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.
Study Type
OBSERVATIONAL
Enrollment
271
Infliximab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis
Adalimumab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis
Västra Götalandsregionen
Gothenburg, Sweden
Percentage of patients achieving steroid-free clinical remission
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).
Time frame: One year after start of anti-TNF therapy
Percentage of patients achieving clinical response
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).
Time frame: Three months after start of anti-TNF therapy
Percentage of patients achieving clinical remission
Partial Mayo score ≤2 with no subscore \>1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).
Time frame: Three months after start of anti-TNF therapy
Percentage of patients achieving biochemical remission
Fecal Calprotectin \<250 mg/kg
Time frame: Three months after start of anti-TNF therapy
Percentage of patients achieving clinical remission
Partial Mayo score ≤2 with no subscore \>1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).
Time frame: One year after start of anti-TNF therapy
Percentage of patients achieving biochemical remission
Fecal Calprotectin \<250 mg/kg
Time frame: One year after start of anti-TNF therapy
Percentage of patients achieving endoscopic response
A decrease in endoscopic Mayo score of 1 or more points (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity).
Time frame: 3-12 months after start of anti-TNF therapy
Percentage of patients achieving endoscopic remission
Endoscopic Mayo score 0-1 (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity).
Time frame: 3-12 months after start of anti-TNF therapy
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