Introduction. The purpose of this study was to describe the clinical and demographic characteristics of UC in Bahia, a Brazilian state, and to identify the variables associated with extensive colitis, steroid therapy, immunosuppression, and colectomy. Methods. In this cross-sectional study UC patients were interviewed, and additional information was collected from the medical records. Descriptive statistics and multivariate Poisson regression analysis were used. Results. This study included 267 individuals, the mean age of whom was 39.4 years at diagnosis. There was a predominance of females and left-side colitis. Extensive colitis was positively associated with male gender, diarrhea, weight loss, and a younger age at diagnosis. In contrast, active smoking and a family history of IBD were negatively associated with extensive colitis. Positive associations were observed between steroid therapy and diarrhea, weight loss, urban patients, extraintestinal manifestations (EIMs), and hospitalization. Younger age and weight loss at diagnosis, a family history of IBD, extensive colitis, EIMs, hospitalization, and steroid therapy were all positively associated with immunosuppression. In contrast, Caucasian individuals, smokers, patients with rectal bleeding, and rural patients areas were all observed to have a decreased likelihood of immunosuppression. Conclusions. Our results corroborate the association between higher prevalence of extensive colitis and younger age at diagnosis. An association between steroid therapy and clinical presentation at diagnosis was observed. The observation that white individuals and rural patients use less immunosuppressive drugs highlights the need to study the influence of environmental and genetic factors on the behavior of UC in this population.

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...

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...

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Introduction: Congenital midline cervical cleft is a rare condition and is frequently misdiagnosed as thyroglossal duct cyst. Otherwise, the combination of congenital midline cervical cleft and thyroglossal duct fibrosis in the same patient is as rare as important to be registered with the intention to inform and offer specific managements details for the literature. Case Presentation: Eight-year-old boy with simultaneous congenital midline cervical cleft and a thyroglossal duct fibrosis. The anatomic, clinical, radiologic, and pathologic characteristics of the congenital midline cervical cleft are described as well as surgical technique for removal and repair with Z-plasty. Conclusion: Congenital midline cervical cleft is a rare condition and when diagnosed must be surgically treated as early as possible. Its differential diagnosis is a clinical challenge.