Long-term safety and effectiveness of tanezumab 10 mg vs. 20 mg for chronic low back pain

Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
Synopsis
849 patients with chronic low back pain (equal or > 3 months) were randomized to receive three intravenous injections of 10 mg or 20 mg of tanezumab followed by up to 4 subcutaneous injections every 8 weeks. This extension study aimed to compare the long-term safety and effectiveness of two different tanezumab doses. Ten and 20 Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: Pfizer Inc
Conflicts: Company Employee
CONTENT IS LOCKED
Why was this study needed now?
Many therapeutic interventions are available for managing chronic low back pain, including opioids and non-steroidal anti-inflammatory analgesics. However, many of these agents are associated with a variety of side-effects when they are used over a long period of time. Tanezumab is a humanized monoclonal antibody suggested to be effective for the management of chronic low back pain. Since low back pain is commonly a longstanding condition, the long-term safety and efficacy of tanezumab still needs to be examined. This study was an extension of a previously reported trial comparing different doses of tanezumab for the treatment of chronic low back pain.
What was the principal research question?
Is the long-term administration of tanezumab safe and effective for patients suffering from chronic low back pain?
Population: 848 patients with chronic low back pain (equal or >3 months duration) who required the routine use of analgesic medication were included in this extension study. All patients underwent a second randomization after completion of the parent study (NCT00876187) to maintain dose blinding. Select analgesic medications (prescription analgesics, over-the-counter analgesics, muscle relaxants) were allowed for managing low back pain during the study period.
Intervention: Tanezumab 10mg: Patients were administered 3 intravenous injections of tanezumab 10 mg. Afterward, patients received up to 4 subcutaneous injections every 8 weeks (n=321, F=52%; age: 53.3 yrs (18-90); mean treatment duration: 194 days; 155 were evaluated at 24 wks).
Comparison: Tanezumab 20mg: Patients were administered 3 intravenous injections of tanezumab 20 mg. Afterward, patients received up to 4 subcutaneous injections every 8 weeks (n=527, F=52.6%; age: 53.2 yrs (22-88); mean treatment duration: 202 days; 258 were evaluated at 24 wks).
Outcomes: Effectiveness was evaluated as the change from baseline in Brief Pain Inventory Short Form (BPI-SF) score of average pain, Roland Morris Disability Questionnaire (RMDQ), Patient’s Global Assessment (PGA) of low back pain, and the percentage of patients with equal or less than 30%, 50%, 70%, and 90% reduction in BPI-SF score. Safety was assessed by recorded adverse events (severity and association to the tested drug) vital signs, physical and neurological examinations, 12-lead electrocardiograms, injection site assessments, and laboratory tests.
Methods: Randomized Non-controlled Trial: Multicenter; Dose-blinded.
Time: Assessments were made at week 4 and 24 post-intervention. The intended treatment duration (64 weeks) was not met due to a partial clinical hold placed by the FDA on studies investigating chronic low back pain due to adverse events in tanezumab phase 3 OA studies, thus too few patients remained in the study after week 24 to estimate response to tanezumab beyond this time point.
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.