Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

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.

Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

“…Looking at the other secondary points, we confirm the favorable safety profile of GOL. In fact, we recorded AEs in 7.9% of patients, lower than that reported by other longterm real-life studies [19][20][21][22][23]. However, it is hypothesized that the high rate of primary failure, with shorter follow-up, could influence these results.…”

“…But real-world studies showed different results. Looking at current real-life studies, focused on GOL persistence beyond 1-2 years, the remission maintenance occurred up to 27% at the 4th year of treatment [22,23]. Significantly, the unfavorable result of this study was obtained in patients naϊve to biologic therapy, while in other studies the better performances were obtained in their own patients [19,22,23].…”

“…However, these studies had generally a relatively small sample size, thus limiting the generalizability of their results and, more important, demonstrating a limited follow-up. To date, three studies have had a follow-up longer than 12 months with a probability of persistence in GOL and of maintenance of response at 1 year J Gastrointestin Liver Dis, ePub ahead printing ranging from 60 to 40% [19,22,23]. However, more studies would be useful to confirm these results.…”

Effectiveness and Safety Profiles of Biological Therapies in Inflammatory Bowel Disease: Real Life Data from an Active Pharmacovigilance Project

“…The treatment failures were mainly reported for GOL, which consistently remained the least frequently used anti-TNFα drug in UC and was used more frequently as a second- and third-line therapy [ 44 ]. Recent studies confirm that UC patients treated with GOL after previous failure of other anti-TNFα drugs had significantly worse outcomes [ 45 , 46 ], whereas the use of the i.v. anti-TNF IFX after failure of s.c. GOL or ADA led to better results [ 47 ].…”

Could Mucosal TNF Transcript as a Biomarker Candidate Help Optimize Anti-TNF Biological Therapy in Patients With Ulcerative Colitis?

“…However, being refractory to existing medicines and disease relapse have frequently been reported ( 8 , 9 ). In the case of drug- refractory disease relapse, alternative second line therapeutic strategies are currently used ( 10 , 11 ). Currently, neutralizing TNF monoclonal antibodies have been widely accepted as one of the standard strategies for the treatment of severe steroid or immunomodulator-refractory or -dependent IBD patients ( 12 ), which results in remarkably improved rates of disease remission and mucosal healing ( 12 ).…”