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Prospective, systematically recorded mycophenolate safety data in Graves' orbitopathy.

Abstract：

CONTEXT: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. DESIGN:Prospective longitudinal study. SETTING:Academic tertiary referral center with a joint thyroid-eye clinic. PATIENTS: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.

journal_name

J Endocrinol Invest

journal_title

Journal of endocrinological investigation

authors

Riedl M,Kuhn A,Krämer I,Kolbe E,Kahaly GJ

doi

10.1007/s40618-016-0441-9

subject

Has Abstract

pub_date

2016-06-01 00:00:00

pages

687-94

issue

6

eissn

0391-4097

issn

1720-8386

pii

10.1007/s40618-016-0441-9

journal_volume

39

pub_type

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