Shear N H, Hartmann M, Toledo-Bahena M E, Gilbert M, Katsambas A, Yao R, Popmihajlov Z
Division of Dermatology, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Department of Dermatology, University of Heidelberg, Heidelberg, Germany.
Qual Life Res. 2016 Aug;25(8):2031-40. doi: 10.1007/s11136-015-1224-z. Epub 2016 Feb 11.
We evaluated the effect of plaque-type psoriasis on health-related quality of life (HRQoL) of patients who received infliximab (IFX) in real-world clinical settings.
REALITY was a prospective, observational, open-label study of the efficacy and safety of up to 98 weeks of IFX (5 mg/kg infused at weeks 0, 2, 6, and every 8 weeks thereafter) in patients with moderate-to-severe plaque-type psoriasis. Patients with ≥25 % Psoriasis Area Severity Index (PASI) improvement (PASI 25) at week 50 were eligible for the Extended Treatment Phase (treatment to week 98). Inclusion criteria were diagnosis of plaque-type psoriasis, age ≥18 years, decision to start IFX, and patient consent. Key secondary efficacy outcomes included the Dermatologic Life Quality Index (DLQI; mean DLQI scores, attainment of DLQI 0/1), which was analyzed over 98 weeks. Post hoc analyses examined improvement in DLQI and the relationship between PASI and DLQI.
In the Treatment Phase, patients (n = 516, 66.0 % men, mean age 46.4 years) had a mean baseline PASI of 18.1. Mean DLQI improved from 12.7 at baseline to 4.7 [mean change (95 % CI); -8.0 (-8.9, -7.1)] at week 50; 64.0 % (229/358) of patients improved by ≥5 DLQI points. At week 50 (n = 362), 37.6 % (95 % CI; 32.7, 42.7) achieved a DLQI of 0. In the Extended Treatment Phase, patients (n = 167, 68.3 % men, mean age 46.6 years) had a mean baseline PASI of 20.4. Mean DLQI improved from 12.3 at baseline to 2.8 at week 98 [mean change (95 % CI); -9.4 (-10.8, -8.0)]; 68.6 % (96/140) of patients improved by ≥5 DLQI points. At week 98 (n = 141), 47.5 % (95 % CI; 39.4, 55.7) achieved a DLQI of 0.
Patients with plaque-type psoriasis who received treatment with IFX for 50 weeks or up to 98 weeks reported substantial HRQoL improvement.
我们评估了斑块型银屑病对在真实临床环境中接受英夫利昔单抗（IFX）治疗的患者健康相关生活质量（HRQoL）的影响。
“真实世界银屑病治疗观察研究（REALITY）”是一项前瞻性、观察性、开放标签研究，旨在评估中重度斑块型银屑病患者接受长达98周IFX（0、2、6周时静脉输注5mg/kg，此后每8周一次）治疗的疗效和安全性。第50周时银屑病面积和严重程度指数（PASI）改善≥25%（PASI 25）的患者有资格进入延长治疗阶段（治疗至第98周）。纳入标准为斑块型银屑病诊断、年龄≥18岁、决定开始IFX治疗以及患者同意。关键次要疗效指标包括皮肤病生活质量指数（DLQI；平均DLQI评分、达到DLQI 0/1），在98周内进行分析。事后分析检查了DLQI的改善情况以及PASI与DLQI之间的关系。
在治疗阶段，患者（n = 516，66.0%为男性，平均年龄46.4岁）基线PASI平均值为18.1。平均DLQI从基线时的12.7改善至第50周时的4.7[平均变化（95%CI）；-8.0（-8.9，-7.1）]；64.0%（229/358）的患者DLQI改善≥5分。在第50周时（n = 362），37.6%（95%CI；32.7，42.7）达到DLQI为0。在延长治疗阶段，患者（n = 167，68.3%为男性，平均年龄46.6岁）基线PASI平均值为20.4。平均DLQI从基线时的12.3改善至第98周时的2.8[平均变化（95%CI）；-9.4（-10.8，-8.0）]；68.6%（96/140）的患者DLQI改善≥5分。在第98周时（n = 141），47.5%（95%CI；39.4，55.7）达到DLQI为0。
接受IFX治疗50周或长达98周的斑块型银屑病患者报告健康相关生活质量有显著改善。
