HealthDay News — For patients with chronic low back pain, tanezumab 10 mg significantly improves pain and function, according to a study published online June 19 in PAIN.
John D. Markman, M.D., from the University of Rochester Medical Center in New York, and colleagues conducted a randomized trial to examine tanezumab in patients with chronic low back pain and a history of inadequate response to standard-of-care analgesics. Patients were randomly assigned to placebo, subcutaneous tanezumab (5 or 10 mg every eight weeks), or oral tramadol prolonged-release (100 to 300 mg/day) for 56 weeks followed by 24-week safety follow-up.
The researchers found that tanezumab 10 mg met the primary end point of significant improvement in low back pain intensity at week 16 versus placebo (least squares mean difference, −0.40; 95 percent confidence interval, −0.76 to −0.04; P = 0.0281). All secondary end points improved significantly with tanezumab 10 mg. Tanezumab 5 mg did not meet the primary end point (treatment difference versus placebo, −0.30; 95 percent confidence interval, −0.66 to 0.07; P = 0.111), and secondary end points were not tested formally. The proportion of patients with ≥50 percent improvement in low back pain intensity at week 16 was 37.4, 43.3, and 46.3 percent in patients who received placebo, tanezumab 5 mg, and tanezumab 10 mg, respectively (odds ratios versus placebo, 1.28 [95 percent confidence interval, 0.97 to 1.70; P = 0.0846] and 1.45 [95 percent confidence interval, 1.09 to 1.91; P = 0.0101], respectively).
“This demonstration of efficacy is a major breakthrough in the global search to develop nonopioid treatments for chronic pain,” Markman said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Pfizer and Eli Lilly, which manufacture tanezumab and funded the study.