Prospective, Systematically Recorded Mycophenolate Safety Data in Graves' Orbitopathy | oneGRAVESvoice

welcome to oneGRAVESvoice

- a positively charged Graves' disease and thyroid eye disease community.
  • join today!
Scientific Articles

Prospective, Systematically Recorded Mycophenolate Safety Data in Graves’ Orbitopathy

key information

source: Journal of Endocrinological Investigation

year: 2016

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

summary/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.

organization: Johannes Gutenberg University Medical Center, Germany

DOI: 10.1007/s40618-016-0441-9

Font Resize

To improve your experience on this site, we use cookies. This includes cookies essential for the basic functioning of our website, cookies for analytics purposes, and cookies enabling us to personalize site content. By clicking on 'Accept' or any content on this site, you agree that cookies can be placed. You may adjust your browser's cookie settings to suit your preferences.
More information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close