Codrina AncuTa,  Cristina PomIrleanu,  Raluca Maxim,  Eugen AncuTa, Cristina Iordache,Cristina Dascalu, Rodica Chirieac<br>Clinical Relevance of Rituximab Immunogenicity <br>in Rheumatoid Arthritis. A pilot study

Codrina AncuTa, Cristina PomIrleanu, Raluca Maxim, Eugen AncuTa, Cristina Iordache,Cristina Dascalu, Rodica Chirieac
Clinical Relevance of Rituximab Immunogenicity
in Rheumatoid Arthritis. A pilot study

Abstract:

Data about immunogenicity of rituximab (RTX), a chimeric monoclonal antibody that targets BCD20+ cells, and its clinical relevance in patients with rheumatoid arthritis (RA) remains controversial. We performed a cross-sectional study in a cohort of forty-three active RA treated with RTX, aiming to systematically assess anti-RTX antibodies (RTX ADA) and drug level (DL). Evaluation for efficacy, safety and immunogenicity was performed in all patients enrolled as follows: disease activity scores, clinical outcomes and adverse events were evaluated at baseline and during the study visit, while RTX ADA and serum drug concentrations were collected as a single-point data. Lab assays (IgG-anti-RTX and DL) were measured using ELISA Progenika kits, with cut-off values of 140 AU/mL for ADA and 0.75µg/mL for drug concentration, respectively. Although the level of residual RTX was undetectable in more than half of cases, RTX ADA were reported only in two out of 43 patients (4.7%). Treatment failure was demonstrated in 4/43 RA, strongly associated with ADA status (p[0.01) and drug level (p[0.01), with a specific profile for secondary non-responders meaning ADA positivity at higher titers (184.75 vs 147.54AU/mL anti-RTX, p[0.05), lower serum RTX (1.10 vs 3.66µg/mL, p[0.05), lower biologic exposure (32.2 vs 38.3 months; p[0.05), higher DAS28-ESR at baseline (6.14 vs 6.7, p[0.05). Low immunogenicity rate was reported in active RA under RTX, potentially associated with impaired drug efficacy. Although anti-RTX antibodies monitoring is relevant only in selected cases, it may represent a key finding towards optimizing biological therapeutics in RA during long-term follow-up. Keywords: immunogenicity, rituximab, rheumatoid arthritis, anti-drug antibodies, drug level

Issue: 2016, Volume 67, Issue 12

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