High-dose Fasinumab improves Chronic Low Back pain and function: Study

The Previous trial on fasinumab suggests that the anti‐nerve growth factor monoclonal antibody improves pain and function in patients with knee or hip osteoarthritis (OA) who have a history of inadequate response or intolerance to analgesics. "Biologic agents that specifically block [nerve growth factor (NGF)] to treat pain may obviate many of the side effects of currently used analgesic medications, such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs), which rely on different mechanisms of action," said Paula Dakin.

To evaluate the safety and efficacy of fasinumab Paula Dakin et al, conducted a phase II/III double-blind, placebo-controlled trial in patients with Chronic Low Back Pain (CLBP). A total of 563 patients, of more than 35 years with the history of inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were included. The patients were randomised to fasinumab 6 or 9 mg subcutaneous every four weeks (Q4W), 9 mg intravenous every eight weeks (Q8W) or placebo group for a period of 16 weeks and followed until week 36. Researchers determined a change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score, as a primary endpoint. Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA) were determined as secondary endpoints.