OBJECTIVE Patients with psoriatic arthritis (PsA) in randomised controlled trials (RCTs) may not reflect patients in clinical practice. The objective was to perform a meta-analysis of PsA patients' characteristics in RCTs of biologic disease-modifying antirheumatic drugs (bDMARDs), and to compare them to patient profiles in a real-world study. METHODS Data sources: (a) Scoping literature review of phase III RCTs of bDMARDs in PsA published 2015-2020; (b) International observational study of PsA patients starting a bDMARD enrolled in 2015-2018 (PsABio: NCT02627768). Data collected at baseline included swollen and tender joint counts (SJC/TJC), enthesitis, skin involvement (body surface area -BSA-), C-reactive protein (CRP), physician global assessment (PhGA) and patient-reported outcomes (HAQ, pain). Univariate random-effects meta-analysis 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 respectively); enthesitis was more frequent in RCTs (64.7% vs 48.2%); as were patients with a BSA≥3% (62.2% vs 54.0%). PhGA was higher in RCTs (59.7mm vs 54.1mm). In contrast, patient-reported outcomes were similar, while CRP was significantly higher in PsABio (1.1 vs 1.4mg/dl). CONCLUSION PsA patients 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 joint counts, skin disease and PhGA, 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：

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银屑病关节炎随机对照试验与真实世界研究的患者概况：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） 患者可能无法反映临床实践中的患者。目的是在生物疾病缓解抗风湿药 （bDMARDs） 的 RCT 中对 PsA 患者的特征进行荟萃分析，并将其与真实世界研究中的患者概况进行比较。方法 数据来源： （a） 2015-2020 年发表的 PsA 中 bDMARD 的 III 期 RCT 的范围界定文献综述;（b） 2015-2018 年入组的 PsA 患者开始 bDMARD 的国际观察研究 （PsABio： NCT02627768）。基线时收集的数据包括关节肿胀和压痛计数 （SJC/TJC）、附着点炎、皮肤受累 （体表面积 -BSA-）、C 反应蛋白 （CRP） 、医师整体评估 （PhGA） 和患者报告的结果 （HAQ、疼痛）。进行单变量随机效应 meta 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。RCT 中的 SJC/TJC 高于 PsABio（合并平均值，分别为 11.8/21.5 和 5.7/11.9）;附着点炎在 RCT 中更常见 （64.7% vs 48.2%）;BSA 患者也是如此≥3% （62.2% vs 54.0%）。RCT 中的 PhGA 较高 （59.7 mm vs 54.1 mm）。相比之下，患者报告的结局相似，而 PsABio 的 CRP 显着更高 （1.1 vs 1.4mg/dl）。结论 在 RCT 中开始 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 真实世界患者的关节计数、皮肤病和 PhGA 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。