1. In this randomized controlled trial, subcutaneous tanezumab resulted in moderate improvements in joint pain and physical function for patients with osteoarthritis compared to placebo.
2. Tanezumab-treated patients had more adverse events and more joint replacements.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Nerve growth factor (NGF) is involved in pain signaling during osteoarthritis (OA), and tanezumab is an IgG2Δa monoclonal antibody that inhibits NGF binding to its receptors. While tanezumab may reduce pain in OA, smaller studies have reported an increase in adverse effects, such as paresthesias. In this randomized controlled trial of OA patients that had failed or could not take standard pharmacological treatments, tanezumab slightly reduced pain and improved function over 16 weeks compared to placebo. However, there was a higher rate of adverse effects and more joint replacements in the tanezumab-treated groups.
Though the findings suggest certain patients may benefit from tanezumab as a second line agent, this study has several limitations. First, the study length was too short to assess the long-term efficacy of tanezumab for chronic OA pain. Second, the estimates of adverse event rates, especially for joint safety events, would be more precise with a much larger treatment population.
Relevant Reading: What is new in pain modification in osteoarthritis?
In-Depth [randomized controlled trial]: This was a randomized, double-blind, placebo-controlled, multicenter, parallel-group, dose-titration study (16-week treatment period, 24-week follow-up period) assessing the efficacy and adverse event profile of subcutaneous tanezumab in patients with moderate to severe hip or knee OA. This study had 698 patients drawn from 89 clinical research sites in the United States, Canada, and Puerto Rico. Patients were randomized to 1 of 3 subcutaneous treatment regimens: tanezumab, 2.5 mg at baseline and week 8 (ie, tanezumab, 2.5 mg); tanezumab, 2.5 mg at baseline and 5 mg at week 8 (ie, tanezumab, 2.5/5 mg); and placebo at baseline and week 8. Least squares mean differences vs placebo were as follows: index joint Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain scores were −0.60 (CI95 −1.07 to −0.13) for tanezumab, 2.5 mg, and −0.73 (CI95 −1.20 to −0.26;) for tanezumab, 2.5/5 mg; WOMAC Physical Function scores were –0.66 (CI95 −1.14 to −0.19) for tanezumab, 2.5 mg, and −0.89 (CI95, −1.37 to −0.42) for tanezumab, 2.5/5 mg; and patient global assessment of osteoarthritis (PGA-OA) scores were –0.22 (CI95 −0.39 to −0.05) for tanezumab, 2.5 mg, and −0.25 (CI95 −0.41 to −0.08) for tanezumab, 2.5/5 mg. During the study, 55.4%, 46.8%, and 49.6% of patients experienced a treatment-emergent AE in the tanezumab, 2.5 mg; tanezumab, 2.5/5 mg; and placebo groups, respectively. More patients in the tanezumab 2.5mg (3.5%) and 2.5/5mg (6.9%) groups need total joint replacements than in placebo (1.7%).
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