Although treatment with any EMA-approved TNFi therapy results in the modulation or neutralisation of TNF-induced or TNF-regulated activity/responses, there are differences among agents with respect to the biologic structure, pharmacokinetics and half-life.1
TNFi therapies approved for RA1-6
A short half-life can result in the rapid elimination from the body.1-6
Adapted from Furst DE, et al. 2006; Enbrel SmPC; Humira SmPC; Remicade SmPC; Simponi SmPC; Cimzia SmPC; Atiqi S, et al. 2020.
A young RA patient worried about treatments that lose effectiveness over time
An RA patient considering starting a family and may need a treatment that can be interrupted
||Many factors impact the efficacy and safety of biologics and how an individual patient responds to the biologic. The presence or absence of neutralising ADAbs is one of these factors but does not allow any conclusions about the overall efficacy and safety of a 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 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.7
¶Antibodies to Enbrel® have been detected in the sera of some subjects treated with Enbrel®. These antibodies have all been non-neutralising and are generally transient. There appears to be no correlation between the antibody development and clinical response or AEs.2
ADAb, anti-drug antibody; AE, adverse event; EMA, European Medicines Agency; F(ab), fragment antigen-binding; MTX, methotrexate; RA, rheumatoid arthritis; SmPC, summary of product characteristics; TNF, tumour necrosis factor; TNFi, tumour necrosis factor inhibitor.
Please click the Prescribing Information link to view the safety and adverse events information of Enbrel®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
PP-ENB-IND-0814 August 2022
Detectable ADAbs may reduce the response of TNFi therapy
These pages are not intended for patients or for members of the general public. The web pages contain promotional content.
If you select 'No', you will be redirected to Pfizer.co.in
For more details on, Who is a Registered Medical Practitioner*, please visit
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 13th September 2019.
Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.
PP-UNP-IND-0012 July 2022