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Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis.
- Source :
-
Annals of the rheumatic diseases [Ann Rheum Dis] 2015 Mar; Vol. 74 (3), pp. e16. Date of Electronic Publication: 2014 Jan 17. - Publication Year :
- 2015
-
Abstract
- Objective: To evaluate the associations between (1) antidrug antibody (ADAb) and therapeutic response, (2) ADAb and serum drug trough levels and (3) serum drug levels and therapeutic responses in rheumatoid arthritis (RA) patients receiving adalimumab or etanercept. Secondarily, we aim (1) to evaluate the concordance between radioimmunoassay and bridging ELISA for ADAb assessment and to evaluate the correlation between two different ELISA methods for detecting drug levels, and (2) to determine the optimal cut-off drug levels for good European League Against Rheumatism (EULAR) response.<br />Methods: ADAb levels were determined by bridging ELISA and radioimmunoassay, and drug levels evaluated using sandwich ELISA among 36 adalimumab-treated patients and 34 etanercept-treated patients at the 6th and 12th month. The optimal cut-off drug levels for EULAR responses were determined by receiver-operating characteristic curve analysis.<br />Results: ADAb was detected in 10 (27.8%) and 13 (36.1%) of adalimumab-treated patients after 12-month therapy using bridging ELISA and radioimmunoassay respectively, but not detected in any of etanercept-treated patients. The presence of ADAb was associated with lower EULAR response and lower drug levels compared with those without ADAb (both p<0.001). Drug trough levels were positively associated with DAS28 decrement (ΔDAS28) (all p<0.001). The optimal cut-off trough levels for adalimumab were 1.274 μg/mL and 1.046 μg/mL, and those for etanercept were 1.242 μg/mL and 0.800 μg/mL for good EULAR response assessed at the 6th and 12th month, respectively.<br />Conclusions: ADAb levels were inversely correlated with therapeutic response and drug levels. The positive correlation between drug levels and ΔDAS28 indicates that drug monitoring would be useful to evaluate therapeutic response of TNF-α inhibitors.<br /> (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)
- Subjects :
- Adalimumab
Adult
Aged
Antibodies, Monoclonal, Humanized blood
Antibodies, Monoclonal, Humanized immunology
Antirheumatic Agents immunology
Arthritis, Rheumatoid immunology
Drug Monitoring
Enzyme-Linked Immunosorbent Assay
Etanercept
Female
Humans
Immunoglobulin G blood
Immunoglobulin G immunology
Male
Middle Aged
Radioimmunoassay
Receptors, Tumor Necrosis Factor blood
Receptors, Tumor Necrosis Factor immunology
Treatment Outcome
Antibodies blood
Antibodies, Monoclonal, Humanized therapeutic use
Antirheumatic Agents blood
Antirheumatic Agents therapeutic use
Arthritis, Rheumatoid drug therapy
Immunoglobulin G therapeutic use
Receptors, Tumor Necrosis Factor therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1468-2060
- Volume :
- 74
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Annals of the rheumatic diseases
- Publication Type :
- Academic Journal
- Accession number :
- 24442879
- Full Text :
- https://doi.org/10.1136/annrheumdis-2013-203893