title: Prospective, systematically recorded mycophenolate safety data in Graves' orbitopathy.
abstract: BACKGROUND
  The antiproliferative mechanism of mycophenolate acid (MPA) suggests a beneficial effect in patients with Graves' orbitopathy (GO).
  
  
  OBJECTIVE
  To systematically analyze for the first time adverse events (AEs) during MPA treatment in GO.
  
  
  METHODS
  Prospective longitudinal study.
  
  
  METHODS
  Academic tertiary referral center with a joint thyroid-eye clinic.
  
  
  METHODS
  Fifty-three consecutive, unselected patients with clinically active and moderate-to-severe GO.
  
  
  METHODS
  MPA 0.720 g was given once daily for 24-weeks in GO patients. AEs were documented and coded according to the standardized medical dictionary for regulatory activities (MedDRA). AE were followed up and seriousness as defined by ICH-guideline E6 was documented. All AEs were analyzed regarding a possible underlying cause and if not, graded as side effect (SE).
  
  
  RESULTS
  Fifty GO patients (93 %) had Graves' disease, 37 (70 %) and 29 (54.7 %) were female and smoker, respectively. Thirty-six patients (68 %) reported at least one AE. A total of 88 AEs were documented, most frequent AEs were insomnia (N = 6), fatigue (N = 5) and optic neuropathy (N = 5), while other AEs occurred in up to three patients (5.6 %), only. In 12 (23 %) patients, at least one SE occurred. All 17 reported SE, i.e. mild infections and gastrointestinal intolerance were within the known safety profile of MPA. No patient dropped MPA medication because of drug-induced SE. Most AEs showed a recovered (76 %) or recovering (16 %) outcome. Seven (13 %) patients were hospitalized, five (62 %) due to optic neuropathy, none of these events was graded as SE.
  
  
  CONCLUSIONS
  MedDRA-coded data documented the good tolerance of a moderate MPA dose in GO patients.
authors.affiliation: Departments of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.|Interdisciplinary Center for Clinical Trials, Johannes Gutenberg University Medical Center, Mainz, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Riedl
authors.affiliation: Interdisciplinary Center for Clinical Trials, Johannes Gutenberg University Medical Center, Mainz, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Kuhn
authors.affiliation: Pharmacy Department, Johannes Gutenberg University Medical Center, Mainz, Germany.
authors.forename: I
authors.initials: I
authors.lastname: Krämer
authors.affiliation: Departments of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Kolbe
authors.affiliation: Departments of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany. gkahaly@uni-mainz.de.
authors.forename: G J
authors.initials: GJ
authors.lastname: Kahaly
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D005260:Female; D049970:Graves Ophthalmopathy / Q000188:drug therapy*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000627:therapeutic use*; D061214:Patient Safety; D011446:Prospective Studies; D062606:Tertiary Care Centers; D055815:Young Adult
chemical_list: D000903:Antibiotics, Antineoplastic; D009173:Mycophenolic Acid
keywords: Graves’ orbitopathy; ICH guideline; Medical dictionary for regulatory activities (MedDRA); Mycophenolate; Safety