title: Long-term use of biologic agents does not increase the risk of serious infections in elderly patients with rheumatoid arthritis.
abstract: This study aimed to determine whether the long-term use of biologic agents increases serious infections in elderly patients with rheumatoid arthritis (RA) and to determine the risk factors of serious infections in biologics-treated elderly RA patients. We retrospectively analyzed the incidence rate of serious infections that required hospitalization between biologics-treated and non-biologic disease-modifying antirheumatic drug (DMARD)-treated elderly RA patients (aged over 65 years). We examined the risk factors for serious infections in biologics-treated elderly RA patients. We found that, during a 3-year observation period, the incidence rate of serious infections was not significantly different between biologics-treated and non-biologic DMARD-treated elderly RA patients [8.0 (95% CI 4.7-13.5) and 6.3 (95% CI 4.1-9.5) events per 100 person-years of follow-up, respectively, P = 0.78]. The time to the first serious infection did not significantly differ between the two groups by the analysis of the Kaplan-Meier curves, either (P = 0.46). We then found that prednisolone doses alone were significantly associated with serious infections in biologics-treated elderly RA patients. Furthermore, we found that prednisolone at 1-4 mg/day was associated with serious infections in biologics-treated patients, but not non-biologic DMARD-treated patients. On the other hand, prednisolone at greater than 5 mg/day was associated with serious infections in both biologics-treated and non-biologics-treated patients. We show that there is not a significant difference between the incidence of serious infections between biologics group and non-biologics group in elderly RA patients (≧65 years) and that even very low-dose glucocorticoid use (prednisolone 1-4 mg/day) is a risk factor for serious infections in biologics-treated elderly RA patients.
authors.affiliation: Research Center for Allergy and Clinical Immunology, Asahi General Hospital, I-1326, Asahi City, Chiba, 289-2511, Japan. kawashima@hospital.asahi.chiba.jp.
authors.forename: Hirotoshi
authors.identifier: http://orcid.org/0000-0002-3788-8897
authors.initials: H
authors.lastname: Kawashima
authors.affiliation: Research Center for Allergy and Clinical Immunology, Asahi General Hospital, I-1326, Asahi City, Chiba, 289-2511, Japan.
authors.forename: Shin-Ichiro
authors.initials: SI
authors.lastname: Kagami
authors.affiliation: Research Center for Allergy and Clinical Immunology, Asahi General Hospital, I-1326, Asahi City, Chiba, 289-2511, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Kashiwakuma
authors.affiliation: Research Center for Allergy and Clinical Immunology, Asahi General Hospital, I-1326, Asahi City, Chiba, 289-2511, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Takahashi
authors.affiliation: Research Center for Allergy and Clinical Immunology, Asahi General Hospital, I-1326, Asahi City, Chiba, 289-2511, Japan.
authors.forename: Masaya
authors.initials: M
authors.lastname: Yokota
authors.affiliation: Research Center for Allergy and Clinical Immunology, Asahi General Hospital, I-1326, Asahi City, Chiba, 289-2511, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Furuta
authors.affiliation: Research Center for Allergy and Clinical Immunology, Asahi General Hospital, I-1326, Asahi City, Chiba, 289-2511, Japan.
authors.forename: Itsuo
authors.initials: I
authors.lastname: Iwamoto
mesh_terms: D000367:Age Factors; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001685:Biological Factors / Q000009:adverse effects* / Q000627:therapeutic use; D016022:Case-Control Studies; D016009:Chi-Square Distribution; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects*; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D007239:Infections / Q000139:chemically induced* / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects*; D012189:Retrospective Studies; D012306:Risk; D018709:Statistics, Nonparametric
chemical_list: D018501:Antirheumatic Agents; D001685:Biological Factors; D005938:Glucocorticoids; D011239:Prednisolone; D008727:Methotrexate
keywords: Aging; Biologic agents; Glucocorticoid; Infection; Rheumatoid arthritis