Abstract
BackgroundPsoriatic arthritis (PsA) presents a unique clinical challenge. Affecting joints, skin, nails, and other organs, it is associated with various comorbidities and has a significant impact on quality of life, social participation and working life. While biologic and other targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) have revolutionised therapy, questions remain about the long-term safety of these agents, and their effectiveness and cost-effectiveness in the real-world clinical setting.Methods/designThe British Society for Rheumatology Psoriatic Arthritis Register (BSR-PsA) is a prospective registry of patients with PsA, recruited from across Great Britain, who are (a) commencing a bDMARD/tsDMARD; or (b) naïve to all bDMARDs/tsDMARDs. Ethical approval was given by the NHS West of Scotland Research Ethics Committee 3 (reference: 18/WS/0126). Clinical data are extracted from participants’ medical records, including symptom onset and diagnosis, joint, skin and nail symptoms, dactylitis and enthesitis. Physical measurements (height, weight and 66/68 joint counts) and a detailed drug history are taken. Participants are also asked to complete questionnaires comprising instruments relating to general health and quality of life, axial disease, sleep and fatigue, impact of disease, functional status, mental health, other symptoms, and occupational status. The study duration is 5 years in the first instance, and all participants are followed up annually until the end of the study. Participants commencing a bDMARD/tsDMARD are also followed up three and six months after the start of therapy. Disease activity, including C-reactive protein, is assessed at each visit; and participants from some centres are invited to donate blood and urine samples for the creation of a biobank.DiscussionComplementing data from randomised trials, results from this study will contribute to the evidence base underpinning the clinical management of psoriatic arthritis. Various analyses will determine the effectiveness and safety of bDMARDs/tsDMARDs in the real-world, will examine the clinical and biological predictors of treatment response, and will provide real-world data on the cost-effectiveness of these therapies, as well as providing informative data important to patients such as quality of life and occupational outcomes.Trial registrationThe full study protocol is registered on the Open Science Framework (https://osf.io/jzs8n).
Highlights
Psoriatic arthritis (PsA) presents a unique clinical challenge
Complementing data from randomised trials, results from this study will contribute to the evidence base underpinning the clinical management of psoriatic arthritis
Good quality long-term data on effectiveness, cost-effectiveness, safety, and other important outcomes in PsA are limited, and much of what is known about the performance and safety of these agents comes from clinical trials. These data are informative, it is often collected on a narrow subset of patients and we have shown, in axial spondyloarthritis, treatment response to biologic therapy in ‘real-world’ patients is significantly lower than is reported in clinical trials [6]
Summary
Various extant registers across Europe collect some data on PsA, including industry-sponsored and independent registers, but the utility of these data is limited. The BSR Biologics Register for Rheumatoid Arthritis (BSRBR-RA) [25] initially included some patients with PsA with a predominant focus on rheumatoid arthritis failed to adequately capture all relevant domains in PsA, especially skin disease and information on PsA-relevant outcomes is limited Being outside their initial remit, when numbers of patients with rheumatoid arthritis increased, recruitment on PsA ceased. Large-scale real-world patient data are required with estimates of QALYs determined using directly collected health economic measures, as well as the clinical tools used elsewhere This will permit robust estimates of cost-effectiveness and will either challenge or confirm the indirect methods used in economic modelling to date.
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