Rheumatology Department, AP-HP, Henri Mondor University Hospital, 51 avenue du Mal de Lattre de Tassigny, 94010 Créteil, France.
Arthritis Res Ther. 2012 Mar 9;14(2):R53. doi: 10.1186/ar3766.
The aim of this study was to evaluate, under real-life conditions, the safety and efficacy of tocilizumab in patients having failed anti-TNFα therapy for spondyloarthritis.
French rheumatologists and internal-medicine practitioners registered on the Club Rhumatismes et Inflammations website were asked to report on patients given tocilizumab (4 or 8 mg/kg) to treat active disease meeting Assessment of SpondyloArthritis International Society (ASAS) criteria for axial or peripheral spondyloarthritis, after anti-TNFα treatment failure. Safety and efficacy after 3 and 6 months were assessed retrospectively using standardised questionnaires.
Data were obtained for 21 patients, 13 with axial spondyloarthritis (46% men; median age, 42 years; disease duration, 11 years; HLA-B27-positive, 92.3%) and eight with peripheral spondyloarthritis (25% men; median age, 40 years; disease duration, 10 years; HLA-B27-positive, 62.5%). No patients with axial disease had at least a 20 mm decrease in the BASDAI, nor a BASDAI50 response or major ASAS-endorsed disease activity score improvements after 3 or 6 months; an ASAS-endorsed disease activity score clinically important improvement was noted at month 3 in five of 13 patients and at month 6 in one of four patients. A good DAS28 response was achieved in four patients with peripheral disease, including one in EULAR remission at month 3. Four patients were still taking tocilizumab at month 6, including one in EULAR remission and one with a good DAS28 response. Tocilizumab was well tolerated, with no serious adverse events. Initially elevated acute-phase reactants declined during tocilizumab therapy.
In patients having failed anti-TNFα therapy, tocilizumab decreased acute-phase reactants but failed to substantially improve axial spondyloarthritis and was inconsistently effective in peripheral spondyloarthritis.
本研究旨在评估托珠单抗在抗 TNFα 治疗失败的脊柱关节炎患者中的安全性和疗效。
要求在 Club Rhumatismes et Inflammations 网站上注册的法国风湿病学家和内科医生报告托珠单抗（4 或 8mg/kg）治疗抗 TNFα 治疗失败后出现活动期疾病的符合脊柱关节炎评估国际协会（ASAS）标准的中轴或外周脊柱关节炎患者。使用标准化问卷回顾性评估 3 个月和 6 个月时的安全性和疗效。
共获得 21 例患者的数据，其中 13 例为中轴脊柱关节炎（46%男性；中位年龄 42 岁；疾病持续时间 11 年；HLA-B27 阳性，92.3%），8 例为外周脊柱关节炎（25%男性；中位年龄 40 岁；疾病持续时间 10 年；HLA-B27 阳性，62.5%）。没有中轴疾病患者 BASDAI 至少降低 20mm，也没有 BASDAI50 应答或主要 ASAS 认可的疾病活动评分改善，在 3 或 6 个月时，13 例患者中有 5 例出现 ASAS 认可的疾病活动评分临床重要改善，4 例患者出现改善。4 例外周疾病患者实现了 DAS28 良好应答，其中 1 例在 3 个月时达到 EULAR 缓解。在 6 个月时，4 例患者仍在使用托珠单抗，其中 1 例达到 EULAR 缓解，1 例 DAS28 良好应答。托珠单抗耐受性良好，无严重不良事件。最初升高的急性期反应物在托珠单抗治疗期间下降。
在抗 TNFα 治疗失败的患者中，托珠单抗降低了急性期反应物，但未能显著改善中轴脊柱关节炎，在外周脊柱关节炎中的疗效不一致。
