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Tanezumab 10 mg subcutaneously considerably decreased
pain following 16 weeks of therapy in patients with difficult-to-treat chronic
low back pain.
According to a recent randomized, double-blind, phase 3 study (56-week treatment; 24-week follow-up) published in ‘PAIN’ journal, the use of tanezumab was linked with a low rate of joint safety events, a few needing joint replacement.
This study aimed to evaluate tanezumab in patients suffering from chronic low back pain (CLBP) and past inappropriate response to analgesics. The patients under consideration were given tanezumab 5 or 10 mg every 8 weeks subcutaneously (SC), tramadol prolonged-release 100-300 mg/day in an oral formulation. At week 16, the primary endpoint was considered as the variation in low back pain intensity (LBPI) with tanezumab versus placebo.
Percentage of patients with ≥50% reduction in LBPI,
variation in Roland Morris Disability Questionnaire, and change in LBPI at week
2 for tanezumab contrasted with placebo was regarded as the secondary
endpoints. Through weeks 56 and 80, the adverse events and joint safety were
evaluated.
At week 16, tanezumab 10 mg fulfilled primary endpoint by
considerably improving LBPI than with placebo. All secondary endpoints improved
significantly with tanezumab 10 mg. Percentage of patients with ≥50%
improvement in LBPI was more in tanezumab 10 mg group at week 16. Also,
pre-specified joint safety events were more common with tanezumab 10 mg dose (Table 1).
Total joint replacement was undertaken by 7 (1.4%) patients in the tanezumab 10 mg group.
The 10 mg dosage of tanezumab significantly improved pain and function better as compared to placebo in patients suffering from CLBP, as concluded.
PAIN
Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety
Markman, John D. et al.
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