在强直性脊柱炎和银屑病关节炎中司库奇尤单抗的一年疗效、保留率和安全性：一项真实世界的多中心研究。
One-year effectiveness, retention rate, and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multicenter study.
机构信息
Rheumatology, Allergology and Clinical Immunology, University of Rome Tor Vergata , Rome, Italy.
UOC di Reumatologia, Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari, Sapienza Università di Roma , Rome, Italy.
出版信息
Expert Opin Biol Ther. 2020 Jul;20(7):813-821. doi: 10.1080/14712598.2020.1761957. Epub 2020 May 13.
BACKGROUND
Secukinumab (SEC) is effective for ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in randomized trials, but real-life data are lacking.
RESEARCH DESIGN AND METHODS
Real-life, prospective observational study on 169 consecutive outpatients at baseline (T0) and at 6 (T6) and 12 months (T12) after starting SEC (39 AS, 23%; 130 PsA, 77%).
RESULTS
Significant improvement was seen at T6 and T12 for all clinical variables, including TJC, SJC, ESR, CRP, DAPSA, ASDAS-CRP, and BASDAI, as well as in patient-reported outcomes like VAS-pain. By multivariable regression analysis, in AS patients high BASDAI at T0 correlated with diagnostic delay (R = 0.4; p = 0.009) and peripheral joint involvement (R = 0.4; p = 0.04). During follow-up, reduction of BASDAI positively correlated with high ESR (R = 0.65; p = 0.04). ASDAS-CRP at T0 positively correlated with high ESR (R = 0.34; p = 0.004). Reduction of ASDAS-CRP from T0 to T6 correlated with current smoking status (R = 0.42; p = 0.003). In PsA patients, reduction of DAPSA score from T0 to T12 is negatively correlated with the presence of metabolic syndrome (R = 0.41; p = 0.0025). SEC was well tolerated; 10 patients discontinued treatment for non-severe adverse events.
CONCLUSIONS
Secukinumab is effective and safe in patients with AS and PsA in a real-life setting.
背景
在随机试验中，司库奇尤单抗（SEC）对强直性脊柱炎（AS）和银屑病关节炎（PsA）有效，但缺乏真实世界的数据。
研究设计和方法
这是一项真实的、前瞻性的观察性研究，共纳入 169 例连续的基线（T0）和开始使用 SEC 后 6 个月（T6）和 12 个月（T12）的门诊患者（39 例 AS，23%；130 例 PsA，77%）。
结果
所有临床变量，包括 TJC、SJC、ESR、CRP、DAPSA、ASDAS-CRP 和 BASDAI，以及患者报告的结局，如 VAS 疼痛，在 T6 和 T12 时均有显著改善。多变量回归分析显示，AS 患者 T0 时 BASDAI 较高与诊断延迟（R=0.4；p=0.009）和外周关节受累（R=0.4；p=0.04）相关。在随访期间，BASDAI 的降低与 ESR 升高呈正相关（R=0.65；p=0.04）。T0 时的 ASDAS-CRP 与 ESR 升高呈正相关（R=0.34；p=0.004）。从 T0 到 T6 的 ASDAS-CRP 降低与当前吸烟状态呈正相关（R=0.42；p=0.003）。在 PsA 患者中，从 T0 到 T12 的 DAPSA 评分降低与代谢综合征的存在呈负相关（R=0.41；p=0.0025）。SEC 耐受性良好；10 例患者因非严重不良事件停止治疗。
结论
SEC 在真实环境中对 AS 和 PsA 患者有效且安全。
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