Introduction

This analysis assessed the psychometric properties of the Psoriasis Symptoms and Impacts Measure (P-SIM), a novel patient-reported outcome (PRO) tool designed to capture patient experiences of the signs, symptoms and impacts of psoriasis.

Methods

Blinded data from the BE RADIANT phase 3b trial of bimekizumab were analysed. In BE RADIANT, patients were randomised 1:1 to bimekizumab 320 mg every 4 weeks (Q4W) or secukinumab 300 mg (weekly until Week 4, then Q4W). Three items (itching, skin pain and scaling) of the P-SIM were electronically assessed throughout the trial and were scored from 0 to 10 (none to very severe signs/symptoms/impacts). Test–retest reliability was determined using intraclass correlations. Convergent validity was assessed between P-SIM and other relevant PRO and clinician-reported outcome (ClinRO) scores. Known-groups validity was assessed by comparing mean P-SIM item scores between patient subgroups based on the Psoriasis Area and Severity Index (PASI)/Investigator’s Global Assessment (IGA) scores. Responsiveness was assessed via correlations between changes from baseline in P-SIM item scores and other relevant PRO and ClinRO scores. Anchor-based responder analyses and empirical cumulative distribution function (eCDF) curves determined responder thresholds.

Results

The three P-SIM items yielded high intraclass coefficients (> 0.70). By Week 48, the three P-SIM items had moderate (> 0.30 and ≤ 0.50) to strong (> 0.50) correlations with other PROs and weaker correlations with ClinROs, demonstrating good convergent validity. For almost all known-group comparisons, statistically significant between-subgroup score differences were seen across all three P-SIM items. Changes from baseline in the P-SIM and other relevant outcomes were above the acceptable threshold of ≤ 0.30, demonstrating sensitivity to change. Anchor-based analyses determined a ≥ four-point reduction from baseline to indicate marked clinically meaningful improvement for the P-SIM.

Conclusion

These results support the validity, reliability and sensitivity to change of the P-SIM in assessing key symptoms (itching, skin pain and scaling) in patients with moderate to severe plaque psoriasis.

Trial registration

NCT03536884.

中文翻译：

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银屑病症状和影响测量 (P-SIM) 的心理测量验证：一种针对斑块型银屑病患者的新型患者报告结果工具，使用 BE RADIANT 3b 期试验报告的数据

介绍

该分析评估了银屑病症状和影响测量 (P-SIM) 的心理测量特性，这是一种新型的患者报告结果 (PRO) 工具，旨在捕捉患者对银屑病体征、症状和影响的体验。

方法

分析了来自 bimekizumab 的 BE RADIANT 3b 期试验的盲法数据。在 BE RADIANT 中，患者以 1:1 的比例随机分配至 bimekizumab 320 mg 每 4 周（第 4 周）或苏金单抗 300 mg（每周至第 4 周，然后是第 4 周）。在整个试验过程中，对 P-SIM 的三个项目（瘙痒、皮肤疼痛和脱屑）进行了电子评估，评分范围为 0 到 10（无到非常严重的体征/症状/影响）。使用组内相关性确定重测信度。在 P-SIM 和其他相关的 PRO 和临床医生报告的结果 (ClinRO) 评分之间评估了收敛有效性。通过比较基于银屑病面积和严重性指数 (PASI)/研究者的全球评估 (IGA) 评分的患者亚组之间的平均 P-SIM 项目评分来评估已知组有效性。通过 P-SIM 项目评分基线变化与其他相关 PRO 和 ClinRO 评分之间的相关性评估反应性。基于锚点的响应者分析和经验累积分布函数 (eCDF) 曲线确定了响应者阈值。

结果

三个 P-SIM 项目产生了较高的组内系数 (> 0.70)。到第 48 周，三个 P-SIM 项目与其他 PRO 具有中度（> 0.30 和 ≤ 0.50）至强（> 0.50）相关性，与 ClinRO 的相关性较弱，显示出良好的收敛效度。对于几乎所有已知的组比较，在所有三个 P-SIM 项目中都可以看到具有统计学意义的亚组间评分差异。P-SIM 和其他相关结果的基线变化高于可接受的阈值 ≤ 0.30，表明对变化的敏感性。基于锚的分析确定从基线减少 ≥ 4 个点，表明 P-SIM 具有显着的临床意义改善。

结论

这些结果支持了 P-SIM 在评估中度至重度斑块型银屑病患者的关键症状（瘙痒、皮肤疼痛和脱屑）方面的有效性、可靠性和敏感性。

试用注册

NCT03536884。