Efficacy and Safety of fasinumab in patients with chronic lo
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A study is conducted to know the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).

In this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged more than 35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9mg subcutaneous every 4 weeks (Q4W), 9mg IV every 8 weeks (Q8W) or placebo.

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). The results are based on a modified intent-to-treat analysis of 563/800 planned patients when enrollment was stopped early given emerging signals of joint risk in other osteoarthritis (OA) studies at doses being tested here.

-Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9mg Q4W and Q8W, but not 6mg (–0.3). RMDQ and PGA improvements to week 16 were greatest for fasinumab 9mg IV. Numerically greater efficacy occurred in patients with, versus those without, peripheral OA over 16 weeks.
-Treatment-emergent adverse events (AEs) occurred in 274/418 patients in the combined fasinumab groups and 94/140 placebo patients. Joint AEs, mostly rapid progressive OA type 1, were more frequent in the combined fasinumab groups (19 events in 16 patients vs 1 event in 1 patient for placebo); all except one occurred in pOA patients.

Conclusively, fasinumab highest doses, but not lower dose, improved both CLBP pain and function. Most joint AEs occurred in pOA patients, consistent with earlier findings in symptomatic OA.

Source: https://ard.bmj.com/content/early/2020/11/30/annrheumdis-2020-217259