A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip

BACKGROUND: Chronic pain due to osteoarthritis (OA) causes considerable burden, and current treatment options are limited. This phase III study aimed to compare the efficacy and safety of fasinumab, an investigational, anti-nerve growth factor monoclonal antibody, with placebo and naproxen in patients with moderate-to-severe pain due to OA of the knee or hip. METHODS: Patients with difficult-to-treat OA were randomised 3:3:3:1 to fasinumab 1 mg subcutaneous (SC) every 4 weeks (Q4W), fasinumab 1 mg SC every 8 weeks (Q8W), naproxen 500 mg orally two times a day or placebo. The co-primary endpoints were changes in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain and physical function subscale scores (0-10) from baseline to week 16 for fasinumab versus placebo; comparison with naproxen was a secondary endpoint. Safety was also assessed. RESULTS: Of 3307 patients randomised, 1801 were included in the analysis for efficacy, and 3014 were included in the safety analysis. Statistically significantly greater reductions in the WOMAC pain and physical function scores, respectively, at week 16 were seen for fasinumab 1 mg Q4W (-2.90 and -2.78) compared with placebo (-2.32 and -2.10) and naproxen (-2.61 and -2.41); all p