Yasuo Oshima1, Hiroshi Tsukamoto, Arinobu Tojo. 1. The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo 108-8639, Japan. 0-oshima@umin.ac.jp
Abstract
BACKGROUND: Though concern of hepatitis B virus (HBV) reactivation by antirheumatic agents has limited therapeutic opportunities in HBV-infected rheumatoid arthritis (RA) patients, the relative risks (RR) among such agents have not been clarified. OBJECTIVE: We compared the reporting of antirheumatic-agent-associated hepatitis B. PATIENTS: We assessed 92 hepatitis B cases and 98,069 controls from a population of 98,161 RA patients registered into the US Food and Drug Administration's (FDA's) adverse event database between 2004 and 2010. MEASUREMENTS: A reporting odds ratio (ROR), a signal suggesting a risk for hepatitis B among antirheumatic agents, was measured. RESULTS: Treatment with corticosteroids [ROR 2.3 (95% confidence interval 1.3-4.0)], methotrexate [4.9 (3.9-6.0)], rituximab [7.2 (5.3-9.9)], tacrolimus [4.2 (1.5-11.9)], or reporting from Japan [2.2 (1.1-4.2)] were associated with higher signal, whereas adalimumab had a lower ROR [0.2 (0.1-0.4)]. LIMITATIONS: There are known limitations of spontaneous reporting, such as underreporting, the Weber effect, reporting bias, indication bias, and limited clinical information such as HBV status. CONCLUSIONS: Adalimumab's low reporting rate is most likely be due to notoriety. However, the possibility that adalimumab might suppress reactivation of HBV cannot be denied. Until the possibility is clarified in well-designed clinical studies, physicians should use adalimumab cautiously in patients with HBV.
BACKGROUND: Though concern of hepatitis B virus (HBV) reactivation by antirheumatic agents has limited therapeutic opportunities in HBV-infected rheumatoid arthritis (RA) patients, the relative risks (RR) among such agents have not been clarified. OBJECTIVE: We compared the reporting of antirheumatic-agent-associated hepatitis B. PATIENTS: We assessed 92 hepatitis B cases and 98,069 controls from a population of 98,161 RApatients registered into the US Food and Drug Administration's (FDA's) adverse event database between 2004 and 2010. MEASUREMENTS: A reporting odds ratio (ROR), a signal suggesting a risk for hepatitis B among antirheumatic agents, was measured. RESULTS: Treatment with corticosteroids [ROR 2.3 (95% confidence interval 1.3-4.0)], methotrexate [4.9 (3.9-6.0)], rituximab [7.2 (5.3-9.9)], tacrolimus [4.2 (1.5-11.9)], or reporting from Japan [2.2 (1.1-4.2)] were associated with higher signal, whereas adalimumab had a lower ROR [0.2 (0.1-0.4)]. LIMITATIONS: There are known limitations of spontaneous reporting, such as underreporting, the Weber effect, reporting bias, indication bias, and limited clinical information such as HBV status. CONCLUSIONS:Adalimumab's low reporting rate is most likely be due to notoriety. However, the possibility that adalimumab might suppress reactivation of HBV cannot be denied. Until the possibility is clarified in well-designed clinical studies, physicians should use adalimumab cautiously in patients with HBV.
Authors: Pilar López-Serrano; Elsa de la Fuente Briongos; Elisa Carrera Alonso; Jose Lázaro Pérez-Calle; Conrado Fernández Rodríguez Journal: World J Hepatol Date: 2015-03-27
Authors: Mary Jane Burton; Jeffrey R Curtis; Shuo Yang; Lang Chen; Jasvinder A Singh; Ted R Mikuls; Kevin L Winthrop; John W Baddley Journal: Arthritis Res Ther Date: 2015-05-22 Impact factor: 5.156
Authors: Yu Bin Seo; Su Jin Moon; Chan Hong Jeon; Joon Young Song; Yoon Kyoung Sung; Su Jin Jeong; Ki Tae Kwon; Eu Suk Kim; Jae Hoon Kim; Hyoun Ah Kim; Dong Jin Park; Sung Hoon Park; Jin Kyun Park; Joong Kyong Ahn; Ji Seon Oh; Jae Won Yun; Joo Hyun Lee; Hee Young Lee; Min Joo Choi; Won Suk Choi; Young Hwa Choi; Jung Hyun Choi; Jung Yeon Heo; Hee Jin Cheong; Shin Seok Lee Journal: Infect Chemother Date: 2020-06