Disclosures: John Markman: Allergan: Other Financial or Material Support, Data Safety Monitoring Board
Aptinyx: Consultant/Advisory Board
Biogen: Consultant/Advisory Board
Chomocell: Consultant/Advisory Board
Clexio Bioscience: Consultant/Advisory Board
Collegium: Consultant/Advisory Board
Daiichi Sankyo: Consultant/Advisory Board
Depomed: Consultant/Advisory Board
Editas Medicine: Consultant/Advisory Board
Eli Lilly: Consultant/Advisory Board
Flexion Therapeutics: Consultant/Advisory Board
Grunenthal: Consultant/Advisory Board
Inspirion: Consultant/Advisory Board
Kempharm: Consultant/Advisory Board
Nektar: Consultant/Advisory Board
Novartis: Data Safety Monitoring Board
Pfizer: Consultant/Advisory Board
Plasma Surgical: Consultant/Advisory Board
Purdue: Consultant/Advisory Board
Quark: Consultant/Advisory Board
Quartet Medicine: Consultant/Advisory Board
Teva: Consultant/Advisory Board
Trevena: Consultant/Advisory Board
Trigemina: Consultant/Advisory Board
Vertiflex: Consultant/Advisory Board

Objective: Assess the efficacy and safety of subcutaneous tanezumab for Chronic Low Back Pain (CLBP).

Design: Randomized, double-blind, 80-week (56-week treatment; 24-week follow up) trial.

Setting: Multi-center.

Participants: Patients with CLBP and history of inadequate response or intolerance to standard of care analgesics.

Interventions: Placebo (N=409), subcutaneous tanezumab (5 mg [N=407] or 10 mg [N=407] every 8 weeks), or oral tramadol prolonged release (100-300 mg daily; N=602).

Main Outcome Measures: Change in low back pain intensity (LBPI) and Roland Morris Disability Questionnaire (RMDQ) scores were assessed at week 16. Safety, including joint safety, was assessed through week 80.

Results: Compared with placebo, tanezumab 10 mg significantly improved LBPI (primary endpoint; LS mean [95% CI] difference = -0.40 [-0.76, -0.04]; P=.0281) and RMDQ (key secondary; LS mean [95% CI] difference = -1.74 [-2.64, -0.83]; P=.0002) at week 16. Changes in LBPI with tanezumab 5 mg were not significant versus placebo (LS mean [95% CI] difference = -0.30 [-0.66, 0.07]; P=.1117). Although mean changes in RMDQ were larger with tanezumab 5 mg than placebo (LS mean [95% CI] difference = -1.32 [-2.21, -0.43]; P=.0035), superiority could not be concluded per the pre-defined testing strategy. Changes in LBPI and RMDQ with tramadol (mean dose=203 mg/day) were not significant versus placebo. Changes in LBPI for both tanezumab groups were not significant versus tramadol. Both tanezumab groups significantly improved RMDQ compared with tramadol (unadjusted for multiplicity). Adverse event rates through 16 weeks were 46.2%, 46.9%, 51.8%, and 56.3% in the placebo, tanezumab 5 mg, tanezumab 10 mg, and tramadol groups, resulting in treatment discontinuation rates of 3.9%, 4.4%, 4.7%, and 8.5%, respectively.

Conclusions: Tanezumab 10 mg significantly improved pain and function at week 16 versus placebo, while tramadol did not. Frequency of AEs and treatment discontinuations due to AEs in both tanezumab groups were lower than tramadol, but higher than placebo.

Level of Evidence: Level I

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/subcutaneous-tanezumab-versus-placebo-or-tramadol-in-patients-with-chronic-low-back-pain-16-week-efficacy-and-safety-results-from-a-phase-3-study/