Index was considered as date of initiation of tofacitinib treatment for UC.
Mayo Score at Initiation of Tofacitinib
Time Frame: At index (from data collected and analyzed retrospectively over 5 months)
Mayo score was composed of four components: rectal bleeding, stool frequency, physician (doctors) assessment of disease activity, and endoscopy findings. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Mayo scores and sub-scores have been collected by doctors independently as part of standard of care.
Partial Mayo Score at Initiation of Tofacitinib
Time Frame: At index (from data collected and analyzed retrospectively over 5 months)
Partial Mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician (doctors) assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Partial Mayo scores and sub-scores have been collected by doctors independently as part of standard of care.
Number of Participants According to Endoscopic Findings Based on Histology
Time Frame: At index (from data collected and analyzed retrospectively over 5 months)
Endoscopic findings were graded from 0 to 3 where 0 = Normal or inactive disease (Normal vascular pattern with arborization of capillaries clearly defined, or with blurring or patchy loss of capillary margins), 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration). Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.
Number of Participants According to Endoscopic Sub Score Based on Mayo Score
Time Frame: At index (from data collected and analyzed retrospectively over 5 months)
Endoscopic findings were graded from 0 to 3 where 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 3 = Severe disease (spontaneous bleeding, ulceration). Mayo score was composed of four components: rectal bleeding, stool frequency, physician assessment of disease activity and endoscopy findings. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.
Secondary Outcomes
- Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- 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(Week 8, Week 16, Week 24 and Week 52)
- 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(Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months(At 1, 2, 3, 6, 12, 24 and 36 months)
- Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline(Week 8, Week 16, Week 24 and Week 52)
- 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(Baseline, Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 8 to Week 16, Week 24, and Week 52(From Week 8 to Week 16, Week 24, and Week 52)
- Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 8 to Week 16, Week 24, and Week 52(From Week 8 to Week 16, Week 24 and Week 52)
- Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52(From Week 16 to Week 24 and Week 52)
- Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52(From Week 16 to Week 24 and Week 52)
- Percentage of Participants in Sustained Steroid Free Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52(From Week 16 to Week 24 and Week 52)
- Percentage of Participants in Sustained Steroid Free Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52(From Week 16 to Week 24 and Week 52)
- Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52(From Week 8 to Week 16, Week 24 and Week 52)
- Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- 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(From Week 8 to Week 16, Week 24 and Week 52)
- 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(From Week 8 to Week 16, Week 24 and Week 52)
- 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(Week 8, Week 16, Week 24, and Week 52)
- 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(Week 8, Week 16, Week 24, and Week 52)
- 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(Week 8, Week 16, Week 24, and Week 52)
- 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(Week 8, Week 16, Week 24, and Week 52)
- Percentage of Participants With Corticosteroid Tapering at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Tapering Rate(Up to Week 52)
- Corticosteroid Tapering Dose(Up to Week 52)
- 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(Week 8, Week 16, Week 24 and Week 52)
- Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- 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(Week 8, Week 16, Week 24 and Week 52)
- Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- 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(Week 8, Week 16, Week 24 and Week 52)
- Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants With Extended Tofacitinib Induction Dose at Week 8, Week 16(Week 8 and Week 16)
- Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52(Week 8, Week 16, Week 24 and Week 52)
- Time to Drug Discontinuation, Colectomy or UC-related Hospitalization(Up to Week 52)
- Number of Previous Treatments(Up to Week 52)
- Number of Participants According to Type of Previous Treatment(Up to Week 52)
- 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(Week 8, Week 16, Week 24 and Week 52)
- 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(Week 8, Week 16, Week 24 and Week 52)
- Percentage of Participants That Had f-Calprotectin Above 250 mg/kg at Baseline(At index (date of initiation of tofacitinib treatment for ulcerative colitis))
- Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52(Baseline, Week 8, Week 16, Week 24 and Week 52)
- 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(From Week 16 to Week 24 and Week 52)
- 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(From Week 16 to Week 24 and Week 52)
- 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(From Week 8 to Week 16, Week 24 and Week 52)
- 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(From Week 8 to Week 16, Week 24 and Week 52)
- Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline(At index (from data collected and analyzed retrospectively over 5 months))