Department of Medicine DIMED, Rheumatology Unit, University of Padova, Padova, Veneto, Italy.
Rheumatology Unit, Department of Medicine-DIMED, Padova University Hospital, Via Giustiniani, 2, 35128, Padova, Italy.
Arthritis Res Ther. 2024 Sep 28;26(1):172. doi: 10.1186/s13075-024-03401-x.
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.
在 48 个月的随访期间评估：1）长期疗效和安全性；2）药物保留率（DRR）；3）共病和 bDMARD 线对 secukinumab 治疗意大利多中心银屑病关节炎（PsA）患者 MDA 和 DAPSA 缓解/低疾病活动度（LDA）的影响。
2016 年至 2023 年，在意大利中心连续入组接受 secukinumab 的 PsA 患者进行前瞻性随访。记录疾病特征、既往/正在进行的治疗、合并症和随访时间。在起始后 6 个月和 12 个月以及 48 个月（T48）进行治疗反应评估。根据临床和人口统计学特征、合并症和 bDMARD 线评估 DRR。记录不良事件（AE）。
共纳入 685 例患者[42.5%为男性]；32.9%为初治患者接受 secukinumab 治疗；74.2%有≥1 种合并症。总体而言，secukinumab 在 T48 时获得了更好的结果：初治患者与非初治患者相比疾病活动度更低[DAPSA 4.0（1.4-8.1）vs. 6.0（2.2-10.4）；p=0.04]；76.9%的初治患者和 66.2%的非初治患者达到 MDA；无合并症的 MDA 与 1-3 种合并症的 MDA 相比为 78.8% vs. 73.3%（p<0.05），无合并症的 MDA 与>3 种合并症的 MDA 相比为 78.8% vs. 48.7%（p<0.001）。初治患者 DAPSA-REM 和 DAPSA-LDA 率更高，但无合并症患者与 1-3 种合并症患者之间无差异，而合并症>3 种的患者略低。由于疗效丧失，233 例患者停止治疗，41 例患者因 AE 停止治疗。T48 时的总体 DRR 为 66%，根据 bDMARD 线（p<0.001）、联合 csDMARDs 的使用（p=0.016）、BMI（p=0.037）和单关节炎/寡关节炎与多关节炎（p=0.012）存在差异。
secukinumab 安全有效，患者在 4 年内持续缓解，药物保留率显著。
