LAUSR

OBJECTIVES To report 24-week safety and effectiveness data of certolizumab pegol (CZP) in Japanese patients with rheumatoid arthritis (RA) from a post-marketing surveillance study. METHODS Enrolled patients were newly receiving CZP. All adverse events (AEs) and adverse drug reactions (ADRs) were recorded for patients who received ≥1 CZP dose. Effectiveness outcomes included: 28-joint Disease Activity Score with erythrocyte sedimentation rate (DAS28-ESR) and EULAR response. Missing data were imputed using last observation carried forward. RESULTS 3,727 patients were enrolled; safety and effectiveness were evaluated in 3,586 and 1,794 patients, respectively. 24.9% of patients reported AEs (n=893/3,586) and 14.7% reported ADRs (528/3,586). Serious AEs and serious ADRs were reported in 8.3% (298/3,586) and 5.3% (190/3,586), respectively. Selected serious ADRs of interest included infections (n=110; 3.1%), tuberculosis (6; 0.2%), interstitial pneumonia (15; 0.4%), malignancy (8; 0.2%) and hepatic function disorder (7; 0.2%). No allergic reactions, autoimmune disease, cardiac failure, demyelinating diseases or pancytopenia were reported. Mean DAS28-ESR reduced from 4.8 (baseline) to 3.4 (final evaluation). At final evaluation, 34.7% of patients achieved EULAR good response. CONCLUSIONS These real-world safety and effectiveness results were consistent with previously reported data, with no new safety signals identified. Long-term, real-world CZP safety and effectiveness data are needed.