Once-Daily Budesonide MMX® Extended-Release Tablets Induce Remission in Patients With Mild to Moderate Ulcerative Colitis: Results From the CORE I Study

Enhanced therapeutic efficacy of budesonide in experimental colitis with enzyme/pH dual-sensitive polymeric nanoparticles

“…13 In the current study, we evaluated the therapeutic applications of Azo-pu ES NPs for colitis therapy using a clinically relevant glucocorticoidbudesonide. Since current budesonide formulations using a single pH-dependent strategy are not satisfactory for treating UC, due to premature drug release in the ileum before reaching the inflamed area of the distal colon, 9 we hypothesized that enzyme/pH dual-sensitive Azo-pu ES NPs loaded with budesonide could retain budesonide and deliver the drug specifically and sufficiently to the distal inflamed segments of the colon, thereby enhancing therapeutic efficacy of budesonide.…”

Bioavailability profile of Uceris MMX extended-release tablets compared with Entocort EC capsules in healthy volunteers

“…16 In the CORE I study, significantly higher rates of symptom resolution were achieved in patients treated with 9 mg Uceris Õ (28.5%) and 6 mg Uceris Õ (28.9%) versus placebo (16.5%; P < 0.05). 14 Similarly, in the CORE II study, significantly higher rates of symptom resolution were achieved in patients receiving 9 mg Uceris Õ (23.9%) versus placebo (11.2%; P < 0.05), but not in patients treated with 6 mg Uceris Õ (13.8%). 15 The objective of the current study was to compare the pharmacokinetics of two doses (6 and 9 mg) of the extended-release Uceris Õ formulation of budesonide with that of 9 mg Entocort Õ EC (supplied as 3 Â 3 mg capsules).…”

Letter: accuracy of liver stiffness measurement – a comparison of two different FibroScan devices

“…2 In one of the two pivotal trials, in which budesonide MMX was compared to Asacol 2.4 g (Warner Chilcott plc, Dublin, Ireland), the therapeutic advantage of budesonide MMX 9 mg over Asacol was only 5.8% and there was no therapeutic advantage over 5-ASA when clinical improvement was taken into account. 3 Asacol, in this study, was a nonpowered reference arm, suggested as active control by the regulatory authorities. We must take into account that 65.3% of the patients in the 2.4 g Asacol arm had a moderate activity and that a recent Cochrane review suggests that patients with moderate activity may benefit from an initial dosage of 4-4.8 g of mesalazine instead of 2.4 g. 4 Moreover, in case of oral 5-ASA failure, adding 5-ASA enema to treatment increases the success rate.…”

“…All consecutive HCV infected patients attending our unit had consecutive liver stiffness measurement with FS502 and FS402, on the same area and by the same observer. Agreement between FS502 and FS402 was characterised using the Kappa index 3 for four cut-offs values: <7.2 kPa (F1), 7.2-12.4 kPa (F2-F3) and >12.4 kPa (F4) 4 and for significant fibrosis (9 kPa). 5 We included 101 patients, mostly men (72 men vs. 29 women) and with a mean BMI: of 25.2 AE 0.85 kg/m 2 .…”