The Latest on Remicade® (Infliximab) in the Treatment of Ankylosing Spondylitis
11/08/2004
The results of a recent study, ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy), published in late October of this year, have shown that Remicade significantly reduces spinal inflammation in those with ankylosing spondylitis.
Remicade is in a relatively new class of biologic medications, the TNF-a inhibitors, which have shown success in treating AS and related diseases. Although Remicade is still pending FDA approval for use in treating ankylosing spondylitis, it has been prescribed off-label. Enbrel® (etanercept) is currently the only FDA approved TNF-a inhibitor for treating AS. Click here for more information on the TNF-a blockers.
ASSERT, a major, multi-center, randomized clinical trial, reported that 61.2% of patients showed at least 20% greater improvement in signs and symptoms after being treated with Remicade for 24 weeks. Patients also showed a median decrease of 73% in spinal inflammation activity scores at 24 weeks.
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The ASSERT study found that Remicade was generally safe and well tolerated. The most commonly reported adverse side effects were upper respiratory tract infections, which occurred at a slightly higher rate in the placebo group (15%) compared to those taking Remicade (14 %).
The study's results come after the FDA sent out an advisory on August 11, 2004 regarding serious adverse hematologic (or blood related) events in some taking the drug. Click here for more information on the advisory.
An article published by the Canadian Medical Association on October 24, 2004, entitled, "Infliximab and Serious Hematologic Events" suggests that doctors check a patient's baseline complete blood count before and shortly after infliximab therapy is started. It further suggests that physicians "warn patients of all serious side effects" as well as to check their complete blood count when necessary, especially in the event of "fever, anemic symptoms, bruising and easy bleeding."
The long term effects of TNF-a Inhibitor treatment are as yet unknown, but professor Jürgen Braun, M.D., lead physician at the Rheumatological Center in Herne and Professor at the Free University of Berlin, and principal investigator for the ASSERT trial, states, "Results like those seen with Remicade are very encouraging for patients with AS."