The effectiveness and safety of infliximab compared with biosimilar CT-P13, in 3112 patients with ulcerative colitis.

ABSTRACT:

Background

CT-P13, a biosimilar of the reference product infliximab, has been approved for the treatment of ulcerative colitis on the basis of the results of trials conducted in patients with spondyloarthritis and rheumatoid arthritis.

Aim

To compare the effectiveness and safety of CT-P13 and the reference product in infliximab-naive patients with ulcerative colitis METHODS: A comparative real-life equivalence cohort study was conducted using the French nationwide health administrative database. Infliximab-naive patients with ulcerative colitis over 15 years of age who started infliximab with no other indications for infliximab were included. The primary outcome was a composite endpoint (death, ulcerative colitis-related surgery, all-cause hospitalisation and reimbursement f

SUBMITTER: Meyer A 

PROVIDER: S-EPMC6767082 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature