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INTRODUCTION

The interleukin-23p19 subunit inhibitor, guselkumab, has demonstrated improvements in clinical and patient-reported outcome (PRO) measures in patients with moderate-to-severe psoriasis. Understanding the relationship among clinical response, PRO measures and baseline characteristics could help clinicians individualize treatment plans. The objective of this analysis was to examine changes in signs, symptoms and quality-of-life (QoL) PRO measures in patients who maintained complete skin clearance through ≥ 3 years in the phase 3 VOYAGE 1 trial.

METHODS

A descriptive post hoc analysis of data from VOYAGE 1 was conducted to compare baseline characteristics of patients who maintained complete skin clearance (Psoriasis Area and Severity Index [PASI] = 0 for ≥ 156 consecutive weeks) versus patients who did not. Mean scores for individual domains of the Dermatology Life Quality Index (DLQI) and Psoriasis Symptom and Sign Diary (PSSD) were evaluated in patients who maintained complete skin clearance, and baseline characteristics of patients who achieved PRO scores of DLQI = 0/1 and PSSD = 0 were compared with those who did not.

RESULTS

Of the 329 patients included in this post hoc analysis, 73 (22.2%) maintained PASI = 0 for ≥ 156 weeks. This group had a numerically lower proportion of patients at baseline with obesity, depression or previous biologic treatment and a higher proportion who had never smoked. Patients who maintained PASI = 0 generally achieved positive DLQI and PSSD outcomes, though some impact of residual disease was observed, largely related to the DLQI "Symptoms and feelings" sub-scale and PSSD components "Dryness," "Redness" and "Itch." Patients reporting continued disease impact (despite sustaining PASI = 0) had greater disease severity at baseline versus those achieving DLQI = 0/1 and PSSD = 0.

CONCLUSION

Clinical measures alone do not capture the full patient experience. While both QoL and clinical symptoms are responsive to highly effective treatment, a subset of patients with complete clinical response is still impacted by their psoriasis. Further investigation into this population is warranted.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02207231.

引言

白细胞介素-23p19亚基抑制剂古塞库单抗已在中度至重度银屑病患者的临床及患者报告结局（PRO）指标方面显示出改善效果。了解临床反应、PRO指标与基线特征之间的关系有助于临床医生制定个体化治疗方案。本分析的目的是在3期VOYAGE 1试验中，研究维持完全皮肤清除状态达≥3年的患者的体征、症状及生活质量（QoL）PRO指标的变化情况。

方法

对VOYAGE 1的数据进行描述性事后分析，比较维持完全皮肤清除状态（银屑病面积和严重程度指数[PASI]=0且连续≥156周）的患者与未维持该状态的患者的基线特征。对维持完全皮肤清除状态的患者评估皮肤病生活质量指数（DLQI）和银屑病症状与体征日记（PSSD）各领域的平均得分，并比较达到DLQI=0/1及PSSD=0的PRO得分的患者与未达到该得分的患者的基线特征。

结果

在本次事后分析纳入的329例患者中，73例（22.2%）维持PASI=0达≥156周。该组患者基线时肥胖、抑郁或曾接受生物治疗的比例在数值上较低，从不吸烟的比例较高。维持PASI=0的患者总体上取得了积极的DLQI和PSSD结果，不过观察到残余疾病有一定影响，主要与DLQI的“症状与感受”子量表以及PSSD的“干燥”“发红”和“瘙痒”部分有关。报告疾病仍有影响（尽管维持PASI=0）的患者基线时的疾病严重程度高于达到DLQI=0/1及PSSD=0的患者。