title: Incidence of serious respiratory infections in patients with rheumatoid arthritis treated with tocilizumab.
abstract: We aimed to demonstrate the incidence of serious respiratory infections in patients with rheumatoid arthritis (RA) treated with tocilizumab (TCZ) monotherapy. We analyzed the incidence of serious respiratory infections in 601 RA patients enrolled in TCZ clinical trials and their extension studies (TCZ cohort) and in 601 age- and sex-standardized RA patients treated in daily clinical practice at Tokyo Women's Medical University (IORRA subsample cohort). The rates of serious respiratory infections were 1.77 per 100 patient-years from 1999 to 2008 in the TCZ cohort and 0.53 per 100 patient-years from 2000 to 2009 in the IORRA subsample cohort. With the IORRA subsample cohort regarded as a standard population, the standardized incidence ratio (SIR) of serious respiratory infection in the TCZ cohort was 3.64 [95% confidence interval (CI) 2.56-5.01], standardized for age and sex; 2.35 (95% CI 1.66-3.24), standardized for age sex, and corticosteroid use; 1.85 (95% CI 1.30-2.55), standardized for age sex, and pre-existing pulmonary involvement; and 2.41 (95% CI 1.68-3.34) standardized for age sex, and disease activity. The risk of serious respiratory infection in the TCZ cohort was approximately double that in the IORRA subsample cohort after standardizing for corticosteroid use, pre-existing pulmonary involvement, or disease activity. This is comparable to the risk reported when tumor necrosis factor (TNF) inhibitors are used.
authors: Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo 162-0054, Japan. daisuke@ior.twmu.ac.jp
authors: Daisuke
authors: D
authors: Hoshi
authors: Ayako
authors: A
authors: Nakajima
authors: Eisuke
authors: E
authors: Inoue
authors: Kumi
authors: K
authors: Shidara
authors: Eri
authors: E
authors: Sato
authors: Mariko
authors: M
authors: Kitahama
authors: Yohei
authors: Y
authors: Seto
authors: Eiichi
authors: E
authors: Tanaka
authors: Wako
authors: W
authors: Urano
authors: Naomi
authors: N
authors: Ichikawa
authors: Yumi
authors: Y
authors: Koseki
authors: Shigeki
authors: S
authors: Momohara
authors: Astuo
authors: A
authors: Taniguchi
authors: Norihiro
authors: N
authors: Nishimoto
authors: Hisashi
authors: H
authors: Yamanaka
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D018501:Antirheumatic Agents / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D016022:Case-Control Studies; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012141:Respiratory Tract Infections / Q000453:epidemiology / Q000209:etiology*; D012307:Risk Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D005938:Glucocorticoids; C502936:tocilizumab