司库奇尤单抗在整个轴性脊柱关节炎谱系中的真实世界经验。

Real-world experience with secukinumab in the entire axial spondyloarthritis spectrum.

作者信息

Sivera Francisca, Núñez-Monje Victoria, Campos-Fernández Cristina, Balaguer-Trull Isabel, Robustillo-Villarino Montserrat, Aguilar-Zamora Marta, Garijo-Bufort Marta, López-Gómez Juan Miguel, Peña-González Carolina, de la Morena Isabel, Bedoya-Sanchís Diego, Yankova-Komsalova Liliya, Conesa-Mateos Arantxa, Martínez-Cristóbal Anna, Navarro-Blasco Francisco Javier, Senabre-Gallego José Miguel, Alegre-Sancho Juan José

机构信息

Rheumatology Department, Hospital General Universitario de Elda, Alicante, Spain.

Departament of Clinical Medicine, Universidad Miguel Hernandez, Elche, Spain.

出版信息

Front Med (Lausanne). 2023 May 11;10:1156557. doi: 10.3389/fmed.2023.1156557. eCollection 2023.

BACKGROUND

Secukinumab is a biologic disease-modifying antirheumatic drug (bDMARD) that has demonstrated efficacy in the treatment of axial spondyloarthritis (axSpA, i.e., ankylosing spondylitis and non-radiographic axSpA) across various clinical trials. However, data of secukinumab in clinical practice is still limited. Here, we aimed to provide real-world data on secukinumab use, effectiveness, and persistence in axSpA.

PATIENTS AND METHODS

Retrospective, multicenter study of patients with a diagnosis of axSpA treated with secukinumab at 12 centers up to June 2021 in the Valencian Community (Spain). Information was gathered on BASDAI measurement, pain, patient and physician global assessment (ptGA, phGA) using a 100-mm visual analog scale (VAS), persistence and other secondary variables by treatment line (first, second, and ≥ third) for up to 24 months.

RESULTS

221 patients were included (69% men; mean age [standard deviation, SD]: 46.7 [12.1] years old). Secukinumab was used as a first-line bDMARD in 38% of patients, as a second-line in 34% and as a ≥ hird-line in 28%. The percentage of patients achieving low disease activity (BASDAI<4) increased from 9% at baseline to 48% at month 6 and was maintained (49%) up to month 24. The greatest improvement in BASDAI was observed in naïve patients (month 6: -2.6; month 24: -3.7), followed by second-line (month 6: -1.9; month 24: -3.1) and ≥ third-line (month 6: -1.3; month 24: -2.3) patients. Reductions in mean pain VAS (-23.3; -31.9), ptGA (-25.1; -31.9) and phGA (-25.1; -31) were also observed at 6 and 24 months. Secukinumab showed an overall 12-months persistence rate of 70% (95% confidence interval [CI]: 63-77%) and a 24-months persistence rate of 58% (95% CI, 51-66%). Patients receiving first-line secukinumab had the highest 24-months persistence rate ( = 0.05).

CONCLUSION

Secukinumab improved disease activity in axSpA patients, especially in naive, and second-line patients, which was accompanied by high persistence rates up to 24 months.

背景

司库奇尤单抗是一种生物性改善病情抗风湿药（bDMARD），在多项临床试验中已证明其对治疗中轴型脊柱关节炎（axSpA，即强直性脊柱炎和非放射学中轴型脊柱关节炎）有效。然而，司库奇尤单抗在临床实践中的数据仍然有限。在此，我们旨在提供关于司库奇尤单抗在axSpA中的使用、有效性和持续性的真实世界数据。

患者与方法

对2021年6月前在西班牙巴伦西亚自治区12个中心接受司库奇尤单抗治疗的axSpA患者进行回顾性多中心研究。收集了关于巴斯强直性脊柱炎疾病活动指数（BASDAI）测量、疼痛、患者和医生整体评估（患者整体评估[ptGA]、医生整体评估[phGA]）的数据，使用100毫米视觉模拟量表（VAS），以及按治疗线（一线、二线和≥三线）划分的持续性和其他次要变量，随访时间长达24个月。

结果

纳入221例患者（69%为男性；平均年龄[标准差，SD]：46.7[12.1]岁）。38%的患者将司库奇尤单抗用作一线bDMARD，34%用作二线，28%用作≥三线。达到低疾病活动度（BASDAI<4）的患者百分比从基线时的9%增加到第6个月时的48%，并维持在（49%）直至第24个月。在初治患者中观察到BASDAI改善最大（第6个月：-2.6；第24个月：-3.7），其次是二线患者（第6个月：-1.9；第24个月：-3.1）和≥三线患者（第6个月：-1.3；第24个月：-2.3）。在第6个月和第24个月时，平均疼痛VAS（-23.3；-31.9）、ptGA（-25.1；-31.9）和phGA（-25.1；-31）也有所降低。司库奇尤单抗的总体12个月持续率为70%（95%置信区间[CI]：63-77%），24个月持续率为58%（95%CI，51-66%）。接受一线司库奇尤单抗治疗的患者24个月持续率最高（P=0.05）。