Long-term safety of ustekinumab in Crohn's disease: Descriptive analysis from an observational post-authorisation safety study using I-CARE cohort data

Background Limited data are available from large, prospective cohort studies evaluating the long-term safety of ustekinumab in patients with Crohn's disease. Aims To evaluate the long-term safety profile of ustekinumab in adult patients with Crohn's disease. Methods RRA-20745 was an observational post-authorisation safety study. Data were derived from the I-CARE study (NCT02377258), a European prospective, observational, multi-centre cohort study. Malignancies, serious infections (including opportunistic infections and tuberculosis), and venous thromboembolism associated with hospitalisations were evaluated. Results Data for 878 patients with Crohn's disease who received ustekinumab (mean follow-up 37.8 months), were included (median age 37.4 years, 58.9 % female, 64.5 % incident ustekinumab users and 35.5 % prevalent users). There were 7 malignancies reported in 7 patients (by organ affected: skin, 3 patients [0.4 %], blood, lymph nodes, rectum, breast, 1 patient [0.1 %] each). Serious infections were reported by 16 (1.8 %) patients (6 prevalent users, 10 incident users). The most common serious infections were gastrointestinal (7 patients, 0.8 %), followed by pulmonary infections (3 patients, 0.3 %). 1 patient (0.1 %; prevalent cohort) reported a bacterial opportunistic infection. No patients reported tuberculosis or venous thromboembolism. Conclusions In the RRA-20745 observational cohort, ustekinumab had a safety profile consistent with that observed in clinical trials and available post-marketing data. Trial registration number NCT02377258.