Addition of Azathioprine in IBD Patients With Immunogenic Failure

Phase 4 Unknown 90 enrolled Védrines, Philippe, M.D.

RandomizedParallel-groupOpen-labelTreatment

Summary

Loss of response under anti-TNF is frequent. 20% of patients with clinical relapse present an immune mediated pharmacokinetic failure. In the last AGA recommendations, switch to another anti-TNF drug is suggested with no indication of immunosuppressive agent. In a recent study, 70% of patients with an immunogenic failure to a first anti-TNF agent developed a new immunogenic failure to the second anti-TNF drug using alone.

Timeline

Start: 2018-07-23
Primary completion: 2019-06-10
Completion: 2020-06-10

Publications

Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azathioprine	Small molecule	2.5 mg/kg	—
Background	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Background	Infliximab	Monoclonal antibody	5 mg/kg	Intravenous

Indications

No indication recorded.