Long-term improvement of psoriasis patients' adherence to topical drugs: testing a patient-supporting intervention delivered by healthcare professionals

Mathias Tiedemann Svendsen, Steven R Feldman, Sören Möller, Line Planck Kongstad, Klaus Ejner Andersen, Mathias Tiedemann Svendsen, Steven R Feldman, Sören Möller, Line Planck Kongstad, Klaus Ejner Andersen

Abstract

Background: Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier to treatment success. Psoriasis patients require support, in order to improve their long-term use of topical drugs. The project aims to test whether a patient-supporting intervention delivered by dermatology nurses can reduce the severity of psoriasis, improve the use of topical drugs, and is cost-effective compared to standard procedure.

Methods: The intervention consists of improved support delivered to patients by three experienced dermatology nurses, who will support patients on a regular basis by consultations with a focus on providing reminder systems, accountability, reinforcement, and building trust in the treatment. Each patient will be supported by the same dermatology nurse throughout the entire study period. The effect will be compared with standard procedure. The intervention will be tested in a randomized controlled trial during a 48-week period. A group of patients with moderate-to-severe psoriasis (psoriasis affecting ≥ 4% of the total body surface area) and 18-85 years of age who are prescribed topical treatment will be randomized to a non-intervention (n ≈ 57) or intervention group (n ≈ 57). Participants in both arms will be prescribed topical preparations containing corticosteroid and/or calcipotriol. The primary outcome will be a change in the severity of psoriasis, measured as reduction in the Lattice-System Physician's Global Assessment. Secondary outcomes will include changes in health-related quality of life (measured by disease specific and generic questionnaires), primary adherence (i.e., proportion of filled prescriptions), and secondary adherence by objective measure (rate of topical drug consumption (obtained by weighing medication packages) compared to estimated recommended consumption). A health economic evaluation is planned to run alongside the trial. Participants' total health costs will be estimated on the basis of health costs reported to the national health registries and costs spent on the intervention, after which a cost-utility and cost-effectiveness analysis will be carried out.

Discussion: If the intervention can reduce the severity of psoriasis in a significant manner and is economically favorable compared to standard treatment, there is potential for implementing the intervention in dermatology clinics.

Trial registration: Clinicaltrials.gov NCT04220554 . Registered on January 7, 2020. Study results, either positive, negative, or inconclusive, will be published on www.clinicaltrials.gov . Trial registration no. with the Danish Regional Committee on Health Research Ethics, registration no. 72613.

Keywords: Adherence; Health-care professionals; Psoriasis; Randomized controlled trial (RCT); Support.

Conflict of interest statement

MTS and KEA have received a grant from the LEO Foundation to conduct the trial. SRF is a speaker for Janssen and Taro; a consultant and speaker for Galderma, Stiefel/GlaxoSmithKline, Abbott Labs, LEO Pharma Inc.; has received grants from Galderma, Janssen, Abbott Labs, Amgen, Stiefel/GlaxoSmithKline, Celgene and Anacor; is a consultant for Amgen, Baxter, Caremark, Gerson Lehrman Group, Guidepoint Global, Hanall Pharmaceutical Co Ltd, Kikaku, Lilly, Merck & Co Inc., Merz Pharmaceuticals, Mylan, Novartis Pharmaceuticals, Pfizer Inc., Qurient, Suncare Research and Xenoport; is on an advisory board for Pfizer Inc.; is the founder of and holds stocks in Causa Research and holds stocks in and is majority owner of Medical Quality Enhancement Corporation; he receives royalties from UpToDate and Xlibris. SM and LPK declare no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Participants’ visits during the trial period. W, week. The study personnel participating in the patient visits are indicated in the boxes
Fig. 2
Fig. 2
Participant flowchart. Superscript lowercase letter “a” indicates the following: adherence rates obtained according to the proportion of prescriptions filled within 7 days after first prescription. Superscript lowercase letter “b” indicates the following: adherence weight obtained by weight: weight of returned canisters divided by weight of estimated amount of use for the entire study period. Superscript lowercase letter “c” indicates the following: adherence rates reported by patient on a study-specific 4-point interval scale. DLQI, Dermatology Life Quality Index. EQ-5D, European Quality of life 5 Dimensions. LS-PGA, Lattice System Physician’s Global Assessment

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