Background/Purpose: The aim of this study was to assess the impact of tight control of early psoriatic arthritis (PsA) in a randomised-controlled trial (RCT) using a treat-to-target approach.

Methods: In this UK multicentre, open-label RCT, 206 patients with early DMARD naive PsA (<24 months symptom duration) were randomised 1:1 to receive either tight control (TC) (4 weekly review) or standard care (StdC) (12 weekly review) for 48 weeks. Patients assigned to the TC group followed a strict treatment protocol with escalation of therapy if minimal disease activity (MDA) criteria¹were not met. All patients in the TC arm were started on methotrexate with rapid escalation to 25mg after 6 weeks if tolerated.  After 12 weeks of therapy, patients were escalated to combination DMARDs if they had not achieved MDA.  After a further 12 weeks, patients were either escalated to anti-TNF therapy if they had ≥3 tender and swollen joints (as per UK NICE guidelines) or to an alternative DMARD in combination with methotrexate if they were not in MDA but had <3 active joints.  Patients assigned to the StdC group were treated by a rheumatologist with no set protocol and no limitations.

The primary outcome was ACR20 response at 48 weeks. Key secondary outcomes included ACR50 and 70, and PASI75 at 48 weeks. Treatment arms were compared using multivariate logistic regression adjusting for arthritis classification and centre. Missing ACR response component data was imputed using multiple imputation for the intention to treat (ITT) population.

Results:

206 patients were recruited from 8 UK centres from 2008-2012 with 101 randomised to TC and 105 to StdC. By week 48, 12 patients had withdrawn (5 TC, 7 StdC) and 12 lost to follow-up (6 TC, 6 StdC). Patients had a median age of 45 (range: 18-80), 52% were male and 71% presented with polyarthritis; these characteristics were similar across treatment arms. In the ITT population, there was significant evidence that the odds of achieving ACR20 at 48 weeks were greater 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) were also greater in the TC arm compared to the StdC arm.  Results for patients with non-missing data are displayed below.

Outcome measure	Patients with all data available (N)	Tight Control	Standard Care
		N (%) achieving outcome
ACR20	172	55 (61.8)	37 (44.6)
ACR50	170	44 (51.2)	21 (25.0)
ACR70	172	33 (38.4)	15 (17.4)
PASI75*	156	44 (58.7)	27 (33.3)
		Median improvement in score (range)
Enthesitis*	145	2 (-12, 13)	1 (-8, 14)
LDI*	53	38 (0, 276)	58.5 (-6, 157)
mNAPSI*	110	3 (-18, 41)	2 (-22, 32)

* only evaluated if involvement at baseline

The most commonly reported adverse events (AEs) were nausea, liver function test abnormalities and infections (e.g. common cold). AEs were reported in 88% of patients, (97% TC vs 80% StdC). 33 serious AEs (SAEs) (25 TC, 8 StdC) were reported across 20 patients (14 TC, 6 StdC) during the course of the study. There were no deaths or unexpected SAEs.

Conclusion: 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 seen.

This study was funded by Arthritis Research UK and Pfizer.

1. Coates et al, Arthritis and Rheum 2010

---

« Back to 2013 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/results-of-a-randomised-controlled-trial-comparing-tight-control-of-early-psoriatic-arthritis-ticopa-with-standard-care-tight-control-improves-outcome/