Article of the month by Dr David Burke
Tanezumab is a neurotrophin nerve growth factor (NGF) monoclonal antibody created as an alternative to nonsteroidal anti-inflammatory drugs for the treatment of osteoarthritis (OA). This study compared the long-term effects of tanexumab and NSAIDs.
This phase three randomized double-blind study was conducted at 446 sites in four continents. The subjects were adults with a clinical diagnosis of hip/knee OA in the index/most painful joint. All were required to have received a stable dose of an oral NSAID for at least 30 days. All subjects received a stable open label oral NSAIDs (naproxen 500 mg twice daily, celecoxib 100 mg twice daily, or diclofenac extended release 75 mg twice daily) for at least the last two weeks. They were then randomized to receive oral NSAIDs twice per day, or tanezumab 2.5 mg SC or tanezumab 5 mg SC every eight weeks. The efficacy endpoints at week 16 were changes in WOMAC pain and physical function scores, and changes in the patient global assessment (PtGA). The primary safety outcomes included a worsening of K/L grade, or a significant decline in joint space width or abnormal bone loss or destruction.
Data were completed for 2996 patients. At week 16, compared to those receiving NSAIDs those treated with tanezumab 5mg had significantly better WOMAC pain and function scores (p=0.015 and p=0.003 respectively), but not better PtGA scores. The proportions of patients who received at least a 50% reduction from baseline in the WOMAC pain scores at week 16 were 54.9%, 56.5% and 51.5% in the tanezumab 2.5mg, tanezumab 5mg and the NSAID group respectively. Composite joint safety events were significantly more prevalent in the tanezumab than in the NSAID group (p = 0.001 for tanezumab 2.5 mg versus NSAIDs; p< 0.001 for tanezumab 5 mg versus NSAIDs).
Conclusion: This study of patients with osteoarthritis found that treatment with subcutaneous tanezumab resulted better pain relief ,but also in more joint safety events.
Hochberg, M et al., Long-Term Safety and Efficacy of Subcutaneous Tanezumab versus Nonsteroidal Anti-Inflammatory Drugs for Hip or Knee Osteoarthritis: A Randomized Trial. Arthritis and Rheumatology. 2021, July; 73 (7): 1167–1177.