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      Definition of treatment goals for moderate to severe psoriasis: a European consensus

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          Abstract

          Patients with moderate to severe psoriasis are undertreated. To solve this persistent problem, the consensus programme was performed to define goals for treatment of plaque psoriasis with systemic therapy and to improve patient care. An expert consensus meeting and a collaborative Delphi procedure were carried out. Nineteen dermatologists from different European countries met for a face-to-face discussion and defined items through a four-round Delphi process. Severity of plaque psoriasis was graded into mild and moderate to severe disease. Mild disease was defined as body surface area (BSA) ≤10 and psoriasis area and severity index (PASI) ≤10 and dermatology life quality index (DLQI) ≤10 and moderate to severe psoriasis as (BSA > 10 or PASI > 10) and DLQI > 10. Special clinical situations may change mild psoriasis to moderate to severe including involvement of visible areas or severe nail involvement. For systemic therapy of plaque psoriasis two treatment phases were defined: (1) induction phase as the treatment period until week 16; however, depending on the type of drug and dose regimen used, this phase may be extended until week 24 and (2) maintenance phase for all drugs was defined as the treatment period after the induction phase. For the definition of treatment goals in plaque psoriasis, the change of PASI from baseline until the time of evaluation (ΔPASI) and the absolute DLQI were used. After induction and during maintenance therapy, treatment can be continued if reduction in PASI is ≥75%. The treatment regimen should be modified if improvement of PASI is <50%. In a situation where the therapeutic response improved ≥50% but <75%, as assessed by PASI, therapy should be modified if the DLQI is >5 but can be continued if the DLQI is ≤5. This programme defines the severity of plaque psoriasis for the first time using a formal consensus of 19 European experts. In addition, treatment goals for moderate to severe disease were established. Implementation of treatment goals in the daily management of psoriasis will improve patient care and mitigate the problem of undertreatment. It is planned to evaluate the implementation of these treatment goals in a subsequent programme involving patients and physicians.

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          Most cited references 25

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          Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use.

          A simple practical questionnaire technique for routine clinical use, the Dermatology Life Quality Index (DLQI) is described. One hundred and twenty patients with different skin diseases were asked about the impact of their disease and its treatment on their lives; a questionnaire, the DLQI, was developed based on their answers. The DLQI was then completed by 200 consecutive new patients attending a dermatology clinic. This study confirmed that atopic eczema, psoriasis and generalized pruritus have a greater impact on quality of life than acne, basal cell carcinomas and viral warts. The DLQI was also completed by 100 healthy volunteers; their mean score was very low (1.6%, s.d. 3.5) compared with the mean score for the dermatology patients (24.2%, s.d. 20.9). The reliability of the DLQI was examined in 53 patients using a 1 week test-retest method and reliability was found to be high (gamma s = 0.99).
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            Research guidelines for the Delphi survey technique.

            Consensus methods such as the Delphi survey technique are being employed to help enhance effective decision-making in health and social care. The Delphi survey is a group facilitation technique, which is an iterative multistage process, designed to transform opinion into group consensus. It is a flexible approach, that is used commonly within the health and social sciences, yet little guidance exists to help researchers undertake this method of data collection. This paper aims to provide an understanding of the preparation, action steps and difficulties that are inherent within the Delphi. Used systematically and rigorously, the Delphi can contribute significantly to broadening knowledge within the nursing profession. However, careful thought must be given before using the method; there are key issues surrounding problem identification, researcher skills and data presentation that must be addressed. The paper does not claim to be definitive; it purports to act as a guide for those researchers who wish to exploit the Delphi methodology.
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              Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial.

