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Войти в исследования Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025
Perioperative Safety and Efficacy of Efgartigimod for Thymoma-Associated Myasthenia Gravis: A Prospective, Multicenter, Phase II Clinical Trial.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Wang Shuai, Zhu Min, Dong Jihong, Zhang Yong, Luo Sushan, Jiang Jiahao, Cheng Zhaozhao, Li Zhijun, Yang Wenping, Yu Yue, Liu Zhengcheng, Fan Jiang, Xu Xiangnan, Liu Peipei, Zhang Zhouao, Can Fang, Liang Fei, Jiang Xifei, Tan Lijie, Ding Jianyong
Аннотация
INTRODUCTION: This study reports the primary perioperative outcomes of efgartigimod in patients with thymoma-associated myasthenia gravis (TAMG).
METHODS: We conducted a prospective, single-arm clinical trial to evaluate the perioperative use of efgartigimod in acetylcholine receptor antibody-positive (AChR-Ab+) generalized TAMG. Efgartigimod was administered intravenously at a dose of 10 mg/kg on days 1, 8, 15, and 22, totaling four doses, with thymomectomy performed on day 9.
RESULTS: A total of 40 patients with TAMG were enrolled, with a median age of 46 years. The predominant thymomectomy approach was T2b minimally invasive thymectomy, performed in 21 of 40 patients (52.5%). All patients were classified as responders on the Myasthenia Gravis Activities of Daily Living, Quantitative Myasthenia Gravis, and Myasthenia Gravis Composite scale, demonstrating improvement across ocular, bulbar, limb, and respiratory muscle strength. At visit 4, myasthenic symptoms were obviously relieved, with reductions of 4.6 on Myasthenia Gravis Activities of Daily Living compared with baseline. Significant reductions were noted in both serum immunoglobulin G and AChR-Ab levels, without affecting other immunoglobulin classes or complement levels, after efgartigimod administration. The mean total postoperative hospitalization stay was 7.1 days. The total incidence of all-grade treatment-emergent adverse events was 62.5%, and the most treatment-emergent adverse events were reported to be mild. Postoperative myasthenic crisis occurred in four patients (10.0%) who underwent extended thymectomy.
CONCLUSION: The satisfactory outcomes and rapid neurologic remission demonstrated efgartigimod had favorable safety and efficacy profiles during the perioperative period of thymomectomy for TAMG. These findings support the potential of efgartigimod as a novel perioperative treatment option for TAMG.
GOV IDENTIFIER: NCT06221501.
METHODS: We conducted a prospective, single-arm clinical trial to evaluate the perioperative use of efgartigimod in acetylcholine receptor antibody-positive (AChR-Ab+) generalized TAMG. Efgartigimod was administered intravenously at a dose of 10 mg/kg on days 1, 8, 15, and 22, totaling four doses, with thymomectomy performed on day 9.
RESULTS: A total of 40 patients with TAMG were enrolled, with a median age of 46 years. The predominant thymomectomy approach was T2b minimally invasive thymectomy, performed in 21 of 40 patients (52.5%). All patients were classified as responders on the Myasthenia Gravis Activities of Daily Living, Quantitative Myasthenia Gravis, and Myasthenia Gravis Composite scale, demonstrating improvement across ocular, bulbar, limb, and respiratory muscle strength. At visit 4, myasthenic symptoms were obviously relieved, with reductions of 4.6 on Myasthenia Gravis Activities of Daily Living compared with baseline. Significant reductions were noted in both serum immunoglobulin G and AChR-Ab levels, without affecting other immunoglobulin classes or complement levels, after efgartigimod administration. The mean total postoperative hospitalization stay was 7.1 days. The total incidence of all-grade treatment-emergent adverse events was 62.5%, and the most treatment-emergent adverse events were reported to be mild. Postoperative myasthenic crisis occurred in four patients (10.0%) who underwent extended thymectomy.
CONCLUSION: The satisfactory outcomes and rapid neurologic remission demonstrated efgartigimod had favorable safety and efficacy profiles during the perioperative period of thymomectomy for TAMG. These findings support the potential of efgartigimod as a novel perioperative treatment option for TAMG.
GOV IDENTIFIER: NCT06221501.