Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial

研究概要

One thousand eight hundred twenty-five patients with chronic low back pain and inadequate response to at least three standard analgesic classes were randomized to receive subcutaneous tanezumab 5 mg (n=407), tanezumab 10 mg (n=407), oral tramadol (n=605), or placebo (n=406). The primary outcome of interest was the patient’s global assessment of low back pain (PGA-LBP). Secondary outcomes included the Brief Pain Inventory-short form (BPI-sf), Treatment Satisfaction Questionnaire for Medication (TSQM), and the modified Patient-Reported Treatment Impact (mPRTI). Outcomes were assessed at weeks 16 and 56. Overall, the results of the study revealed that tanezumab 10 mg provided significantly greater improvements over placebo in PGA-LBP, BPI-sf, and TSQM at week 16, while tramadol did not differ from placebo. These benefits were modestly maintained at week 56, though no significant differences were observed between tanezumab and tramadol. These findings suggest that tanezumab may provide clinically meaningful improvements in pain and function in select CLBP patients.