ABSTRACT

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 (R² = 0.4; p = 0.009) and peripheral joint involvement (R² = 0.4; p = 0.04). During follow-up, reduction of BASDAI positively correlated with high ESR (R² = 0.65; p = 0.04). ASDAS-CRP at T0 positively correlated with high ESR (R² = 0.34; p = 0.004). Reduction of ASDAS-CRP from T0 to T6 correlated with current smoking status (R² = 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 (R² = 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.

摘要

背景：Secukinumab（SEC）在随机试验中对强直性脊柱炎（AS）和银屑病关节炎（PsA）有效，但缺乏现实生活中的数据。

研究设计和方法：在开始SEC后的基线（T0），6（T6）和12个月（T12）连续169位门诊患者的真实，前瞻性观察性研究（39 AS，23％; 130 PsA，77％）。

结果：在T6和T12时，所有临床变量（包括TJC，SJC，ESR，CRP，DAPSA，ASDAS-CRP和BASDAI）以及患者报告的结果（如VAS疼痛）均得到了显着改善。通过多变量回归分析，在AS患者中，T0时高BASDAI与诊断延迟（R ²  = 0.4; p = 0.009）和周围关节受累（R ²  = 0.4; p = 0.04）相关。在随访期间，BASDAI的降低与高ESR呈正相关（R ²  = 0.65； p = 0.04）。T0时的ASDAS-CRP与高ESR正相关（R ²  = 0.34； p = 0.004）。将ASDAS-CRP从T0降低到T6与当前吸烟状况相关（R ² = 0.42; p = 0.003）。在PsA患者中，DAPSA评分从T0降低到T12与代谢综合征的存在呈负相关（R ²  = 0.41； p = 0.0025）。SEC的容忍度很高；10例因非严重不良事件而终止治疗。

结论：Secukinumab在现实生活中对AS和PsA患者有效且安全。