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: To assess efficacy and safety of subcutaneous tanezumab versus tramadol for Chronic Low Back Pain (CLBP).

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

Setting: Multi-center.

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

Interventions: Placebo, subcutaneous tanezumab (5mg or 10mg every 8 weeks), or oral tramadol prolonged release (100-300 mg daily). At week 16, patients receiving placebo were switched (1:1) to tanezumab 5 or 10mg.

Main Outcome Measures: Low back pain intensity (LBPI) and Roland Morris Disability Questionnaire (RMDQ) were assessed at week 56. Safety, including pre-specified joint safety events, was assessed through week 80.

Results: Improvements in LBPI and RMDQ, relative to baseline and tramadol, were maintained throughout the study but were not significantly better than tramadol (N=605; mean dose=209mg/day) at week 56 for tanezumab 5mg (N=407; LS mean [95% CI] difference = -0.11 [-0.51,0.28] for LBPI and -0.44 [-1.47,0.58] for RMDQ) or 10mg (N=407; LS mean [95%] difference = -0.21 [-0.61,0.18] for LBPI and -0.83 [-1.84,0.18] for RMDQ). Adverse event (AE) rates through week 56 were 58.3%, 63.7%, and 65.4% in the tanezumab 5mg (N=506), tanezumab 10mg (N=502), and tramadol (N=602) groups, resulting in treatment discontinuation rates of 6.7%, 7.4%, and 10.5%, respectively. Rapidly progressive osteoarthritis occurred in 1.4% (type 1 n=12; type 2 n=2) and 0.2% (type 1 n=1) of tanezumab- and tramadol-treated patients, respectively. Subchondral insufficiency fracture and total joint replacement occurred in 0.4% (n=4) and 0.7% (n=7) of tanezumab-treated patients; none with tramadol. No joint safety events occurred with placebo.

Conclusions: Improvement in pain and function with tanezumab was maintained long-term but was not significantly better than tramadol at week 56. AE-related treatment discontinuations were more frequent with tramadol; joint safety events were more frequent with tanezumab.

Level of Evidence: Level I

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/subcutaneous-tanezumab-versus-tramadol-for-chronic-low-back-pain-efficacy-and-safety-results-from-a-56-week-phase-3-study-with-a-24-week-follow-up-period/