OBJECTIVE Patients with psoriatic arthritis (PsA) in randomized controlled trials (RCTs) may not reflect patients with PsA in clinical practice. Our objective was to perform a metaanalysis comparing the characteristics of patients with PsA in RCTs of biologic disease-modifying antirheumatic drugs (bDMARDs) to patient profiles in a real-world study. METHODS Data sources included (1) a scoping literature review of phase III RCTs of bDMARDs in PsA published between 2015 and 2020, and (2) an international observational study of patients with PsA starting a bDMARD enrolled between 2015 and 2018 (PsABio; ClinicalTrials.gov: NCT02627768). Data collected at baseline included swollen and tender joint counts (SJC/TJC), presence of enthesitis, skin involvement (body surface area [BSA]), C-reactive protein (CRP), physician global assessment (PGA), and patient-reported outcomes (PROs; Health Assessment Questionnaire [HAQ], pain). Univariate random effects metaanalysis was conducted to calculate pooled means and proportions. RESULTS Overall, 5654 patients from 10 RCTs were compared to 930 PsABio patients. Demographic data were similar. SJC/TJC were higher in RCTs than in PsABio (pooled means: 11.8/21.5 vs 5.7/11.9), and enthesitis was more frequent in RCTs (64.7% vs 48.2%), as were patients with a BSA ≥ 3% (62.2% vs 54%). PGA was higher in RCTs (59.7 vs 54.1). In contrast, PROs were similar, whereas CRP was significantly higher in PsABio (1.4 vs 1.1 mg/dL). CONCLUSION Patients with PsA starting a bDMARD in RCTs had highly active disease and a high patient-reported disease burden. In contrast, PsABio real-world patients starting a bDMARD had lower SJC/TJC, skin involvement, and PGA, but presented with similar patient-reported disease burden. The extrapolation of RCT data in clinical practice should take these elements into account.

中文翻译：

---

随机对照试验中的患者概况与银屑病关节炎的真实世界研究：范围审查和荟萃分析。


目的 随机对照试验 （RCT） 中的银屑病关节炎 （PsA） 患者在临床实践中可能无法反映 PsA 患者。我们的目的是进行荟萃分析，将生物疾病缓解抗风湿药 （bDMARDs） 的 RCT 中 PsA 患者的特征与真实世界研究中的患者概况进行比较。方法 数据来源包括 （1） 2015 年至 2020 年间发表的 psA 中 bDMARD 的 III 期 RCT 的范围界定文献综述，以及 （2） 一项针对 2015 年至 2018 年间开始 bDMARD 的 PsA 患者的国际观察性研究 （PsABio;ClinicalTrials.gov： NCT02627768）。基线时收集的数据包括肿胀和压痛关节计数 （SJC/TJC）、附着点炎的存在、皮肤受累 （体表面积 [BSA]）、C 反应蛋白 （CRP）、医师整体评估 （PGA） 和患者报告结果 （PROs;健康评估问卷 [HAQ]，疼痛）。进行单变量随机效应荟萃分析以计算合并均值和比例。结果 总体而言，将来自 10 项 RCT 的 5654 例患者与 930 例 PsABio 患者进行了比较。人口统计数据相似。随机对照试验中的 SJC/TJC 高于 PsABio（汇总均值：11.8/21.5 对 5.7/11.9），附着点炎在 RCT 中更常见（64.7% 对 48.2%），BSA ≥的患者也更常见 3%（62.2% 对 54%）。RCT 中的 PGA 更高 （59.7 vs 54.1）。相比之下，PRO 相似，而 PsABio 的 CRP 显着更高 （1.4 vs 1.1 mg/dL）。结论 在 RCT 中开始使用 bDMARD 的 PsA 患者具有高度活跃的疾病和较高的患者报告疾病负担。相比之下，开始使用 bDMARD 的 PsABio 真实世界患者的 SJC/TJC 、皮肤受累和 PGA 较低，但表现出相似的患者报告疾病负担。 临床实践中 RCT 数据的外推应考虑这些因素。