Back to Journals » Clinical and Experimental Gastroenterology » Volume 8

Impact of switching from mycophenolate mofetil to enteric-coated mycophenolate sodium on gastrointestinal side effects in patients with autoimmune disease: a Phase III, open-label, single-arm, multicenter study

Authors Manger B, Hiepe F, Schneider M, Worm M, Wimmer P, Paulus E, Schwarting A

Received 30 January 2015

Accepted for publication 1 May 2015

Published 21 July 2015 Volume 2015:8 Pages 205—213


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Professor Andreas M Kaiser

Bernhard Manger,1 Falk Hiepe,2 Matthias Schneider,3 Margitta Worm,4 Peter Wimmer,5 Eva-Maria Paulus,5 Andreas Schwarting6

1University Hospital Erlangen, Med Clinic III Polyclinic, Erlangen, 2Rheumatology, University Hospital Charité, Campus Mitte, Berlin, 3Policlinic of Rheumatology, Heinrich-Heine-Universität, Düsseldorf, 4Department of Dermatology, Venereology and Allergology, University Hospital Charité, Campus Mitte, Berlin, 5Novartis Pharma GmbH, Nürnberg, 6Department of Internal Medicine, Johannes Gutenberg University, Mainz, Germany

Background: The purpose of this study was to assess changes in gastrointestinal symptom severity in patients with autoimmune disease who were switched from mycophenolate mofetil to enteric-coated mycophenolate sodium (EC-MPS).
Methods: In this national, explorative, single-arm study, 111 patients were enrolled and switched to equimolar EC-MPS at baseline. The primary endpoint was change in the Gastrointestinal Symptom Rating Scale (GSRS) total score after 6–8 weeks of treatment (Visit 2). The optional follow-up visit was 6–12 weeks after completion of the study (Visit 2). Secondary endpoints were changes in GSRS subscale score; changes in gastrointestinal-related quality of life measured by the Gastrointestinal Quality of Life Index (GIQLI); and general health-related quality of life (HRQoL) measured by Psychological General Well-Being Index and assessment of overall treatment effect (OTE). Change was evaluated by paired t-tests.
Results: At Visit 2, the mean ± standard deviation GSRS total score improved from 2.28±1.13 to 2.02±0.93 points. The change (-0.28±0.92 points, P=0.002) was statistically significant. The change at the follow-up visit (-0.36±0.94 points, P=0.001) was statistically significant and more than the minimal clinical important difference. GSRS subscores showed statistically significant and clinically relevant improvement for abdominal pain (-0.51±1.2 points, P<0.001) and indigestion (-0.42±1.33 points, P=0.002). Overall GIQLI score showed significant improvement from baseline to Visit 2 (-5.8±18.6 points, P=0.002). Per OTE, improvement was reported in 44.1% and 34.2% patients as rated by physicians and patients, respectively. The majority of patients (55%) reported OTE-HRQoL as unchanged. Diarrhea and nausea were the commonly reported adverse events.
Conclusion: Patients switched to EC-MPS experienced less gastrointestinal symptom burden and showed improvement in HRQoL.

Keywords: mycophenolate mofetil, enteric-coated mycophenolate sodium, autoimmune disease, patient-reported outcome, health-related quality of life

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]