title: 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)).
abstract: 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in the withdrawal group underwent a phased withdrawal of medication where the last treatment added was the first withdrawn.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.
authors: York Teaching Hospitals NHS Trust, York, North Yorkshire, UK.
authors: Anna
authors: A
authors: Moverley
authors: Laura
authors: L
authors: Coates
authors: Helena
authors: H
authors: Marzo-Ortega
authors: Robin
authors: R
authors: Waxman
authors: David
authors: D
authors: Torgerson
authors: Kim
authors: K
authors: Cocks
authors: Judith
authors: J
authors: Watson
authors: Philip S
authors: PS
authors: Helliwell
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012008:Recurrence; D028761:Withholding Treatment
chemical_list: D018501:Antirheumatic Agents; D007166:Immunosuppressive Agents
references: Arthritis Rheum. 2002 Sep;46(9):2310-9
references: 12355478
references: Rheumatology (Oxford). 2008 Jun;47(6):872-6
references: 18400836
references: Ann Rheum Dis. 2009 Sep;68(9):1387-94
references: 18952643
references: Arthritis Rheum. 2009 Oct 15;61(10 ):1373-8
references: 19790120
references: Arthritis Rheum. 2003 Oct;48(10):2750-62
references: 14558079
references: Am J Clin Dermatol. 2003;4(7):441-7
references: 12814334
references: Ann Rheum Dis. 2013 Jun;72(6):986-91
references: 22798567
references: J Rheumatol. 2014 Jun;41(6):1212-7
references: 24882854
references: Ann Rheum Dis. 2010 Jan;69(1):48-53
references: 19147615
references: Int J Immunopathol Pharmacol. 2013 Jul-Sep;26(3):833-8
references: 24067486
references: Br J Rheumatol. 1986 May;25(2):206-9
references: 3708236
references: J Rheumatol. 2007 Jan;34(1):123-9
references: 17216680
references: Dermatologica. 1978;157(4):238-44
references: 357213
references: Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii14-7
references: 15708927
references: Ann Rheum Dis. 2012 Mar;71(3):319-26
references: 21803753
references: Arthritis Rheum. 2006 Aug;54(8):2665-73
references: 16871531
references: Br J Rheumatol. 1996 Aug;35(8):781-90
references: 8761194
references: Med Care. 1995 Apr;33(4 Suppl):AS264-79
references: 7723455
references: Rheumatology (Oxford). 2006 Jan;45(1):112
references: 16278287