针对银屑病患者的家庭与办公室窄带紫外线-B 光疗:LITE 随机临床试验。

IF 11.5 1区 医学 Q1 DERMATOLOGY JAMA dermatology Pub Date : 2024-09-25 DOI:10.1001/jamadermatol.2024.3897
Joel M Gelfand, April W Armstrong, Henry W Lim, Steven R Feldman, Sandra M Johnson, W C Cole Claiborne, Robert E Kalb, Jeannette Jakus, Aaron R Mangold, R Hal Flowers, Tina Bhutani, John R Durkin, Jerry Bagel, Scott Fretzin, Michael P Sheehan, James Krell, Margo Reeder, Jessica Kaffenberger, Francisca Kartono, Junko Takeshita, Alisha M Bridges, Eric Fielding, Umbereen S Nehal, Kenneth L Schaecher, Leah M Howard, Guy S Eakin, Suzette Báez, Brooke E Bishop, Robert C Fitzsimmons, Maryte Papadopoulos, William B Song, Kristin A Linn, Rebecca A Hubbard, Daniel B Shin, Kristina Callis Duffin
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引用次数: 0

摘要

重要性:办公室光疗治疗银屑病具有成本效益,但很难获得。家庭光疗是患者的首选,但临床数据有限,尤其是对肤色较深的患者:比较家用窄带 UV-B 光疗与办公室光疗对银屑病的疗效:光疗有效性研究是一项由研究者发起的、务实的、开放标签、平行组、多中心、非劣效随机临床试验,在美国 42 家学术和私人临床皮肤科诊所的常规护理中进行。入组时间为 2019 年 3 月 1 日至 2023 年 12 月 4 日,随访至 2024 年 6 月。参与者年龄在12岁及以上,患有斑块状或凹陷型银屑病,适合接受家庭和诊室光疗:干预措施:参与者被随机分配接受带有引导模式剂量计的家用窄带紫外线-B 光疗机治疗,或接受为期 12 周的诊室窄带紫外线-B 光疗常规护理,然后再进行为期 12 周的观察:主要疗效结果:主要疗效结果为干预期结束时的医生总体评估(PGA)二分法,即皮肤清晰/基本清晰(评分≤1),以及第12周时皮肤科生活质量指数(DLQI)评分为5分或更低(对生活质量无影响或影响较小):在 783 名患者(平均 [SD] 年龄为 48.0 [15.5] 岁;376 [48.0%] 为女性)中,393 人接受了家庭光疗,390 人接受了办公室光疗,其中 350 人(44.7%)为皮肤光型 (SPT) I/II,350 人(44.7%)为 SPT III/IV,83 人(10.6%)为 SPT V/VI。共有 93 名患者(11.9%)正在接受系统治疗。基线时,平均(标清)PGA 为 2.7(0.8),DLQI 为 12.2(7.2)。第 12 周时,接受家庭光疗的 129 名患者(32.8%)和接受诊室光疗的 100 名患者(25.6%)的皮肤达到透明/基本透明,DLQI 为 5 或更低的患者分别有 206 名(52.4%)和 131 名(33.6%)。在总体人群和所有 SPTs 中,家用光疗在 PGA 和 DLQI 方面均不劣于诊室光疗。与诊室光疗相比,家庭光疗的治疗依从性更好(202 名患者 [51.4%] vs 62 名患者 [15.9%];P 结论及意义:在这项随机临床试验中,在日常临床实践中,家庭光疗与诊室光疗对斑块状或凹陷型银屑病同样有效,而且对患者造成的负担更小:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT03726489。
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Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis: The LITE Randomized Clinical Trial.

Importance: Office-based phototherapy is cost-effective for psoriasis but difficult to access. Home-based phototherapy is patient preferred but has limited clinical data, particularly in patients with darker skin.

Objective: To compare the effectiveness of home- vs office-based narrowband UV-B phototherapy for psoriasis.

