Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial

Abstract

Background Early intervention and tight control of inflammation optimise outcomes in rheumatoid arthritis but these concepts have not been evaluated in psoriatic arthritis (PsA). We aimed to assess the effect of tight control on early PsA using a treat-to-target approach. Methods Patients with early, DMARD naïve, PsA were randomised 1:1 to receive either tight control (4 weekly review with escalation of therapy if criteria not met) or standard care (12 weekly review) for a period of 48 weeks. Clinical outcomes were recorded by a blinded assessor every 12 weeks. The primary outcome was the proportion of patients achieving an ACR20 response at 48 weeks. The primary analysis was by intention-to-treat (ITT) with multiple imputation for missing ACR components. Cost-effectiveness was also evaluated. Findings 206 patients were randomised to receive tight control (TC) (n=101) or standard care (StdC) (n=105). In the ITT patient population, odds of achieving an ACR20 response at 48 weeks were higher in the TC arm compared to the StdC arm (odds ratio (OR): 1.91, 95% CI: 1.03, 3.55, p=0.0392). The odds of achieving ACR50 (OR: 2.36, 95% CI: 1.25, 4.47, p=0.0081); and ACR70 (OR: 2.64, 95% CI: 1.32, 5.26, p=0.0058); and PASI75 (OR: 2.92, 95%CI: 1.51, 5.65, p=0.0015) at 48 weeks were also higher in the TC arm. A greater improvement was observed for patient reported outcomes including BASDAI, BASFI, PsAQoL, HAQ score and ASAS 20/40 in the TC arm. There was no difference in the change of radiographic scores between the treatment arms at week 48 (p=0.9779). The mean incremental cost-effectiveness ratio (ICER) was £50,723 per QALY. Serious adverse events (SAEs) (25 TC, 8 StdC) were reported from 20 (9.7%) patients (14 (13.9%) TC, 6 (5.7%) StdC) during the course of the study. There were no unexpected SAEs or deaths. Interpretation Tight control of PsA disease activity using a treat-to-target approach significantly improves joint and skin outcomes for newly diagnosed PsA patients with no unexpected SAEs observed. Funding This study was funded by Arthritis Research UK and Pfizer. The research team acknowledges the support of the National Institute for Health Research and the Comprehensive Clinical Research Network in supporting this research. Trial Registration ISCRCTN30147736 and NCT01106079