Title: | Therapeutic drug monitoring of adalimumab in RA: no predictive value of adalimumab serum levels and anti-adalimumab antibodies for prediction of response to the next bDMARD |
Author(s): | Ulijn, E.; Broeder, N. den ; Wientjes, M.; Herwaarden, N. van; Meek, I.L.; Tweehuysen, L.; Maas, A. van der; Bemt, B.J.F van den ; Broeder, A.A. den |
Publication year: | 2020 |
Source: | Annals of the Rheumatic Diseases, vol. 79, iss. 7, (2020), pp. 867-873 |
ISSN: | 0003-4967 |
DOI: | https://doi.org/10.1136/annrheumdis-2020-216996 |
Publication type: | Article / Letter to editor |
Please use this identifier to cite or link to this item : https://hdl.handle.net/2066/220022 ![]() |
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Subject: | Radboudumc 0: Other Research RIHS: Radboud Institute for Health Sciences Radboudumc 18: Healthcare improvement science RIHS: Radboud Institute for Health Sciences Radboudumc 5: Inflammatory diseases RIHS: Radboud Institute for Health Sciences Radboudumc 5: Inflammatory diseases RIMLS: Radboud Institute for Molecular Life Sciences |
Organization: | Gastroenterology Rheumatology Clinical Pharmacy |
Journal title: |
Annals of the Rheumatic Diseases
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Volume: | vol. 79 |
Issue: | iss. 7 |
Page start: | p. 867 |
Page end: | p. 873 |
Abstract: |
BACKGROUND: After adalimumab treatment failure, tumour necrosis factor inhibition (TNFi) and non-TNFi biological disease-modifying anti-rheumatic drugs (bDMARDs) are equally viable options on a group level as subsequent treatment in rheumatoid arthritis (RA) based on the current best evidence synthesis. However, preliminary data suggest that anti-adalimumab antibodies (anti-drug antibodies, ADA) and adalimumab serum levels (ADL) during treatment predict response to a TNFi as subsequent treatment. OBJECTIVE: To validate the association of presence of ADA and/or low ADL with response to a subsequent TNFi bDMARD or non-TNFi bDMARD. Sub-analyses were performed for primary and secondary non-responders. METHODS: A diagnostic test accuracy retrospective cohort study was done in consenting RA patients who discontinued adalimumab after >3 months of treatment due to inefficacy and started another bDMARD. Inclusion criteria included the availability of (random timed) serum samples between ≥8 weeks after start and ≤2 weeks after discontinuation of adalimumab, and clinical outcome measurements Disease Activity Score in 28 joints - C-reactive protein (DAS28-CRP) between 3 to 6 months after treatment switch. Test characteristics for EULAR (European League Against Rheumatism) good response (DAS28-CRP based) after treatment with the next (non-)TNFi bDMARD were assessed using area under the receiver operating characteristic and sensitivity/specificity. RESULTS: 137 patients were included. ADA presence was not predictive for response in switchers to a TNFi (sensitivity/specificity 18%/75%) or a non-TNFi (sensitivity/specificity 33%/70%). The same was true for ADL levels in patients that switched to a TNFi (sensitivity/specificity 50%/52%) and patients that switched to a non-TNFi (sensitivity/specificity 32%/69%). Predictive value of ADA and ADL were similar for both primary and secondary non-responders to adalimumab. CONCLUSIONS: In contrast to earlier research, we could not find predictive value for response to a second TNFi or non-TNFi for either ADA or random timed ADL.
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