AI Article Synopsis

  • A phase 3 clinical trial evaluated the effectiveness of tanezumab (10 mg) in patients with chronic low back pain (CLBP) who didn’t respond well to standard treatments, showing significant improvements in pain and overall treatment satisfaction compared to a placebo over 56 weeks.
  • Participants received different treatments including tanezumab (5 mg and 10 mg), tramadol, or a placebo, with assessments looking at pain levels and quality of life at weeks 16 and 56.
  • Results showed that while tanezumab improved pain and satisfaction significantly at week 16 compared to placebo, the benefits were slightly less at week 56, and tramadol did not provide significant advantages over placebo.

Article Abstract

Introduction: A recent phase 3, randomized, placebo- and tramadol-controlled trial (56-week treatment/24-week safety follow-up) demonstrated efficacy of tanezumab 10 mg 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.

Methods: Patients received placebo (up to week 16; n = 406), subcutaneously administered (SC) tanezumab 5 mg (every 8 weeks; n = 407), SC tanezumab 10 mg (every 8 weeks; n = 407), or orally administered tramadol prolonged-release (100-300 mg/day; n = 605) for 56 weeks. 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.

Results: At week 16, significant (p < 0.05) improvements over placebo were evident with tanezumab for the PGA-LBP (10 mg) 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 week 56. However, the magnitude of improvements was modestly lower at week 56 relative to week 16. Tramadol did not improve PGA-LBP or BPI-sf scores versus placebo at week 16. Most differences between tanezumab and tramadol at week 56 did not reach the level of statistical significance for all endpoints.

Conclusions: 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.

Clinicaltrials: gov: NCT02528253.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9633876PMC
http://dx.doi.org/10.1007/s40122-022-00424-7DOI Listing

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