Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Medical College of Wisconsin, Milwaukee, WI, USA.
Br J Dermatol. 2021 Dec;185(6):1146-1159. doi: 10.1111/bjd.20568. Epub 2021 Sep 8.
BACKGROUND: Psoriasis is a chronic disease requiring long-term therapy. OBJECTIVES: Physician- and patient-reported outcomes were evaluated through week 252 in VOYAGE 1 and VOYAGE 2. METHODS: In total, 1829 patients were randomized at baseline to receive guselkumab 100 mg every 8 weeks, placebo or adalimumab. Patients receiving placebo crossed over to guselkumab at week 16. Patients receiving adalimumab crossed over to guselkumab at week 52 in VOYAGE 1, and randomized withdrawal and retreatment occurred at weeks 28-76 in VOYAGE 2; all patients then received open-label guselkumab through week 252. Efficacy and health-related quality of life (HRQoL) endpoints were analysed through week 252. Safety was monitored through week 264. RESULTS: The proportions of patients in the guselkumab group who achieved clinical responses at week 252 in VOYAGE 1 and VOYAGE 2, respectively, were 84·1% and 82·0% [≥ 90% improvement in Psoriasis Area and Severity Index (PASI)]; 82·4% and 85·0% [Investigator's Global Assessment (IGA) 0 or 1]; 52·7% and 53·0% (100% improvement in PASI) and 54·7% and 55·5% (IGA 0). HRQoL endpoints were achieved as follows: 72·7% and 71·1% of patients (Dermatology Life Quality Index 0 or 1: no effect on patient's life); 42·4% and 42·0% [Psoriasis Symptoms and Signs Diary (PSSD) symptom score = 0] and 33·0% and 31·0% (PSSD sign score = 0). As measured in VOYAGE 2 only, approximately 45% of patients achieved ≥ 5-point reduction in Short Form-36 physical and mental component scores, and 80% reported no anxiety or depression (Hospital Anxiety and Depression Scale scores < 8). Similar findings were reported for adalimumab crossovers. These effects were maintained from week 52 in VOYAGE 1 and week 100 in VOYAGE 2. No new safety signals were identified. CONCLUSIONS: Guselkumab maintains high levels of clinical response and improvement in patient-reported outcomes through 5 years in patients with moderate-to-severe psoriasis.
背景:银屑病是一种需要长期治疗的慢性疾病。
目的:通过 VOYAGE 1 和 VOYAGE 2 的第 252 周评估医生和患者报告的结果。
方法:共有 1829 例患者在基线时随机分配接受古塞库单抗 100mg 每 8 周、安慰剂或阿达木单抗治疗。接受安慰剂的患者在第 16 周交叉接受古塞库单抗治疗。接受阿达木单抗的患者在 VOYAGE 1 中第 52 周交叉接受古塞库单抗治疗,并在 VOYAGE 2 中第 28-76 周随机停药和重新治疗;所有患者随后通过第 252 周接受开放标签古塞库单抗治疗。通过第 252 周分析疗效和健康相关生活质量(HRQoL)终点。通过第 264 周监测安全性。
结果:在 VOYAGE 1 和 VOYAGE 2 中,分别有 84.1%和 82.0%(≥90%的银屑病面积和严重程度指数(PASI)改善)、82.4%和 85.0%(研究者全球评估(IGA)0 或 1)、52.7%和 53.0%(PASI 100%改善)和 54.7%和 55.5%(IGA 0)的古塞库单抗组患者达到临床反应。达到以下 HRQoL 终点:72.7%和 71.1%的患者(皮肤病生活质量指数 0 或 1:对患者生活无影响);42.4%和 42.0%(银屑病症状和体征日记(PSSD)症状评分=0)和 33.0%和 31.0%(PSSD 体征评分=0)。仅在 VOYAGE 2 中测量,约 45%的患者达到了 SF-36 身体和精神成分评分至少 5 分的降低,80%的患者报告无焦虑或抑郁(医院焦虑和抑郁量表评分<8)。阿达木单抗交叉患者也有类似的发现。这些效果从 VOYAGE 1 的第 52 周和 VOYAGE 2 的第 100 周保持。未发现新的安全性信号。
结论:古塞库单抗可在中重度银屑病患者中维持长达 5 年的高临床反应和患者报告结局改善。
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