title: Safety of infliximab used in combination with leflunomide or azathioprine in daily clinical practice.
abstract: OBJECTIVE
  To investigate the safety of infliximab (INF) combination therapy with leflunomide (LEF) or azathioprine (AZA) in patients with rheumatoid arthritis (RA).
  
  
  METHODS
  A standardized questionnaire on the use of INF in combination with LEF or AZA was mailed to hospital physicians and collected over a 2 month period. Adverse events (AE) and the reasons for withdrawal of combination therapy were analyzed.
  
  
  RESULTS
  Data on 225 patients with RA were collected retrospectively. INF was used in combination with LEF in 171 patients and with AZA in 54. The duration of INF exposure was similar in both groups (mean 8.8 mo). AE were reported in 75 patients (33.3%), 60 LEF/INF (35%) and 15 AZA/INF combinations (27.8%) (p=nonsignificant). No unexpected AE were observed. The main AE were infections (6.2%), cytopenia (5.8%), hepatotoxicity (5.8%), reactions to infusion (5.3%), and skin reactions (4%). At the time the questionnaires were sent out, 161 patients were continuing combination therapies. The main reasons for drug withdrawal were AE (53 patients, 23.5%), inefficacy (10 patients, 4%), and one temporary discontinuation for surgery.
  
  
  CONCLUSIONS
  Our study suggests that INF used in combination with LEF or AZA could be an alternative to methotrexate/INF combinations.
authors.affiliation: Department of Rheumatology, Medical University, Rennes, France. aleth.perdriger@chu-rennes.fr
authors.forename: Aleth
authors.initials: A
authors.lastname: Perdriger
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Kuntz
authors.forename: Olivier
authors.initials: O
authors.lastname: Brocq
authors.forename: Rym
authors.initials: R
authors.lastname: Kara-Terki
authors.forename: Xavier Le
authors.initials: XL
authors.lastname: Loet
authors.forename: Alain
authors.initials: A
authors.lastname: Cantagrel
authors.forename: Stephan
authors.initials: S
authors.lastname: Pavy
authors.forename: Chantal Job
authors.initials: CJ
authors.lastname: Deslandre
authors.forename: Françoise
authors.initials: F
authors.lastname: Debiais
authors.forename: Bernard
authors.initials: B
authors.lastname: Combe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology; D001379:Azathioprine / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000069285:Infliximab; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000077339:Leflunomide; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D007555:Isoxazoles; D000069285:Infliximab; D000077339:Leflunomide; D001379:Azathioprine; D008727:Methotrexate