Rheumatology | 2019

Adalimumab drug and antidrug antibody levels do not predict flare risk after stopping adalimumab in RA patients with low disease activity

 
 
 
 
 

Abstract


OBJECTIVE\nTo establish whether serum adalimumab (ADA) trough level (ADA-TL) and antidrug antibody (ADA-ab) level predict flare after stopping ADA in established RA patients with long-standing low disease activity.\n\n\nMETHODS\nFrom the clinical trial Potential Optimalisation and Effectiveness of TNF-blockers, 210 RA patients stopping ADA, who had been using ADA (40 mg/2 weeks) for >1 year with conventional synthetic DMARDs and who had low disease activity (DAS28 < 3.2, or the rheumatologist s assessment of low disease activity with CRP < 10 mg/l) for at least 6 months prior to stopping, were followed for 1 year. The ADA-TL was measured (by ELISA) 12-17 days after the last ADA injection; if it was low, ADA-abs were measured (by an antigen-binding test). Association between time-to-flare and ADA-TL was evaluated by area under the receiver operating characteristic curve and Cox regression.\n\n\nRESULTS\nA total of 106 (51%) patients flared within 1 year after stopping ADA. The area under the receiver operating characteristic curve for flare and ADA-TL was 0.50 (95% CI 0.42-0.58), P = 0.92. The hazard ratio for flare for ADA-TL ⩾ 5 μg/ml (adequate level) vs <5 μg/ml was 0.93 (95% CI: 0.63-1.36) (not significant). Of the 4 patients with high ADA-ab levels, 2 patients (50%) experienced a flare.\n\n\nCONCLUSION\nFlare risk within the year following stopping ADA is not predicted by the ADA-TL or ADA-abs assessed at the moment of stopping.\n\n\nTRIAL REGISTRATION\nNetherlands Trial Register, http://www.trialregister.nl, NTR3112.

Volume 58
Pages 427–431
DOI 10.1093/rheumatology/key292
Language English
Journal Rheumatology

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