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Low immunogenicity risk found for patients with RA taking tocilizumab
The immunogenicity risk for both subcutaneous and intravenous tocilizumab was low for patients with rheumatoid arthritis, according to a recently published analysis.
Gerd R. Burmester, MD, a professor of medicine and clinical researcher at the Charit University Hospital in Berlin, and colleagues evaluated anti-drug antibody (ADA) development and its impact on safety and efficacy for tocilizumab as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). They assessed data from five phase 3 subcutaneous trials, eight intravenous studies and one clinical pharmacology safety analysis, which included more than 50,000 samples. There were 8,974 patients in total. The researchers evaluated the correlations between ADA development, clinical response, adverse events and pharmacokinetics.
The researchers found 1.5% of patients who took subcutaneous tocilizumab developed ADAs compared with 1.2% for the intravenous group. In addition, 0.7% of patients who received tocilizumab as monotherapy developed ADAs compared with 2% for the concomitant csDMARD groups. However, there were no correlations between ADA development and pharmacokinetics, anaphylaxis, hypersensitivity, injection site reactions or loss of efficacy. – by Will Offit
Disclosures: Burmester reports grants and honoraria for consultation and lectures from Roche. Please see the full study for a list of all other relevant disclosures.