AUSTIN, TX—Fulranumab, an investigational human recombinant monoclonal antibody (IgG2) to human nerve growth factor (NGF), improved pain and functioning in patients with inadequately controlled moderate-to-severe osteoarthritis pain of the hip and knee, according to results presented reported during the American Pain Society’s 30th Annual Scientific Meeting. Impact of pain relief on patient-reported functioning, activities, and sleep was also evaluated in the 12-week efficacy phase of this ongoing phase 2 randomized trial.
The 133-week, double-blind, placebo-controlled trial is designed to assess the analgesic efficacy and tolerability of fulranumab in addition to a patient’s current pain therapy, noted Susan Vallow, RPh, MBA, of Janssen Global Services, Raritan, NJ, and colleagues. Patients aged 40 to 80 years were randomized to 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). Patients completed the SF-36, Brief Pain Inventory-Short Form (BPI), and MOS Sleep Scale (MOS-SS) at baseline and 12-week endpoint. Patients also answered a daily question on pain interference with sleep. A total of 466 patients were enrolled in the study; 58% were women, 85% were white, and mean age was 61 years.
At Week 12, most SF-36 subscales, including physical functioning, improved; significant improvements vs. placebo were noted for the Bodily Pain subscale (3mg q4wk and 10mg q8wk groups; P<0.04), Vitality Subscale (3mg q4wk, 3mg q8wk, 6mg q8wk and 10mg q8wk groups; P<0.04), and Physical Component Subscale (10mg q8wk group; P=0.01).
Compared with placebo, fulranumab significantly improved the BPI Pain Intensity Subscales and Pain Interference with Activities subscale scores (3mg q4wk and 10mg q8wk groups; P<0.05). Fulranumab 3mg q4wk, 3mg q8wk, and 10mg Q8wk also significantly improved pain interference with sleep vs. placebo (P<0.05) Sleep Adequacy (MOS-SS) improved across fulranumab groups vs placebo (P<0.05).
The investigators concluded that fulranumab improved vitality and degree to which pain interfered with activities of daily living and sleep, areas often affected in patients with moderate-to-severe osteoarthritis pain. This study was funded by Johnson & Johnson Pharmaceutical Research & Development, LLC.
NOTE: On December 23, 2010, the U.S. Food and Drug Administration put all trials of fulranumab on clinical hold due to concerns of possible increased risk of osteonecrosis and/or rapid progression of osteoarthritis associated with the anti-NGF drug class.