P146 - The short-term efficacy and safety of adalimumab in Crohn's disease (CD) patients – a retrospective study

Abstract

Background: Anti TNF-α blockers are increasingly used in IBD. Good short and long term effects were reported with infliximab. Adalimumab is a fully humanized anti TNF-α antibody with reported efficacy in remission induction and maintenance of CD in clinical studies. Only few post-marketing reports were published. Aim: To evaluate short-term efficacy and safety of adalimumab in the treatment of active CD. Methods: Demographic and clinical information as well as adverse events (AE) were retrospectively recorded for patients treated with adalimumab for at least 1 month. Treatment regimen was identical for all patients160 mg at week 0, 80 mg at week 2 and 40 mg every other week since week 4. Results: Forty patients with active CD were included, 21 females, average age 37.7±16.6 years. Disease duration was 12.2±10.6 years. Forty percent of the patients had inflammatory disease behavior, 30% penetrating, and 30% stricturing. A third was past or present smokers. Twenty-five patients (62%) were previously treated with infliximab. The major reason for stopping previous infliximab treatment was loss of response. CDAI was 383±114 at baseline and 169±108 after 3 months of adalimumab treatment (n=21, p<0.001). Moreover, remission at 3 months was 50% and in 80% a 100-point decrease in CDAI was observed. The shortterm effect of adalimumab in post infliximab patients was slightly lower compared to biologicnaive patients. Fifteen patients (37%) had AE. Injection site reactions in 4, vomiting and abdominal pain in 3, flu like symptoms in 3, headache and dizziness in 3, hypertension in 1 and hematuria in 1. There were no short-term infectious complications. Eight patients (20%) stopped adalimumab treatment-5 due to non-response and 3 due to AE (headache, hematuria and hypertension). Fifty percent of the patients who had AE to infliximab also had an AE to adalimumab. Patients treated with concomitant immunomodulators (n=8) or concomitant steroids and immunomodulators (n=4) had better clinical response at 3 months compared to those on concomitant steroids alone (n=5) (75, 75 and 20%, respectively, p= 0.22). Conclusions: Adalimumab is an effective short-term treatment for active CD. Patients naive to biologic treatments seem to have better shortterm response to adalimumab. Concomitant immunomodulators contribute to treatment efficacy. A fifth of the patients stopped treatment due to no response or side effects. Thus, a need for additional treatment strategies and preparations still exists.