Gary S. Hoffman, MD; Maria C. Cid, MD; Mahboob U. Rahman, MD, PhD
Potential Financial Conflicts of Interest:Employment: M.U. Rahman (Centocor).
Hoffman G., Cid M., Rahman M.; How Is Infliximab Harmful?. Ann Intern Med. 2008;148:166. doi: 10.7326/0003-4819-148-2-200801150-00015
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Published: Ann Intern Med. 2008;148(2):166.
Although we appreciate Dr. Arkfeld's thoughtful communication, we stand by the original conclusion that the use of infliximab plus corticosteroids is of no benefit in the treatment of patients with newly diagnosed GCA and may be harmful. Clinical trials generally are too small for safety signals to be evaluated by using statistical testing. This is especially true for a trial the size of ours, and therefore a judgment regarding the benefit versus the risk must be based on clinical information. In our trial, 10 infusion reactions occurred in 6 patients in the infliximab group, whereas none occurred in the placebo group. Although most reactions were of only mild-to-moderate intensity, 1 patient discontinued therapy because of dyspnea and flushing. Although not of clinical consequence, antibodies to double-stranded DNA occurred in 16% of patients in the infliximab group and were not found in any patients in the control group.
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