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.
The aim of the study in these patients with an immune mediated pharmacokinetic failure was to compare two strategies: Switch to a second anti-TNF alone or switch to a second anti-TNF with addition of azathioprine Comparing rates of clinical failure, rates of immunogenic failure and finally adverse events during a follow-up of 24 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
impact of addition of azathioprine after a switch of a second anti-TNF agent
Switch to a second anti-TNF drug alone without addition of azathioprine
Clinic of Montbrison
Montbrison, Pays de la Loire Region, France
RECRUITINGclinical failure
clinical relapse or serious adverse event requiring stopping treatment during follow up
Time frame: 24 months
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