Abstract Details

Title Subcutaneous Tanezumab Versus Tramadol for Chronic Low Back Pain: Efficacy and Safety Results from a 56-Week Phase 3 Study with a 24-Week Follow Up Period

Topic Pain

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 6-008

Objective

Assess efficacy and safety of tanezumab in patients with chronic low back pain (CLBP) and history of inadequate response or intolerance to standard-of-care analgesics.

Background Tanezumab, a monoclonal antibody against nerve growth factor, is in development for treatment of chronic pain.

Design/Methods

In this randomized double-blind trial, patients received placebo, subcutaneous tanezumab (5mg or 10mg every 8 weeks), or oral tramadol prolonged-release (100-300mg/day). At week 16, patients receiving placebo were switched (1:1) to tanezumab 5 or 10mg. Efficacy (Low Back Pain Intensity [LBPI] and Roland Morris Disability Questionnaire [RMDQ]) was assessed through week 56. Safety, including joint safety, was assessed through week 80. Week 56 data is presented here; week 16 data is presented in our companion abstract.

Results Improvements in LBPI and RMDQ, relative to baseline and tramadol, were maintained throughout the study but were not significantly better than tramadol (N=605; mean dose=209mg/day) at week 56 for tanezumab 5mg (N=407; LS mean [95% CI] difference= -0.11 [-0.51,0.28] for LBPI and -0.44 [-1.47,0.58] for RMDQ) or 10mg (N=407; LS mean [95%] difference= -0.21 [-0.61,0.18] for LBPI and -0.83 [-1.84,0.18] for RMDQ). Adverse event (AE) rates through week 56 were 58.3%, 63.7%, and 65.4% in the tanezumab 5mg (N=506), tanezumab 10mg (N=502), and tramadol (N=602) groups, with treatment discontinuation rates of 6.7%, 7.4%, and 10.5%, respectively. Rapidly progressive osteoarthritis occurred in 1.4% (type 1 n=12; type 2 n=2) and 0.2% (type 1 n=1) of tanezumab- and tramadol-treated patients, respectively. Subchondral insufficiency fracture and total joint replacement occurred in 0.4% (n=4) and 0.7% (n=7) of tanezumab-treated patients; none with tramadol. No joint safety events occurred with placebo.

Conclusions

Improvements in pain and function with tanezumab were maintained long-term, but were not significantly better than tramadol at week 56. AE-related treatment discontinuations were more frequent with tramadol; joint safety events were more frequent with tanezumab.

Authors/Disclosures
John Markman, MD, FAAN (Eli Lilly) PRESENTER	Dr. Markman has received personal compensation for serving as an employee of Eli LIlly.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Lars Viktrup	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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