Impact of pain relief with fulranumab in the treatment of patients with moderate to severe osteoarthritis pain

Chronic pain impacts many aspects of patients’ lives, including their ability to perform daily activities and obtain adequate sleep. Fulranumab, a human recombinantmonoclonal antibody to human nerve growth factor, is being investigated for chronic pain treatment. Impact of pain relief on patient-reported functioning, activities and sleep was evaluated during the 12-week efficacy phase of an ongoing 104-week, phase 2, double-blind, placebo-controlled trial designed to assess fulranumab’s analgesic efficacy and tolerability, in addition to current pain therapy, in patients with inadequately controlledmoderate-tosevere osteoarthritis pain (hip and knee). Randomized patients received subcutaneous injections in one of six groups: placebo, fulranumab 1mg or 3mg every 4 weeks (Q4wk), or fulranumab 3mg, 6mg, or 10mg every 8 weeks (Q8wk). The SF-36, Brief Pain Inventory-Short Form (BPI), and MOS Sleep Scale (MOS-SS) were completed at baseline and endpoint (12 weeks). Patients also answered a daily question on pain interference with sleep. Primary efficacy and detailed safety results are presented elsewhere. Patients (N=466, intent-to-treat) were 58%women, 85%white, age 61 years. Most SF-36 subscales, including physical functioning, improved: significant improvements versus placebo occurred for Bodily Pain subscale (3mgQ4wk and 10mgQ8wk groups; p<0.04), Vitality Subscale (3mgQ4wk, 3mgQ8wk, 6mgQ8wk and 10mgQ8wk groups; p<0.04), and Physical Component Subscale (10mgQ8wk group; p=0.01). Fulranumab, significantly (p<0.03 versus placebo) improved the BPI Pain Intensity Subscales and Pain Interference with Activities subscale scores (3mgQ4wk and 10mgQ8wk groups). Fulranumab 3mgQ4wk, 3mgQ8wk, and 10mgQ8wk also significantly (p<0.05 versus placebo) improvedpain interferencewith sleep. SleepAdequacy (MOS-SS) improved across fulranumab groups (p<0.03 versus placebo). Fulranumab, in addition to improving pain, improved functioning, vitality and the degree to which pain interfered with activities of daily living and sleep, areas often impacted in patients with moderate-to-severe osteoarthritis pain. Funded by Johnson & Johnson Pharmaceutical Research & Development, LLC.