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Enteric-coated budesonide for the induction and maintenance of remission of Crohn's disease in children.

Abstract：

OBJECTIVE:These studies evaluated the safety and efficacy of enteric-coated budesonide for the induction and maintenance of remission of mild-to-moderate Crohn's disease (CD) in children. METHODS:The consecutive, multicenter, open-label, non-comparative studies enrolled patients aged 6-17 years. In the induction study, patients with active CD of the ileum and/or ascending colon received budesonide 9 mg or 6 mg once daily for 8 weeks; in the maintenance study, patients in remission received budesonide 6 mg once daily for 12 weeks. The primary objective was assessment of safety, including glucocorticosteroid-related side effects and serum cortisol levels. Efficacy was assessed using the Pediatric Crohn's Disease Activity Index (PCDAI), and health-related quality of life (HRQoL) using the IMPACT-III questionnaire. RESULTS:In the induction study (n = 108), most adverse events were related to CD, commonly abdominal pain; possible glucocorticosteroid-related effects included acne and increased appetite but without significant weight gain. Subnormal morning cortisol levels were observed in 32 of 103 patients after 8 weeks. Budesonide reduced disease activity from baseline (mean ± standard deviation, 9.1 ± 8.5 vs. 19.1 ± 10.1, p < .001) with 58.1% of patients reaching remission (PCDAI <10); HRQoL improved (p < .001). In the maintenance study (n = 50), mean disease activity worsened (p = .047) with HRQoL unchanged (p = .33). CONCLUSIONS:Budesonide treatment was generally well tolerated, although the potential for adrenal suppression was noted. Budesonide was effective for induction of remission in children with mild-to-moderate CD but not for maintaining remission (ClinicalTrials.gov identifiers: NCT01444092, NCT01453946).

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

Cohen SA,Aloi M,Arumugam R,Baker R,Bax K,Kierkuś J,Koletzko S,Lionetti P,Persson T,Eklund S

doi

10.1080/03007995.2017.1313213

subject

Has Abstract

pub_date

2017-07-01 00:00:00

pages

1261-1268

issue

eissn

0300-7995

issn

1473-4877

journal_volume

pub_type

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Enteric-coated budesonide for the induction and maintenance of remission of Crohn's disease in children.