Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease

Andreas Tromm, Ivan Bunganič, Eva Tomsová, Z. Tulassay, Milan Lukáš, Jan Kykal, Marian Bátovský, Bohumil Fixa, Libor Gabalec, Rifaat Safadi, Heinzjochen Kramm, I. Altorjay, Hanns Löhr, Ioannis Koutroubakis, Simon Barmeir, Davor Štimac, Elke Schäffeler, Christoph Glasmacher, Karin Dilger, Ralf MohrbacherRoland Greinwald

Research output: Article

62 Citations (Scopus)

Abstract

Background & Aims Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD. Methods We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-Lcoated oral mesalamine (4.5 g/day). Results The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ≤150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (Δ70) or 100 or more (Δ100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Δ70, P = .11; Δ100, P = .15), or between the 2 budesonide groups (Δ70, P = .38; Δ100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3% and 5% of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups. Conclusions Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-Lcoated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen.

Original languageEnglish
Pages (from-to)425-434
Number of pages10
JournalGastroenterology
Volume140
Issue number2
DOIs
Publication statusPublished - febr. 2011

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Mesalamine
Budesonide
Crohn Disease
Multicenter Studies
Therapeutics
Confidence Intervals
Safety

ASJC Scopus subject areas

  • Gastroenterology

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Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. / Tromm, Andreas; Bunganič, Ivan; Tomsová, Eva; Tulassay, Z.; Lukáš, Milan; Kykal, Jan; Bátovský, Marian; Fixa, Bohumil; Gabalec, Libor; Safadi, Rifaat; Kramm, Heinzjochen; Altorjay, I.; Löhr, Hanns; Koutroubakis, Ioannis; Barmeir, Simon; Štimac, Davor; Schäffeler, Elke; Glasmacher, Christoph; Dilger, Karin; Mohrbacher, Ralf; Greinwald, Roland.

In: Gastroenterology, Vol. 140, No. 2, 02.2011, p. 425-434.

Research output: Article

Tromm, A, Bunganič, I, Tomsová, E, Tulassay, Z, Lukáš, M, Kykal, J, Bátovský, M, Fixa, B, Gabalec, L, Safadi, R, Kramm, H, Altorjay, I, Löhr, H, Koutroubakis, I, Barmeir, S, Štimac, D, Schäffeler, E, Glasmacher, C, Dilger, K, Mohrbacher, R & Greinwald, R 2011, 'Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease', Gastroenterology, vol. 140, no. 2, pp. 425-434. https://doi.org/10.1053/j.gastro.2010.11.004
Tromm, Andreas ; Bunganič, Ivan ; Tomsová, Eva ; Tulassay, Z. ; Lukáš, Milan ; Kykal, Jan ; Bátovský, Marian ; Fixa, Bohumil ; Gabalec, Libor ; Safadi, Rifaat ; Kramm, Heinzjochen ; Altorjay, I. ; Löhr, Hanns ; Koutroubakis, Ioannis ; Barmeir, Simon ; Štimac, Davor ; Schäffeler, Elke ; Glasmacher, Christoph ; Dilger, Karin ; Mohrbacher, Ralf ; Greinwald, Roland. / Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. In: Gastroenterology. 2011 ; Vol. 140, No. 2. pp. 425-434.
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abstract = "Background & Aims Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD. Methods We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-Lcoated oral mesalamine (4.5 g/day). Results The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ≤150), at the final visit occurred in 69.5{\%} (107 of 154) of patients given budesonide vs 62.1{\%} (95 of 153) of patients given mesalamine (difference, 7.4{\%}; 95{\%} repeated confidence interval, -4.6{\%} to 18.0{\%}; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (Δ70) or 100 or more (Δ100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Δ70, P = .11; Δ100, P = .15), or between the 2 budesonide groups (Δ70, P = .38; Δ100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3{\%} and 5{\%} of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups. Conclusions Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-Lcoated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen.",
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T1 - Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease

AU - Tromm, Andreas

AU - Bunganič, Ivan

AU - Tomsová, Eva

AU - Tulassay, Z.

AU - Lukáš, Milan

AU - Kykal, Jan

AU - Bátovský, Marian

AU - Fixa, Bohumil

AU - Gabalec, Libor

AU - Safadi, Rifaat

AU - Kramm, Heinzjochen

AU - Altorjay, I.

AU - Löhr, Hanns

AU - Koutroubakis, Ioannis

AU - Barmeir, Simon

AU - Štimac, Davor

AU - Schäffeler, Elke

AU - Glasmacher, Christoph

AU - Dilger, Karin

AU - Mohrbacher, Ralf

AU - Greinwald, Roland

PY - 2011/2

Y1 - 2011/2

N2 - Background & Aims Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD. Methods We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-Lcoated oral mesalamine (4.5 g/day). Results The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ≤150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (Δ70) or 100 or more (Δ100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Δ70, P = .11; Δ100, P = .15), or between the 2 budesonide groups (Δ70, P = .38; Δ100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3% and 5% of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups. Conclusions Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-Lcoated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen.

AB - Background & Aims Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD. Methods We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-Lcoated oral mesalamine (4.5 g/day). Results The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ≤150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (Δ70) or 100 or more (Δ100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Δ70, P = .11; Δ100, P = .15), or between the 2 budesonide groups (Δ70, P = .38; Δ100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3% and 5% of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups. Conclusions Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-Lcoated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen.

KW - Mesalamine

KW - Mesalazine

KW - RCT

KW - Remission

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