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| |  Tanezumab Appears Effective in Relieving Chronic Low Back Pain Compared With Placebo: Presented at APS By Kristina Rebelo SAN DIEGO -- May 15, 2009 -- Compared with placebo, tanezumab provides statistically significant and clinical meaningful effects in patients with persistent low back pain (LBP), researchers stated here at the 28th Annual Scientific Meeting of the American Pain Society (APS). Study results, presented on May 8, showed that a single intravenous (IV) infusion of tanezumab was significantly superior to naproxen and placebo in its analgesic efficacy in patients with LBP over a 12-week period, and had an acceptable safety profile. Nathaniel Katz, MD, Analgesic Research, Needham, Massachusetts, and Tufts University School of Medicine, Boston, Massachusetts, and colleagues enrolled patients with chronic nonradiculopathic LBP for more than 3 months prior to screening that required regular analgesic medication use. The primary location for patients' LBP was between the twelfth thoracic vertebra and the lower gluteal folds. The pain was classified by the Quebec Task Force in Spinal Disorders as Category 1 or 2, corresponding to pain without radiation or pain with proximal radiation. Patients were randomised to 1 of 3 groups: (1) tanezumab 200 mcg/kg IV and an oral placebo on day 1 (n = 88); (2) placebo IV and oral naproxen 500 mg BID, days 1-85 (n = 88); or (3) IV and oral placebo (n = 41). The primary outcome was average Low Back Pain Intensity (aLBPI; scale of 0-10) scores at week 6. Secondary outcomes included treatment response (>=30% or >=50% reduction in aLBPI) and Roland-Morris Disability Questionnaire score (RMDQS). Mean baseline characteristics were similar across groups (aged 50-52 years; aLBPI 6.5-6.7). Using a predefined repeated measures analysis, mean change in aLBPI from baseline to week 6 was greater with tanezumab (-3.37) versus naproxen (-2.54; P = .004) and placebo (-1.96; P < .001). Tanezumab was associated with significant improvements in >=50% treatment response (57%) versus naproxen (34%; P = .002) and placebo (20%; P < .001), and in RMDQS (-7.70) versus naproxen (-4.69; P < .001) and placebo (-3.93; P < .001).
Study medications were well tolerated with few patients discontinuing the study due to adverse events (AEs). AEs did cause the discontinuation of 4.5% of patients in the tanezumab group; 3.4% of patients in the naproxen group; and 4.9% of patients in the placebo group. Altered peripheral sensation AEs were reported in 11.4% (tanezumab); 3.4% (naproxen); and 2.4% (placebo) of patients. One patient in the tanezumab group had an AE of peripheral neuropathy and hyperesthesia; however, both resolved before the end of the study. This patient was examined by a consulting neurologist who found no evidence of peripheral neuropathy. Funding for this study was provided by Pfizer, Inc. [Presentation title: Tanezumab, an Anti-Nerve Growth Factor (NGF) Antibody, for the Treatment of Chronic Low Back Pain (CLBP) -- A Randomized, Controlled, Double-Blind, Phase 2 Trial. Abstract 227]
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