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  • Lauritzen Quinn posted an update 3 days, 21 hours ago

    We evaluated our approach with two years of data on from 5,774 obstetric inpatient encounters from the EHR system of Northwestern Memorial Hospital. The results indicated that the average LOS for patients with patterns of repetitious location transfers (RLTs) was 4.25 days (95% confidence interval [4.02, 4.47]) longer than patients with no RLT. This difference reduced to 3.62 days (95% confidence interval [3.61, 3.64]) after adjusting for age, race and billed diagnoses. We further discovered 21 indicative factors of RLT (statistically significant with a significance level of 0.05), in the form of billed diagnosis codes, each of which exhibited an odds ratio larger than 4. This study suggests that RLT patterns are associated with a prolonged LOS in the obstetric setting. As such, healthcare organizations may need to pay more attention to patients with RLTs to refine location transfers workflow and to boost efficiency in obstetric care.Phenylketonuria (PKU) due to recessively inherited phenylalanine hydroxylase (PAH) deficiency is among the most common inborn errors of metabolism. Dietary therapy begun early in infancy prevents the major manifestations of the disease but shortcomings to treatment continue to exist including lifelong commitment to a complicated and unpalatable diet, poor adherence to diet in adolescence and adulthood, and consequently a range of unsatisfactory outcomes, including neuropsychiatric disorders, frequently develop. Selleck CC-115 Novel treatments that do not strictly depend upon dietary protein restriction are actively sought. This review discusses the potential for and the limitations of permanently curative cell-directed treatment of PKU, including liver-directed gene therapy and gene editing, if initiated during early infancy. A fictional but realistic vignette of a family with a new baby girl recently diagnosed with PKU is presented. What is needed to permanently cure her?These days, the use of biosimilars for the treatment of bio-naive patients is well established. However, the transition of patients being treated with a bio-originator to its biosimilar is still a topic of discussion. The main issue is which approach to use when initiating the non-medical transition. The first real-world examples contain both mandatory and non-mandatory approaches, resulting in a variety of acceptance and discontinuation rates. At this moment a non-mandatory approach, based on shared decision making, is preferred by international guidelines and the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases. However, clear definitions of mandatory and non-mandatory are lacking, as a result of which these terms may be wrongly used in some studies. This article aims to provide an overview of transition approaches used in the Netherlands, and how the approach used relates to acceptance and discontinuation rates of the biosimilar.Objective/aim SB4 (BenepaliĀ®), the Etanercept biosimilar, is licenced in the UK for the same indications as the reference product, EnbrelĀ®. In 2016, the Rheumatology Department at Blackpool Teaching Hospitals switched the Etanercept patients, who gave consent, to SB4. A proportion of these patients switched back to Etanercept and therefore we aimed to investigate the reasons of SB4 withdrawal and compare our results with the current evidence. Methods We included all the patients switched to SB4 until April 2018, identified from the departmental biologics database. We also searched the published and grey literature through November 2018 for similar articles. Results 72 Etanercept patients switched to SB4, of which 19 (26.4%) switched back to Etanercept within 6 months on the biosimilar product. All the 19 patients remained on Etanercept until the time of data analysis. The main reason of withdrawal was loss of effect (LOE, 58%). In RA, the duration on Etanercept was associated with SB4 withdrawal (OR 1.43 [95% CI 1.02, 2.00]) and LOE was reflected in the DAS- 28, PGS and CRP increase and in the number of tender joints (all p less then 0.05). We found ten observational studies reporting 3184 patients, who switched from Etanercept to SB4 and 432 of them (14%) stopped SB4. Conclusion The majority (73.6%) stayed on SB4, which is consistent with the current evidence. Taking also into consideration the results of the other studies, it is unclear if this withdrawal is a true failure on SB4, nocebo effect or spontaneous disease flare.A biosimilar is a biological medicinal product that is highly similar to an already authorized original biological medicinal product. The introduction of biosimilars may allow for a reduction in health care costs, due to discount pricing. Current clinical studies and real-world data suggest that the biosimilar SB4 is equivalent to etanercept with respect to efficacy and safety. Additional real-world safety data for SB4 via pharmacovigilance studies are needed to draw conclusions regarding the risks of rare adverse events such as serious infections and malignancy. Clinical trial design of biosimilars should be standardised to improve consistency, increase confidence and facilitate interpretation of data. Where there are health economic advantages of switching from originator to biosimilar, patients should be appropriately informed, and, ideally, in order to minimise nocebo responses and maximise benefit, switching should be undertaken by shared decision-making between the physician and patient on a case-by-case basis.Biologic agents are macromolecules, and as such, they have a high level of structural heterogeneity. Treatment with such agents has been extremely expensive limiting thus their availability to increasing numbers of patients; therefore, many manufacturers chose to develop biologics that are highly similar to the originators, the biosimilars. The immunological properties of both products should therefore be characterized and compared. The biosimilar developers must have a complete qualitative documentation, appropriate preclinical pharmacodynamic and pharmacokinetic studies, and finally comparative studies with the originator to define the relative similarity in terms of biologic activity, quality characteristics, efficacy and safety. Immunogenicity assessment of the biosimilars continues through clinical trials and pharmacovigilance programs.