The clinical immunogenicity of the human monoclonal antibody golimumab has been validated using a novel, highly sensitive, anti-drug antibody detection assay, according to results from a study published in Rheumatology.
Researchers analyzed 3871 serum samples from 3 completed phase 3 randomized controlled trials that assessed the immunogenicity of golimumab in patients with various rheumatic disorders, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Anti-drug antibody titers were measured using a novel drug-tolerant enzyme immunoassay (EIA), which was cross-validated with the original assay used during the trials. Furthermore, they investigated the links between antidrug antibodies and golimumab efficacy, safety, and pharmacokinetics.
After analysis, investigators reported that 31.7% vs 4.1% of patients were anti-drug antibody-positive, as measured from the drug-tolerant immunoassay and original EIA, respectively. In addition, participants who were anti-drug antibody-positive had lower serum golimumab levels compared with those who were not.
Despite an almost 8-fold difference in anti-drug antibody concentration, researchers saw no influence of antibody levels on golimumab clinical efficacy or safety in study participants.
“Golimumab immunogenicity with the [drug-tolerant enzyme immunoassay] is consistent with existing knowledge regarding the clinical relevance of [anti-drug antibodies] detected with the original-EIA in patients with rheumatological disorders,” the researchers wrote.
“The clinical implications of golimumab immunogenicity remained unchanged regardless of assay method used to detect anti-drug antibodies,” they concluded.
Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis [published online November 8, 2018]. Rheumatology. doi: 10.1093/rheumatology/key309