Tanezumab reduces pain intensity, improves daily function in patients with chronic low back pain
Treatment with tanezumab, a monoclonal antibody against nerve growth factor, significantly reduces pain intensity and improves daily function in patients with chronic low back pain, according to a trial presented at EULAR 2020.
This phase III trial included patients with chronic low back pain who were randomly assigned to receive placebo (n=409; mean age 49.0 years), subcutaneous tanezumab 5 mg (n=407; mean age 48.7 years) or 10 mg (n=407; mean age 49.1 years) every 8 weeks, or oral tramadol prolonged-release 100–300 mg/day (n=602; mean age 48.4 years). Brief Pain Inventory-short form (BPI-sf) scores were used to assess the severity of pain and impact on daily function at week 16. [EULAR 2020, abstract OP0090]
At baseline, mean BPI-sf average pain scores were 7.00 and 6.88 for the tanezumab 5 and 10 mg groups, respectively, and 6.95 and 6.97 for the placebo and tramadol groups, respectively.
At week 16, patients who received tanezumab 5 or 10 mg had significant improvements from baseline in BPI-sf scores for average pain compared with those who received placebo (least squares [LS] mean difference, -0.37; p=0.04 for 5 mg or -0.46; p≤0.01 for 10 mg).
Patients treated with tanezumab 5 or 10 mg also reported significant improvements in worst pain (LS mean difference, -0.52 and -0.54, respectively; p≤0.01 for both) and pain interference index scores (LS mean difference, -0.41; p=0.03 and -0.58; p≤0.01) at week 16 compared with placebo.
Greater improvements were also seen across all BPI-sf domains of daily function with tanezumab 10 mg compared with placebo or tramadol. These included general activity (-3.35 vs -2.70 or -2.89; p<0.05), walking ability (-3.15 vs -2.55 or -2.68; p<0.05), sleep (-3.44 vs -2.92 or -3.00; p<0.05), and normal work (-3.33 vs -2.64 or -2.87; p<0.05).
Patients treated with tanezumab 5 mg also demonstrated significant improvements vs placebo in terms of general activity (-3.20 vs -2.70; p<0.05), sleep (-3.88 vs -2.92; p<0.05), and normal work (-3.15 vs -2.64; p<0.05).
The researchers found no statistically significant differences between the tramadol and placebo treatment groups with regard to any BPI-sf domains of daily function.
According to study investigator Dr Serge Perrot from Paris Descartes University in Paris, France, patients in this study “had no, or minimal, clinical and radiographic evidence of osteoarthritis in the knees, hips, and shoulders.”
“[These findings showed that,] after 16 weeks, [treatment with] tanezumab 5 or 10 mg led to significant improvements in worst pain, average pain, and overall pain interference index compared with placebo in patients with chronic low back pain,” he said.