Research Article: Clinical study of eculizumab with or with not tacrolimus in the treatment of generalized myasthenia gravis
Abstract:
Eculizumab, an antibody that inhibits the complement system, and the immunosuppressant Tacrolimus are both authorized for treating patients with generalized myasthenia gravis (GMG). This study seeks to evaluate and compare the clinical effectiveness of Eculizumab with or with not Tacrolimus in the treatment of generalized myasthenia gravis.
A retrospective study was performed involving 95 patients with GMG treated with Eculizumab at three hospitals in China. Among them, 80 patients were included in the analysis: 57 received Eculizumab alone, while 23 were treated with a combination of Eculizumab and Tacrolimus. The main outcome assessed was the percentage of GMG patients who reached Minimal Symptom Expression (MSE). Secondary outcomes included changes in MG-Activities of Daily Living (MG-ADL) scale, Quantitative Myasthenia Gravis (QMG) score, CH50 concentration, and doses of pyridostigmine and prednisolone. Additionally, the safety profiles of both treatment groups were examined.
In the main outcome, a higher proportion of patients reached MSE status when treated with a combination of Eculizumab and Tacrolimus compared to Eculizumab alone (Eculizumab: 29 patients, 50.9% vs Eculizumab and Tacrolimus: 18 patients, 78.3%; p<0.05). Regarding secondary outcomes, both treatment groups showed significant improvements in clinical symptoms, as indicated by notable reductions in QMG and MG-ADL scores, along with a significant reduction in prednisolone dosage. Furthermore, analysis of secondary outcome parameters revealed no significant differences between the two groups (p>0.05). The decrease in complement CH50 concentration is accompanied by a decrease in QMG and MG-ADL scores, indicating that Eculizumab treats GMG through the mechanism of complement system. In terms of security, hyperuricemia was more commonly associated with the combination therapy of Eculizumab and Tacrolimus than with Eculizumab alone.
Our research indicates that Eculizumab can effectively reduce disability in GMG patients by inhibiting complement system activation under real-world clinical conditions in China. We observed a correlative link between Eculizumab and Tacrolimus combination treatment and an increased probability of achieving MSE status, in comparison with Eculizumab monotherapy. However, combination therapy is associated with a higher risk of elevated serum uric acid among GMG patients, which necessitates regular close monitoring of renal function.
Introduction:
Eculizumab, an antibody that inhibits the complement system, and the immunosuppressant Tacrolimus are both authorized for treating patients with generalized myasthenia gravis (GMG). This study seeks to evaluate and compare the clinical effectiveness of Eculizumab with or with not Tacrolimus in the treatment of generalized myasthenia gravis.
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