Tanezumab reduced pain, increased function in patients with hip OA
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Researchers found tanezumab was effective in treating patients with hip osteoarthritis compared to placebo, although they observed higher adverse event rates in the tanezumab group in a double-blind, placebo-controlled phase 3 trial that lasted 32 weeks.
“Tanezumab treatment provided superior pain relief, improvement in physical function and [Patients’ Global Assessment] PGA vs. placebo in patients with painful hip [osteoarthritis] OA, and was generally well-tolerated in this study,” Mark T. Brown, MD, and colleagues wrote in their study abstract.
The researchers randomly treated 621 patients with 2.5-mg, 5-mg, 10-mg of intravenous tanezumab or placebo at baseline and weeks 8 and 16 of the study. They used the WOMAC and PGA scores at those time periods to determine if the patients improved. Brown and colleagues found significant improvements in pain and function in the tanezumab group; however, the frequency of adverse events (AEs) they reported was higher in the tanezumab group (55% to 58%) than the placebo group (44%).
“The tanezumab OA clinical program was temporarily placed on hold because of AEs leading to joint replacement,” the investigators wrote.
One patient in the 10-mg tanezumab group, two patients in the 5-mg tanezumab group, two patients in the 2.5-mg tanezumab group and three patients randomized to placebo treatment underwent total joint replacements due to AEs. In all, eight hips and one shoulder of patients in the study were ultimately replaced with a prosthesis, according to the results.