Disease activity-guided tapering of biologics in patients with inflammatory arthritis: a pragmatic, randomized, open-label, equivalence trial

ObjectiveTo evaluate whether disease activity-guided tapering of biologics compared to continuation as usual care enables a substantial dose reduction while disease activity remains equivalent.MethodIn this pragmatic, randomized, open-label, equivalence trial, adults with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis in low disease activity on stable-dose biologics for >= 12 months were randomized 2:1 into either the tapering group, i.e. disease activity-guided prolongation of the biologic dosing interval until flare or withdrawal, or the control group, i.e. maintaince of baseline biologics with a possible small interval increase at the patients request. The co-primary outcome in the intention-to-treat population was met if superiority in >= 50% biologic reduction at 18 months was demonstrated and disease activity was equivalent (equivalence margins +/- 0.5). ResultsNinety-five patients were randomized to tapering and 47 to control, of whom 37% (35/95) versus 2% (1/47) achieved >= 50% biologic reduction at 18 months. The risk difference was statistically significant [35%, 95% confidence interval (CI) 24%-45%], while disease activity remained equivalent [mean difference 0.05, 95% CI -0.12-0.29]. A statistically significant flare risk was observed [tapering 41% (39/95) vs control 21% (10/47), risk difference 20%, 95% CI 4%-35%]; but, only 1% (1/95) and 6% (3/47) had persistent flare and needed to switch to another biological drug. ConclusionsDisease activity-guided tapering of biologics in patients with inflammatory arthritis enabled one-third to achieve >= 50% biologic reduction, while disease activity between groups remained equivalent. Flares were more frequent in the tapering group but were managed with rescue therapy.

Automated summary

This study aimed to evaluate whether disease activity-guided tapering of biologics enables a significant dose reduction while maintaining equivalent disease activity. The results showed that disease activity-guided tapering of biologics allowed one-third of the patients to achieve a reduction of 50% or more, while disease activity remained equivalent between the tapering and control groups. Although flare rates were higher in the tapering group, they could be managed with rescue therapy.