P-061 Clinical and Demographic Characteristics Associated with Extensive Colitis in Patients with UC in Two Reference Centers at Salvador, Bahia/Brazil

Abstract

BACKGROUND: Ulcerative colitis (UC) affects between 37 and 238 people per 100,000 in the United States. Golimumab (GLM), an anti-TNF therapy, was recently approved for the treatment of moderate to severe UC. Increasing concerns about the budgetary impact of biologic therapies has intensified the need to understand the cost implications of their use. The primary objective of this study was to assess the cost per unit of effectiveness and number needed to treat (NNT) of patients receiving maintenance therapy of GLM after achieving clinical response during an induction period. METHODS: A cost effectiveness model was developed using the results of the PURSUIT-Maintenance (PURSUIT-M) study, a 54 week Phase 3 randomized, placebo-controlled, double-blind maintenance study of the safety and efficacy of GLM among individuals who had not used biologic therapy previously. This analysis evaluated the placebo-adjusted cost per clinical response, clinical remission, and mucosal healing. Clinical response was measured as sustained clinical response through week 54. Clinical remission was measured at week 30 and week 54. Patients had to be in clinical remission at both time periods. Mucosal healing was measured at the same time points and manner as clinical remission. The number needed to treat (NNT) was calculated for each of these endpoints. The PURSUIT-M study included a GLM 100 mg and GLM 50 mg treatment arms. However, the 50 mg treatment arm was excluded since it is not the FDA-approved labeled dose. Medication costs were calculated by applying the July, 2013 wholesale acquisition costs based on the FDA-labeled dosing requirements. RESULTS: The cost per clinical response and NNT for clinical response of GLM was $184,690 and 6, respectively. The cost per remission and the NNT for patients in remission was $268,640, and 8, respectively. The cost per mucosal healing and NNT of mucosal healing was $213,617 and 7, respectively. CONCLUSIONS: This analysis revealed that the cost effectiveness of GLM for the maintenance therapy of UC ranged from $184,690 for clinical response to $268,640 for clinical remission. The NNT ranged from 6 to 8 for the endpoints studied. Further studies using real-world data may provide a better understanding of the cost effectiveness of anti-TNF therapies and allow comparisons among different medications.BACKGROUND: The influence of clinical features, such as duration and disease activity, complications, intestinal resection, and use of corticosteroids on bone mineral density (BMD) in ulcerative colitis (UC) patients is already defined. However, the association between BMD and nutritional factors is still controversial and poorly investigated. The aim of this study was to evaluate the anthropometric features, body composition and BMD in UC patients. METHODS: Cross-sectional study with 65 adult outpatients, recruited from 2 reference centers of inflammatory bowel disease, in the city of Salvador, Bahia, Brazil. Between September/2012 and March/2013, patients underwent to anthropometric evaluation (body ma...