Abstract
A recent phase3, randomized, placebo- and tramadol-controlled trial (56-week treatment/24-week safety follow-up) demonstrated efficacy of tanezumab 10mg in patients with chronic low back pain (CLBP) and a history of inadequate response to standard-of-care analgesics. Here, we report on the clinical meaningfulness of treatment response in this study, focused on secondary measures of pain, interference with daily functions, overall disease status, and satisfaction with treatment. Patients received placebo (up to week16; n = 406), subcutaneously administered (SC) tanezumab 5mg (every 8weeks; n = 407), SC tanezumab 10mg (every 8weeks; n = 407), or orally administered tramadol prolonged-release (100-300mg/day; n = 605) for 56weeks. Patient's global assessment of low back pain (PGA-LBP), Brief Pain Inventory-short form (BPI-sf), Treatment Satisfaction Questionnaire for Medication (TSQM), and modified Patient-Reported Treatment Impact (mPRTI) were assessed at weeks 16 and 56. At week16, significant (p < 0.05) improvements over placebo were evident with tanezumab for the PGA-LBP (10mg) and most BPI-sf (both doses), TSQM (both doses), and mPRTI (both doses) items assessed. Improvements over baseline persisted for the PGA-LBP and BPI-sf at week56. However, the magnitude of improvements was modestly lower at week56 relative to week16. Tramadol did not improve PGA-LBP or BPI-sf scores versus placebo at week16. Most differences between tanezumab and tramadol at week56 did not reach the level of statistical significance for all endpoints. The totality of the evidence as captured by measures of pain, interference with daily function, patient overall assessment of disease status, and satisfaction with treatment demonstrates the clinically meaningful benefit of tanezumab for some patients with CLBP compared with placebo. gov: NCT02528253.
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