Budesonide MMX for the Induction of Remission of Mild to Moderate Ulcerative Colitis: A Pooled Safety Analysis

Gary R Lichtenstein, Simon Travis, Silvio Danese, Geert D'Haens, Luigi Moro, Richard Jones, Michael Huang, E David Ballard, Robert Bagin, Yun Hardiman, Raul Collazo, William J Sandborn, Gary R Lichtenstein, Simon Travis, Silvio Danese, Geert D'Haens, Luigi Moro, Richard Jones, Michael Huang, E David Ballard, Robert Bagin, Yun Hardiman, Raul Collazo, William J Sandborn

Abstract

Background and aims: Cumulative safety and tolerability of budesonide MMX, a once-daily oral corticosteroid for inducing mild to moderate ulcerative colitis remission, was examined.

Methods: Data from three randomized, double-blind, placebo-controlled, phase II or III studies [budesonide MMX 9 mg, 6 mg, or 3mg for 8 weeks]; one phase II study [randomisation to budesonide MMX 9 mg or placebo for 4 weeks, then open-label budesonide MMX 9 mg for 4 weeks]; and one open-label study [budesonide MMX 9 mg for 8 weeks] were pooled.

Results: Patients randomised to budesonide MMX 9 mg [n = 288], 6 mg [n = 254], or placebo [n = 293] had similar rates of adverse events [AEs] [27.1%, 24.8%, and 23.9%, respectively] and serious AEs [2.4%, 2.0%, and 2.7%, respectively]; treatment-related AEs and serious AEs were reported by 11.8% and 13.5%, and 5.9% and 2.2%, respectively, of patients receiving budesonide MMX 3mg [n = 17] or open-label budesonide MMX 9 mg [n = 89]. Mean morning plasma cortisol concentrations were normal from baseline to final visit across randomised groups; in patients receiving open-label budesonide, mean cortisol concentration was 129.9 nmol/l after 4 weeks, returning to normal concentrations at final visit. Budesonide MMX was not associated with an overall increased risk for glucocorticoid-related adverse effects.

Conclusions: Budesonide MMX 9 mg was associated with normal mean cortisol concentrations at final visit and an AE incidence comparable to placebo. Overall, budesonide MMX was safe and well tolerated for inducing remission of patients with mild to moderate ulcerative colitis.

Keywords: Budesonide MMX; safety; tolerability; ulcerative colitis.

Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Figures

Figure 1.
Figure 1.
Mean morning plasma cortisol concentrations. *Of the 89 patients who received open-label budesonide MMX 9mg, several had previously completed 8 weeks of treatment with budesonide MMX 9mg [n = 12] or budesonide MMX 6mg [n = 16] in CORE 1, and thus had 16 weeks of consecutive exposure to budesonide MMX. †p < 0.0001; ‡p = 0.03; §p = 0.93; ¶p = 0.01, for changes from baseline to final visit.

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