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DOI 10.1001/jamadermatol.2024.3897

Медицинская библиотека · JAMA dermatology · 2024

Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis: The LITE Randomized Clinical Trial.

Gelfand Joel M, Armstrong April W, Lim Henry W, Feldman Steven R, Johnson Sandra M, Claiborne W C Cole, Kalb Robert E, Jakus Jeannette, Mangold Aaron R, Flowers R Hal, Bhutani Tina, Durkin John R, Bagel Jerry, Fretzin Scott, Sheehan Michael P, Krell James, Reeder Margo, Kaffenberger Jessica, Kartono Francisca, Takeshita Junko, Bridges Alisha M, Fielding Eric, Nehal Umbereen S, Schaecher Kenneth L, Howard Leah M, Eakin Guy S, Báez Suzette, Bishop Brooke E, Fitzsimmons Robert C, Papadopoulos Maryte, Song William B, Linn Kristin A, Hubbard Rebecca A, Shin Daniel B, Callis Duffin Kristina

Сравнительное исследованиеEquivalence TrialСтатьяМногоцентровое исследованиеPragmatic Clinical TrialРандомизированное исследованиеПеревод в очереди

Аннотация

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.

Для цитирования: Gelfand Joel M, Armstrong April W, Lim Henry W, Feldman Steven R, Johnson Sandra M, Claiborne W C Cole, Kalb Robert E, Jakus Jeannette, Mangold Aaron R, Flowers R Hal, Bhutani Tina, Durkin John R, Bagel Jerry, Fretzin Scott, Sheehan Michael P, Krell James, Reeder Margo, Kaffenberger Jessica, Kartono Francisca, Takeshita Junko, Bridges Alisha M, Fielding Eric, Nehal Umbereen S, Schaecher Kenneth L, Howard Leah M, Eakin Guy S, Báez Suzette, Bishop Brooke E, Fitzsimmons Robert C, Papadopoulos Maryte, Song William B, Linn Kristin A, Hubbard Rebecca A, Shin Daniel B, Callis Duffin Kristina. Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis: The LITE Randomized Clinical Trial.. JAMA dermatology. 2024. DOI: 10.1001/jamadermatol.2024.3897.

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