Abstract
The objective of the study was to evaluate whether Point-of-Care (POC) assays are equivalent to ELISAs for measuring residual trough levels of adalimumab (ADA) in a cohort of Inflammatory Bowel Disease (IBD) patients. ADA trough levels obtained by POC assays were used to optimize patients in daily clinical practice. Different assays (three ELISAs (Enzyme-Linked ImmunoSorbent Assay) from two different suppliers and two POC assays) were compared to measure ADA trough levels in a first cohort of 31 IBD patients. All assays revealed a high correlation within the assays, ranging from 0.86 to 0.99. Cut-off values were always higher with ELISAs than with POC assays. Then, a small prospective clinical study with a second cohort of 37 IBD patients was performed to compare POC assays and ELISAs for their ability to optimize patients on the basis of the measured ADA trough levels. The use of a POC assay to monitor ADA trough levels did not improve the follow-up of patients with loss of response, as they were always optimized whatever their ADA residual rate. For patients in clinical remission, a POC assay can be useful in some clinical situations to maintain or de-escalate ADA doses according to the measured trough levels. In conclusion, different assays for ADA monitoring are quite equivalent. A POC assay could be only useful for a proactive strategy for asymptomatic patients with a sub-therapeutic dose of ADA, but new therapeutic thresholds need to be identified.
Highlights
Adalimumab (ADA), is a fully human anti-TNF (Tumor Necrosis Factor α) monoclonal antibody [1] used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease (CD), ulcerative colitis (UC), chronic psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, and uveitis [2]
ADA trough levels were first measured in a first cohort of 31 Inflammatory Bowel Disease (IBD) patients (Table 1)
Twenty patients were in clinical remission (20 CD, mean age: 30.5 years, sex ratio M/F: 1.2); 12 patients were had been previously treated with another anti-TNF drug (9 with infliximab); 22 patients were optimized with ADA (40 mg ew)
Summary
Adalimumab (ADA), is a fully human anti-TNF (Tumor Necrosis Factor α) monoclonal antibody [1] used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease (CD), ulcerative colitis (UC), chronic psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, and uveitis [2]. The use of ADA reduces the signs and symptoms of moderate to severe CD [3] and has been approved in the UK since 2009 [4] It has been approved by the FDA for the treatment of moderate to severe UC cases in adults [5]. Loss of response to anti-TNFα antibodies such as infliximab (IFX) or ADA has been widely attributed to the induction of specific immunogenicity and to the development of anti-drug antibodies [6]. In this case, dose escalation should be considered if the decrease of the drug concentration is not attributed to immunogenicity failure. In the presence of anti-drug antibodies, a switch to other anti-TNFα agents or to other biotherapies could be beneficial for the patients
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