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Dermatology
Protocol
Quality of life, treatment satisfaction and efficacy of non-biological systemic therapies in patients with plaque psoriasis: study protocol for a prospective observational study
  1. Christine Fink1,
  2. Timo E Schank1,
  3. Nina Trenkler1,
  4. Lorenz Uhlmann2,
  5. Knut Schäkel1
  1. 1 Department of Dermatology, University of Heidelberg, Heidelberg, Germany
  2. 2 Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany
  1. Correspondence to Christine Fink; christine.fink{at}med.uni-heidelberg.de

Abstract

Introduction Psoriasis vulgaris often leads to a significant impaired quality of life and dissatisfaction with the existing therapeutic approaches. However, patients’ quality of life and treatment satisfaction are of utmost importance, since it is positively related to therapy adherence and encourages patient’s compliance. The study described herein evaluates the quality of life, treatment satisfaction and efficacy during the initial 6 months of treatment with a non-biological systemic agent in a real-life clinical setting.

Methods and analysis This observational study compares quality of life, treatment satisfaction and the efficacy of non-biological systemic therapy between 60 patients suffering from plaque psoriasis receiving the non-biological systemic therapies with apremilast, methotrexate and fumaric acid esters.

Ethics and dissemination Ethics approval was provided by the ethics committee of the medical faculty of the University of Heidelberg. Ethics approval number is S-298/2015. The design and the final results of the study will be published and made available to the public.

Trial registration number German Clinical Trial Register (DRKS): DRKS00008721 (https://www.germanctr.de/).

  • Psoriasis
  • otezla
  • apremilast
  • methotrexate
  • fumaric acid esters
  • quality of life
  • treatment satisfaction
  • efficacy
  • non-biologic systemic therapies

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-014279

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    Footnotes

    • Contributors CF, LU and KS participated in the development and the implementation of the study (sample size, protocol, submission to ethics committee, data management). LU performed the data handling and statistical analysis. CF, TES, NT, LU and KS helped to draft and to review the paper. All authors read and approved the final manuscript.

    • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Ethics approval Ethics approval was provided by the ethic committee of the medical faculty of the University of Heidelberg. Ethics approval number S-298/2015.

    • Provenance and peer review Not commissioned; externally peer reviewed.