chronic inflammation of the joints Psoriatic arthritis and axial spondyloarthritis
Conditions
Interventions
The following T2T strategy will be adviced to rheumatologists: For patients
allocated to the T2T strategy with tapering attempt group the TNFi dose will be
reduced about one third by extending the i
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Eligible patients are >= 16 years of age at the time of signing the informed consent form AND 1) have peripheral SpA of the psoriatic arthritis subtype diagnosed clinically by the rheumatologist , supported by the Classification Criteria for Psoriatic Arthritis (CASPAR) and/or 2) have axial SpA of the axial spondyloarthritis subtype, supported by the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, AND - Are using full dose, or at least > 50% of the authorized defined daily dose (DDD), of an originator or biosimilar TNFi (adalimumab, certolizumab, etanercept, golimumab, infliximab); - Patients have to have stable LDA, Psoriatic Arthritis Disease Activity Score (PASDAS)
Exclusion criteria
Exclusion criteria: - Previous recorded unsuccessful dose reduction of TNFi in the previous 24 months, - Comorbidities expected to hamper successful dose reduction (e g Crohns disease, Ulcerative colitis, Psoriasis, Uveitis), - Not able to have 12 months follow-up (life expectancy, planned relocation), - Not able to measure outcome (language, other limitations)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in proportion of patients between T2T strategy with or without tapering attempt who are in LDA state (PASDAS | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the proportion of patients in the intervention group able to reduce their TNFi dose, able to discontinue TNFi altogether, or not able to reduce TNFi dose without an increase in disease activity, respectively, - To compare the differences in efficacy between the intervention versus control group with TNFi measured by change in PASDAS and BSA of the skin and/or ASDAS at 3, 6, 9 and 12 months follow-up, - To assess the difference in the change from baseline in functioning measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) and Bath Ankylosing Spondylitis Functional Index (BASFI - axSpA only) between both groups with TNFi at 3, 6, 9, and 12 months follow-up, - To estimate cost-effectiveness ratio of the T2T strategy with tapering attempt of TNFi compared to the T2T strategy without tapering attempt, - To compare (dosage and) proportion of patients using NSAID, corticosteroid*s or cs/b/tsDMARDs between intervention and control group at 12 months follow up, - To predict in the intervention group which baseline factors (including [change in] serum drug levels and antidrug antibody levels) are associated with successful and maintained dose reduction, - To compare the difference in cumulative incidence of flare between the intervention and control group at 12 months follow up, - To assess the safety of this strategy with respect to proportion of patients developing adverse events with special attention to allergic (injection) reactions and infections | — |
Countries
Netherlands
Outcome results
None listed