Biologic agents for rheumatoid arthritis--negotiating the NICE technology appraisals

In England and Wales, the National Institute for Health and Clinical Excellence (NICE) has provided guidance [technology appraisals (TAs) 130, 186, 195, 198 and 225] on the use of biologic drugs for the treatment of RA. This is based on an analysis of efficacy, safety and cost-effectiveness, and has resulted in a complex management pathway that restricts freedom to prescribe biologics according to their licensed indications. Specifically, TNF antagonists are the only class of biologics that can be used first line in DMARD-inadequate responders, and only in patients with a persistent 28-joint DAS score of ≥5.1. Alternative biologic agents are denied to those with contraindications to anti-TNF drugs and are also not supported following intolerance to TNF antagonists. Rituximab is the only class of biologic permitted after TNF antagonist inefficacy, in the absence of a contraindication to its use, whereas abatacept and tocilizumab are licensed and may be a more efficacious choice at this stage in some patient groups. Furthermore, for patients who demonstrate sequential inadequate responses, treatment is restricted to one TNF antagonist, rituximab and tocilizumab, whereas abatacept is only a permitted choice when rituximab is contraindicated or has been withdrawn because of an adverse event. In this review, we discuss the treatment algorithm published by NICE, and suggest alternatives where perceived deficiencies exist.     

Usefulness of Acarbose and Dietary Modifications to Limit Glycemic Variability Following Roux-en-Y Gastric Bypass as Assessed by Continuous Glucose Monitoring

Abstract Background: About 70% of the patients operated on for a gastric bypass (Roux-en-Y gastric bypass [RYGB]) suffer from dumping syndrome. In these patients, previous studies have demonstrated a high glycemic variability with hypoglycemia and with altered continuous glucose monitoring (CGM) profiles. The aim of this study was to evaluate the effect of treatment with dietary counseling plus acarbose administration on the symptoms and on the characteristics of the CGM profile. Subjects and Methods: Eight consecutive patients with dumping syndrome were given dietary counseling for 6 weeks and also treated with acarbose (50-100?mg three times a day). Their symptoms and the features of the CGM were compared before and after treatment. Results: The symptoms disappeared in seven patients. There was a significant increase in the time to the interstitial glucose (IG) peak and a reduction in the rate of the IG increase after a meal and in the rate of the IG decrease following the peak. The time below 60?mg/dL was significantly decreased, and the minimal IG value was significantly increased. The maximum and mean IG levels and the time above 140?mg/dL were decreased, but not significantly. Six patients spent more than 1% of the time with IG values below 60?mg/dL before treatment, but after treatment this was reduced to one patient. Before treatment only one patient had an IG level neither below 60 or above 140?mg/dL, and after treatment four patients were in this category. Conclusions: Dietary counseling and acarbose treatment eliminated the symptoms and improved the CGM profile of patients suffering from dumping syndrome after RYGB.     

Probiotics for the Treatment of Inflammatory Bowel Disease

Probiotics are organisms which provide a desired and beneficial effect on human health. With recent evidence implicating a disruption in the balance of the gastrointestinal microbiome and intestinal immunity as a potential trigger for inflammatory bowel disease (IBD), there has been growing interest in using probiotics as an adjunct to standard anti-inflammatory and immune suppressing therapy. Animal models describe potential and plausible mechanisms of action for probiotics to counter inflammation of colonic mucosa. Although there are insufficient data to recommend probiotics in ulcerative colitis or Crohn's disease, good evidence supports the use of specific probiotics for maintenance of remission in pouchitis. Although there are limited regulatory standards for the agents, probiotics are relatively safe with minimal reported side effects or contraindications. More rigorous studies need to be published supporting efficacy and safety of these agents before they become a mainstay of IBD medical treatment.