Tanezumab reduces osteoarthritic knee pain: results of a randomized, double-blind, placebo-controlled phase iii trial
The Journal of Pain, 07/17/2012
Brown MT et al. – The tanezumab osteoarthritis (OA) clinical program is currently on clinical hold due to potential adverse reactions leading to joint replacement.Methods
- This was a 32–week, randomized, double–blind, placebo–controlled phase III trial.
- The patient criteria included diagnosis of OA; Western Ontario and McMaster Universities OA Index (WOMAC) Pain and Physical Function subscale scores of ≥5 and ≥4, respectively; Patient's Global Assessment of Osteoarthritis (PGA) ≥3; and failure of nonopiate pain medications or candidacy for invasive interventions.
- Patients received 3 intravenous doses of tanezumab (2.5, 5, or 10 mg) or placebo.
- The co–primary efficacy end points were changes in WOMAC subscales and PGA at week 16.
- Adverse events were monitored throughout.
- Overall, 690 patients (61% female) were randomized and treated.
- Those treated with tanezumab showed significant improvement in the 3 co–primary end points (P ≤ .015 for all).
- The incidence of adverse events was 55 to 60% for tanezumab–treated patients versus 48% for placebo–treated patients.
- Joint replacement was reported in 4 patients, 1 in each treatment group; a total of 5 joints were replaced (1 index knee and 4 hips).