Study patients had moderate to severe knee or hip OA pain and no pain relief from, or experienced intolerance to, acetaminophen, oral non-steroidal anti-inflammatory drugs, tramadol or opioids. Patients were randomized to receive 2.5 mg or 5 mg of subcutaneous tanezumab or placebo at baseline and Weeks 8 and 16. Co-primary endpoints were the change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, WOMAC Physical Function and Patient Global Assessment of OA (PGA-OA) scores at Week 24. The study also assessed safety.
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Patients receiving 5 mg of subcutaneous tanezumab met all co-primary endpoints. Patients treated with 2.5 mg of tanezumab met WOMAC Pain and Physical Function endpoints, but not the PGA-OA endpoint.
Adverse events and adverse event discontinuations were similar in the groups. Serious adverse events occurred more frequently in tanezumab-treated patients than in placebo-treated patients. Two deaths occurred in the group taking 5 mg of tanezumab, but they were not deemed treatment related.
Total joint replacements occurred in 7% of patients in the 5 mg tanezumab group, 7.8% of patients in the 2.5 mg tanezumab group and 6.7% of patients in the placebo group. Total joint replacements were primarily seen as normal OA progression (58/79; 73.4%). Pre-specified joint safety events occurred in the tanezumab-treated patients, which included rapidly progressive OA, subchondral insufficiency fracture and primary osteonecrosis.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Berenbaum F, Blanco FJ, Guermazi A, et al. Subcutaneous tanezumab for osteoarthritis pain: A 24-week phase 3 study with a 24-week follow up (LB0007). Ann Rheum Dis. 2019 Jun. 78(suppl 2):A262.