The CHOICE trial: adalimumab demonstrates safety, fistula healing, improved quality of life and increased work productivity in patients with Crohn's disease who failed prior infliximab therapy.

BACKGROUND: Adalimumab induces and maintains remission in adults with Crohn's disease. AIM: To evaluate safety, fistula healing, quality of life and work productivity in adalimumab-treated patients who failed infliximab, including primary nonresponders. METHODS: After a ≥8-week infliximab washout, patients with moderate-to-severe Crohn's disease received open-label adalimumab as induction (160/80 mg at weeks 0/2) and maintenance (40 mg every other week) therapies. At/after 8 weeks, patients with flare/nonresponse could receive weekly therapy. Minimum study duration was 8 weeks, continuing until the commercial availability of adalimumab for Crohn's disease. RESULTS: Of 673 patients enrolled, 17% were infliximab primary nonresponders and 83% were initial responders. Three percent of patients had serious infections (mainly abscesses). Complete fistula healing was achieved by 34/88 (39%) patients with baseline fistulas. Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients, as well as the subgroup of primary nonresponders. CONCLUSIONS: Blinded clinical trials have shown adalimumab to be both an effective first-line therapy for anti-TNF-naïve patients and an important treatment option for infliximab-refractory or -intolerant patients. This trial presents open-label experience to support further the safety and effectiveness of adalimumab in patients who failed infliximab therapy, including primary nonresponders (NCT00338650).

Galactomannan from the seeds of Mimosa scabrella: a scale-up process.

In view of the wide industrial applications of galactomannans as a thickening agent, those of Mimosa scabrella (bracatinga), a leguminous tree abundant in Southern Brazil, are under investigation. Seeds of bracatinga were processed on a pilot plant scale in order to obtain its galactomannan. The process consisted of successive milling, enzyme inactivation, aqueous extraction, precipitation of polysaccharide, and drying and milling. The product was obtained in 20% yield, with characteristics similar to those obtained on the laboratory scale, namely mannose:galactose ratio (M:G) 1.1:1.0 and intrinsic viscosity. Considering the seed availability in the metropolitan regions of Curitiba, it should be possible to obtain 3000 ton/year of this polysaccharide.