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| |  Tanezumab Combats Chronic Osteoarthritic Knee Pain: Presented at WCP By Sara Freeman GLASGOW, United Kingdom -- August 25, 2008 -- Tanezumab is well tolerated and provides effective relief of moderate-to-severe chronic pain due to knee osteoarthritis (OA), researchers reported here at the 12th World Congress on Pain (WCP). Tanezumab is a humanised, monoclonal antibody that targets nerve growth factor (NGF), a protein vital for new nerve growth after injury. NGF is involved in the survival and differentiation of sensory and sympathetic neurons, and evidence suggests that it could be involved in the development of chronic pain in several conditions, including OA of the knee. "Chronic joint pain is the principal patient complaint in OA, but many patients have poor tolerability or response to current therapies," said Thomas J. Schnitzer, Northwestern University of Feinberg School of Medicine, Chicago, Illinois, and colleagues. The randomised, double-blind, placebo-controlled, phase 2 clinical trial, presented on August 19, assessed the safety and efficacy of tanezumab in patients with knee OA who had not fully responded to other analgesic or nonopioid pain killers. After a 3-day wash-out period, 450 patients were randomised (75 in each arm of the study) to receive placebo or 1 of 5 doses of tanezumab (10, 25, 50, 100, or 200 mcg/kg). Tanezumab was given by intravenous injection on days 1 and 56. Patients were followed for 16 weeks. They were also offered the option of enrolling in an open-label extension phase for a further 10 weeks. Compared with placebo-treated patients, patients treated with tanezumab experienced significantly less knee pain on walking. The mean change in walking pain in the affected knee from baseline to week 16 was a decrease of 15.5% in the placebo group and a decrease of 32.1% in the group given tanezumab 10 mcg/kg (P < .001). Similar improvements over placebo were observed with the 25-, 50-, 100-, and 200-mcg/kg doses of the drug, at -36%, -31%, -42.5%, and -45.2%, respectively (all P < .001). Tanezumab was also found to result in significantly better scores on the Subject Global Assessment of therapy compared with placebo, as well as scores on the Western Ontario and McMaster Universities Osteoarthritis Index for the pain, stiffness, and physical function subscales. Use of rescue medications was reduced with the active treatment from 83.6% in the placebo group to 72.8% in the overall tanezumab group (P = .053). Headache, upper respiratory tract infection, and paraesthesia were the 3 most commonly reported adverse effects associated with tanezumab use, reported by 8.9%, 7.3%, and 6.8% of patients, respectively. "Adverse events caused discontinuation of 5.9% of tanezumab-treated patients," but no placebo-treated patient withdrew for this reason, the researchers said. Nevertheless, they concluded that tanezumab is well tolerated and "may be an effective treatment option for the management of pain related to OA of the knee." Funding for this study was provided by Pfizer Inc. [Presentation title: Efficacy and Safety of Tanezumab (PF04383119), an Anti-Nerve Growth Factor (NGF) Antibody, for Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee: A Randomized Trial. Abstract PT214]
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