Objectives Tocilizumab, an anti-IL-6 receptor antibody, was investigated in patients with refractory Takayasu arteritis (TAK) in a phase 3 randomized controlled trial. In this post hoc analysis, we investigated whether tocilizumab treatment inhibited the progression of vascular lesions caused by TAK in these patients. Methods Included patients received at least one dose of tocilizumab and underwent CT at baseline and at week 48 after tocilizumab initiation. Three radiologists not involved in the original trial independently evaluated the CT images. Twenty-two arteries from each patient were assessed for change from baseline in wall thickness (primary endpoint), dilatation/aneurysm, stenosis/occlusion or wall enhancement for at least 96 weeks after tocilizumab initiation. Patient-level assessments were also conducted. Results In 28 patients, 86.7% of 22 arteries had improved or stable wall thickness at week 96. Proportions of patients with improved or stable, partially progressed or newly progressed lesions were 57.1%, 10.7% and 28.6%, respectively, for wall thickness; proportions with improved or stable lesions were 92.9% for dilatation/aneurysm, and 85.7% for stenosis/occlusion. Patients with newly progressed lesions, reflecting more refractory disease, were prescribed glucocorticoids at dosages that could not be reduced below 0.1 mg/kg/day at week 96. Conclusions Approximately 60% of patients with TAK did not experience progression in wall thickness within 96 weeks after initiation of tocilizumab treatment. Few patients experienced progressed dilatation/aneurysm, or stenosis/occlusion. Wall thickness progression likely resulted from refractory TAK. Patients who experience this should be monitored regularly by imaging, and additional glucocorticoid or immunosuppressive treatment should be considered to avoid vascular progression. Trial registration Japan Pharmaceutical Information Centre number, JapicCTI-142616.

中文翻译：

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托珠单抗治疗难治性大动脉炎患者的血管成像：随机对照试验的事后分析

目的 抗 IL-6 受体抗体 Tocilizumab 在 3 期随机对照试验中在难治性大动脉炎 (TAK) 患者中进行了研究。在这项事后分析中，我们调查了托珠单抗治疗是否抑制了这些患者中由 TAK 引起的血管病变的进展。方法 纳入的患者接受了至少一剂托珠单抗，并在基线和托珠单抗开始后 48 周接受了 CT 检查。三名未参与原始试验的放射科医师独立评估了 CT 图像。在托珠单抗开始后至少 96 周内，评估了每位患者的 22 条动脉壁厚（主要终点）、扩张/动脉瘤、狭窄/闭塞或壁增强的基线变化。还进行了患者级别的评估。结果 28 例患者中，86 例。在第 96 周时，22 条动脉中有 7% 的管壁厚度改善或稳定。病变改善或稳定、部分进展或新进展的患者的管壁厚度分别为 57.1%、10.7% 和 28.6%；病变改善或稳定的比例为扩张/动脉瘤的92.9%，狭窄/闭塞的85.7%。在第 96 周，有新进展的病变（反映更多难治性疾病）的患者被规定的糖皮质激素剂量不能低于 0.1 mg/kg/天。结论 大约 60% 的 TAK 患者在 96 周内没有出现壁厚进展托珠单抗治疗开始后。少数患者出现进展性扩张/动脉瘤或狭窄/闭塞。壁厚进展可能是由耐火 TAK 引起的。出现这种情况的患者应定期进行影像学监测，并应考虑额外的糖皮质激素或免疫抑制治疗以避免血管进展。试验注册日本药品信息中心编号，JapicCTI-142616。