Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
infliximab, adalimumab, anti-TNF therapy
Brief summary
Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations. The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment.
Interventions
DRUGInfliximab
Infliximab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis
DRUGAdalimumab
Adalimumab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis
Sponsors
Vastra Gotaland Region
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-100 years. * Diagnosis of ulcerative colitis confirmed by endoscopy and histology. * Mild, moderate and severe disease activity. * Initiation of IFX or ADA-treatment at one of the centers of the study.
Exclusion criteria
* Clinical remission. * Previous colonic surgery (resection of colonic segment or colectomy). * Primary indication for anti-TNF therapy by other disease than UC. * Prior use of any anti-TNF or other biologic or small molecule therapy. * Rescue therapy (i.e. infliximab used on hospitalized patients receiving intravenous corticosteroids).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving steroid-free clinical remission | One year after start of anti-TNF therapy | Partial Mayo score ≤2 with no subscore \>1 and no use of steroids between 6 and 12 months after start of anti-TNF therapy (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving clinical response | Three months after start of anti-TNF therapy | A decrease in the partial Mayo score from baseline of 2 or more points, along with either a rectal bleeding subscore of 0 or 1 or a decrease in the rectal bleeding subscore of 1 point or more (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). |
| Percentage of patients achieving clinical remission | Three months after start of anti-TNF therapy | Partial Mayo score ≤2 with no subscore \>1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). |
| Percentage of patients achieving endoscopic response | 3-12 months after start of anti-TNF therapy | A decrease in endoscopic Mayo score of 1 or more points (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity). |
| Percentage of patients achieving endoscopic remission | 3-12 months after start of anti-TNF therapy | Endoscopic Mayo score 0-1 (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity). |
| Percentage of patients achieving biochemical remission | Three months after start of anti-TNF therapy | Fecal Calprotectin \<250 mg/kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively | Three months and one year after start of anti-TNF therapy | Partial Mayo score ≤2 with no subscore \>1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). |
Countries
Sweden
Outcome results
None listed