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.