A clinical trial studying fasinumab for chronic low back pain (CLBP) showed that high doses of fasinumab improved pain and function, but were also associated with adverse events, according to a study published in Annals of the Rheumatic Diseases.
The safety and efficacy trial included CLBP patients (n=563) with a history of inadequate pain relief or intolerance to analgesic therapy. The participants were randomised to fasinumab 6 or 9 mg subcutaneous every four weeks (Q4W), 9 mg intravenous every eight weeks (Q8W) or placebo. The primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score. Key secondary efficacy variables included Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA).
Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg groups. RMDQ and PGA improvements to week 16 were greater for intravenous fasinumab 9 mg. Joint adverse events, mostly rapid progressive osteoarthritis (OA) type 1, were more frequent in the combined fasinumab groups than in placebo.
This study validates concerns about the use of fasinumab in CLBP subjects with concomitant OA, the authors say. Further studies with longer treatment and follow-up are needed to inform benefit-risk, they conclude.