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| |  Biomarkers Provide Early Clues to Eventual Clinical Response to Infliximab Treatment of Ankylosing Spondylitis and Psoriatic Arthritis By Bruce Sylvester WASHINGTON, DC -- November 16, 2006 -- Infliximab (Remicade) appears to produce early changes in certain blood proteins, or biomarkers, that can help predict clinical response to treatment in patients with ankylosing spondylitis (AS) or psoriatic arthritis (PsA). This finding was presented here on November 14th at the American College of Rheumatology - Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR-ARHP). "We found that modulation of certain serum markers was associated with improvement in clinical response in both ankylosing spondylitis and psoriatic arthritis," said lead investigator Sudha Visvanathan, PhD, assistant director of clinical pharmacology and experimental medicine, Centocor Research and Development, Inc., Malvern, Pennsylvania. "This finding could help us identify much earlier those patients that will benefit from infliximab treatment." To study the effect of anti-tumor necrosis factor (TNF) therapy on inflammation and bone turnover, researchers compared clinical and biomarker responses in subjects with ankylosing spondylitis or psoriatic arthritis who had received 5 mg/kg of infliximab to responses in placebo subjects. The investigators used blood samples taken from 261 patients from the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT) and 107 patients from the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT II). They measured several biomarkers associated with inflammation, including interleukin-6 (IL-6), vascular endothelial growth factor (VEGF), C-reactive protein (CRP) and bone formation (bone alkaline phosphatase and osteocalcin). Results show that infliximab significantly reduced IL-6 and VEGF levels within 2 weeks in patients with both diseases compared with placebo. This early significant clinical reduction (by week 2) in IL-6 in infliximab subjects correlated to improvement in clinical response measures - 20% in the Assessment of Ankylosing Spondylitis and 20% improvement using ACR criteria for psoriatic arthritis -- at 14 or 24 weeks. Likewise, decreases in CRP seen at weeks 14 or 24 correlated with improvement in clinical response to treatment with infliximab. Baseline VEGF values were associated significantly with clinical response measures in patients receiving placebo treatment. "The findings suggest that IL-6 may be a good, early indicator of improvement in response to infliximab treatment for potentially debilitating and progressive diseases like ankylosing spondylitis and psoriatic arthritis," Dr. Visvanathan added. The study was supported by Centocor.
[Presentation title: Comparison of the Effect of Infliximab on Inflammation and Bone Formation Biomarkers and Associations With Clinical Response in Ankylosing Spondylitis and Psoriatic Arthritis. Abstract 2016]
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