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FRIMEDBIO-Fri prosj.st. med.,helse,biol

Disease understanding and personalized treatment in psoriatic arthritis: Closing the knowledge gap

Alternative title: Persontilpasset behandling og forståelse av sykdomsmekanismer ved psoriasisleddgikt

Awarded: NOK 8.0 mill.

Psoriatic arthritis (PsA) is an inflammatory disease which may affect several musculoskeletal structures and skin. The same drugs are not effective for all manifestations of the disease, but clinical assessment of disease activity can be difficult. The aim of the current project is to improve PsA care by increasing the understanding of how the disease affects the individual patient, and assess if disease outcomes are improved if treatment is tailored based on imaging assessments of inflammation in addition to other clinical assessments of disease activity. The project will focus on data from the NOR-SPRINT trial, but also use data from a medication registry. NOR-SPRINT is a 2-year randomized, single-blinded study where PsA patients are randomized to either 1) A conventional treatment strategy with structured clinical assessment of disease activity or 2) A comprehensive treatment strategy with structured clinical and imaging assessment of disease activity. In the imaging group, treatment will be tailored to the inflammation activity assessed by ultrasound and magnetic resonance imaging (MRI), in addition to clinical findings. 202 patients will be included. All patients will be examined clinically, radiographs, MRI and ultrasound performed, and adverse events recorded. The primary endpoint of the study is sustained disease activity remission. Biobanking will allow for analyses of biomarkers. This project addresses central challenges in a diverse disease, with considerable burden for the patient and society. The results will enable clinicians to make better choices regarding time- and cost consuming investigations, while providing optimal treatment for the patients. All 12 study centers in NOR-SPRINT are now actively recruiting participants, and study personell are focusing on inclusion and follow-up of the included patients.

--Background and aim-- Psoriatic arthritis (PsA) is a heterogeneous inflammatory disease which may affect several musculoskeletal structures and skin. Treatment should be tailored to the individual based on clinical presentation, as the relevant drugs are not effective for all disease features. However, clinical assessment may be difficult. The aim of the current project is to improve PsA care by increasing the understanding of how the disease affects the individual patient, and assess if disease outcomes are improved if treatment is tailored based on the patient's individual disease characteristics. A number of objectives are outlined in four work packages --Methods-- The project will focus on data from the NOR-SPRINT trial, but also use data from the NOR-DMARD registry. NOR-SPRINT is a 2-year randomized, single-blinded, superiority study where PsA patients are randomized 1:1 to: 1) A conventional treat-to-target strategy with structured clinical assessment of disease activity 2) A comprehensive treat-to-target strategy with structured clinical and imaging assessment of disease activity. In the imaging group, treatment will be tailored to the inflammation activity assessed by ultrasound (peripheral joints, tendons and entheses) and MRI (spine and SI-joints), in addition to clinical findings. 202 patients will be included. All patients will be examined clinically, radiographs will be acquired and adverse events recorded. The primary endpoint of the study is sustained remission, with a number of secondary endpoints. Biobanking will allow for analyses of biomarkers. Analysis plans will be developed for each work package. --Relevance and benefit to patient and society-- This project addresses central challenges in a diverse disease, with a considerable cost to society. The results will enable clinicians to make better choices regarding time- and cost consuming investigations, while providing optimal treatment for the patients and sound health-economic priorities.

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FRIMEDBIO-Fri prosj.st. med.,helse,biol

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