Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Simon P L Travis, Silvio Danese, Limas Kupcinskas, Olga Alexeeva, Geert D'Haens, Peter Raymond Gibson, Luigi Moro, Richard C Jones, Emerson David Ballard II, Johan Masure, Matteo Rossini, William J Sandborn

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Abstract

Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC). Design Patients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score =1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a =1-point reduction in endoscopic index score from baseline. Results 410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4 , 8.3 , 12.6 and 4.5 , respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95 CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2 vs 33.7 ) and endoscopic improvement (42.2 vs 31.5 ) versus placebo. The rate of histological healing (16.5 vs 6.7 ; p=0.0361) and proportion of patients with symptom resolution (23.9 vs 11.2 ; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups. Conclusion Budesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.
Original languageEnglish
Pages (from-to)433 - 441
Number of pages9
JournalGut
Volume63
Issue number3
DOIs
Publication statusPublished - 2014

Cite this

Travis, S. P. L., Danese, S., Kupcinskas, L., Alexeeva, O., D'Haens, G., Gibson, P. R., ... Sandborn, W. J. (2014). Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut, 63(3), 433 - 441. https://doi.org/10.1136/gutjnl-2012-304258
Travis, Simon P L ; Danese, Silvio ; Kupcinskas, Limas ; Alexeeva, Olga ; D'Haens, Geert ; Gibson, Peter Raymond ; Moro, Luigi ; Jones, Richard C ; Ballard II, Emerson David ; Masure, Johan ; Rossini, Matteo ; Sandborn, William J. / Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. In: Gut. 2014 ; Vol. 63, No. 3. pp. 433 - 441.
@article{e764afd6bc9343f5801b2ccfe7d0d84a,
title = "Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study",
abstract = "Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC). Design Patients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score =1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a =1-point reduction in endoscopic index score from baseline. Results 410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4 , 8.3 , 12.6 and 4.5 , respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95 CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2 vs 33.7 ) and endoscopic improvement (42.2 vs 31.5 ) versus placebo. The rate of histological healing (16.5 vs 6.7 ; p=0.0361) and proportion of patients with symptom resolution (23.9 vs 11.2 ; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups. Conclusion Budesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.",
author = "Travis, {Simon P L} and Silvio Danese and Limas Kupcinskas and Olga Alexeeva and Geert D'Haens and Gibson, {Peter Raymond} and Luigi Moro and Jones, {Richard C} and {Ballard II}, {Emerson David} and Johan Masure and Matteo Rossini and Sandborn, {William J}",
year = "2014",
doi = "10.1136/gutjnl-2012-304258",
language = "English",
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pages = "433 -- 441",
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Travis, SPL, Danese, S, Kupcinskas, L, Alexeeva, O, D'Haens, G, Gibson, PR, Moro, L, Jones, RC, Ballard II, ED, Masure, J, Rossini, M & Sandborn, WJ 2014, 'Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study', Gut, vol. 63, no. 3, pp. 433 - 441. https://doi.org/10.1136/gutjnl-2012-304258

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. / Travis, Simon P L; Danese, Silvio; Kupcinskas, Limas; Alexeeva, Olga; D'Haens, Geert; Gibson, Peter Raymond; Moro, Luigi; Jones, Richard C; Ballard II, Emerson David; Masure, Johan; Rossini, Matteo; Sandborn, William J.

In: Gut, Vol. 63, No. 3, 2014, p. 433 - 441.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

AU - Travis, Simon P L

AU - Danese, Silvio

AU - Kupcinskas, Limas

AU - Alexeeva, Olga

AU - D'Haens, Geert

AU - Gibson, Peter Raymond

AU - Moro, Luigi

AU - Jones, Richard C

AU - Ballard II, Emerson David

AU - Masure, Johan

AU - Rossini, Matteo

AU - Sandborn, William J

PY - 2014

Y1 - 2014

N2 - Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC). Design Patients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score =1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a =1-point reduction in endoscopic index score from baseline. Results 410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4 , 8.3 , 12.6 and 4.5 , respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95 CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2 vs 33.7 ) and endoscopic improvement (42.2 vs 31.5 ) versus placebo. The rate of histological healing (16.5 vs 6.7 ; p=0.0361) and proportion of patients with symptom resolution (23.9 vs 11.2 ; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups. Conclusion Budesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.

AB - Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC). Design Patients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score =1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a =1-point reduction in endoscopic index score from baseline. Results 410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4 , 8.3 , 12.6 and 4.5 , respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95 CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2 vs 33.7 ) and endoscopic improvement (42.2 vs 31.5 ) versus placebo. The rate of histological healing (16.5 vs 6.7 ; p=0.0361) and proportion of patients with symptom resolution (23.9 vs 11.2 ; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups. Conclusion Budesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.

UR - http://gut.bmj.com/content/63/3/433.full.pdf+html

U2 - 10.1136/gutjnl-2012-304258

DO - 10.1136/gutjnl-2012-304258

M3 - Article

VL - 63

SP - 433

EP - 441

JO - Gut

JF - Gut

SN - 0017-5749

IS - 3

ER -