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首页> 外文期刊>Modern rheumatology >Long-term safety and efficacy of weekly subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis who had an inadequate response to subcutaneous tocilizumab every other week: Results from the open-label extension of the SHINOBI study
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Long-term safety and efficacy of weekly subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis who had an inadequate response to subcutaneous tocilizumab every other week: Results from the open-label extension of the SHINOBI study

机译：每周皮下对皮肤病患者的长期安全性和疗效，对类风湿性关节炎的患者进行了对皮下对皮下丁证章的反应不足：Shinobi研究的开放标签延伸结果

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Objective: To evaluate the long-term safety and efficacy of subcutaneous tocilizumab (TCZ-SC) monotherapy administered weekly (qw) in patients with rheumatoid arthritis who had an inadequate response to TCZ-SC every other week (q2w). Methods: Patients who completed 12 weeks of double-blind treatment with either TCZ-SC q2w monotherapy or TCZ-SC qw monotherapy were switched to or continued to receive open-label treatment with TCZ-SC qw monotherapy for 40 weeks. Safety and efficacy were assessed. Subgroup analyses of Disease Activity Score based on 28 joints using erythrocyte sedimentation rate (DAS28-ESR) were performed at 12 weeks. Results: The incidence of adverse events was 464.4/100 patient-years (PY). The incidence of infection was 121.3/100 PY. The safety profile of TCZ-SC qw monotherapy was consistent with that of prior studies of TCZ. No additional safety concerns were observed. Improvement from baseline in DAS28-ESR was maintained at week 52 in patients who continued TCZ-SC qw and improved in patients who switched from TCZ-SC q2w to qw. At week 12, the efficacy of TCZ-SC qw monotherapy was greater than that of TCZ-SC q2w monotherapy irrespective of weight and BMI subgroups. Conclusion: The long-term weekly dosing of TCZ-SC monotherapy was well tolerated and efficacy was maintained over 52 weeks.
机译：目的：评价皮下对照（QW）对类风湿性关节炎患者给药的长期安全性和疗效，对TCZ-SC的反应不足（Q2W）。方法：用TCZ-SC Q2W单药治疗或TCZ-SC QW单药治疗完成12周的双盲治疗，或继续使用TCZ-SC QW单药治疗40周的开放标签治疗。评估安全性和疗效。基于28个关节使用红细胞沉降率（DAS28-ESR）的亚组分析疾病活动评分（DAS28-ESR）在12周内进行。结果：不良事件的发生率为464.4 / 100患者 - 年（PY）。感染的发生率为121.3 / 100 py。 TCZ-SC QW单疗法的安全性曲线与TCZ的先前研究一致。没有观察到额外的安全问题。 DAS28-ESR中的基线改善于第52周维持在持续TCZ-SC QW的患者中，并改善从TCZ-SC Q2W转换为QW的患者。在12周，无论体重和BMI亚组如何，TCZ-SC QW单药治疗的疗效大于TCZ-SC Q2W单疗法的疗效。结论：TCZ-SC单药治疗的长期每周给药良好，疗效超过52周。

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