How Is Infliximab Harmful?

  1. Gary S. Hoffman, MD;
  2. Maria C. Cid, MD; and
  3. Mahboob U. Rahman, MD, PhD
  1. From Cleveland Clinic, Cleveland, OH 44195; Hospital Clinic, Barcelona, Spain; and Centocor Research and Development, Malvern, PA 19355

    IN RESPONSE:

    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 …

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