Infliximab therapy for moderately severe Crohn’s disease and ulcerative colitis: a retrospective comparison over 6 years

Abstract

Background:Infliximab has shown benefit in Crohn’s disease (CD) and ulcerative colitis (UC).Objective:Evaluation of long-term outcome of therapy for both diseases.Methods:We analyzed retrospectively patients treated at infusion centers from one institution. Demographic, laboratory parameters leading up to biologic therapy and the subsequent pattern of outcomes in either disease were established as a database. Initial failure, subsequent need to change therapy, or need to adjust therapy were evaluated. Kruskal–Wallis (nonparametric) tests to compare two groups and Kaplan–Meier survival curve analysis were used to compare outcomes.Results:Over approximately 6 years, 71 CD and 26 UC patients received 999 and 215 infusions, respectively, for a median of 62 months. Of these, 17% for CD and 19% for UC patients were primary failures. Following the start of infliximab, 18% of CD and 11% of UC patients required stoppage and switching to another type of therapy. In either CD or UC patients, 54% or 62%, respectively, continued therapy without the need to change to other treatments. Few serious side effects were noted. No important statistically significant differences in treatment patterns or outcome were observed between the groups.Discussion:Long-term treatment of both inflammatory bowel diseases reflects outcomes of clinical trials.Conclusions:This study emphasizes similarities between CD and UC and reports therapeutic success for an extended time.

Ashkenazi Jewish Origin Protects Against Formation of Antibodies to Infliximab and Therapy Failure

“…Seow et al 33 reported that ATI development rates were significantly higher in UC patients in comparison with previous reports concerning CD patients, but in another study, no statistically significant difference in therapy outcome between the groups was found. 34 In our study, no difference was discernible as to either ATI formation or infliximab therapy failure in UC versus CD patients, although the number of UC patients was limited (n = 34) so the study may be underpowered to detect such difference.…”

Surgery in the age of biologics

“…Median follow-up in this group was 4.5 years; importantly, however, primary non-responders were excluded. A single-center retrospective study in Canada demonstrated a markedly lower surgical rate, with only 5/71 (7%) with a median follow-up of 62 months [36]. There have been several other studies with shorter follow-up whose rates of surgery in biologic-treated patients range from 15% to 33% [37, 38, 40].…”

“…(2013) [35]1993–2010Retrospective multi-center276*Infliximab18% no prior surgery for CD; 24% prior surgery for CD54 months (median)Alzafir et al . (2011) [36]2002–2008Retrospective single-center71Infliximab7%62 months (median)Caviglia et al . (2007) [37]1999–2005Retrospective single-center40Infliximab20%27 months (median)Ljung et al .…”

A Narrative Systematic Review and Categorisation of Outcomes in Inflammatory Bowel Disease to Inform a Core Outcome Set for Real-world Evidence

“…The concept of a COS, ''an agreed standardised set of outcomes that should be measured and reported as a minimum in all clinical studies and trials in specific areas of health or health care'', was pioneered in Rheumatology 8 and the success in overcoming recognised universal outcome research barriers, was instrumental in the inception of the Core Outcome Measures in Effectiveness Trials (COMET) initiative subsequently adopted by other specialities. The COMET database currently holds nine registered IBD projects: six systematic reviews to inform the development of COS focusing on efficacy and safety in clinical trials in paediatric IBD, 9 IBD, 10 UC, 11 pouchitis, 12 fistulising perianal CD, 13 and CD 14 , and three COS development studies for fistulising perianal CD, 15 patient-centred outcomes in IBD, 16 and paediatric IBD. 17 There is no registered COS for RWE in IBD.…”