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Prescribing Phototherapy
Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomized controlled non-inferiority trial (PLUTO study)
- Mayke B G Koek, research fellow¹,
- Erik Buskens, professor of medical technology assessment²³,
- Huib van Weelden, investigator photodermatology¹,
- Paul H A Steegmans, dermatologist ⁴,
- Carla A F M Bruijnzeel-Koomen, professor of dermatology/allergology¹,
- Vigfús Sigurdsson, dermatologist¹
+ Author Affiliations
¹ Department of Dermatology/Allergology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, Netherlands
² Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
³ Julius 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@koek.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it
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.
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