Categories
Change Password!
Reset Password!
10 mg Tanezumab may offer significant benefits to some individuals with moderate to severe chronic low back pain.
According to the analysis of a Phase 3 trial, Tanezumab displayed remarkable improvements over placebo for most measures of pain, interference with daily activities, and therapy satisfaction after 16 weeks of therapy, while alteration in pain and interference with daily functions with Tramadol was not considerably distinct from placebo. Tanezumab's effects may sustain up to 56 weeks in people with chronic low back pain (CLBP).
A previous 56-Week, randomized, placebo- and Tramadol-controlled, Phase 3 trial showed effectiveness of 10 mg Tanezumab in CLBP patients and a past history of unsatisfactory response to standard-of-care analgesics. The goal of John D. Markman et al. was to report on clinical meaningfulness of therapeutic response in this study, focused on secondary outcomes of pain, hindrance with daily functions, overall disease status, and treatment satisfaction.
For 56 weeks, patients were given either placebo (up to week 16; n = 406), 5 mg Tanezumab administered subcutaneously (every 8 weeks; n = 407), subcutaneously 10 mg Tanezumab (every 8 weeks; n = 407), or oral Tramadol prolonged-release (100-300 mg/day; n = 605). At weeks 16 and 56, evaluation of the Patient's global assessment of low back pain (PGA-LBP), the Brief Pain Inventory-short form (BPI-sf), the Treatment Satisfaction Questionnaire for Medication (TSQM), and the modified Patient-Reported Treatment Impact (mPRTI) was done.
For the PGA-LBP (10 mg) and the majority of the BPI-sf (both doses), TSQM (both doses), and mPRTI (both doses) items evaluated at week 16, Tanezumab showed substantial improvements over placebo. For the BPI-sf and PGA-LBP, improvements persisted at week 56 when compared to baseline. However, compared to week 16, the amount of benefits was somewhat smaller in week 56. In comparison to the placebo, Tramadol did not raise BPI-sf or PGA-LBP scores at week 16. At week 56, the majority of the differences between Tramadol and Tanezumab were not statistically significant for all outcomes.
Tanezumab thus exhibited a significant advantage over placebo for some patients with moderate-to-severe CLBP, as shown by the totality of the data, which included satisfaction with therapy, patient overall evaluation of disease state, interference with daily function, and measures of pain.
Pain and Therapy
Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial
John D. Markman et al.
Comments (0)