Background & Aims This study evaluates the long-term safety in all patients treated with infliximab for IBD in our hospital over a 14 year period.
Methods: The medical records of 734 infliximab and 666 not-infliximab treated IBD patients were reviewed for adverse events. Time of onset and outcome, severity and concomitant medication were recorded.
Results: Patients and controls were followed up for serious adverse events with a median follow-up of 58 (IQR 33-88) months and 144 months (IQR 83-.163) respectively. A total of 113 severe adverse events (SAE) occurred in 93 (13%) of the infliximab patients and 157 SAEs in 126 (19%) of the control patients (OR 1.33 (0.56- 3.00, p=0.45). There was no difference between the two groups in terms of mortality, malignancies and infection rate. Tuberculosis was diagnosed in two infliximab patients who had negative skin tests at baseline whereas none of 16 patients with positive skin tests who received prophylaxis developed tuberculosis. Concomitant therapy with steroids was the only independent risk factor for infections in infliximab treated patients [OR 2.69 (1.18-6.12), p=0.018]. The most commonly observed systemic side effects were skin eruptions including psoriasiform eruptions in 150 patients (20%).
Conclusions: Long-term infliximab therapy has a good safety profile overall in our cohort.