title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  Patients switched to EC-MPS experienced less gastrointestinal symptom burden and showed improvement in HRQoL.
authors.affiliation: University Hospital Erlangen, Med Clinic III Polyclinic, Erlangen, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Manger
authors.affiliation: Rheumatology, University Hospital Charité, Campus Mitte, Berlin, Germany.
authors.forename: Falk
authors.initials: F
authors.lastname: Hiepe
authors.affiliation: Policlinic of Rheumatology, Heinrich-Heine-Universität, Düsseldorf, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Schneider
authors.affiliation: Department of Dermatology, Venereology and Allergology, University Hospital Charité, Campus Mitte, Berlin, Germany.
authors.forename: Margitta
authors.initials: M
authors.lastname: Worm
authors.affiliation: Novartis Pharma GmbH, Nürnberg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Wimmer
authors.affiliation: Novartis Pharma GmbH, Nürnberg, Germany.
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Paulus
authors.affiliation: Department of Internal Medicine, Johannes Gutenberg University, Mainz, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schwarting
keywords: autoimmune disease; enteric-coated mycophenolate sodium; health-related quality of life; mycophenolate mofetil; patient-reported outcome