BACKGROUNDInflammatory bowel diseases (IBD) have been associated with a low quality of life (QoL) and a negative impact on work productivity compared to the general population. Information about disease control, patient-reported outcomes (PROs), treatment patterns and use of healthcare resources is relevant to optimizing IBD management.AIMTo describe QoL and work productivity and activity impairment (WPAI), treatment patterns and use of healthcare resources among IBD patients in Brazil.METHODSA multicenter cross-sectional study included adult outpatients who were previously diagnosed with moderate to severe Crohn’s disease (CD) or ulcerative colitis (UC). At enrolment, active CD and UC were defined as having a Harvey Bradshaw Index ≥ 8 or a CD Activity Index ≥ 220 or calprotectin > 200 µg/g or previous colonoscopy results suggestive of inadequate control (per investigator criteria) and a 9-point partial Mayo score ≥ 5, respectively. The PRO assessment included the QoL questionnaires SF-36 and EQ-5D-5L, the Inflammatory Bowel Disease Questionnaire (IBDQ), and the WPAI questionnaire. Information about healthcare resources and treatment during the previous 3 years was collected from medical records. Chi-square, Fisher’s exact and Student’s t-/Mann-Whitney U tests were used to compare PROs, treatment patterns and the use of healthcare resources by disease activity (α = 0.05).RESULTSOf the 407 patients in this study (CD/UC: 64.9%/35.1%, mean age 42.9/45.9 years, 54.2%/56.6% female, 38.3%/37.1% employed), 44.7%/25.2% presented moderate-to-severe CD/UC activity, respectively, at baseline. Expressed in median values for CD/UC, respectively, the SF-36 physical component was 46.6/44.7 and the mental component was 45.2/44.2, the EQ-visual analog scale score was 80.0/70.0, and the IBDQ overall score was 164.0/165.0. Moderate to severe activity, female gender, being unemployed, a lower educational level and lower income were associated with lower QoL (P < 0.05). Median work productivity impairment was 20% and 5% for CD and UC patients, respectively, and activity impairment was 30%, the latter being higher among patients with moderate to severe disease activity compared to patients with mild or no disease activity (75.0% vs 10.0%, P < 0.001). For CD/UC patients, respectively, 25.4%/2.8% had at least one surgery, 38.3%/19.6% were hospitalized, and 70.7%/77.6% changed IBD treatment at least once during the last 3 years. The most common treatments at baseline were biologics (75.3%) and immunosuppressants (70.9%) for CD patients and 5-ASA compounds (77.5%) for UC patients.CONCLUSIONModerate to severe IBD activity, especially among CD patients, is associated with a substantial impact on QoL, work productivity impairment and an increased number of IBD surgeries and hospitalizations in Brazil.

Objective: The objective of this study is to evaluate the performance of mathematical models used in non-invasive diagnosis of liver fibrosis in nonalcoholic fatty liver disease (NAFLD) patients to determine when the patient needs to be referred to a hepatologist. Subjects and methods: Patients referred by endocrinologists to the liver outpatient departments in two hospitals in Curitiba, Brazil, over a 72-month period were analyzed. The results calculated using the APRI, FIB 4, FORNS and NAFLD Fibrosis Score non-invasive liver fibrosis assessment models were analyzed and compared with histological staging of this population. Results: Sixty-seven patients with NAFLD were analyzed. Forty-two of them (62.68%) were female, mean age was 54.76 (±9.63) years, mean body mass index 31.42 (±5.64) and 59 (88.05%) of the 67 cases had glucose intolerance or diabetes. A diagnosis of steatohepatitis was made in 45 (76.27%) of the 59 biopsied patients, and advanced liver fibrosis (stages 3 and 4) was diagnosed in 18 (26.86%) of the 67 patients in the study population. The FIB 4 and NAFLD Fibrosis Score models had a high negative predictive value (93.48% and 93.61%, respectively) in patients with severe liver fibrosis (stages 3 and 4). Conclusion: In conclusion, use of the FIB 4 and NAFLD Fibrosis Score models in NAFLD patients allows a diagnosis of severe liver disease to be excluded. Arch Endocrinol Metab. 2017;61(3):276-81.

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-Background -Primary hypolactasia is a common condition where a reduced lactase activity in the intestinal mucosa is present. The presence of abdominal symptoms due to poor absorption of lactose, which are present in some cases, is a characteristic of lactose intolerance. Objective -Evaluate the efficacy of a product containing exogenous lactase in tablet form compared to a reference product with proven effectiveness in patients with lactose intolerance. Methods -Multicentre, randomized, parallel group, single-blind, comparative non-inferiority study. One hundred twenty-nine (129) adult lactose intolerance patients with hydrogen breath test results consistent with a diagnosis of hypolactasia were randomly assigned to receive the experimental product (Perlatte ® -Eurofarma Laboratórios S.A.) or the reference product (Lactaid ® -McNeilNutritionals, USA) orally (one tablet, three times per day) for 42 consecutive days. Results -Data from 128 patients who actually received the studied treatments were analysed (66 were treated with the experimental product and 62 with the reference product). The two groups presented with similar baseline clinical and demographic data. Mean exhaled hydrogen concentration tested at 90 minutes after the last treatment (Day 42) was significantly lower in the experimental product treated group (17±18 ppm versus 34±47 ppm) in the per protocol population. The difference between the means of the two groups was -17 ppm (95% confidence interval [95% CI]: -31.03; -3.17). The upper limit of the 95% CI did not exceed the a priori non-inferiority limit (7.5 ppm). Secondary efficacy analyses confirmed that the treatments were similar (per protocol and intention to treat population). The tolerability was excellent in both groups, and there were no reports of serious adverse events related to the study treatment. Conclusion -The experimental product was non-inferior to the reference product, indicating that it was an effective replacement therapy for endogenous lactase in lactose intolerance patients. HEADINGS -Lactase. Lactose intolerance. beta-Galactosidase. Clinical trial.

