EFG vs IVIG in TAMG

Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study

This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor (AChR) antibody-positive thymoma patients with myasthenia gravis in order to provide reliable evidence for clinical decision-making.

Inclusion Criteria:

1. Patients aged >18 years and ≤75 years, with an expected survival time >12 months;
2. Patients with generalized myasthenia gravis;
3. MG-ADL ≥6;
4. Positive for AChR antibody;
5. Diagnosed with thymoma by enhanced chest CT or MRI;
6. Patients with thymoma combined with myasthenia gravis who are diagnosed by MDT and need to undergo thymectomy;
7. Patients with American Society of Anesthesiologists (ASA) grade 1-2;
8. Able to understand the study situation and sign the Informed Consent.

Exclusion Criteria:

1. MGFA type V;
2. Patients who have undergone median sternotomy;
3. Confirmed history of congestive heart failure; poorly controlled angina pectoris with drug treatment; electrocardiogram (ECG) confirmed transmural myocardial infarction; poorly controlled hypertension; clinically significant valvular heart disease; or high-risk uncontrolled arrhythmia;
4. Patients with weight loss of more than 5kg in the past month; severe uncontrolled systemic disease, such as active infection or poorly controlled diabetes; patients with hemorrhagic diseases and bleeding tendencies; coagulation dysfunction, bleeding tendency or receiving thrombolytic or anticoagulant therapy; patients with grade II-IV bone marrow suppression;
5. Females with positive serum pregnancy test or in lactation period, and males and females of childbearing age who are unwilling to use adequate contraceptive measures during treatment;
6. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
7. Patients with peripheral nervous system disorders or significant mental disorders and a history of central nervous system disorders;
8. Patients participating in other clinical studies simultaneously;
9. Patients who cannot tolerate single-lung ventilation during surgery; severe cardiac complications, cardiovascular decompensation, patients with implanted cardiac pacemakers;
10. Patients in the acute inflammatory period due to bacterial, viral or other microbial infections; known active infections of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), or known HIV seropositivity;
11. Patients who have undergone thoracic surgery due to tuberculous pleurisy, mesothelioma, lung disease, or diaphragmatic disease, with ipsilateral lung atelectasis involving one lobe or more than one lobe;
12. Serum IgG level <4.5 g/L;
13. Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month;
14. Thrombosis, renal impairment or renal failure;
15. Allergic to human immunoglobulin or have other severe allergic history;
16. Selective IgA deficiency with anti-IgA antibodies;
17. Subjects with impaired function of major organs, abnormal blood routine, lung, liver, kidney and cardiac function, and the following laboratory test results:

Blood: white blood cells <4.0×10^9/L, absolute neutrophil count (ANC) <2.0×10^9/L, platelet count <100×10^9/L, hemoglobin <90g/L; Liver function: serum bilirubin >1.5 times the upper normal limit; ALT and AST >1.5 times the upper normal limit; Renal function: serum creatinine (SCr) >120 μmol/L, creatinine clearance rate (CCr) <60 ml/min;