2007
DOI: 10.1136/ard.2007.072967
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Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis

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Cited by 384 publications
(257 citation statements)
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“…Among the latter, six patients discontinued due to pneumonia. Pneumonia was the most frequent adverse event observed in previous Japanese post-marketing surveillance (PMS) evaluation of infliximab [40] and etanercept [27], which is consistent with the results of our study. However, it should be noted that susceptibility to infection is an important concern not only in association with anti-TNF therapies but also with the anti–IL-6 activity of tocilizumab.…”
Section: Discussionsupporting
confidence: 93%
“…Among the latter, six patients discontinued due to pneumonia. Pneumonia was the most frequent adverse event observed in previous Japanese post-marketing surveillance (PMS) evaluation of infliximab [40] and etanercept [27], which is consistent with the results of our study. However, it should be noted that susceptibility to infection is an important concern not only in association with anti-TNF therapies but also with the anti–IL-6 activity of tocilizumab.…”
Section: Discussionsupporting
confidence: 93%
“…Multivariate logistic regression analysis identified the following risk factors for serious infection: age ≥ 65 years, longer disease duration (≥ 10 yrs), previous or concurrent respiratory disease, and mean concomitant corticosteroid dose > 5 mg/day (prednisolone equivalent). The risk factors for serious infection identified in our study are similar to the findings reported from the all-patient PMS conducted for infliximab, etanercept, and adalimumab in Japan 1,13,14,15 . Patients with 3 or more of these risk factors had a cumulative incidence of serious infection about 10 times that of patients with no risk factors.…”
Section: Rheumatologysupporting
confidence: 79%
“…Additionally, because hepatitis B reactivation has been reported during treatment with other biologics, especially for anti-tumor necrosis factor therapy, careful screening and monitoring are also strongly recommended for patients given TCZ treatment 15 . In our study, the incidence rate of ILD (0.5%) was equivalent to that found in the PMS of infliximab (0.5%) and etanercept (0.6%) in Japan 1,13 . Because infection could be a trigger for the onset of interstitial pneumonia, careful monitoring of infection will be important for patients with a concurrent or medical history of ILD.…”
Section: Rheumatologysupporting
confidence: 52%
“…In Japan, a strict postmarketing surveillance program was implemented that mandated the registration of all patients with RA receiving infliximab, with a tracking period of 6 months for each patient. Of the 5,000 patients tracked, this postmarketing surveillance program identified 108 patients (2.2%) with bacterial pneumonia and 14 patients (0.3%) with tuberculosis (7). Notably, 22 patients (0.4%) with Pneumocystis jiroveci pneumonia (PCP) were identified in the same postmarketing surveillance program (7), a much higher number than was found in corresponding studies in the US (3).…”
Section: Introductionmentioning
confidence: 74%
“…The incidences of PCP during the postmarketing surveillance programs of infliximab and etanercept in Japan were 0.4% and 0.23%, respectively (7,8). The corresponding incidence reported in the US is ϳ0.01% (25).…”
Section: Discussionmentioning
confidence: 99%