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      Switch to Biological Agent in Psoriasis Significantly Improved Clinical and Patient-Reported Outcomes in Real-World Practice

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          Abstract

          Background: Although clinical studies have shown efficacy of biological agents in moderate to severe psoriasis, observational studies of real-world effectiveness are rare. Objective: To analyse the psoriasis area and severity index (PASI) and quality of life by the EQ-5D questionnaire and dermatology quality of life index (DLQI) in psoriasis patients who switched from conventional systemic treatment to biological agents in clinical practice. Furthermore, to analyse patient groups with the highest benefit of biological agents. Methods: Longitudinal, observational study based on the Swedish National Registry for Systemic Treatment of Pso-riasis, PsoReg. Outcomes of biological-naïve patients who switched to a biological agent (n = 267) were analysed before switch and at the first follow-up. Results: Patients significantly improved in EQ-5D, DLQI and PASI (p < 0.001). Patients with DLQI ≥10 and/or PASI ≥10 had the greatest benefits from biological agents in terms of EQ-5D. Conclusions: Patients with moderate to severe psoriasis benefit from biological agents in clinical practice; the patients with the highest benefits were those with high pretreatment PASI and DLQI scores.

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          Most cited references19

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          Severe Psoriasis – Oral Therapy with a New Retinoid

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

            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 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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              Critical review of generic and dermatology-specific health-related quality of life instruments.

              The measurement of health-related quality of life (HRQOL) is increasingly important in patients with skin diseases. Despite the availability of a variety of instruments and new psychometric techniques, there is no consensus as to which HRQOL instruments are to be preferred in dermatology. The objective of this review is to evaluate the generic HRQOL measures (i.e., health profiles) that have been used in dermatology (Short-Form-36 (SF-36) and -12, NHP, SIP, World Health Organization Quality of Life (WHOQOL)-100 and -BREF) and all dermatology-specific HRQOL measures (Dermatology Life Questionnaire Index, Skindex-29, -16, and -17, Dermatology Quality of Life Scales, and Dermatology-Specific Quality of Life). Criteria for evaluation were adapted from existing guidelines and included conceptual and measurement model, reliability, validity, responsiveness, item functioning, meaning of scores, administrative burden, respondent burden, the availability of alternative forms, and of cultural and language adaptations. Furthermore, an overview of skin diseases in which the included HRQOL tools have been used is presented. Although the selection of the appropriate HRQOL instrument remains a trade-off between various psychometric properties and research objectives, for now, we recommend the combination of SF-36 and Skindex-29 as the instruments of choice in dermatology. Promising new instruments for future research are the WHOQOL and the Skindex-17.
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                Author and article information

                Journal
                DRM
                Dermatology
                10.1159/issn.1018-8665
                Dermatology
                S. Karger AG
                1018-8665
                1421-9832
                2012
                March 2013
                16 January 2013
                : 225
                : 4
                : 326-332
                Affiliations
                aDivision of Dermatology and Venereology, Department of Public Health and Clinical Medicine, Umeå University, Umeå; bSwedish Institute for Health Economics, cClinical Research, Skåne University Hospital, Department of Clinical Sciences, Lund University, and dInstitute for Economic Research, School of Economics, Lund University, Lund, Sweden
                Author notes
                *Marcus Schmitt-Egenolf, Dermatology and Venereology, Public Health and Clinical Medicine, Umeå University, SE-901 85 Umeå (Sweden), E-Mail marcus.schmitt-egenolf@dermven.umu.se
                Article
                345715 Dermatology 2012;225:326-332
                10.1159/000345715
                23328678
                44edf9e9-9d28-4bed-b542-315f8d789013
                © 2013 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                : 05 September 2012
                : 07 November 2012
                Page count
                Figures: 2, Tables: 3, Pages: 7
                Categories
                Original Paper

                Oncology & Radiotherapy,Pathology,Surgery,Dermatology,Pharmacology & Pharmaceutical medicine
                Biological agents,PASI,EQ-5D,DLQI,Psoriasis,Register

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