Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis

Abstract

Our aim was to evaluate real-world safety and effectiveness in a 6-month postmarketing surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions (n = 610, 4.4%) and rash (n = 339, 2.4%), whereas pneumonia (n = 116, 0.8%) and interstitial lung disease (n = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) (p \ 0.001); 84.3% of patients had good or moderate EULAR responses at week 24. The percentage of patients achieving remission increased significantly from week 4 (9.3%) to week 24 (18.9%) (p \ 0.001). Patients with early moderate RA were less likely to experience SAEs and were more likely to achieve remission compared with patients with more severe disease. The safety and effectiveness of etanercept was demonstrated in Japanese patients in one of the largest observational trials conducted thus far in RA patients treated with biologics.

Safety of Abatacept Administered Intravenously in Treatment of Rheumatoid Arthritis: Integrated Analyses of up to 8 Years of Treatment from the Abatacept Clinical Trial Program

“…Several patients had diffuse B cell lymphoma, which is known to occur with increased frequency in patients with RA 37 . IR of lymphoma observed here were comparable with those observed with other biologic agents 24,30 , and registry data suggest that biologics are not associated with any further increase in the already elevated lymphoma occurrence in RA 38 .…”

“…Previous studies 15,24,25,26,27 have demonstrated an increase in serious infections, such as pneumonia and TB, in patients receiving some anti-TNF therapies compared with other biologic or nonbiologic DMARD. The IR of serious infection among patients treated with IV abatacept presented in our study was similar to, or less than, that previously reported in other integrated or pooled safety analyses of biologic agents in RA 28,29 .…”

Effectiveness and Safety of Tocilizumab: Postmarketing Surveillance of 7901 Patients with Rheumatoid Arthritis in Japan

“…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.…”

Characteristics of Tuberculosis in Patients with Rheumatoid Arthritis: A Retrospective Single-center Study

“…Patients undergoing anti-TNF therapy frequently develop extrapulmonary tuberculosis (1)(2)(3)(4). However, it remains unknown whether this high frequency of extrapulmonary tuberculosis is a characteristic of RA patients undergoing anti-TNF therapy or whether anti-TNF therapy is not a factor in RA patients, as the characteristics of tuberculosis infection in RA patients treated without anti-TNF therapy have not been fully elucidated.…”