Azuaga A B, Frade-Sosa B, Laiz A, Estrada P, Prior-Español A, Horcada L, Polino L, Moreno M, Moragues C, Urruticoechea-Arana A, Sellas A, Tandaipan J L, Torrente-Segarra V, Garcia-Miguel J, Ros I, Ordoñez S, Moya P, Reina D, Mateo-Soria L, Fito C, Beltrán E, Pujol M, Cuervo A M, Cañete J D, Ramírez Julio
Arthritis Unit, Rheumatology Department, Hospital Clínic, Villarroel 170, 08036, Barcelona, Spain.
Rheumatology Department, Hospital Santa Creu i Sant Pau, Barcelona, Spain.
Clin Rheumatol. 2020 Oct;39(10):2963-2971. doi: 10.1007/s10067-020-05057-9. Epub 2020 Apr 13.
To assess the effectiveness and survival of ustekinumab (UST) among patients with psoriatic arthritis (PsA) treated under routine clinical care.
Multicenter study. Epidemiological and clinical data was collected through electronic medical records of all patients with PsA who started UST in 15 hospitals of Spain.
Two hundred and one patients were included, 130 (64.7%) with 45 mg and 71 (35.3%) with 90 mg. One hundred and thirty one patients (65.2%) had previously received another biological therapy. The median baseline DAS 28 ESR was 3.99, and Psoriasis Area and Severity Index (PASI) was 3. Overall, there was a significant decrease in DAS66/68 CRP, swollen joint count (SJC), tender joint count (TJC), and PASI in the first month of treatment, with earlier improvement in skin (PASI) than joints outcomes. Survival was numerically lower in patients with UST 45 mg (58.1%) than 90 mg (76.1%), although significant differences were not found (p = 0.147). When comparing naïve and < 1 TNF blocker versus > 2 TNF blocker-experienced patients, a significantly earlier response was seen in the former group regarding SJC (p = 0.029) at 1 month. Fifty-one patients (25.3%) stopped UST due to joint inefficacy and 4 patients due to adverse events (1.9%). Drug survival was significantly better in patients with fewer lines of previous biological agents (p = 0.003 for < 1 TNF blocker versus > 2 TNF blocker users).
UST was effective in PsA patients in a routine clinical care setting. Patients with UST 90 mg and fewer lines of previous biologics achieved better and faster responses. Key Points • Largest cohort of patients with PsA in treatment with UST with specific rheumatological indication. • First cohort of patients with PsA comparing effectiveness of UST according to 45/90 mg dose.
评估乌司奴单抗（UST）在接受常规临床治疗的银屑病关节炎（PsA）患者中的有效性和生存率。
多中心研究。通过西班牙15家医院中所有开始使用UST的PsA患者的电子病历收集流行病学和临床数据。
纳入201例患者，130例（64.7%）使用45mg，71例（35.3%）使用90mg。131例患者（65.2%）先前接受过另一种生物治疗。基线DAS 28 ESR中位数为3.99，银屑病面积和严重程度指数（PASI）为3。总体而言，治疗第一个月时，DAS66/68 CRP、肿胀关节计数（SJC）、压痛关节计数（TJC）和PASI均显著下降，皮肤（PASI）改善早于关节指标。UST 45mg患者的生存率在数值上低于90mg患者（58.1%对76.1%），尽管未发现显著差异（p = 0.147）。比较初治和<1种TNF阻滞剂使用者与>2种TNF阻滞剂经验者，前一组在1个月时SJC方面的反应明显更早（p = 0.029）。51例患者（25.3%）因关节无效停用UST，4例患者因不良事件停用（1.9%）。先前生物制剂使用线数较少的患者药物生存率显著更高（<1种TNF阻滞剂使用者与>2种TNF阻滞剂使用者相比，p = 0.003）。
在常规临床治疗环境中，UST对PsA患者有效。使用90mg UST且先前生物制剂使用线数较少的患者反应更好、更快。要点 • 接受UST治疗且有特定风湿病指征的PsA患者的最大队列。 • 首个根据45/90mg剂量比较UST有效性的PsA患者队列。
