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Abstract: Anti-tumor necrosis factor alpha antibodies have been used with increasing frequency despite the number of reported adverse effects. Further new information is still emerging. Here we report the case of a 71-years-old patient affected by Crohn''s disease and HCV-positive who developed Guillain–Barrè syndrome after four injections of fully human anti-tumor necrosis factor alpha antibodies (adalimumab). Indication for the treatment was severe clinical recurrence of Crohn''s disease following intestinal resection. Guillain–Barrè syndrome was treated by intravenous immunoglobulins, and methylprednisolone and plasmapheresis were started with a progressive partial resolution of neurological symptoms. To date, Crohn''s disease was maintained in clinical remission with low dose steroid therapy. [Copyright &y& Elsevier]

Background & Aims: Few data are available on effects of biologic therapies in patients more than 65 years old with inflammatory bowel disease (IBD). We evaluated the risk and benefits of therapy with tumor necrosis factor (TNF) inhibitors in these patients. Methods: We collected data from patients with IBD treated with infliximab (n = 2475) and adalimumab (n = 604) from 2000 to 2009 at 16 tertiary centers. Ninety-five patients (3%) were more than 65 years old (52 men; 37 with ulcerative colitis and 58 with Crohn''s disease; 78 treated with infliximab and 17 with adalimumab). The control group comprised 190 patients 65 years old or younger who were treated with both biologics and 190 patients older than 65 years who were treated with other drugs. The primary end points were severe infection, cancer, or death. Results: Among patients more than 65 years old who received infliximab and adalimumab, 11% developed severe infections, 3% developed neoplasms, and 10% died. No variable was associated with severe infection or death. Among control patients more than 65 years old, 0.5% developed severe infections, 2% developed cancer, and 2% died. Among control patients less than 65 years old, 2.6% developed severe infections, none developed tumors, and 1% died. Conclusions: Patients older than 65 years treated with TNF inhibitors for IBD have a high rate of severe infections and mortality compared with younger patients or patients of the same age that did not receive these therapeutics. The effects of anti-TNF agents in older patients with IBD should be more thoroughly investigated, because these patients have higher mortality related to hospitalization than younger patients. [Copyright &y& Elsevier]

Abstract: Background and aim: Complementary and alternative medicines (CAM) are being used increasingly by patients with Crohn''s disease (CD) and ulcerative colitis (UC). We aimed to assess the prevalence and usage of CAM in different geographical areas of Italy and possible predictors of their use. Methods and materials: A structured questionnaire, administered to outpatients, attending 8 general hospitals and 9 tertiary referral centres, was completed by 2011 patients (909 CD, 1087 UC and 15 indeterminate colitis). 583 patients lived in the North, 659 in Central Italy and 769 in the South. Results: CAM users were 475 (23.6%) with no regional differences in their distribution. Usage correlated significantly with female gender (p =0.030), higher education (p =0.021), hospitalization rates (p =0.000), extra-intestinal complications (p =0.000), non-adherence to conventional treatments (p =0.054), adverse reactions to conventional treatments (p =0.000), and active disease (p =0.007); 5-ASA usage was associated with a more limited use of CAM (p =0.005). Dietary changes or supplements and prayer were significantly more frequently reported in South, while Northern Italian patients more frequently used homeopathy, herbal medicines and physical exercises. Patients in Central Italy adopted an intermediate behavior. CAM use ameliorated the patient''s general well-being according to two thirds of the users. Costs were higher for Northern patients than in Central or Southern Italy. Conclusion: One in four IBD patients in Italy use CAM. More money is spent on CAM in Northern Italy. Regional differences emerged as regards the type of CAM but not in terms of disease features, frequency of and reasons for CAM use, or perceived effects. [Copyright &y& Elsevier]

Abstract: Introduction: High-grade evidence is lacking for most therapeutic decisions in Crohn''s disease. Appropriateness criteria were developed for upper gastro-intestinal, extra-intestinal manifestations and drug safety during conception, pregnancy and breastfeeding in patients with Crohn''s disease, to assist the physician in clinical decision making. Methods: The European Panel on the Appropriateness of Crohn''s Disease Therapy (EPACT II), a multidisciplinary international European expert panel, rated clinical scenarios based on evidence from the published literature and panelists'' own clinical expertise. Median ratings (on a 9-point scale) were stratified into three categories: appropriate (7–9), uncertain (4–6 with or without disagreement) and inappropriate (1–3). Experts were also asked to rank appropriate medications by priority. Results: Proton pump inhibitors, steroids, azathioprine/6-mercaptopurine and infliximab are appropriate for upper gastro-duodenal Crohn''s disease; for stenosis, endoscopic balloon dilation is the first-line therapy, although surgery is also appropriate. Ursodeoxycholic acid is the only appropriate treatment for primary sclerosing cholangitis. Infliximab is appropriate for Pyoderma gangrenosum, ankylosing spondylitis and uveitis, steroids for Pyoderma gangrenosum and ankylosing spondylitis, adalimumab for Pyoderma gangrenosum and ankylosing spondylitis, cyclosporine-A/tacrolimus for Pyoderma gangrenosum. Mesalamine, sulfasalazine, prednisone, azathioprine/6-mercaptopurine, ciprofloxacin, and probiotics, may be administered safely during pregnancy or for patients wishing to conceive, with the exception that male patients considering conception should avoid sulfasalazine. Metronidazol is considered safe in the 2nd and 3rd trimesters whereas infliximab is rated safe in the 1st trimester but uncertain in the 2nd and 3rd trimesters. Methotrexate is always contraindicated at conception, during pregnancy or during breastfeeding, due to its known teratogenicity. Mesalamine, prednisone, probiotics and infliximab are considered safe during breastfeeding. Conclusion: EPACT II recommendations are freely available online (www.epact.ch). The validity of these criteria should now be tested by prospective evaluation. [Copyright &y& Elsevier]