When the results of the retrospective Edmonton clinical practice review were compared with those reported in the randomized, placebo controlled, clinical trial with infliximab, the response rates were found to be similar (73% and 81%, respectively). Nevertheless, the complete response rate was lower in the present study than in the earlier studies (17% and 48%, respectively). The reasons for these differences likely relate to both patient inclusion criteria and definition of response.
The median time to response was two weeks, and the median duration of response was 12 weeks — similar to the results from previous studies.
In our treatment group, 17 of 32 (53%) patients taking concomitant corticosteroids were able to reduce or eliminate their requirements for corticosteroids. In addition, the mean dose of corticosteroids (prednisone) before (5.6 mg) and after infliximab (3.6 mg) decreased significantly (P=0.019). This magnitude of corticosteroid sparing is similar to that described previously in retrospective clinical reviews from Rochester, Minnesota (73%), Chicago, Illinois (69%) and Providence, Rhode Island (40%).
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For patients who did not respond to the initial dose of infliximab, subsequent doses of infliximab resulted in only a 14% response rate, suggesting that patients who do not respond to an initial dose of infliximab are unlikely to respond to subsequent doses. This finding is similar to that identified in the Providence, Rhode Island study (12%), but is slightly lower than that described in the Rochester, Minnesota study (30%) or the clinical trial by Targan et al (34%).