Enbrel® is not associated with clinically relevant immunogenicity1,2,*,†
Although ADAbs to Enbrel® have been detected in some patients, they have all been non-neutralising and appear to have no correlation to clinical events or AEs.1
Percentage of ADABs3
From a meta-analysis of 68 studies (RA, SpA and IBD) which evaluated a total of 14,651 patients, 8766 patients had RA.3,‡
Adapted from Thomas SS, et al. 2015.
*Many factors impact the efficacy and safety of biologics and how an individual patient responds to a biologic. The presence or absence of neutralising ADAbs is one of these factors but does not lead to any conclusions about the overall efficacy and safety of the drug. The occurrence of ADAbs is also influenced by several factors, including co-treatment with immunosuppressive drugs such as MTX. As immunogenicity analyses are product-specific, comparison of antibody production rates with those from other products is not appropriate. ADAbs can be neutralising or non-neutralising and both may impact the bioavailability and safety of the drug. Neutralising antibodies bind to the binding site of the therapeutic protein and neutralise it whereas non-neutralising antibodies bind to the therapeutic protein but do not neutralise it.4
†Antibodies to Enbrel® have been detected in the sera of some subjects treated with it. These antibodies have all been non-neutralising and are generally transient. There appears to be no correlation between antibody development and clinical response or AEs.1
‡Study design: Thomas SS, et al. 2015.
The objective of this study was to examine the immunogenicity of TNFi (Enbrel®, adalimumab, infliximab, golimumab and certolizumab) in RA, SpA and IBD, and to examine the potential effect of ADAbs on the reduction in clinical response through a systematic literature review and meta-analysis.3
A comprehensive literature search was conducted using 3 databases (PubMed, Web of Science and the Cochrane Library) to identify studies examining the immunogenicity of TNFi in autoimmune diseases between 1966 and 31 December 2013. Inclusion criteria required that the studies be written in English, and also that they be RCTs, observational studies or case reports involving more than 5 patients, and that the patients be aged ≥18 years. Studies were excluded if they were strictly genetic with no clinical correlation, if the patients had concomitant cancer within 5 years of the study or if the patients had a renal disease requiring dialysis. Double extraction was followed by a third extraction if needed.3
Random-effect models were generated for the meta-analysis of 68 studies (N=14,651) to estimate the OR of the ADAb effects on TNFi response. Regression analysis was used to compare among the drugs and diseases.3
ADAb, anti-drug antibody; AE, adverse event; CI, confidence interval; IBD, inflammatory bowel disease; MTX, methotrexate; OR, odds ratio; RA, rheumatoid arthritis; RCT, randomised controlled trial; SpA, spondyloarthritis; TNFi, tumour necrosis factor inhibitor.
References:
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