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Infliximab improves spinal mobility in AS, data reveal

Wednesday, December 12 2007 | Comments

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What's This? Treatment with infliximab appears to result in clinically meaningful and sustained improvements in spinal mobility among patients with ankylosing spondylitis, according to 2-year data from the ASSERT trial.

"Previous studies have shown that spinal immobility is associated with functional disability, impaired quality of life, and loss of productivity," the authors wrote.

In the double-blind, Phase III trial, patients with active AS were randomized to receive infliximab 5 mg/kg (n=201) at weeks 0, 2, 6, and every 6 weeks thereafter, or placebo (n=78). At week 24, the placebo-treated patients crossed over to receive infliximab 5 mg/kg and continued to receive infliximab through week 96. At week 36, the patients originally randomized to receive infliximab who had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >3 at 2 consecutive visits had their dose increased to 7.5 mg/kg through week 96. All of the patients had a final evaluation at week 102.

Bath Ankylosing Spondylitis Metrology Index (BASMI) scores and chest expansion were measured to assess the patients' range of motion. Clinically meaningful improvement was defined as a change of >=1 in the BASMI score.

The patients who received infliximab had significantly greater improvements in BASMI scores relative to those who received placebo at week 24 (-0.7 vs -0.2, respectively; P=.02). Additionally, the infliximab-treated patients had significantly greater improvements in chest expansion relative to the placebo-treated patients at the same time point (mean change in chest expansion, 43.6% vs 18.7%; P=.03).

The patients who crossed over to infliximab had similar improvements in BASMI scores and chest expansion at weeks 54, 78, and 102 as compared with those originally randomized to receive infliximab.

Overall, the patients who received infliximab had a greater median improvement in the individual BASMI components (ie, cervical rotation, tragus-to-wall distance, lateral flexion, modified Schober's test, and intermalleolar distance) than did those who received placebo. These improvements were significantly correlated with improvement in BASMI score.

Further, 53% of the infliximab-treated patients achieved a clinically meaningful improvement in BASMI score compared with 31% of the placebo-treated patients who did so (P<.01). The infliximab-treated patients also maintained a gradual improvement in BASMI score and chest expansion after week 24, which was sustained at week 102. (Braun J, et al. Poster 1153.)

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