Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data.
作者： Chak Sing Lau , Yi-Hsing Chen , Keith Lim , Marc de Longueville , Catherine Arendt
DOI: 10.1007/S10067-020-05248-4
关键词: Tuberculosis 、 Rheumatoid arthritis 、 Certolizumab pegol 、 Psoriatic arthritis 、 Internal medicine 、 Pharmacovigilance 、 In patient 、 Clinical trial 、 Viral hepatitis 、 Medicine
摘要: To evaluate the incidence rate (IR) of tuberculosis (TB) and viral hepatitis B C (HBV/HCV) during certolizumab pegol (CZP) treatment, worldwide in Asia-Pacific countries, across clinical trials post-marketing reports (non-interventional studies real-world practice). CZP safety data were pooled 49 from 1998 to June 2017. Post-marketing initial commercialization until March 2015 (TB)/February 2017 (HBV/HCV). All suspected TB HBV/HCV cases underwent centralized retrospective review by external experts. Incidence rates (IRs) calculated per 100 patient-years (PY) exposure. Among 11,317 trial patients (21,695 PY), 62 confirmed (IR 0.29/100 PY) including 2 Japan (0.10/100 3 other countries (0.58/100 PY). From > 238,000 PY estimated exposure, there 31 (0.01/100 PY): 5 (0.05/100 1 (0.03/100 Reported regional IRs highest eastern Europe (0.17/100 central (0.09/100 Mexico (0.16/100 Across trials, was HBV reactivation no HCV cases. > 420,000 (0.001/100 reactivations; new HCV; plus reactivations (0.008/100 risk is aligned with nationwide rates, being slightly higher excluding Japan. Overall, treatment currently relatively low, as can be minimized patient/physician education, screening, vigilant according international guidelines.
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