Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study)

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/cm 2 , difference 5.4, 95% confidence interval −5.2 to 16.0), and the occurrence of short term side effects did not differ.

Pattern of drug use in the management of psoriasis in a tertiary care hospital: a prospective study

“…In other studies, the treatment response in chronic plaque psoriasis did not differ significantly between GC monotherapy and GCs combined with other topical agents when continued up to 6 months. 5,19,21,[23][24][25][26][27][28] Hence, it appears that GC monotherapy alone may be sufficient in most of the patients with chronic plaque psoriasis when it is not very severe (PASI score <4), and addition of other topical agents may only produce a marginal improvement in response.…”

Current Approach to Phototherapy Applications in Dermatology Practice: Part 2. Phototherapy in Vitiligo, Mycosis Fungoides, Atopic Dermatitis, Sclerosing Diseases and Psoriasis

“…Bu alanda öncü bir çalışma olarak kabul edilebilecek PLUTO çalışmasında, psoriasis hastalarında evde uygulanan dar bant UVB tedavisinin, hastanede uygulanan fototerapi ile benzer etkinlikte olduğu ve benzer yan etki profiline sahip olduğu gösterilmiştir (113). İngiltere, Hollanda ve Amerika'da evde fototerapi uygulanması ile ilgili farklı düzenlemeler bulunmaktadır (114).…”

Protocolos de Fototerapia no Tratamento da Psoríase

“…A instalação de unidades de fototerapia UVB no domicílio pode ultrapassar esta limitação, apresentando níveis de segurança e eficácia sobreponíveis à terapêutica realizada em regime hospitalar. 16 Também em termos económicos esta modalidade é custo-efectiva, uma vez que diminui as ausências laborais e, constitui uma alternativa real a terapêuticas biológicas mais dispendiosas.…”