TY - JOUR T1 - Effects of Low-dose Infliximab on Spinal Inflammation on Magnetic Resonance Imaging in Ankylosing Spondylitis JF - The Journal of Rheumatology JO - J Rheumatol SP - 1553 LP - 1555 DO - 10.3899/jrheum.100422 VL - 37 IS - 8 AU - MARTIN RUDWALEIT Y1 - 2010/08/01 UR - http://www.jrheum.org/content/37/8/1553.abstract N2 - In 2003, infliximab was the first anti-tumor necrosis factor (TNF) agent to be approved by both the European Medicines Agency and the US Food and Drug Administration for the treatment of active ankylosing spondylitis (AS) that responds insufficiently to standard therapy, usually nonsteroidal antiinflammatory drugs. All initial trials in AS — whether the initial open-label studies or placebo-controlled trials — were conducted using the 5 mg/kg infliximab dosing scheme1,2. In the placebo-controlled trial of 69 patients from Germany that led to approval of the drug, the interval between infliximab 5 mg/kg infusions was 6 weeks after the initial infusions at Week 0, Week 2, and Week 61. The dose and infusion interval of infliximab in AS clinical trials was chosen in analogy to the treatment schedule of infliximab in Crohn’s disease because according to the concept of spondyloarthritis as a group of interrelated diseases, Crohn’s disease appeared to be more akin to AS than rheumatoid arthritis (RA) and was the first spondyloarthropathy related disease for which approval of infliximab had been obtained. Therefore, the 5 mg/kg infliximab dose given every 6 or 8 weeks was used in the clinical trials in AS, and not the 3 mg/kg dose every 8 weeks that had been approved in RA. Unfortunately and in contrast to RA, no dose-finding studies with infliximab were ever performed in AS. Thus, from a scientific point of view we simply do not know whether infliximab 5 mg/kg every 6 weeks is the optimum treatment schedule for active AS.In recent years a few clinical studies were published using the 3 mg/kg dose of infliximab in AS given every 8 weeks. In summary, these usually small and open-label studies revealed response rates that were similar to3,4 or lower than5 … Address correspondence to Dr. M. Rudwaleit, Department of Rheumatology, Ev. Krankenhaus Hagen-Haspe, Brusebrinkstrasse 20, 58135 Hagen, Germany. E-mail: rudwaleit{at}evk-haspe.de ER -