Department of Dermatology and Wound Healing, Cardiff University School of Medicine, Cardiff University, Cardiff, UK.
Medical University of South Carolina, Charleston, SC, USA.
J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1715-1721. doi: 10.1111/jdv.14384. Epub 2017 Jul 19.
Chronic spontaneous/idiopathic urticaria (CSU/CIU) has substantial detrimental effects on health-related quality of life (HRQoL) with an effect comparable to or worse than many other skin diseases.
To assess the effect of omalizumab on CSU patients' HRQoL, measured by the Dermatology Life Quality Index (DLQI) in three phase III studies ASTERIA I, ASTERIA II and GLACIAL.
A post hoc analysis examined changes in DLQI scores, distribution of patients across DLQI bands and the proportion reaching minimal clinically important difference (MCID) following omalizumab vs. placebo.
Omalizumab 300 mg significantly improved total DLQI scores vs. placebo, with a mean decrease from baseline to week 12 of -10.3 vs. -6.1 (P < 0.0001) in ASTERIA I, -10.2 vs. -6.1 (P = 0.0004) in ASTERIA II and -9.7 vs. -5.1 (P < 0.0001) in GLACIAL. A significant shift from high disease impact on life at baseline towards less impact at week 12 was seen with omalizumab 300 mg vs. placebo (P < 0.001; all studies). The proportion of patients where change in mean total DLQI score from baseline to week 12 reached an MCID of ≥4 was 74.1%, 76.0% and 77.2% in ASTERIA I, II and GLACIAL, respectively (P < 0.01; all studies).
Maximum duration of omalizumab treatment was 24 weeks.
This additional analysis assessed the impact of CSU and benefit of treatment with omalizumab by exploring different facets of DLQI data by treatment arm at multiple assessment points. The original aspects of analysis included applying the concept of the recently validated score for the MCID of the DLQI, changes in DLQI domain scores and in the distribution of subjects based on validated total DLQI score bands. It showed consistently that omalizumab provides significant and clinically relevant improvements in many aspects of HRQoL that are important to patients with CSU. These results contribute to a better understanding of the impact of CSU and its treatment on patients and can support clinical decision-making in routine medical practice.
慢性自发性/特发性荨麻疹（CSU/CIU）对健康相关生活质量（HRQoL）有实质性的不利影响，其影响可与许多其他皮肤病相当或更差。
通过三项 III 期研究（ASTERIA I、ASTERIA II 和 GLACIAL）中的皮肤病生活质量指数（DLQI）评估奥马珠单抗对 CSU 患者 HRQoL 的影响。
一项事后分析检查了奥马珠单抗与安慰剂相比，DLQI 评分的变化、DLQI 评分分布以及达到最小临床重要差异（MCID）的患者比例。
奥马珠单抗 300mg 与安慰剂相比，总 DLQI 评分显著改善，ASTERIA I 中从基线到第 12 周的平均下降为-10.3 与-6.1（P < 0.0001），ASTERIA II 中为-10.2 与-6.1（P = 0.0004），GLACIAL 中为-9.7 与-5.1（P < 0.0001）。与安慰剂相比，奥马珠单抗 300mg 治疗后基线时疾病对生活的高影响显著向第 12 周时的低影响转移（P < 0.001；所有研究）。从基线到第 12 周，平均总 DLQI 评分变化达到 MCID 的患者比例在 ASTERIA I、II 和 GLACIAL 中分别为 74.1%、76.0%和 77.2%（P < 0.01；所有研究）。
奥马珠单抗治疗的最长时间为 24 周。
通过在多个评估点按治疗组探索 DLQI 数据的不同方面，这项额外分析评估了 CSU 的影响和奥马珠单抗治疗的获益。分析的原始方面包括应用最近验证的 DLQI MCID 评分的概念、DLQI 域评分的变化以及基于验证的总 DLQI 评分分布的受试者分布。结果一致表明，奥马珠单抗在 CSU 患者 HRQoL 的许多方面提供了显著且具有临床意义的改善，这些方面对患者很重要。这些结果有助于更好地了解 CSU 及其治疗对患者的影响，并为常规医疗实践中的临床决策提供支持。
Zotero 插件
