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一项多中心、前瞻性、观察性研究,考察了在希腊常规护理环境中,接受英夫利昔单抗治疗的中重度斑块型银屑病患者,BMI 和腰围等危险因素对生活质量改善和临床应答的影响。

A multicenter, prospective, observational study examining the impact of risk factors, such as BMI and waist circumference, on quality of life improvement and clinical response in moderate-to-severe plaque-type psoriasis patients treated with infliximab in routine care settings of Greece.

机构信息

State Dermatology Clinic, A. Syggros Hospital of Venereal and Skin Diseases, Athens, Greece.

1st Department of Dermatology, A. Syggros Hospital, University of Athens, Athens, Greece.

出版信息

J Eur Acad Dermatol Venereol. 2018 May;32(5):768-775. doi: 10.1111/jdv.14802.

DOI:10.1111/jdv.14802
PMID:29356149
Abstract

BACKGROUND

Obesity has been associated with moderate-to-severe plaque psoriasis severity and PASI 75 response attainment of biologic therapies, but findings are inconsistent.

OBJECTIVE

This study aimed to examine the association of body mass index (BMI) and waist circumference (WC) on disease severity, to identify potential patient characteristics associated with response attainment and to assess the impact of infliximab on the patients' health-related quality of life (HRQoL) among infliximab-treated patients in the routine care setting of Greece.

METHODS

This was a multicenter, prospective, observational study of adult moderate-to-severe plaque psoriasis patients who had initiated treatment with originator infliximab within 2 weeks prior to enrolment. Postenrolment visits occurred at 14 ± 4, 30 ± 4 and 54 ± 4 weeks following treatment onset.

RESULTS

Between October 2012 and June 2014, 136 eligible patients (62.5% males) with a median age of 48.6 years, BMI of 29.6 kg/m and WC of 107.0 cm at enrolment were recruited by 21 dermatology hospital/private offices. All patients had received prior psoriasis treatment(s); 62.5% were biologic-naïve. Mean baseline psoriasis area severity index (PASI) and Dermatology Quality of Life Index (DLQI) scores were 23.4 ± 13.6 and 15.0 ± 8.3, respectively. A low correlation was observed between WC at enrolment and baseline PASI [ρ = 0.324 (P < 0.001)]. Over a median 48.4 weeks of infliximab exposure, 89.3% of the per protocol set achieved a PASI 75 response. At 14, 30 and 54 weeks, the PASI 75 attainment rate was 66.4%, 74.8% and 76.6%, respectively; the clinically meaningful DLQI improvement (≥5 point decrease) rate was 68.9%, 75.7% and 69.8%, respectively. BMI category and abdominal obesity at enrolment did not impact PASI 75 or DLQI improvement rate attainment.

CONCLUSION

In the routine care of Greece, infliximab reduced disease activity and improved the quality of life of moderate-to-severe psoriasis patients through 1 year of treatment, independent of their BMI and WC.

摘要

背景

肥胖与中度至重度斑块型银屑病的严重程度以及生物制剂治疗的 PASI75 反应获得有关,但研究结果并不一致。

目的

本研究旨在检查体重指数(BMI)和腰围(WC)与疾病严重程度之间的关系,确定与反应获得相关的潜在患者特征,并评估英夫利昔单抗对希腊常规治疗环境中接受英夫利昔单抗治疗的患者的健康相关生活质量(HRQoL)的影响。

方法

这是一项多中心、前瞻性、观察性研究,纳入了在入组前 2 周内开始接受英夫利昔单抗原研药治疗的中度至重度斑块型银屑病成年患者。入组后第 14±4、30±4 和 54±4 周进行随访。

结果

2012 年 10 月至 2014 年 6 月,共纳入了 136 名符合条件的患者(62.5%为男性),中位年龄为 48.6 岁,BMI 为 29.6kg/m2,WC 为 107.0cm。所有患者均接受过先前的银屑病治疗;62.5%为生物制剂初治患者。基线时的平均银屑病面积严重程度指数(PASI)和皮肤病生活质量指数(DLQI)分别为 23.4±13.6 和 15.0±8.3。在登记时 WC 与基线 PASI 之间观察到低相关性[ρ=0.324(P<0.001)]。在接受英夫利昔单抗治疗的中位 48.4 周期间,89.3%的符合方案人群达到 PASI75 反应。在第 14、30 和 54 周时,PASI75 获得率分别为 66.4%、74.8%和 76.6%;临床意义上的 DLQI 改善(≥5 分降低)率分别为 68.9%、75.7%和 69.8%。登记时的 BMI 类别和腹部肥胖与 PASI75 或 DLQI 改善率的获得无关。

结论

在希腊的常规治疗中,英夫利昔单抗通过 1 年的治疗减轻了中度至重度银屑病患者的疾病活动度,并改善了他们的生活质量,这与他们的 BMI 和 WC 无关。

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