Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data
Web of Science
AuthorLau, CS; Chen, Y-H; Lim, K; de Longueville, M; Arendt, C; Winthrop, K
Source TitleClinical Rheumatology
PublisherSPRINGER LONDON LTD
University of Melbourne Author/sLim, Keith
AffiliationMedicine, Western Health
Document TypeJournal Article
CitationsLau, C. S., Chen, Y. -H., Lim, K., de Longueville, M., Arendt, C. & Winthrop, K. (2020). Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data. CLINICAL RHEUMATOLOGY, 40 (3), pp.867-875. https://doi.org/10.1007/s10067-020-05248-4.
Access StatusOpen Access
INTRODUCTION/OBJECTIVES: To evaluate the incidence rate (IR) of tuberculosis (TB) and viral hepatitis B and C (HBV/HCV) during certolizumab pegol (CZP) treatment, worldwide and in Asia-Pacific countries, across clinical trials and post-marketing reports (non-interventional studies and real-world practice). METHOD: CZP safety data were pooled across 49 clinical trials from 1998 to June 2017. Post-marketing reports were from initial commercialization until March 2015 (TB)/February 2017 (HBV/HCV). All suspected TB and HBV/HCV cases underwent centralized retrospective review by external experts. Incidence rates (IRs) were calculated per 100 patient-years (PY) of CZP exposure. RESULTS: Among 11,317 clinical trial patients (21,695 PY), 62 TB cases were confirmed (IR 0.29/100 PY) including 2 in Japan (0.10/100 PY) and 3 in other Asia-Pacific countries (0.58/100 PY). From > 238,000 PY estimated post-marketing CZP exposure, there were 31 confirmed TB cases (0.01/100 PY): 5 in Japan (0.05/100 PY), 1 in other Asia-Pacific countries (0.03/100 PY). Reported regional TB IRs were highest in eastern Europe (0.17/100 PY), central Europe (0.09/100 PY), and Mexico (0.16/100 PY). Across clinical trials, there was 1 confirmed HBV reactivation and no HCV cases. From > 420,000 PY estimated post-marketing CZP exposure, 5 HBV/HCV cases were confirmed (0.001/100 PY): 2 HCV reactivations; 1 new HCV; plus 2 HBV reactivations in Japan (0.008/100 PY). CONCLUSIONS: CZP TB risk is aligned with nationwide TB rates, being slightly higher in Asia-Pacific countries excluding Japan. Overall, TB and HBV/HCV risk with CZP treatment is currently relatively low, as risk can be minimized with patient/physician education, screening, and vigilant treatment, according to international guidelines. KEY POINTS: • TB rates were highest in eastern/central Europe, Mexico, and Asia-Pacific regions. • With the implementation of stricter TB screening and risk evaluations in 2007, especially in high TB incidence countries, there was a notable reduction TB occurrence. • Safety profile of biologics in real-world settings complements controlled studies. • TB and hepatitis (HBV/HCV) risk with certolizumab pegol (CZP) treatment is low.
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