Design, setting, and participants: The Light Treatment Effectiveness study was an investigator-initiated, pragmatic, open-label, parallel-group, multicenter, noninferiority randomized clinical trial embedded in routine care at 42 academic and private clinical dermatology practices in the US. Enrollment occurred from March 1, 2019, to December 4, 2023, with follow-up through June 2024. Participants were 12 years and older with plaque or guttate psoriasis who were candidates for home- and office-based phototherapy.

Interventions: Participants were randomized to receive a home narrowband UV-B machine with guided mode dosimetry or routine care with office-based narrowband UV-B for 12 weeks, followed by an additional 12-week observation period.

Main outcomes and measures: The coprimary effectiveness outcomes were Physician Global Assessment (PGA) dichotomized as clear/almost clear skin (score of ≤1) at the end of the intervention period and Dermatology Life Quality Index (DLQI) score of 5 or lower (no to small effect on quality of life) at week 12.

Results: Of 783 patients enrolled (mean [SD] age, 48.0 [15.5] years; 376 [48.0%] female), 393 received home-based phototherapy and 390 received office-based phototherapy, with 350 (44.7%) having skin phototype (SPT) I/II, 350 (44.7%) having SPT III/IV, and 83 (10.6%) having SPT V/VI. A total of 93 patients (11.9%) were receiving systemic treatment. At baseline, mean (SD) PGA was 2.7 (0.8) and DLQI was 12.2 (7.2). At week 12, 129 patients (32.8%) receiving home-based phototherapy and 100 patients (25.6%) receiving office-based phototherapy achieved clear/almost clear skin, and 206 (52.4%) and 131 (33.6%) achieved DLQI of 5 or lower, respectively. Home-based phototherapy was noninferior to office-based phototherapy for PGA and DLQI in the overall population and across all SPTs. Home-based phototherapy, compared to office-based phototherapy, was associated with better treatment adherence (202 patients [51.4%] vs 62 patients [15.9%]; P < .001), lower burden of indirect costs to patients, and more episodes of persistent erythema (466 of 7957 treatments [5.9%] vs 46 of 3934 treatments [1.2%]; P < .001). Both treatments were well tolerated with no discontinuations due to adverse events.

Conclusions and relevance: In this randomized clinical trial, home-based phototherapy was as effective as office-based phototherapy for plaque or guttate psoriasis in everyday clinical practice and had less burden to patients.

Trial registration: ClinicalTrials.gov Identifier: NCT03726489.

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来源期刊
JAMA dermatology
JAMA dermatology DERMATOLOGY-
CiteScore
14.10
自引率
5.50%
发文量
300
期刊介绍: JAMA Dermatology is an international peer-reviewed journal that has been in continuous publication since 1882. It began publication by the American Medical Association in 1920 as Archives of Dermatology and Syphilology. The journal publishes material that helps in the development and testing of the effectiveness of diagnosis and treatment in medical and surgical dermatology, pediatric and geriatric dermatology, and oncologic and aesthetic dermatologic surgery. JAMA Dermatology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. It is published online weekly, every Wednesday, and in 12 print/online issues a year. The mission of the journal is to elevate the art and science of health and diseases of skin, hair, nails, and mucous membranes, and their treatment, with the aim of enabling dermatologists to deliver evidence-based, high-value medical and surgical dermatologic care. The journal publishes a broad range of innovative studies and trials that shift research and clinical practice paradigms, expand the understanding of the burden of dermatologic diseases and key outcomes, improve the practice of dermatology, and ensure equitable care to all patients. It also features research and opinion examining ethical, moral, socioeconomic, educational, and political issues relevant to dermatologists, aiming to enable ongoing improvement to the workforce, scope of practice, and the training of future dermatologists. JAMA Dermatology aims to be a leader in developing initiatives to improve diversity, equity, and inclusion within the specialty and within dermatology medical publishing.
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