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TNF Inhibitors
OP0063 Three month results of a Double-Blind, Placebo Controlled Phase III Clinical Trial of Infliximab in Active Ankylosing Spondylitis
J Brandt, R Alten, G Burmester, E Gromnica-Ihle, H Kellner, M Schneider, H Sorenson, H Zeidler, W Thriene, J Sieper, J Braun

In a previous open label study, patients with severe ankylosing spondylitis (AS) improved with infliximab therapy. This abstract presents with three month follow-up on 77 patients with active AS (1984 New York Criteria) who were randomized to receive infliximab 5 mg/kg (weeks 0, 2, 6 then every 2 months) or placebo . Active disease was defined as a Bath AS Disease Activity Index (BASDAI) >4, ands pain >4 on a numeric range scale (NRS). Patients with a >50% improvement in the BASDAI were categorized as responders. At 3 months, 50% of the infliximab group and 10% of the placebo group were responders. Three serious adverse events were noted: tuberculosis, allergic lung granulmatosus, and leukopenia of unknown etiology.

Editorial Comment: The role of tumor necrosis factor (TNF) inhibition in the treatment of AS is unclear. However with the success of TNF inhibitors in psoriatic arthritis and inflammatory bowel disease there is reason to be optimistic that these agents would have a role in AS. This short-term study confirms that infliximab does improve the signs and symptoms of AS. Longer term studies showing efficacy and tolerability still need to be done. We hope that future studies will show these agents to be disease modifying as well.

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