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A feasibility study for a randomised controlled trial of treatment withdrawal in psoriatic arthritis (RETREAT (F))

Biologic therapy is effective for all aspects of psoriatic disease, but these drugs are costly and the long-term effects are unknown. The high relapse rate we found in this feasibility study indicates that an alternative trial design of partial treatment withdrawal, possibly including a patient preference arm, should be considered.

Why did we do this research?

Biologic therapy is effective for all aspects of psoriatic disease, but these drugs are costly and the long-term effects are unknown. In addition, drugs such as methotrexate cause concern about long-term adverse events. The purpose of this study was to test the feasibility of drug withdrawal from patients with psoriatic arthritis in a stable low disease state. 

What did we do?

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, 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in the withdrawal group underwent a phased withdrawal of medication where the last treatment added was the first withdrawn.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 three months before study exit. 

Who was involved?

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 nine failed eligibility criteria so that 17 patients (29.8 % of the 57 eligible patients), were randomised at a ratio of 2:1 in favour of the withdrawal arm (11 withdrawals, 6 standard care). 

What did we find?

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 three (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.

Publications

Moverley A, Coates L, Marzo-Ortega H, Waxman R, Torgerson D, Cocks K, Watson J, Helliwell PS. 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)). Clin Rheumatol. 2015 Aug;34(8):1407-12. DOI: 10.1007/s10067-015-2886-1

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