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document
A feasibility study for a randomised controlled trial of treatment withdrawal in psoriatic arthritis ( REmoval of treatment for patients in REmission in psoriatic ArThritis ( RETREAT ( F ) ) . TNF therapy is effective for all aspects of psoriatic disease , but these drugs are costly and the long-term effects are unknown . Further , methotrexate causes concern with long-term adverse events . The purpose of this pilot study was to test the feasibility of drug withdrawal from patients with psoriatic arthritis , in stable low disease state . We examined the availability of patients , their willingness to participate , study procedures , and the proportion of patients in the withdrawal arm who relapsed during the study . Low disease state was defined by minimal disease activity criteria ( MDA ) , and relapse by failure to achieve these criteria . Patients in the withdrawal group underwent a phased withdrawal of medication where the last treatment added was the first withdrawn . Assessments were monthly for 3 months before study exit . Seventy-two patients were invited to participate , of which 57 were found to be eligible . Twenty-six ( 36.1 % ) subsequently attended the screening visit but 9 failed eligibility criteria so that 17 patients ( 29.8 % of the 57 eligible patients , 95 % confidence interval ( CI ) 18.4 , 43.4 % ) were randomised at a ratio of 2:1 in favour of the withdrawal arm ( 11 withdrawals , 6 standard care ) . Six patients experienced a flare , all of whom were in the withdrawal arm ( relapse rate 54.6 % , 95 % CI 23.4 , 83.3 % ) . Four of the flares were apparent from visit 3 ( 8 weeks after starting withdrawal ) . Given the high relapse rate , an alternative trial design of partial treatment withdrawal , possibly including a patient preference arm , is recommended .
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Intervention_Pharmacological
drug withdrawal
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Intervention_Pharmacological
withdrawal arm
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Intervention_Pharmacological
phased withdrawal of medication
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Intervention_Pharmacological
withdrawn
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Intervention_Pharmacological
withdrawal arm
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Intervention_Pharmacological
withdrawal arm
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Intervention_Pharmacological
withdrawal )
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Outcome_Other
test the feasibility
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Outcome_Mental
availability of patients
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Outcome_Mental
their willingness to participate
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Outcome_Mental
study procedures
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Outcome_Mental
the proportion of patients in the withdrawal arm who relapsed
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Outcome_Other
Assessments
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Outcome_Physical
flare
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Outcome_Physical
relapse rate
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Participant_Condition
psoriatic arthritis
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Participant_Condition
patients with psoriatic arthritis , in stable low disease state .
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Participant_Sample-size
Seventy-two
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Participant_Sample-size
57