Quality of life, treatment satisfaction and efficacy of non-biological systemic therapies in patients with plaque psoriasis: study protocol for a prospective observational study

BMJ Open. 2017 Jun 30;7(6):e014279. doi: 10.1136/bmjopen-2016-014279.

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/).

Keywords: Psoriasis; apremilast; efficacy; fumaric acid esters; methotrexate; non-biologic systemic therapies; otezla; quality of life; treatment satisfaction.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Dermatologic Agents / therapeutic use
  • Fumarates / therapeutic use
  • Humans
  • Methotrexate / therapeutic use
  • Patient Compliance
  • Patient Satisfaction*
  • Personal Satisfaction
  • Pilot Projects
  • Prospective Studies
  • Psoriasis / psychology*
  • Psoriasis / therapy*
  • Quality of Life*
  • Thalidomide / analogs & derivatives
  • Thalidomide / therapeutic use

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Dermatologic Agents
  • Fumarates
  • Thalidomide
  • apremilast
  • Methotrexate

Associated data

  • DRKS/DRKS00008721