Dose reduction and withdrawal of TNF inhibitors in patients with Psoriatic Arthritis and Axial Spondyloarthritis

Randomised controlled trial of dose reduction and withdrawal strategies of TNF inhibitors in Psoriatic Arthritis and Axial Spondyloarthritis. “Dose REduction Strategy Study of TNF inhibitors in Psoriatic arthritis and axial Spondyloarthritis patients: DRESS-PS.” - Dose reduction and withdrawal strategies of TNF inhibitors in PsA and axSpA.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003432-72-NL

Enrollment

234

Registered

2018-09-13

Start date

2018-10-23

Completion date

Unknown

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults diagnosed with Psoriatic Arthritis en Axial Spondyloarthritis.

Interventions

Trade Name: Tumor Necrosis Factor alpha (TNF-a) Inhibitors: Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab Product Name: Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab Pharma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients are > 18 years of age AND - Fulfil the Classification Criteria for Psoriatic Arthritis (CASPAR) and have peripheral SpA of the psoriatic arthritis subtype diagnosed clinically by the rheumatologist and/or fulfil the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA AND - Are using full dose, or at least > 50% of the authorized defmed daily dose (DDD), of an origmator or biosimilar TNFi (adalimumab, certolizumab, etanercept, golimumab, infliximab) AND - Patients have to have stable LDA, Psoriatic Arthritis Disease Activity Score (PASDAS) s 3 2 and a skin measure of Body Surface Area mvolvement (modified BSA) using a target of 3% as used by rheumatologists in climcal practice for PsA and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) =65 years) yes F.1.3.1 Number of subjects for this age range 47

Exclusion criteria

Exclusion criteria: - Previous recorded unsuccessful dose reduction of TNFi, - 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
Main Objective: The aim of the study is to compare the proportion of patients with PsA and axSpA having LDA state for at least 6 months, at 12 months between usual care and dose reduction strategy against a prespecified non-inferiority margin In addition, a cost-effectiveness analysis will be performed to assess the cost effectiveness of dose reduction in comparison to usual care.;Secondary Objective: - To determine the proportion of PsA and axSpA patients in the intervention group that can successfully reduce or discontinue TNFi use; - To determine the change in PASDAS and ASDAS for each visit in both dose reduction and usual care groups; - To determine the incidence of flare in both dose reduction and usual care groups; - To determine the functioning in both groups; - To determine the cost-effectiveness of dose reduction versus usual care; - To determine the proportion of patients using NSAID, corticosteroid or cs/b/tsDMARD’s in both groups; - To determine safety of dose reduction (adverse events and infections); - To identify baseline factors which can predict successful and maintained dose reduction. ;Primary end point(s): The difference in proportion of patients between dose reduction arm versus usual care who are m LDA state (PASDAS <32 and modified BSA <3% of the skin (PsA)), ASDAS < 2 1 (axSpA) and an absence of active extra-articular symptoms) in the dose reduction arm versus usual care with TNFi at 12 months follow-up, compared to the prespecified non-inferiority margin of 0 2 (20%).;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The aim of the study is to compare the proportion of patients with PsA and axSpA having LDA state for at least 6 months, at 12 months between usual care and dose reduction strategy against a prespecified non-inferiority margin In addition, a cost-effectiveness analysis will be performed to assess the cost effectiveness of dose reduction in comparison to usual care.;Secondary Objective: - To determine the proportion of PsA and axSpA patients in the intervention group that can successfully reduce or discontinue TNFi use; - To determine the change in PASDAS and ASDAS for each visit in both dose reduction and usual care groups; - To determine the incidence of flare in both dose reduction and usual care groups; - To determine the functioning in both groups; - To determine the cost-effectiveness of dose reduction versus usual care; - To determine the proportion of patients using NSAID, corticosteroid or cs/b/tsDMARD’s in both groups; - To determine safety of dose reduction (adverse events and infections); - To identify baseline factors which can predict successful and maintained dose reduction. ;Primary end point(s): The difference in proportion of patients between dose reduction arm versus usual care who are m LDA state (PASDAS <32 and modified BSA <3% of the skin (PsA)), ASDAS < 2 1 (axSpA) and an absence of active extra-articular symptoms) in the dose reduction arm versus usual care with TNFi at 12 months follow-up, compared to the prespecified non-inferiority margin of 0 2 (20%).;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Secondary end point(s): -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 dose reduction arm versus usual care 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 functionmg measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) and Bath Ankylosing Spondylitis Functional Index (BASFI - axSpA only) between the dose reduction arm versus usual care with TNFi at 3, 6, 9, and 12 months follow-up, - To estimate cost effectiveness ratio of the protocolised dose reduction/withdrawal strategy of TNFi compared to usual care, - To compare (dosage and) proportion of patients using NSAID, corticosteroid’s or cs/b/tsDMARDs between intervention and usual care group at 12 months follow up, - To predict m 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 dose reduction arm versus usual care 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 allergie (injection) reactions and infections;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12 months	—

Measure

Time frame

Secondary end point(s): -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 dose reduction arm versus usual care 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 functionmg measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) and Bath Ankylosing Spondylitis Functional Index (BASFI - axSpA only) between the dose reduction arm versus usual care with TNFi at 3, 6, 9, and 12 months follow-up, - To estimate cost effectiveness ratio of the protocolised dose reduction/withdrawal strategy of TNFi compared to usual care, - To compare (dosage and) proportion of patients using NSAID, corticosteroid’s or cs/b/tsDMARDs between intervention and usual care group at 12 months follow up, - To predict m 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 dose reduction arm versus usual care 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 allergie (injection) reactions and infections;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12 months

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Countries

Netherlands

Contacts

Public ContactAlfons den Broeder

Sint Maartenskliniek

A.denbroeder@maartenskliniek.nl0031243659729

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026