From the Rheumatology Division.
Pharmacy Department, and.
J Clin Rheumatol. 2018 Oct;24(7):381-384. doi: 10.1097/RHU.0000000000000751.
BACKGROUND/AIMS: Ustekinumab (UST) is a fully human immunoglobulin G1 monoclonal antibody approved for treating moderate to severe psoriasis and, more recently, psoriatic arthritis (PsA) as well. However, information regarding its clinical usefulness in a real-world setting is scarce. We aimed to evaluate the effectiveness and safety of UST in a real-world clinical setting.
This single-center observational study included PsA outpatients (n = 50) treated with UST from March 2015 to March 2017. Only patients who used at least 3 doses of UST were analyzed. The percentage of patients who achieved a minimal disease activity (MDA) response was collected. The impact of the disease was also evaluated according to the recently developed Psoriatic Arthritis Impact of Disease (PsAID) questionnaire. A binary logistic regression multivariate model was performed to look for variables predicting MDA.
Twenty-seven patients (54%) reached an MDA state. Mean PsAID in MDA group was 3.5 ± 2.9 versus 6.8 ± 5.1 in non-MDA patients (p < 0.001). Among the patients who achieved MDA, 19 (70.4%) had a patient-acceptable symptom state according to the PsAID, whereas only 5 (21.7%) of the 23 patients who did not reach an MDA achieved a patient-acceptable symptom state (p < 0.001). Higher basal Psoriasis Area and Severity Index decreased the odds of achieving MDA (odds ratio [OR], 0.80; 95% CI, 0.65-0.99; p = 0.038), whereas a longer use of UST (OR, 1.52; 95% CI, 1.13-2.06; p = 0.015) and a previous failure to 1 anti-tumor necrosis factor α (OR, 18; 95% CI, 2.52-128.63; p = 0.004) increased this odds. We found no major safety problems.
Ustekinumab was effective and safe in this PsA population. Minimal disease activity and PsAID may be useful tools in the evaluation of PsA therapeutic interventions in routine clinical practice.
背景/目的：乌司奴单抗（UST）是一种全人源 IgG1 单克隆抗体，已被批准用于治疗中重度银屑病，最近也用于治疗银屑病关节炎（PsA）。然而，关于其在真实世界环境中的临床应用效果的信息还很有限。我们旨在评估 UST 在真实世界临床环境中的有效性和安全性。
这项单中心观察性研究纳入了 2015 年 3 月至 2017 年 3 月期间接受 UST 治疗的 PsA 门诊患者（n=50）。仅对至少使用 3 剂 UST 的患者进行分析。收集达到最小疾病活动度（MDA）应答的患者比例。根据最近开发的银屑病关节炎疾病影响量表（PsAID）评估疾病的影响。进行二元逻辑回归多变量模型，以寻找预测 MDA 的变量。
27 例患者（54%）达到 MDA 状态。MDA 组的平均 PsAID 为 3.5±2.9，而非 MDA 患者为 6.8±5.1（p<0.001）。在达到 MDA 的患者中，19 例（70.4%）根据 PsAID 达到了患者可接受的症状状态，而在未达到 MDA 的 23 例患者中，只有 5 例（21.7%）达到了患者可接受的症状状态（p<0.001）。较高的基础银屑病面积和严重程度指数降低了达到 MDA 的可能性（比值比[OR]，0.80；95%置信区间，0.65-0.99；p=0.038），而 UST 使用时间较长（OR，1.52；95%置信区间，1.13-2.06；p=0.015）和先前抗肿瘤坏死因子-α治疗失败（OR，18；95%置信区间，2.52-128.63；p=0.004）增加了达到 MDA 的可能性。我们未发现主要的安全性问题。
在该 PsA 人群中，乌司奴单抗是有效且安全的。最小疾病活动度和 PsAID 可能是评估常规临床实践中 PsA 治疗干预效果的有用工具。
