TSI and Its Relationship With Graves' Disease Relapse

Study Overview
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Brief Summary
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The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are: To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD. To determine an optimal cut-off of TSI level for predicting GD relapse. To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.

Detailed Description
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Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.

Official Title
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Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse

Conditions
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Graves Disease, Immunoglobulin, Anti-Thyroid Antibodies Disorder

Intervention / Treatment
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* Diagnostic Test: TSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association. TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of ≤10 mg. Propylthiouracil (PTU): at doses of ≤200 mg. Exclusion Criteria: Hyperthyroidism due to other causes Patients who were intolerant to ATD or had serious side effects with ATD. TSIs were measured in pregnancy. Patients treated with surgery or radioactive iodine.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ATD withdrawal<br>ATD treatment was decided to be stopped at the discretion of the attending physician. Then, patients were followed after ATD withdrawal to determine who would have relapse of GD. Finally, patients were divided into 2 groups: Relapse and No relapse | Diagnostic Test: TSI<br>* TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).<br>|
| No ATD withdrawal<br>Patients treated with ATD still the end of the study | Diagnostic Test: TSI<br>* TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with GD relapse | Patients who had relapse of hyperthyroidism due to GD | at least 1 year after ATD withdrawal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG. | TSI level before planning for ATD withdrawal | before ATD withdrawal | 
| Optimal cut-off of TSI level for predicting GD relapse | Optimal cut-off of TSI level before ATD withdrawal for predicting GD relapse | before ATD withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TSI, recurrent Graves' disease, Graves' ophthalmopathy, treatment duration, anti-thyroid drug, cut-off