to evaluate over a 48-month follow-up period the: 1) long-term effectiveness and safety; 2) drug retention rate (DRR); 3) impact of comorbidities and bDMARDs line on MDA and DAPSA remission/low disease activity (LDA) of secukinumab in a multicenter Italian cohort of PsA patients. Consecutive PsA patients receiving secukinumab were followed prospectively in Italian centers between 2016 and 2023. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were recorded. Treatment response was evaluated at 6 and 12 months after initiation, and every year up to 48 months (T48). DRR was assessed according to clinical and demographic features, comorbidities and bDMARDs line. Adverse events (AE) were recorded. Six hundred eighty-five patients [42.5% male] were enrolled; 32.9% naïve received secukinumab; 74.2% had ≥ 1 comorbidity. Overall, secukinumab yielded improved outcomes at T48: naïve maintained lower disease activity vs. non-naïve [DAPSA 4.0 (1.4–8.1) vs. 6.0 (2.2–10.4);p = 0.04]; 76.9% naïve and 66.2% non-naïve achieved MDA; MDA no comorbidities vs. 1–3 comorbidities 78.8% vs. 73.3% (p < 0.05), and MDA no comorbidities vs. > 3 comorbidities 78.8% vs. 48.7% (p < 0.001). DAPSA-REM and DAPSA-LDA rates were higher in naïve patients, albeit similar between those without comorbidities vs. 1–3 comorbidities, and slightly lower in those with > 3 comorbidities. Treatment was discontinued in 233 patients due to loss of effectiveness, and in 41 due to AE. The overall DRR at T48 was 66%, with differences according to bDMARDs line (p < 0.001), use of combined csDMARDs (p = 0.016), BMI (p = 0.037) and mono/oligoarthritis vs. polyarthritis (p = 0.012). Secukinumab proved safe and effective, and patients achieved sustained remission with a notable drug retention rate at 4 years. What is already known on this topic? • Secukinumab is a novel drug for psoriatic arthritis (PsA), but real-life long-term safety and effectiveness data are lacking. What this study adds? • Our findings confirmed the safety and notable effectiveness on all PsA domains (arthritis, enthesitis, dactylitis, spinal symptoms, psoriasis, PROs and inflammatory markers), over a 48-month follow-up period. • The drug retention rate (DRR) is considerably high at 48 months. The main clinical disease pattern (peripheral/axial involvement), male gender, age, and the presence of comorbidities do not influence the DRR of secukinumab over time. • The first line of bDMARDs seems to favor MDA and remission/low disease activity DAPSA achievement and drug retention, while fewer than 3 comorbidities have no impact on these outcomes. How this study might affect research, practice or policy • This study supports the effectiveness of secukinumab, which also seems to be a valid option for multi-drug failure patients; the safety of secukinumab means it can be used in patients with comorbidities, older age, higher BMI, and in particular cardiovascular conditions and metabolic syndrome.

中文翻译：

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苏金单抗治疗银屑病关节炎的四年有效性、安全性和药物保留率：现实生活中的意大利多中心队列


在 48 个月的随访期内评估： 1) 长期有效性和安全性； 2）药物保留率（DRR）； 3) 在意大利多中心 PsA 患者队列中，合并症和 bDMARD 对苏金单抗 MDA 和 DAPSA 缓解/低疾病活动度 (LDA) 的影响。 2016 年至 2023 年间，意大利中心对连续接受苏金单抗的 PsA 患者进行了前瞻性随访。记录了疾病特征、既往/正在进行的治疗、合并症和随访持续时间。治疗反应在开始后 6 个月和 12 个月进行评估，每年评估直至 48 个月 (T48)。 DRR 根据临床和人口特征、合并症和 bDMARD 线进行评估。记录不良事件（AE）。招募了 685 名患者（42.5% 为男性）； 32.9% 未接受过苏金单抗治疗； 74.2% 有 ≥ 1 种合并症。总体而言，苏金单抗在 T48 时产生了改善的结果：与非初治者相比，初治者保持较低的疾病活动性 [DAPSA 4.0 (1.4–8.1) vs. 6.0 (2.2–10.4)；p = 0.04]； 76.9% 的新手和 66.2% 的非新手实现了 MDA； MDA 无合并症与 1-3 种合并症相比 78.8% 对 73.3% (p < 0.05)，MDA 无合并症与 > 3 种合并症相比 78.8% 对 48.7% (p < 0.001)。初次接受治疗的患者中 DAPSA-REM 和 DAPSA-LDA 率较高，尽管在没有合并症的患者与有 1-3 种合并症的患者之间相似，但在有 > 3 种合并症的患者中，DAPSA-REM 和 DAPSA-LDA 率略低。 233 名患者因疗效丧失而停止治疗，41 名患者因 AE 而停止治疗。 T48 时的总体 DRR 为 66%，差异取决于 bDMARD 线 (p < 0.001)、联合 csDMARD 的使用 (p = 0.016)、BMI (p = 0.037) 以及单关节炎/少关节炎与多关节炎 (p = 0.012) 。 苏金单抗被证明是安全有效的，患者在 4 年时获得了持续缓解，药物保留率显着。关于这个主题已有哪些已知信息？ • Secukinumab 是一种治疗银屑病关节炎 (PsA) 的新药，但缺乏现实生活中的长期安全性和有效性数据。这项研究增加了什么？ • 经过 48 个月的随访，我们的研究结果证实了该药物对所有 PsA 领域（关节炎、附着点炎、指趾炎、脊柱症状、牛皮癣、PRO 和炎症标志物）的安全性和显着有效性。 • 48 个月的药物保留率(DRR) 相当高。随着时间的推移，主要临床疾病模式（外周/中轴受累）、男性、年龄和合并症的存在不会影响苏金单抗的 DRR。 • bDMARD 的第一线似乎有利于MDA 和缓解/低疾病活动性DAPSA 成就和药物保留，而少于3 种合并症对这些结果没有影响。这项研究可能如何影响研究、实践或政策 • 这项研究支持苏金单抗的有效性，这似乎也是多种药物治疗失败患者的有效选择。苏金单抗的安全性意味着它可以用于患有合并症、年龄较大、体重指数较高的患者，特别是心血管疾病和代谢综合征的患者。