TY - JOUR
T1 - Disease activity-guided tapering of biologics in patients with inflammatory arthritis
T2 - a pragmatic, randomized, open-label, equivalence trial
AU - Uhrenholt, L.
AU - Christensen, R.
AU - Dreyer, L.
AU - Hauge, E. M.
AU - Schlemmer, A.
AU - Loft, A. G.
AU - Rasch, M. N.B.
AU - Horn, H. C.
AU - Gade, K. H.
AU - Østgård, R. D.
AU - Taylor, P. C.
AU - Duch, K.
AU - Kristensen, S.
PY - 2023/9
Y1 - 2023/9
N2 - Objective: To evaluate whether disease activity-guided tapering of biologics compared to continuation as usual care enables a substantial dose reduction while disease activity remains equivalent. Method: In 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). Results: Ninety-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. Conclusions: Disease 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. .
AB - Objective: To evaluate whether disease activity-guided tapering of biologics compared to continuation as usual care enables a substantial dose reduction while disease activity remains equivalent. Method: In 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). Results: Ninety-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. Conclusions: Disease 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. .
KW - Adalimumab/therapeutic use
KW - Adult
KW - Antirheumatic Agents/therapeutic use
KW - Arthritis, Rheumatoid/drug therapy
KW - Biological Factors
KW - Biological Products/therapeutic use
KW - Etanercept/therapeutic use
KW - Humans
UR - http://www.scopus.com/inward/record.url?scp=85147671575&partnerID=8YFLogxK
U2 - 10.1080/03009742.2023.2164979
DO - 10.1080/03009742.2023.2164979
M3 - Journal article
C2 - 36745114
AN - SCOPUS:85147671575
SN - 0300-9742
VL - 52
SP - 481
EP - 492
JO - Scandinavian Journal of Rheumatology
JF - Scandinavian Journal of Rheumatology
IS - 5
ER -