Abstract
Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.
Highlights
Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world
More than 10% of patients had some concomitant immune-mediated disease: rheumatoid arthritis (7 patients, 3.7%), psoriasis (5 patients, 2.6%), ankylosing spondylitis (3 patients, 1.6%), and other diseases (5 patients, 2.6%)
We assessed the persistence with golimumab up to 4 years in patients with ulcerative colitis (UC) in real world
Summary
Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients. The primary aim of this study was to estimate the probability of long-term persistence with golimumab therapy in patients with UC in real life. Secondary aims were to ascertain rates of hospitalisation, surgery, and adverse events during follow-up; to establish if there are differences between patients previously treated with anti-TNF and naive patients; and to assess possible factors associated with long-term persistence of golimumab
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