HandScan criteria versus ACR/EULAR Boolean remission as treatment target in early rheumatoid arthritis: results of a randomized controlled trial.

OBJECTIVES

The HandScan is a novel method to quickly and objectively quantify RA disease activity using optical spectral transmission in hands and wrists. The aim of this study was to investigate whether treat-to-target (T2T) in early RA patients aimed at 'HandScan' remission is non-inferior to that aimed at ACR/EULAR 2011 'Boolean' remission.

METHODS

We performed a multicentre randomized double-blind, non-inferiority trial. Newly diagnosed RA patients naive to DMARDs were randomized 1:1 to targeting HandScan remission or Boolean remission. At monthly visits, treatment was intensified/continued/deescalated according to the respective target following a predefined treatment schedule. Primary outcome was the HAQ score at 18 months, and non-inferiority was tested using a non-inferiority margin of 0.2 with a one-sided alpha of 0.05.

RESULTS

Of the 56 patients included per arm, a remarkably high number was not able to follow the T2T protocol (HandScan: 95%, Boolean: 80%, P = 0.01). The main reason was that patients and/or rheumatologists felt there was overtreatment (43%, 32%). HAQ at 18 months was 0.21 (95% CI: 0.01-0.40) units lower (i.e. better) in the Boolean arm. Thus, non-inferiority was absent for the HandScan target. Sensitivity analyses confirmed this conclusion. The HandScan target required more intensive treatment than the Boolean target, indicating overtreatment.

CONCLUSION

Current HandScan remission criteria are not suitable for a T2T strategy in early RA since they may lead to overtreatment and inferior clinical outcomes. Additionally, both treatment targets lead to extraordinarily high non-adherence rates predominantly based on the feeling of overtreatment.

TRIAL REGISTRATION: International Clinical Trials Registry Platform, www.trialsearch.who.int, NTR6388.