Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease.
OBJECTIVE
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-L-coated 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-L-coated 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.
Ev. Krankenhaus Hattingen GmbH, Klinik für Innere Medizin, Hattingen, Germany. a.tromm@krankenhaus-hattingen.de
Andreas
A
Tromm
Ivan
I
Bunganič
Eva
E
Tomsová
Zsolt
Z
Tulassay
Milan
M
Lukáš
Jan
J
Kykal
Marian
M
Bátovský
Bohumil
B
Fixa
Libor
L
Gabalec
Rifaat
R
Safadi
Heinz-Jochen
HJ
Kramm
István
I
Altorjay
Hanns
H
Löhr
Ioannis
I
Koutroubakis
Simon
S
Bar-Meir
Davor
D
Stimac
Elke
E
Schäffeler
Christoph
C
Glasmacher
Karin
K
Dilger
Ralf
R
Mohrbacher
Roland
R
Greinwald
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019819:Budesonide / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D012074:Remission Induction; D012720:Severity of Illness Index; D012907:Smoking; D016896:Treatment Outcome; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D019804:Mesalamine; D019819:Budesonide