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Article: Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data
Title | Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data |
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Authors | |
Keywords | Pharmacovigilance Psoriatic arthritis Rheumatic diseases Rheumatoid arthritis Spondyloarthritis |
Issue Date | 2021 |
Publisher | Springer UK. The Journal's web site is located at http://www.springer.com/medicine/rheumatology/journal/10067 |
Citation | Clinical Rheumatology, 2021, v. 40, p. 867-875 How to Cite? |
Abstract | 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. |
Persistent Identifier | http://hdl.handle.net/10722/307895 |
ISSN | 2023 Impact Factor: 2.9 2023 SCImago Journal Rankings: 0.872 |
PubMed Central ID | |
ISI Accession Number ID | |
Errata |
DC Field | Value | Language |
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dc.contributor.author | Lau, CS | - |
dc.contributor.author | Chen, YH | - |
dc.contributor.author | Lim, K | - |
dc.contributor.author | de Longueville, M | - |
dc.contributor.author | Arendt, C | - |
dc.contributor.author | Winthrop, K | - |
dc.date.accessioned | 2021-11-12T13:39:27Z | - |
dc.date.available | 2021-11-12T13:39:27Z | - |
dc.date.issued | 2021 | - |
dc.identifier.citation | Clinical Rheumatology, 2021, v. 40, p. 867-875 | - |
dc.identifier.issn | 0770-3198 | - |
dc.identifier.uri | http://hdl.handle.net/10722/307895 | - |
dc.description.abstract | 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. | - |
dc.language | eng | - |
dc.publisher | Springer UK. The Journal's web site is located at http://www.springer.com/medicine/rheumatology/journal/10067 | - |
dc.relation.ispartof | Clinical Rheumatology | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.subject | Pharmacovigilance | - |
dc.subject | Psoriatic arthritis | - |
dc.subject | Rheumatic diseases | - |
dc.subject | Rheumatoid arthritis | - |
dc.subject | Spondyloarthritis | - |
dc.title | Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data | - |
dc.type | Article | - |
dc.identifier.email | Lau, CS: cslau@hku.hk | - |
dc.identifier.authority | Lau, CS=rp01348 | - |
dc.description.nature | published_or_final_version | - |
dc.identifier.doi | 10.1007/s10067-020-05248-4 | - |
dc.identifier.pmid | 32740672 | - |
dc.identifier.pmcid | PMC7895783 | - |
dc.identifier.scopus | eid_2-s2.0-85088876738 | - |
dc.identifier.hkuros | 329865 | - |
dc.identifier.hkuros | 329866 | - |
dc.identifier.volume | 40 | - |
dc.identifier.spage | 867 | - |
dc.identifier.epage | 875 | - |
dc.identifier.isi | WOS:000554424900001 | - |
dc.publisher.place | United Kingdom | - |
dc.relation.erratum | doi:10.1007/s10067-020-05356-1 | - |