title: Adverse events and infections in patients with rheumatoid arthritis treated with conventional drugs or biologic agents: a real world study.
abstract: OBJECTIVE
  Treatment of rheumatoid arthritis (RA) with disease-modifying anti-rheumatic drugs (DMARDs), either synthetic (sDMARDs) or biologic agents (bDMARDs) has significantly improved disease outcome. However, the impact of therapy-related adverse events (AEs), mild, moderate or serious, on disease outcome is under debate. The purpose of the study was to test the hypothesis that AEs, including infections, are rather common in patients receiving bDMARDs than in those receiving sDMARDs.
  
  
  METHODS
  Analysis of the medical records of patients followed in a single outpatient clinic was performed. In total, 1403 adults (295 men, 1108 women) were included in the analysis (969 treated with sDMARDs only, 434 with bDMARDs). All AEs and infections were recorded and their severity was graded according to international criteria. Incident rates were calculated and Kaplan-Meier plots as well as Cox proportional-hazards models were performed to examine the association of treatment groups with the risk of any AE.
  
  
  RESULTS
  The risk of any AE, irrespective of severity, was significantly higher in patients with bDMARDs with the adjusted hazard ratio being 1.98 (95% CI: 1.64 to 2.39). Patients in the biologic group treated initially with infliximab or adalimumab had a higher risk of AE compared to patients receiving etanercept or other biologic agents. Among patients treated with methotrexate, those receiving a dose below 10 mg had a higher risk of any AE when compared to those receiving higher doses.
  
  
  CONCLUSIONS
  The risk of any AE among RA patients treated with bDMARDs was significantly higher compared to those treated with sDMARDs.
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Christos E
authors: CE
authors: Lampropoulos
authors: Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National University of Athens, Athens, Greece.
authors: Philippos
authors: P
authors: Orfanos
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Vasiliki-Kalliopi
authors: VK
authors: Bournia
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Theofilos
authors: T
authors: Karatsourakis
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Clio
authors: C
authors: Mavragani
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Dimitrios
authors: D
authors: Pikazis
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Menelaos N
authors: MN
authors: Manoussakis
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Athanasios G
authors: AG
authors: Tzioufas
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Haralampos M
authors: HM
authors: Moutsopoulos
authors: Department of Pathophysiology, Medical School, National University of Athens, Greece.
authors: Panayiotis G
authors: PG
authors: Vlachoyiannopoulos
mesh_terms: D000328:Adult; D000368:Aged; D000554:Ambulatory Care Facilities; D018501:Antirheumatic Agents / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D001688:Biological Products / Q000009:adverse effects*; D003141:Communicable Diseases / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology; D005260:Female; D006115:Greece / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products