真实世界中 608 例银屑病关节炎患者使用司库奇尤单抗的疗效和安全性：一项为期 24 个月的前瞻性、多中心研究。
Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study.
机构信息
Rheumatology Unit, Department of Medicine, University of Padova, Padova, Veneto, Italy
Rheumatology Unit, Department of Medicine, University of Padova, Padova, Veneto, Italy.
出版信息
RMD Open. 2021 Feb;7(1). doi: 10.1136/rmdopen-2020-001519.
OBJECTIVES
To evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) differences in the outcomes according to the biological treatment line: biologic-naïve patients () versus multifailure () patients.
METHODS
Consecutive patients with PsA receiving secukinumab were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical values were recorded at baseline (T0), 6(T6), 12(T12) and 24(T24) months. Effectiveness was evaluated overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded.
RESULTS
608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with . At T24, MDA was achieved in 75.71% of and 70.37% of . Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05).
CONCLUSIONS
In a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.
目的
在接受司库奇尤单抗治疗的意大利多中心银屑病关节炎（PsA）患者队列中进行评估：（1）司库奇尤单抗的长期疗效和安全性；（2）药物保留率和最小疾病活动度（MDA）；（3）根据生物治疗线的差异：生物初治患者（）与多线治疗失败患者（）的结局差异。
方法
连续入组接受司库奇尤单抗治疗的 PsA 患者，前瞻性评估。收集疾病特征、既往/正在进行的治疗、合并症和随访时间。在基线（T0）、6（T6）、12（T12）和 24（T24）个月记录疾病活动/功能/临床评分和生化值。采用描述性统计评估疗效随时间的变化；采用多变量 Cox 和逻辑回归模型评估 T6 时药物停药和 MDA 的预测因素。记录感染和不良事件。
结果
共纳入 608 例患者（41.28%为男性；平均（SD）年龄 52.78（11.33）岁）；227 例（37.34%）患者将司库奇尤单抗作为一线生物治疗药物，381 例（62.66%）患者作为二线（或更多线）生物治疗药物。司库奇尤单抗的有效性在多个结局方面得到了证实，例如强直性脊柱炎疾病活动评分（T0=3.26（0.88）vs T24=1.60（0.69）；p=0.02）和银屑病关节炎疾病活动指数（T0=25.29（11.14）vs T24=7.69（4.51）；p<0.01）。在 T24 时，与相比，显示出较低的银屑病面积严重程度指数（p=0.04）、红细胞沉降率和 C 反应蛋白（p=0.03；p=0.05）和关节计数（p=0.03）。在 T24 时，达到 MDA 的患者中，为 75.71%，为 70.37%。123 例（20.23%）患者因原发性/继发性治疗失效而停止治疗，22 例患者因不良事件而停止治疗。整个队列中，T24 时的保留率为 71%，不同剂量的司库奇尤单抗（p=0.004）和性别（p=0.05）存在一定差异。
结论
在真实临床环境中，司库奇尤单抗在所有银屑病关节炎领域均安全有效，药物保留率高。
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