Improving first line treatment options for people newly diagnosed with psoriatic arthritis: a UK based cohort study.

Study type
Protocol
Date of Approval
Study reference ID
22_001773
Lay Summary

Psoriatic arthritis is a type of arthritis that affects 150,000 people in the UK. Its main symptoms are joint pain, stiffness and swelling; and patients are often diagnosed late, which can lead to irreversible joint damage. One in three people with the skin condition psoriasis (which causes thick patches of skin that are red and itchy) will develop psoriatic arthritis.

People with psoriatic arthritis are more likely to have other medical problems such as heart disease. Treatments used in psoriatic arthritis have side-effects that could cause or worsen their other medical problems. However, we do not fully understand the impact of these side-effects in people with psoriatic arthritis who have other medical conditions.

Aim:
1. To assess the side-effects of the treatments used for people with psoriatic arthritis who have other medical conditions.

Technical Summary

Aims:
To research the prevalence and accrual of co-morbidities amongst patients with recently diagnosed psoriatic arthritis.
To assess the safety of the first-line treatments used in people with co-morbidities newly diagnosed with psoriatic arthritis.

Objectives:
To determine the incidence, prevalence, and risk of developing of co-morbidities in psoriatic arthritis.
To identify co-morbidity clusters in psoriatic arthritis and characterise first-line drug use within each cluster.
To assess the safety of the use of conventional synthetic disease modifying anti-rheumatic drugs used in people with psoriatic arthritis and co-morbidities to identify adverse drug reactions of special interest.

Methods:
Study design: population-based retrospective cohort study using routinely collected clinical data previously mapped.

Data sources: CPRD GOLD and CPRD AURUM linked to Hospital Episode Statistics Admitted Patient Care Office for National Statistics data, and Patient-level Index of Multiple Deprivation.

Participants: incident diagnosis of psoriatic arthritis.

Outcomes to be measured: co-morbidities in psoriatic arthritis, adverse drug reactions of conventional synthetic disease modifying anti-rheumatic drugs (myocardial infarction, stroke, hepatotoxicity, cancer, infections and leukopenia/ pancytopaenia) and all-cause death.

The known predictors of psoriatic arthritis identified (such as raised body mass index, nail psoriasis) will be studied.

Follow-up: from first diagnosis to the earliest of death, transfer-out, or end of data availability.

Analysis:
Clusters of co-morbidities will be identified using K-means, hierarchical clustering, Gaussian mixture models and fuzzy c-means. Cox and Fine and Gray models will be estimated.

Public health benefits:
This project will be used to improve our understanding of the co-morbidities that occur in people with psoriatic arthritis and help us to better understand the safety of the first line treatments used for people with psoriatic arthritis with co-morbidities. The results will be used to update current treatment guidelines providing evidence based tailored advice on how to manage people with psoriatic arthritis who have other co-morbidities.

Health Outcomes to be Measured

The main outcomes of this study are:
- Record of an episode for the development of co-morbidities in psoriatic arthritis (PsA) patients.
- Record of conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs): methotrexate, sulfasalazine, hydroxychloroquine and leflunamide.
- Record of an episode for the development of adverse drug reactions of the csDMARDs: myocardial infarction, stroke, arrhythmia, cardiovascular disease related death, hepatotoxicity, cancer, infections, leukopenia and pancytopenia.
- Record of all-cause death.

Collaborators

Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Marta Pineda Moncusi - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Arani Vivekanantham - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Laura Coates - Collaborator - University of Oxford
Sara Khalid - Collaborator - University of Oxford

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation