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.