Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Vastra Gotaland Region

Status

Completed

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Treatments

Drug: Infliximab

Drug: Adalimumab

Study type

Observational

Funder types

Other

Identifiers

NCT06269185

2024_IFXvsADAinUC

Details and patient eligibility

About

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.

Enrollment

271 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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).