Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study)
BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b1542 (Published 07 May 2009) Cite this as: BMJ 2009;338:b1542
- Mayke B G Koek, research fellow1,
- Erik Buskens, professor of medical technology assessment23,
- Huib van Weelden, investigator photodermatology1,
- Paul H A Steegmans, dermatologist4,
- Carla A F M Bruijnzeel-Koomen, professor of dermatology/allergology1,
- Vigfús Sigurdsson, dermatologist1
- 1Department of Dermatology/Allergology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, Netherlands
- 2Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
- 3Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands
- 4Department of Dermatology, St Antonius Hospital, Nieuwegein, Netherlands
- Correspondence to: M B G Koek author{at}koek.com
- Accepted 29 December 2008
Abstract
Objective To determine whether ultraviolet B phototherapy at home is equally safe and equally effective as ultraviolet B phototherapy in an outpatient setting for patients with psoriasis.
Design Pragmatic multicentre single blind randomised clinical trial (PLUTO study).
Setting Dermatology departments of 14 hospitals in the Netherlands.
Participants 196 patients with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy. The first 105 consecutive patients were also followed for one year after therapy.
Intervention Ultraviolet B phototherapy at home using a TL-01 home phototherapy unit compared with standard narrowband ultraviolet B phototherapy in an outpatient setting. Both therapies were done in a setting reflecting routine daily practice in the Netherlands.
Main outcome measures The main outcome measure was effectiveness as measured by the proportion of patients with a 50% or more reduction of the baseline psoriasis area and severity index (PASI) or self administered psoriasis area and severity index (SAPASI), called the PASI 50 and SAPASI 50 (relevant treatment effect). Another outcome of effectiveness was the percentage reduction in median scores on the PASI as well as SAPASI. Also the proportions of patients reaching the PASI 75 and SAPASI 75 (successful treatment effect), and the PASI 90 and SAPASI 90 (almost complete clearance) were calculated. Other secondary outcomes were quality of life (SF-36, psoriasis disability index), burden of treatment (questionnaire), patients’ preferences and satisfaction (questionnaire), and dosimetry and short term side effects (diary).
Results 82% of the patients treated at home compared with 79% of the patients treated in an outpatient setting reached the SAPASI 50 (difference 2.8%, 95% confidence interval −8.6% to 14.2%), and 70% compared with 73% reached the PASI 50 (−2.3%, −15.7% to 11.1%). For patients treated at home the median SAPASI score decreased 82% (from 6.7 to 1.2) and the median PASI score decreased 74% (from 8.4 to 2.2), compared with 79% (from 7.0 to 1.4) and 70% (from 7.0 to 2.1) for patients treated in an outpatient setting. Treatment effect as defined by the mean decline in PASI and SAPASI scores was significant (P<0.001) and similar across groups (P>0.3). Total cumulative doses of ultraviolet B light were similar (51.5 v 46.1 J/cm2, difference 5.4, 95% confidence interval −5.2 to 16.0), and the occurrence of short term side effects did not differ. The burden of undergoing ultraviolet B phototherapy was significantly lower for patients treated at home (differences 1.23 to 3.01, all P≤0.001). Quality of life increased equally regardless of treatment, but patients treated at home more often rated their experience with the therapy as “excellent” (42%, 38/90) compared with patients treated in the outpatient department (23%, 20/88; P=0.001).
Conclusion Ultraviolet B phototherapy administered at home is equally safe and equally effective, both clinically and for quality of life, as ultraviolet B phototherapy administered in an outpatient setting. Furthermore, ultraviolet B phototherapy at home resulted in a lower burden of treatment and led to greater patients’ satisfaction.
Trial registration Current Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930.
Footnotes
We thank the patients; Chantal Cornelis (research nurse) for coordinating the contacts with the patients and with the participating hospitals and home care institutions; the dermatologists, residents, and other contributing employees of the Departments of Dermatology of the following hospitals: University Medical Center Utrecht, Hilversum Hospital, Academic Hospital Maastricht, Diakonessen Hospital Utrecht and Zeist, Meander Hospital Amersfoort, Groene Hart Hospital Gouda, Academic Medical Center Amsterdam, Erasmus Medical Center Rotterdam, Vrije Universiteit Medical Center Amsterdam, Gelre Hospital Apeldoorn, Reinier de Graaf Groep Delft and Voorburg, AntoniusMesosGroup Hospitals Utrecht, and the Lucas Andreas Hospital Amsterdam; and all employees of the participating home care institutions Medizorg, Farmadomo, and stichting Begeleiding Extramurale zorg (BEM).
Contributors: MBGK, EB, PHAS, VS, and CAFMB-K contributed to the study concept and design. MBGK, HvW, and Chantal Cornelis were involved in the acquisition of data, and HvW and Chantal Cornelis provided administrative, technical, and material support. MBGK, EB and VS played a part in the analysis and interpretation of the data. MBGK was the overall study manager and drafted the manuscript. All authors revised the manuscript critically for important intellectual content and gave final approval of the manuscript to be submitted for publication. VS is the guarantor.
Funding: This study was supported by grant 945-02-017 from the Netherlands Organisation for Health Research and Development. The funder had no role in the study design; in the collection, management, analysis, and interpretation of data; in the preparation, review, or approval of the manuscript, or in the decision to submit the article for publication. The researchers are independent from the funders.
Competing interests: None declared.
Ethical approval: This study was approved by the institutional review board of the University Medical Center Utrecht (02/090-O).
- Accepted 29 December 2008
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