Once versus three times daily dosing of oral budesonide for active Crohn's disease: A double-blind, double-dummy, randomised trial

Abstract

Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn's disease.

Fabrication, Physico-Chemical, and Pharmaceutical Characterization of Budesonide-Loaded Electrospun Fibers for Drug Targeting to the Colon

“…The recommended daily dose is 9 mg orally for up 8 weeks . The full effect is usually achieved within 2–4 weeks.…”

“…16,17 The recommended daily dose is 9 mg orally for up 8 weeks. 18 The full effect is usually achieved within 2-4 weeks. For maintenance of clinical remission, the dosage of 6 mg daily is recommended.…”

Oral budesonide in gastrointestinal and liver disease: A practical guide for the clinician

“…For induction of remission, an oral dose of 9 mg/day is recommended, given as 9 mg once‐daily or 3 mg t.i.d., to be continued for up to 8 weeks. Once‐daily dosing appears to be as effective as 3 mg t.i.d . and may support improved adherence.…”

“…Numerous randomized trials have compared budesonide versus placebo or comparator therapies, and assessed different dosing regimens, for the induction of remission in Crohn's disease. Meta‐analyses based on these trials have shown that oral budesonide is more efficacious than mesalazine or placebo when used for the induction of remission in mild to moderate active Crohn's disease, with no difference in side effects .…”

Objective Assessment of Endoscopic Disease Activity and Mucosal Healing

“…In trials utilizing the CDEIS, a score < 6 [67] has been used to define partial endoscopic healing or endoscopic remission and <3 [67], 4 [68], ≤4 [69] or 0 [70] to define complete mucosal healing. In trials utilizing the SES-CD a score of <3 [69,71,72,73] or equal to 0 [24,70,[74][75][76] has previously been used to define endoscopic remission or minimal endoscopic activity although a study by Moskovitz et al [77] validated the cutoff values as 0-2 for endoscopic remission, 3-6 for mild endoscopic disease, 7-15 for moderate endoscopic disease activity and ≥16 for severe endoscopic disease activity. In regard to defining endoscopic response to treatment, Ferrante et al [78] demonstrated that a decrease from baseline of both the CDEIS and the SES-CD score of at least 50 % was most predictive of corticosteroid free remission by week 50.…”