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.

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“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.

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Reference

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