title: Risk of tuberculosis, serious infection and lymphoma with disease-modifying biologic drugs in rheumatoid arthritis patients in Taiwan.
abstract: OBJECTIVE
  To determine the risk of adverse events in rheumatoid arthritis (RA) patients treated with biological disease-modifying anti-rheumatic drugs (bDMARD) versus traditional DMARDs (tDMARD).
  
  
  METHODS
  This retrospective study used Taiwan's National Health Insurance Research Database to capture data for adult patients diagnosed with RA between 1 January 1999 and 31 December 2009 and treated with tDMARD or bDMARD. The endpoints were patients with cases of an inpatient serious bacterial infection (SBI), diagnosis of tuberculosis (TB) or lymphoma. Within the bDMARD cohort, individual bDMARDS with adequate data were also compared (adalimumab and etanercept). Propensity-score matching was used to adjust for significant (P ≤ 0.05) patient characteristics. Incidence rate ratios (IRR) of SBI/TB/lymphoma cases versus non-cases were adjusted for exposure time (rate per 100,000 patient-years) and 95% confidence intervals were constructed to assess whether IRRs differed from 1.0.
  
  
  RESULTS
  Of 34,947 potential patients, 7888 tDMARD, 3459 bDMARD (including 1492 etanercept and 746 adalimumab) patients were matched for analysis. A total of 2150 cases were identified and of these 1711 were SBI, 406 as TB and 33 as lymphoma. For all cases except SBI, the IRR (95% CI) was higher for bDMARD versus tDMARD (SBI 1.04 [0.89-1.19]; TB 2.67 [2.12-3.34]; lymphoma 3.24 [1.37-7.06]). Excepting lymphoma, IRR was higher for adalimumab versus etanercept (SBI 1.83 [1.19-2.77]; TB 2.35 [1.29-4.15]; lymphoma 1.49 [0.03-18.66]).
  
  
  CONCLUSIONS
  There was a higher risk for specified infections and lymphoma with bDMARD versus tDMARD and adalimumab versus etanercept.
authors.affiliation: Division of Allergy Immunology & Rheumatology, Changhua Christian Hospital, Changhua, Taiwan; Department of Nursing, College of Medicine & Nursing, HungKuang University, Taichung, Taiwan.
authors.forename: Ying-Ming
authors.initials: YM
authors.lastname: Chiu
authors.forename: Hui-Chu
authors.initials: HC
authors.lastname: Lang
authors.forename: Hsiao-Yi
authors.initials: HY
authors.lastname: Lin
authors.forename: Ming-Ta
authors.initials: MT
authors.lastname: Yang
authors.forename: Chi-Hui
authors.initials: CH
authors.lastname: Fang
authors.forename: Ya-Wen
authors.initials: YW
authors.lastname: Yang
authors.forename: Vernon F
authors.initials: VF
authors.lastname: Schabert
authors.forename: Boxiong
authors.initials: B
authors.lastname: Tang
mesh_terms: D018501:Antirheumatic Agents / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D001688:Biological Products / Q000009:adverse effects*; D016009:Chi-Square Distribution; D016208:Databases, Factual; D005260:Female; D006801:Humans; D016867:Immunocompromised Host; D015994:Incidence; D016015:Logistic Models; D008137:Longitudinal Studies; D008223:Lymphoma / Q000139:chemically induced* / Q000453:epidemiology / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000139:chemically induced* / Q000453:epidemiology / Q000276:immunology; D057216:Propensity Score; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013624:Taiwan / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D014376:Tuberculosis / Q000139:chemically induced* / Q000453:epidemiology / Q000276:immunology; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha
keywords: epidemiology; health services and health care economics; rheumatoid arthritis