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• W2331539127 abstract "To assess the safety and efficacy of 8 weeks of openlabel treatment with oral budesonide MMX (B-MMX) 9 mg extended-release tablets in patients with active, mild to moderate ulcerative colitis, who failed to achieve clinical and endoscopic remission in a previous Ph3, 8-week induction study (Ph3 results presented at DDW 2011 (Sandborn WJ, et al.). Patients from a previous Ph3 study (Parent Study) who completed 8 weeks of induction therapy in any treatment group (B-MMX 9 mg; B-MMX 6 mg; Asacol® [mesalamine] 2400 mg; or placebo), and who were not in remission were eligible to enroll in the present study to receive an additional 8 weeks of open label B-MMX 9 mg. The primary endpoint was induction of clinical and endoscopic remission, defined by strict criteria with a UCDAI score ≤1 after 8 weeks, with scores of 0 for rectal bleeding & stool frequency, no mucosal friability after colonoscopy, & ≥1-point reduction from baseline in the endoscopic index score. Clinical improvement (≥3 point reduction in UCDAI), endoscopic improvement (≥1 point reduction in the UCDAI mucosal appearance subscore), & symptom resolution (score of 0 for rectal bleeding & stool frequency from UCDAI) were also evaluated at the end of the treatment. Sixty patients were dosed. Fifty-two (86.7%) completed the study. Overall rates of remission, clinical improvement, endoscopic improvement, and symptom resolution were 25.0%, 26.7%, 40.0%, and 33.3%, respectively. Overall frequencies of Treatment Emergent AEs (TEAEs) were similar across treatment groups. Treatment-related AEs and potential glucocorticoid-related effects were infrequent and occurred to a similar extent by treatment groups. (Table) Mean morning plasma cortisol (MPC) levels remained within normal limits (138 to 690 nmol/L) regardless of prior therapy (228.1 nmol/L and 167.4 nmol/L at Baseline and Week 8, respectively). Among the 28 patients previously exposed to 8 weeks of B-MMX treatment, the additional 8 weeks of open label B-MMX 9 mg showed a minimal decrease in MPC relative to baseline (mean Δ= -4.0 nmol/L, SD = 149.47). No Caption available. No Caption available. 25% of patients achieved robust clinical and endoscopic remission and 33.3% achieved complete symptom resolution with 8 weeks of open label BMMX 9 mg after initial treatment allocation in a placebo controlled trial failed to induce remission. An additional 8 week course of B-MMX 9 mg in patients previously exposed to B-MMX treatment does not significantly affect MPC. Therapy with B-MMX for up to 16 consecutive weeks was safe and well-tolerated." @default.
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• W2331539127 date "2011-12-01" @default.
• W2331539127 modified "2023-09-27" @default.
• W2331539127 title "Induction of remission with oral budesonide MMX® (9 mg) tablets in oatients with mild to moderate, active Ulcerative Colitis: A multicenter, open-label efficacy and safety study" @default.
• W2331539127 doi "https://doi.org/10.1097/00054725-201112002-00066" @default.
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