Rheumatology Unit, Department of Medicine, University of Padova, Padova, Veneto, Italy
Rheumatology Unit, Department of Medicine, University of Padova, Padova, Veneto, Italy.
RMD Open. 2021 Feb;7(1). doi: 10.1136/rmdopen-2020-001519.
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.
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.
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).
In a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.
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。
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。
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。
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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