The goal of this observational study is to evaluate how well advanced therapies work in adults with psoriatic arthritis (PsA) who are starting a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) as part of routine care.
The main questions are:
* Do treatment responses differ according to the number of previous advanced therapies? * Can anti-drug antibodies (ADAs) or blood drug levels help predict treatment effectiveness?
Researchers will compare participants receiving earlier-line versus later-line advanced therapies to assess differences in treatment response and antibody development.
Participants will allow collection of routine clinical assessment data, complete questionnaires on symptoms and quality of life, and provide blood samples before treatment and at 12 weeks.
Age ≥18 years
Clinical diagnosis of PsA meeting CASPAR criteria
Starting a new b/tsDMARD, irrespective of line of therapy
Switching b/tsDMARD therapy for psoriasis or spondyloarthritis alone, without active psoriatic arthritis.
Previous treatment with the same b/tsDMARD being started at baseline.
Inability or unwillingness to provide informed consent.
Adults with a confirmed diagnosis of PsA, meeting CASPAR classification criteria, who are initiating a new advanced therapy (b/tsDMARD) as part of routine NHS care.
Cohort
Prospective
Biologic or targeted synthetic DMARD (b/tsDMARD)
DrugThis is a non-interventional observational study. Participants will receive biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) as part of routine NHS clinical care, and no treatment will be assigned by the study. Participants will be categorised into cohorts according to the line of advanced therapy being initiated at study entry (first line, second/third line, fourth/fifth line, and sixth line or beyond). The study will evaluate treatment outcomes, circulating drug levels, and anti-drug antibody (ADA) status across these treatment-line groups. All treatment decisions remain at the discretion of the treating clinician.
Clinical Disease Activity in Psoriatic Arthritis (cDAPSA)
The cDAPSA is the primary outcome and is a validated composite measure of disease activity in PsA. It is calculated as the sum of the tender joint count (0-68 joints), swollen joint count (0-66 joints), patient global assessment of disease activity (0-10 cm visual analogue scale), and patient assessment of arthritis pain (0-10 cm VAS). Unlike the full DAPSA, cDAPSA does not include C-reactive protein. Scores provide a continuous measure of disease activity, with established thresholds to categorise disease states: remission (≤4), low disease activity (\>4-13), moderate disease activity (\>13-27), and high disease activity (\>27).
Body Surface Area of Psoriasis (BSA)
In the BSA assessment, the patient's hand (including the palm, fingers, and thumb) will be used as the reference point for measuring how much of their skin is affected by psoriasis, representing roughly 1% of the body's surface. The BSA palm method will be used for the evaluation of BSA affected by psoriasis as follows: * Head and neck=10% (10 palms) * Upper extremities=20% (20 palms) * Trunk=30% (30 palms) * Lower extremities=40% (40 palms) * Total BSA=100%
Minimal Disease Activity (MDA)
Minimal Disease Activity (MDA) is a validated composite outcome used in psoriatic arthritis to define a state of low disease activity across the main clinical domains. A patient is considered to have achieved MDA if they meet at least 5 out of the following 7 criteria: 1. Tender joint count ≤1 2. Swollen joint count ≤1 3. Psoriasis-affected body surface area (BSA) ≤3% 4. Patient pain visual analogue scale (VAS) ≤15 mm 5. Patient global assessment of disease activity VAS ≤20 mm 6. Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤0.5 7. Tender entheseal points ≤1
Psoriatic Arthritis Impact of Disease-9 (PsAID-9)
The PsAID-9 is a short, validated tool designed to capture the impact of psoriatic arthritis from the patient's perspective \[14\]. It consists of nine domains that patients rate on a 0-10 numerical rating scale, where higher scores indicate worse status. The domains are: pain, fatigue, skin problems, work/leisure activities, functional capacity, discomfort, sleep disturbance, coping, and anxiety/fear. Each domain is weighted according to its relative importance, and an overall weighted mean score (0-10) is calculated. A score below 4 is generally considered to represent a patient-acceptable symptom state.
Health Assessment Questionnaire-Disability Index (HAQ-DI)
The HAQ-DI contains 20 items divided into 8 domains that measure: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Study participants will be required to indicate the degree of difficulty they experience in each domain in the past week on a 4-point scale that ranges from 0 (without difficulty) to 3 (unable to do). The HAQ-DI score ranges from 0 to 3. A lower HAQ-DI score indicates an improvement in function.
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Royal United Hospitals Bath NHS Foundation Trust
Lead sponsor
University of Bath
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
