source: Journal of Endocrinological Investigation

year: 2016

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

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.

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