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P377. Safety profile and discontinuation rate of infliximab and adalimumab in patients with Crohn's disease and ulcerative colitis: experience from a tertiary care hospital in Qatar over a 7 year period

M. Sharma1, S. Al Kaabi1, N. Al Dweik1, A. John1, H. Wani1, K. Al Ejji1, M. Al Mohanadi1, M. Derbala1, R. Yacoub1, F. Pasic1, T. Butt1, M. ElBedawi2, R. Singh3, 1Hamad Medical Corporation, Medicine, Doha, Qatar, 2Weill Cornell Medical School in Qatar, Medicine, Doha, Qatar, 3Hamad Medical Corporation, CCS, Doha, Qatar

Background

Tumor Necrosis Factor (TNF) blockers (Infliximab and adalimumab) have been used in treatment of Crohn's disease (CD) and Ulcerative colitis (UC) with a good safety record. Recent reports indicate that discontinuation of treatment with these agents in Crohn's disease can result in relapse of disease.

Aim: To evaluate safety profile and discontinuation rate of infliximab and adalimumab in patients with Crohn's disease and Ulcerative colitis in Arabic population. Secondary aims included elucidating the reasons for discontinuation of drug.

Methods

All consecutive patients diagnosed with either CD or UC from January 2005-December 2011 at a tertiary health care centre were included. Among those, patient with moderate to severe disease who failed treatment with immunomodulators (“step-up approach”) or had predicted severe disease at onset, received either infliximab or adalimumab on a scheduled basis. All patients were followed up prospectively to assess response and side effects to the therapy. Patients with unclassified colitis or with less than 6 months of follow up were excluded from the study.

Results

In the study period, 364 patients were diagnosed with either Crohn's disease or Ulcerative Colitis. Of them, 58 subjects (16%) (CD 40, UC-18) received either infliximab or adalimumab. The mean age of the patients was 32 years and 35 were males. 52 (89.7%) patients were of Arabic origin. The mean duration of treatment was 26 months. Forty-seven patients (84%) had initial response to the treatment, five (8.4%) developed side-effects and two were lost to follow up. Among the side-effects, two developed anaphylactic reaction to infliximab, two developed severe sepsis along the treatment, one developed cytomegalovirus related retinitis and in one patient with testicular seminoma remained well despite treatment with infliximab.

Twenty-one patients (36.2%) discontinued treatment with anti-TNF drugs (CD-13, UC-8). Among patients with CD, seven patients discontinued treatment due to non response, three due to sustained clinical benefit, two due to serious adverse effects and one was lost to follow up. Among UC patients, three stopped treatment due to non response, two because of persistent clinical remission, two due to adverse effects and one was lost to follow up.

Conclusion

Infliximab and Adalimumab have a good safety profile in Arabic population on a long term basis. The main reason for discontinuation of these drugs is due to lack of response or achievement of clinical remission.