BackgroundChildhood-onset systemic lupus erythematosus (cSLE) is a chronic autoimune disease with fluctuating disease activity. Neurospichiatric manifestations are common and vary from common manifestations such as headache and anxiety to life threatening manifestations such as acute confusional syndrome. Ataxia has not been studied frequently in cSLE.ObjectivesTo determine the prevalence of ataxia in cSLE and clinical, laboratory and treatment features associated with its occurrence. To determine neuroimaging features associated with ataxia, especially medullary area and cerebellar volume.MethodsWe included 62 cSLE patients followed at the State university of Campinas and 28 healthy controls with similar age and gender distribution. All patients and controls were evaluated for ataxia using Scale for the assessment and rating of ataxia (SARA), validated in portugues. All subjects realized magnetic resonance imaging using a 3 tesla scanner (Phillips). Sagittal T1 1mm thick slices were used for analysis. Medullary area and excentricity and cerebellar volume were analyzed using semiautomatic computer segemntation software (SpineSeg and Neuroline).ResultsWe observed ataxia in 22 out of 62 (35.5%) patients and in none of the controls (p=0.002). Ataxia was associated with the presence of neuropsychiatric manifestations (p=0.003) and antifosfolipid antibodies (p=0.005). None of the other clinical, laboratory or treatment features were associated with ataxia. Medullary area was significant smaller in cSLE when compared to controls (p=0.002). Reduction of medullar area was associated with cumulative corticosteroid dose (r=-0.43; p=0.008) and the presence of ataxia (p=0.003). Cerebellar volume was significantly reduced in cSLE patients when compared to controls (p<0.001). Cerebellar atrophy was associated with medullary area (r=0.46; p=0.001). None of the other clinical, laboratory and treatment features were associated with cerebellar volume.ConclusionsAtaxia is frequently observed in cSLE and associated with neuropsychiatric manifestations and antiphospholipid antibodies. Neuroimaging features, especially medullary volume is associated with ataxia and cerebellar atrophy may be secondary.Disclosure of InterestNone declared
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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