Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
A Study of Tanezumab in Adults with Chronic Low Back Pain (NCT00876187).
Kivitz1, A., Gimbel2, Joseph, Bramson3, Candace, Nemeth3, Mary Ann, Keller4, David, Brown4, Mark T., West5, Christine R.
A randomized, double-blind, placebo (PBO)- and active-controlled phase 2 study was conducted to investigate the efficacy and safety of tanezumab (TNZ), a humanized monoclonal antibody that specifically inhibits nerve growth factor vs. naproxen (NAP) and PBO as analgesic treatment for chronic low back pain (LBP).
Patients with moderate to severe, chronic, non radiculopathic LBP, received TNZ (20, 10, or 5 mg IV every 8 weeks, and oral PBO), NAP (500 mg BID starting at randomization and TNZ vehicle IV), or PBO (TNZ vehicle IV and oral PBO). Patients recorded daily pain scores for average LBP Intensity (aLBPI; an 11-point numeric rating scale). Mean Changes from Baseline (MCB) to Week 16 in the daily aLBPI for TNZ vs. PBO and vs. NAP were primary efficacy endpoints. Key secondary efficacy endpoints were change from Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ; a measure of function used for LBP) and change from Baseline to Week 16 in the Patient Global Assessment (PGA) of LBP. Adverse event (AE) incidence was also assessed.
A total of 1347 patients were randomized and treated. TNZ 20 mg (MCB:-2.18; p<0.001), TNZ 10 mg (MCB:-2.06; p<0.001), and NAP (MCB:-1.66; p=0.037) but not TNZ 5 mg (MCB:-1.58; p=0.113) showed significant improvements in aLBPI versus PBO (MCB:-1.25) at Week 16. Improvements in aLBPI with TNZ 20 mg (p=0.006) and TNZ 10 mg (p=0.035) were also superior to NAP (Figure). Improvements in the RDMQ versus PBO (MCB:-1.75) were observed with TNZ 20 mg (MCB:-2.80; p=0.006) and TNZ 10 mg (MCB:-3.18; p<0.001) but not with TNZ 5 mg (MCB:-2.37; p=0.125) or NAP (MCB:-2.07; p=0.405). Improvements in the PGA versus PBO (MCB:-0.40) were seen with all TNZ treatments (MCB:-0.67, -0.65 and -0.58 by decreasing dose; p<=0.030), but not with NAP (MCB:-0.50; p=0.197). Additionally, both TNZ 20 mg and 10 mg treatment showed significant improvements in efficacy vs. NAP-treatment as measured by the RMDQ (p<= 0.042) and PGA (p<=0.038).
The overall incidence of AEs was similar among the TNZ treatment groups (range: 58.064.4%) but higher than the NAP (48.1%) and PBO (52.2%) treatment groups. The most common AE was paresthesia (TNZ 20 mg, 12.9%; 10 mg, 7.1%; and 5 mg, 4.7%; NAP, 1.7%; and PBO, 2.2%). The incidence of serious AEs was highest in the PBO group and the rate of discontinuation across all treatments was low. There were no reported cases of osteonecrosis or total joint replacement. The AE profile for the TNZ, NAP and PBO treatment groups was comparable to that of previous TNZ studies in patients with osteoarthritis and other conditions of chronic pain.
Treatment with TNZ (20 mg and 10 mg) resulted in superior analgesic efficacy and improvements in pain, function and global assessment as measured by the aLBPI, RDMQ and PGA compared to PBO and NAP treatment. Results indicate that TNZ is efficacious in the treatment of chronic LBP. No new safety signals were identified.
To cite this abstract, please use the following information:
Kivitz, A., Gimbel, Joseph, Bramson, Candace, Nemeth, Mary Ann, Keller, David, Brown, Mark T., et al; A Study of Tanezumab in Adults with Chronic Low Back Pain (NCT00876187). [abstract]. Arthritis Rheum 2011;63 Suppl 10 :741