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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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>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 &gt;\u2009238,000 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 &gt;\u2009420,000 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).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>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.<jats:table-wrap><jats:table><jats:tbody>\n                      <jats:tr>\n                        <jats:td colspan=\"2\"><jats:bold>Key Points:<\/jats:bold><jats:italic>\u2022 TB rates were highest in eastern\/central Europe, Mexico, and Asia-Pacific regions.<\/jats:italic><jats:italic>\u2022 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.<\/jats:italic><jats:italic>\u2022 Safety profile of biologics in real-world settings complements controlled studies.<\/jats:italic><jats:italic>\u2022 TB and hepatitis (HBV\/HCV) risk with certolizumab pegol (CZP) treatment is low.<\/jats:italic><\/jats:td>\n                      <\/jats:tr>\n                    <\/jats:tbody><\/jats:table><\/jats:table-wrap><\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10067-020-05248-4","type":"journal-article","created":{"date-parts":[[2020,8,1]],"date-time":"2020-08-01T23:04:11Z","timestamp":1596323051000},"page":"867-875","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data"],"prefix":"10.1007","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6698-8355","authenticated-orcid":false,"given":"Chak Sing","family":"Lau","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi-Hsing","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith","family":"Lim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"de Longueville","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Arendt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Winthrop","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,8,1]]},"reference":[{"key":"5248_CR1","doi-asserted-by":"publisher","first-page":"2287","DOI":"10.1002\/art.10524","volume":"46","author":"MF Doran","year":"2002","unstructured":"Doran MF, Crowson CS, Pond GR, O\u2019Fallon WM, Gabriel SE (2002) Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. 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