ArticleJournal of endocrinological investigation2016
Prospective, systematically recorded mycophenolate safety data in Graves' orbitopathy.
Article in Journal of endocrinological investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Efficacy and safety of mycophenolate mofetil in the treatment of moderate to severe Graves' orbitopathy: a meta-analysis.Bioengineered · 2022Pooled it
- Systemic safety analysis of mycophenolate in Graves' orbitopathy.Journal of endocrinological investigation · 2020Pooled it
- Unravelling the pathogenic mechanisms in Graves' orbitopathy.European thyroid journal · 2025Review
- Real world effectiveness of Mycophenolate-sodium therapy in patients at risk with Graves' orbitopathy.Thyroid research · 2025Article
- Review
- Efficacy of Compound Betamethasone Periocular Injection Combined With Oral Mycophenolate Mofetil in Active Thyroid-Associated Ophthalmopathy: A Pilot Study.International journal of endocrinology · 2025Article
- Targeted immunotherapies for Graves' thyroidal & orbital diseases.Frontiers in immunology · 2025Review
- Dysthyroid optic neuropathy: emerging treatment strategies.Journal of endocrinological investigation · 2023Review
- 2022 Update on Clinical Management of Graves Disease and Thyroid Eye Disease.Endocrinology and metabolism clinics of North America · 2022Review
- Thyrotropin receptor antibodies and Graves' orbitopathy.Journal of endocrinological investigation · 2021Review
- Real-World Efficacy and Safety of Mycophenolate Mofetil in Active Moderate-to-Sight-Threatening Thyroid Eye Disease.Clinical ophthalmology (Auckland, N.Z.) · 2021Article
- Management of Graves Thyroidal and Extrathyroidal Disease: An Update.The Journal of clinical endocrinology and metabolism · 2020Review
- New insights into the pathogenesis and nonsurgical management of Graves orbitopathy.Nature reviews. Endocrinology · 2020Review
- Review
- Thyroid Eye Disease: How A Novel Therapy May Change The Treatment Paradigm.Therapeutics and clinical risk management · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextThe antiproliferative mechanism of mycophenolate acid (MPA) suggests a beneficial effect in patients with Graves' orbitopathy (GO).
objectiveTo systematically analyze for the first time adverse events (AEs) during MPA treatment in GO.
designProspective longitudinal study.
settingAcademic tertiary referral center with a joint thyroid-eye clinic. PATIENTS: Fifty-three consecutive, unselected patients with clinically active and moderate-to-severe GO.
methodsMPA 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).
resultsFifty 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.
conclusionsMedDRA-coded data documented the good tolerance of a moderate MPA dose in GO patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.