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Infliximab May Help Patients with Active Ankylosing Spondylitis: Presented at ACR

By Jerry Ingram

ORLANDO, FL -- October 31, 2003 -- Infliximab may be an effective treatment for patients with active ankylosing spondylitis, according to research presented here on October 26^th at the Annual Meeting of the American College of Rheumatology.

"Patients with active ankylosing spondylitis respond quite well to this kind of treatment, and the effect of the treatment continues for over 2 years," said Joachim Sieper, MD, University Hospital Benjamin Franklin, Free University of Berlin, Germany.

For this follow-up, 2-year study, Dr. Stieper and his fellow investigators examined 54 of the 70 patients who had participated in an initial placebo-controlled study on the efficacy of infliximab. All patients in the observational phase continued taking 5 mg/kg of infliximab intravenous every 6 weeks until week 102. The researchers assessed disease activity by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI). Additionally, quality of life was evaluated by the short form 36 and C-reactive protein levels.

Researchers found that 70% of patients continued treatment through the 102-week study period (49/70). Twenty-one patients dropped out, with 14 dropping out due to adverse events and only 3 due to lack of efficacy; 4 patients dropped out due to other reasons, including non-compliance. In an intention to treat analysis, 30 patients achieved 50% improvement of the BASDAI at week 102. In the completer analysis, a decrease of disease activity at baseline was also observed.

Dr. Sieper stated that the mean BASDAI at Week 0 was 6.4 ; at Week 54 it was 2.5 ; and at Week 102 it was 2.6 . Significantly, at Week 102, 26.5% of the completers were in partial remission according to the Assessment in Ankylosing Spondylitis criteria.

The following adverse events were observed in the participants: one tuberculosis, one transient allergic granulomatosis of the lung, one chronic polyarthritis, two transient symmetric polyarthritis with development of antinuclear antibodies but no anti-DNA antibodies, one mild skin lupus, one transient mild leucopaenia, one moderate elevation of liver enzymes, one herpes zoster, one pancreatitis, and four infusion-related reactions.

Overall, the German team observed marked improvement in 70% of the patients over 2 years, with no decrease in efficacy or increase in side effects.


[Study Title: Two Year Follow Up Results of a Controlled Trial of the Anti-TNF Alpha Antibody Infliximab in Active Ankylosing Spondylitis: Abstract 352]

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