Thursday, December 17, 2015
Among 10 patients who developed inflammation of the ileoanal anastomosis, or J-pouch, all reported clinical improvements in stool frequency, and symptomatic relief typically was observed within 2 to 3 weeks after treatment with serum-derived bovine immunoglobulin/protein isolate (SBI), according to Larry Good, MD, of South Nassau Communities Hospital in Oceanside, N.Y.
The product, also known as EnteraGam, is derived from bovine plasma that has been USDA approved and contains immunoglobulins (primarily IgG), albumin, and other proteins. Pouchitis is not currently included in the labeling for EnteraGam.
Pre clinical IBD
Thursday, December 17, 2015
The preclinical detection of markers such as IL-6 and high sensitivity C-reactive protein (CRP) suggests that there is a time lag between the initiation of mucosal immune dysfunction and disease manifestations, the researchers noted.
“Preclinical disease phases have been described for other immune-mediated inflammatory disorders such as rheumatoid arthritis, where inflammatory markers also appear to be elevated several years in advance of symptomatic disease,” they stated.
Multiple studies have demonstrated that patients with rheumatoid arthritis (RA) are positive for rheumatoid factor and/or antibodies to citrullinated protein antigens from 2 to 10 years before symptoms appear. Those preclinical findings are today being explored for potential in early disease detection and even prevention.
Monday, December 14, 2015
Rifaximin EIR 800 bid for moderately active crohns
Friday, December 11, 2015
The trial, called UNITI-2, enrolled patients with moderate to severe Crohn’s disease who had failed traditional therapies but were naive to or at least had not failed a tumor necrosis factor (TNF) inhibitor, reported Dr. Brian Feagan, professor of medicine, University of Western Ontario, London. Results of a second and parallel phase III trial with ustekinumab, called UNITI-1, which enrolled TNF inhibitor failures, have not yet been reported.
In UNITI-2, 628 patients were randomized to placebo, 130 mg of ustekinumab in a fixed subcutaneous dose of 130 mg, or a weight-based dose of 6 mg/kg of subcutaneous ustekinumab. Major enrollment criteria, other than failure of a non-TNF inhibitor therapy, included a Crohn’s disease activity index (CDAI) score between 220 and 450. The primary endpoint was a CDAI reduction of at least 100 points at 6 weeks. Clinical remission at 8 weeks, defined as CDAI less than 150, was a secondary endpoint.
The primary endpoint was reached by 28.7% randomized to placebo, 51.7% of those randomized to the fixed dose of ustekinumab, and 55.5% of those randomized to weight-based dosing. The advantage for the active treatment arms was statistically significant (both P less than .001). For the secondary endpoint of clinical remission at 8 weeks, the rates were 19.6% for placebo, 30.6% (P = .009 vs. placebo) for fixed-dose ustekinumab, and 40.2% (P less than .001 vs. placebo) for the weight-based dose.