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* = Presenting author

P583 Real-world use and effectiveness of golimumab for ulcerative colitis in Canada

B. Bressler1, M. Williamson*2, F. Camacho3, B. Sattin2, A. H. Steinhart4

1University of British Columbia, Vancouver, Canada, 2Janssen Inc, Toronto, Canada, 3Damos Inc, Toronto, Canada, 4University of Toronto, Toronto, Canada

Background

The efficacy of golimumab (GLM) to induce and maintain remission in biologic-naïve patients with ulcerative colitis (UC) is well established from controlled clinical trials. However, GLM’s real-world effectiveness, important to physicians and payors, remains largely unexplored. The aim of this study was to describe the real-world use of GLM, to examine the rate of persistence of GLM therapy in a large cohort of Canadian patients with UC, and to assess factors that predict discontinuation during GLM maintenance treatment of UC.

Methods

In Canada, patients with UC treated with GLM are managed through a nationwide patient support programme (PSP), BioAdvance®. This PSP maintains records analogous to, but often more detailed than, claims databases (eg, patient demographics, prescription data, etc). We conducted a retrospective study of UC patients receiving GLM maintenance therapy from August 2012 to August 2015 following primary response to therapy (patients with incomplete data were excluded). Kaplan–Meier analysis was used to assess time to time to discontinuation, defined as no confirmed dose in > 60 days.

Results

In total, 136 UC patients (50.7% male) with a mean (SD) age of 44.4 (15.6) years were included in the analysis. The majority of patients (72.1%) treated with GLM were naïve to anti-tumour necrosis factors (TNF). The initial dose for the majority of the subjects in the analysis (77.6%) was 200 mg, and 71.6% received 100 mg of GLM q4wk as maintenance therapy. The median time to discontinuation was 530 days; approximately 63% remained on therapy after 1 year (Figure 1). Patients with prior anti-TNF-exposure did not appear to persist on therapy for less time than anti-TNF-naïve patients (550 vs 530 days, p > 0.05). A Cox proportional hazards model failed to detect any significant interaction between discontinuation and age, gender, GLM dose, or prior anti-tumour necrosis factor (TNF) exposure. Dose optimisation occurred in 3.6% of patients.

Figure 1. Kaplan-Meier survival curve showing rate of persistence in golimumab responders.

Conclusion

In this large national cohort, 63% of responders to GLM persisted on therapy after 1 year, and few underwent dose optimisation. The median time to GLM discontinuation was 530 days. This dataset represents the largest real-life analysis of GLM patients to date. This real-life cohort is consistent with others showing a substantiated rate of persistence compared with that seen in randomised controlled trials (RCTs).