BACKGROUND: There is scarce data regarding efficacy and safety of vedolizumab in inflammatory bowel diseases in Latin America. OBJECTIVE: To describe the first observational real-world experience with vedolizumab in Latin American inflammatory bowel diseases patients. METHODS: Retrospective observational multicentric study of patients with Crohn’s disease (CD) and ulcerative colitis (UC) who used vedolizumab at any phase of their treatment. Clinical remission and response (according to Harvey-Bradshaw index for CD and Mayo score for UC), mucosal healing, need for surgery and adverse events were evaluated. RESULTS: A total of 90 patients were included (52 with CD and 38 with UC), the majority with previous exposure to anti-TNF agents (88.46% in CD and 76.31% in UC). In CD (as observed analysis) remission rates at weeks 12, 26 and 52 were 42.89% (21/49), 61.9% (26/42) and 46.15% (12/26), respectively. In UC, remission rates at weeks 12, 26 and 52 were 28.94% (11/38), 36.66% (11/30) and 41.17% (7/17). Mucosal healing rates were 36.11% in CD and 43.4% in UC. During the study period, 7/52 CD patients underwent major abdominal surgery and 4/38 UC patients needed colectomy. CONCLUSION: Vedolizumab was effective in induction and maintenance of clinical response and remission in CD and UC, with no new safety signs.

-Background -Adalimumab is a monoclonal antibody, tumor necrosis factor-alpha (TNFα) inhibitor that has efficacy for inducing and maintaining remission in moderate-to-severe ulcerative colitis. Real world studies with adalimumab in Latin American ulcerative colitis patients are scarce.Objective -To assess the clinical remission rates in induction and maintenance with adalimumab therapy in ulcerative colitis. Declared conflict of interest of all authors: Damião AOMC (Nestle, Janssen, Abbvie, Pfizer and Takeda), Moraes AC (Janssen, Abbvie, Takeda), Teixeira FV (Janssen, Abbvie, Ferring, Takeda, Pfizer), Ludvig JC (Janssen, Abbvie, Takeda), Nones RB (Abbvie, Takeda), Saad-Hossne R (Janssen, Abbvie), Sassaki LY (Janssen, Abbvie, Takeda), Kotze PG (Janssen, Abbvie, Ferring, Takeda, Pfizer The rate of colectomy in ULTRA II trial was less than 5%, without stratification regarding the previous use of another anti-TNF agent (8) . The drug was approved by Food and Drug Administration (FDA) and National Sanitary Surveillance Agency (ANVISA), in 2012 and 2014, respectively (14) . Despite the results of the clinical trials, there is a discrepancy between those and real world data in UC (15) , similar to what was observed in terms of efficacy of ADA in Crohn's disease (CD) (13) . Retrospective studies of case series tend to have higher effectiveness rates than randomized trials, which have a more strict analysis. Furthermore, it is enquired what the ideal dose of ADA in the management of UC would be needed (12) , showing the need of data from real life studies to better define the drug's role in treatment algorithms. There is scarce real world data on the use of ADA in UC reported in Brazil and Latin America, which motivated the present study (1,2,9,10,18,28,29) . The primary aim of this study was to analyze clinical remission rates in ADA induction and maintenance in UC treatment. Secondary objectives were to analyze clinical response, endoscopic remission, colectomy rates, adverse events, and secondary loss of response, besides dose optimization or drug switching during the follow-up period. Adalimumab for ulcerative colitis: results of a Brazilian multicenter observational study METHODS Study designThis was a longitudinal, analytical, observational and retrospective study of a case series of patients with moderate-to-severe UC under ADA therapy. All patients were treated in seven referral centers for inflammatory bowel disease (IBD) from south/southeast Brazil, and were analyzed from

overall CD patients 3 and more than 90% of patients with rectal involvement. 4 The management of PFCD is multidisciplinary, with intensive medical therapy associated to multiple surgical procedures. This usually results in significant physical and psychological impact in patients' lives. There are significant limitations of conventional medical treatment in PFCD (corticosteroids, immunosuppressants, and antibiotics). Fistula healing rates are low with this strategy and recurrence is frequent. 5 Some prospective studies have demonstrated the efficacy of biologics in controlling perianal fistulas in CD. Present et al., 6 in the first randomized controlled study with biologics for the treatment of fistulizing CD, demonstrated the effectiveness of infliximab (IFX) in closing abdominal and perianal fistulas. Sands et al., 7 in the ACCENT 2 study, demonstrated the better efficacy of IFX as compared to

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