医学
托珠单抗
泼尼松龙
安慰剂
内科学
风湿性多肌痛
不利影响
临床终点
优势比
荟萃分析
随机对照试验
强的松
疾病
巨细胞动脉炎
替代医学
血管炎
病理
作者
Meha Sharma,Siddharth Kumar Das,Ritin Mohindra,Deep Dutta
标识
DOI:10.1111/1756-185x.70106
摘要
ABSTRACT Aims No meta‐analysis has holistically analyzed and summarized the efficacy and safety of tocilizumab in polymyalgia rheumatica (PMR). We undertook this meta‐analysis to address this knowledge‐gap. Methods Electronic databases were searched for RCTs involving patients living with PMR receiving tocilizumab in intervention arm, and placebo/active comparator in control arm. Primary outcome was to evaluate percentage of patients able to achieve C‐reactive protein PMR assessment score (CRP‐PMR‐AS) < 10 or prednisolone dose < 5 mg/day or > 10 mg/dL decline in prednisolone from baseline. Secondary outcomes were to determine percentage of patients able to totally stop prednisolone and adverse‐events. Results From initially screened 115 articles, data from 2 RCTs (136 patients) was analyzed. In addition, a descriptive analysis of 8 observational studies (356 patients) was also done. After 24‐weeks of clinical use, patients with PMR receiving tocilizumab had significantly higher chances of achieving composite primary end‐point defined as CRP‐PMR‐AS < 10 and either prednisone dosage < 5 mg/day or decrease in prednisolone dosage by > 10 mg/day compared to baseline [odds ratio (OR) 4.89 (95% CI: 2.34–10.23); p < 0.001; I 2 = 0%], compared to placebo. Patients with PMR receiving tocilizumab also had significantly higher chances of being able to stop prednisolone compared to placebo [OR 4.45 (95% CI: 2.06–9.61); p < 0.001; I 2 = 0%]. Occurrence of total adverse‐events [risk ratio (RR) 1.24 (95% CI: 0.50–3.12); p = 0.64; I 2 = 0%], adverse‐events leading to treatment discontinuation [RR 0.45 (95% CI: 0.10–2.02); p = 0.29; I 2 = 17%], and infections [RR 1.71 (95% CI: 0.83–3.52); p = 0.14; I 2 = 6%] were comparable in patients receiving tocilizumab as compared to placebo. Observational studies have noted lung infections, neutropenia and increased cholesterol with tocilizumab use. Conclusion Tocilizumab is well tolerated and is effective for managing PMR. Tocilizumab is an effective glucocorticoid sparing agent in PMR.
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