              Tumour necrosis factor alpha (TNFalpha) is thought to play a part in the pathogenesis of psoriasis. We assessed the efficacy and safety of continuous treatment with infliximab, a monoclonal antibody that binds to and neutralises the activity of TNFalpha, in patients with psoriasis. In this phase III, multicentre, double-blind trial, 378 patients with moderate-to-severe plaque psoriasis were allocated in a 4:1 ratio to receive infusions of either infliximab 5 mg/kg or placebo at weeks 0, 2, and 6, then every 8 weeks to week 46. At week 24, placebo-treated patients crossed over to infliximab treatment. Skin and nail signs of psoriasis were assessed using the psoriasis area and severity index (PASI) and nail psoriasis severity index (NAPSI), respectively. The primary endpoint, analysed on an intention-to-treat-basis, was the proportion of patients achieving at least a 75% improvement in PASI from baseline to week 10. At week 10, 80% (242/301) of patients treated with infliximab achieved at least a 75% improvement from their baseline PASI (PASI 75) and 57% (172/301) achieved at least a 90% improvement (PASI 90), compared with 3% and 1% in the placebo group, respectively (p<0.0001). At week 24, PASI 75 (82% for infliximab vs 4% for placebo) and PASI 90 (58%vs 1%) were maintained (p<0.0001). At week 50, 61% achieved PASI 75 and 45% achieved PASI 90 in the infliximab group. Infliximab was generally well tolerated in most patients. Infliximab is effective in both an induction and maintenance regimen for the treatment of moderate-to-severe psoriasis, with a high percentage of patients achieving sustained PASI 75 and PASI 90 improvement through 1 year.
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                Author and article information

                Contributors
                +49-431-5971508 , +49-431-5971543 , umrowietz@dermatology.uni-kiel.de
                Journal
                Arch Dermatol Res
                Archives of Dermatological Research
                Springer-Verlag (Berlin/Heidelberg )
                0340-3696
                1432-069X
                21 September 2010
                21 September 2010
                January 2011
                : 303
                : 1
                : 1-10
                Affiliations
                [1 ]Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany
                [2 ]Department of Dermatology, Århus University Hospital, Århus, Denmark
                [3 ]Dermatologikum Hamburg, Hamburg, Germany
                [4 ]Department of Dermatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
                [5 ]Dermatology Centre, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK
                [6 ]Division of Evidence Based Medicine (dEBM), Department of Dermatology, Charité-Universitätsmedizin, Campus Berlin-Mitte, Berlin, Germany
                [7 ]A. Sygros Hospital, University of Athens Medical School, Athens, Greece
                [8 ]Department of Dermatology, School of Medicine, Charles University, Prague, Czech Republic
                [9 ]Department of Dermatology, Stavanger University Hospital, Stavanger, Norway
                [10 ]Centre of Dermatovenereology, Clinic of Infectious Diseases, Dermatovenereology and Microbiology, Vilnius University, Vilnius, Lithuania
                [11 ]Centro de Dermatologia Epidermis, Faculty of Medicine, Instituto CUF, Porto, Portugal
                [12 ]Department of Dermatology, Hospital Universitario La Princesa, Madrid, Spain
                [13 ]Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy
                [14 ]Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary
                [15 ]Hôpital LARREY, Toulouse, France
                [16 ]Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands
                [17 ]Department of Dermatology and Allergology, Päijät-Häme Central Hospital, Lahti, Finland
                [18 ]Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wrocław, Poland
                [19 ]Dermatology Clinic Rosenbach and Partner, Osnabrück, Germany
                [20 ]Dermatology Department, University Hospital Leuven, Leuven, Belgium
                [21 ]St John’s Institute of Dermatology, London, UK
                [22 ]Dermatology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
                [23 ]Department of Dermatology, Sozialmedizinisches Zentrum Ost, Donauspital, Vienna, Austria
                [24 ]Department of Dermatology, Bern University Hospital, University of Bern, Bern, Switzerland
                1080
                10.1007/s00403-010-1080-1
                3016217
                20857129
                © Springer-Verlag 2010
                Categories
                Special Article
                Custom metadata
                © Springer-Verlag 2011

                Dermatology

                consensus, psoriasis, severity, patient care, treatment goals

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