The safety and efficacy of leflunomide in combination with infliximab in rheumatoid arthritis

Arthritis Rheum. 2004 Apr 15;51(2):228-32. doi: 10.1002/art.20228.


Objective: To report the safety and efficacy of leflunomide (LEF) in combination with infliximab (INF) for the treatment of rheumatoid arthritis.

Methods: In an open, multicenter, retrospective study, data were collected on the safety and efficacy of LEF and INF.

Results: Eighty-eight patients received the combination of LEF and INF for an average of 6.6 months and a total exposure of 581 patient-months. The mean duration of LEF was 17 +/- 9 months (range 3-32 months; median 18.5 months) with an average of 4.8 INF infusions per patient. In all but 3 subjects, LEF was used initially and INF was added later. Infusion reactions occurred in 3 patients (0.7% of all infusions). A total of 34% of subjects experienced adverse events and in 6 (6.8% of the group) these were deemed serious. Ten infections occurred when patients were taking the combination; 9 patients recovered fully and 1 died of bacterial pneumonia. A lifetime smoker developed lung cancer and another patient was found to have colon cancer.

Conclusions: The adverse events noted within the combination therapy group were in keeping with the known risks of each drug when used individually. Limited data were available on efficacy, but a general improvement in disease control was noted with the combination of drugs, which for most patients involved the addition of INF to previous use of LEF.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects*
  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / adverse effects*
  • Arthritis, Rheumatoid / drug therapy*
  • Drug Therapy, Combination
  • Female
  • Hospitalization
  • Humans
  • Infections / diagnosis
  • Infliximab
  • Isoxazoles / administration & dosage
  • Isoxazoles / adverse effects*
  • Leflunomide
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Isoxazoles
  • Infliximab
  • Leflunomide