Addition of Azathioprine in IBD Patients With Immunogenic Failure

Launched by VÉDRINES, PHILIPPE, M.D. · Jun 25, 2018

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • IBD Patients in clinical failure under anti-TNF (Infliximab (IFX) or Adalimumab (ADA) in monotherapy at the optimal dose) ADA: 40mg/7 days, IFX: 10mg/kg/8 weeks Active disease CD: HBI \> 5 with Calprotectin \> 250 µg/g stool UC: Total Mayo Score \> 4 with an endoscopic subscore \> 1 Anti-TNF monotherapy for at least 4 months and optimization for at least two months
• • Patients with an immune mediated PK failure Undetectable rates of anti-TNF and high Ab against anti-TNFs \> 20ng/mL for ATI and AAA (Elisa Theradiag) on two consecutive samples
• • Patients who have agreed to and signed the consent form
• Exclusion Criteria:
• • Unclassified colitis
• • Pregnant woman
• • Crohn's disease CD with a exclusive anoperineal phenotype
• • Contraindication or intolerance to azathioprine
• • Primary non-responder patients To the first anti-TNF or After the switch to a - second anti-TNF
• • Ostomy