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.