Status: Ongoing First registered on: 27/02/2019
Last updated on: 12/08/2019
1. Study identification
EU PAS Register NumberEUPAS28564
Official titlePersistence and adherence to novel systemic pharmacological treatment of moderate to severe psoriasis vulgaris – A register-based cohort study in Finland, Sweden, and Norway
Study title acronym
Study typeObservational study
Brief description of the studyPsoriasis vulgaris is an incurable disease, 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 the disease. Since psoriasis vulgaris is considered a chronic disease, 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, Sweden and Norway 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEPID Research
Department/Research group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Hakkarainen
First name Katja
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Finland
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed24/09/2018
Start date of data collection01/07/201914/05/2019
Start date of data analysis30/08/2019
Date of interim report, if expected31/12/2019
Date of final study report30/09/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesJanssen Pharmaceutica NV100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Hakkarainen
First name Katja
Address line 1EPID Research Oy
Address line 2Första långgatan 20, 6th Floor 
Address line 3 
CityGothenburg 
PostcodeSE-413 28 
CountrySweden
Phone number (incl. country code)46738427442 
Alternative phone number 
Fax number (incl. country code) 
Email address katja.hakkarainen@epidresearch.com
Public Enquiries
Title Dr 
Last name Hakkarainen 
First name Katja 
Address line 1EPID Research Oy 
Address line 2Första långgatan 20, 6th Floor 
Address line 3 
CityGothenburg 
PostcodeSE-413 28 
CountrySweden 
Phone number (incl. country code)46738427442 
Alternative phone number 
Fax number (incl. country code) 
Email address katja.hakkarainen@epidresearch.com 
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