Study identification

EU PAS number

EUPAS28564

Study ID

50021

Official title and acronym

Persistence and adherence to novel systemic pharmacological treatment of moderate to severe psoriasis vulgaris and psoriatic arthritis – A register-based cohort study in Finland and Sweden

DARWIN EU® study

No

Study countries

Finland
Sweden

Study description

Psoriasis is a noncommunicable complex and multifactorial immune-mediated inflammatory disease, occurring in the skin and often involves joints. The most common form of psoriasis (90% of cases) is psoriasis vulgaris (PsV, also known as plaque psoriasis), resulting in inflamed itchy skin, mostly manifesting on the scalp, elbows, and knees. Approximately 30% of PsV patients develop psoriatic arthritis (PsA), chronic inflammatory arthritis, where in addition to the skin manifestation, joints are also affected with pain, swelling and stiffness. In about 80% of PsA patients, arthritis manifestation follows to the PsV development. These diseases are incurable, and the aim of the treatment is symptom remission. Novel systemic drugs, including biologic drugs targeting immunomodulating cytokines and the phosphodiesterase 4 inhibitor apremilast, can be used for the treatment of moderate to severe symptoms of these diseases. Since PsV and PsA are considered as chronic diseases, long-term treatment is necessary to maintain efficacy. The real-world evidence on the treatment patterns of biologics and apremilast in the Nordic countries is limited. The main aim of this retrospective, population- and register-based cohort study is to investigate the persistence and adherence of drugs dispensed from community pharmacies for patients with moderate to severe psoriasis vulgaris. The study will include persons who initiate treatment with adalimumab, brodalumab, etanercept, ustekinumab, secukinumab, ixekizumab, guselkumab, certolizumab pegol, tildrakizumab, or apremilast in Finland and Sweden during the study period of 2008-2020. The treatment patterns of interest include treatment gaps and restarts as well as switches during a follow-up period of up to 13 years. The study will be based on nationwide registers.

Study status

Ongoing
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Laura Saarelainen

Primary lead investigator

Study timelines

Date when funding contract was signed

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Planned:
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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Janssen Pharmaceutica NV
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable