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Arthritis Rheum. 2004 Apr 15;51(2):228-32.

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

Author information

1
University of Wisconsin, Madison, Wisconsin, USA. keh@medicine.wisc.edu

Abstract

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.

PMID:
15077264
DOI:
10.1002/art.20228
[Indexed for MEDLINE]
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