Golimumab Use in Bio-experienced Ulcerative Colitis Patients

Abstract

Introduction: Golimumab is a human anti-tumor necrosis factor alpha (TNF- α) antibody approved for the treatment of moderate to severe ulcerative colitis (UC) in adults. It was found to be more efficacious compared to placebo in bio-naïve patients with ulcerative colitis. Due to the exclusion of patients with prior biologic experience in the PURSUIT trials, limited data exists in this population. The aim of our study is to evaluate the efficacy of golimumab in bio-experienced patients (as a second or third line anti-TNF agent) in comparison to bio-naive UC patients.Figure 1Figure 2Figure 3Methods: We performed a retrospective chart review of moderate to severe UC patients treated with golimumab at Fondren IBD clinic in Houston Methodist Hospital. Data for patient demographics, disease duration, location, severity, concomitant immunomodulator therapy and prior biologic use in these patients was collected. Clinical and biochemical parameters used to predict response (UC disease activity index(UCDAI), ESR, CRP, albumin levels) were obtained at first visit prior to initiation of golimumab and at subsequent visits post induction. Categorical and continuous variables were compared using chi square and t-test respectively. All p values calculated were two-tailed with 0.05 alpha level of significance. Results: 20 patients with an average age of 39.4 +/-13.4 years (mean +/- SD) were included in the study. See Table 1. The mean follow-up duration between the 1st and 2nd visit was 127.8 +/-83 days (mean +/- SD). Golimumab was used in 10 bio-experienced patients. Result details are shown in table 2. There was a definite drop in UCDAI scores in our patients (7.75 +/-5.2 to 3.9 +/- 4.6), regardless of them being bio-naïve or experienced. Interestingly, a paradoxical trend of ESR and CRP was noted. Patients receiving golimumab as first line biologic had decreased ESR and increased CRP whereas bio-experienced patients had reduced CRP and higher ESR. Mucosal healing was demonstrated in 3 patients who underwent endoscopy after initiation of golimumab (Mayo endoscopy score of 0). Conclusion: This is the first study which reports the endoscopic efficacy of golimumab in bio-experienced patients. Golimumab seems to be a promising therapy for patients with moderate to severe UC. Our results show that regardless of its use in bio-experienced patients as second or third line anti-TNF therapy, there is a significant improvement in UCDAI scores after treatment. Larger study designs will help better delineate this finding.