Patients treated with a high dose of the human monoclonal antibody fasinumab showed improved chronic lower back pain and restored normal functioning in patients, according to data published in the Annals of the Rheumatic Diseases.
Administering 9 mg of fasinumab every 4 or 8 weeks, instead of the standard 6 mg, showed improvements in chronic lower back pain and function in the osteoarthritis patients.
Chronic LBP (CLBP) is defined as pain persisting for more than 3 months. According to the treatment guidelines, initial treatment should involve non-pharmacological interventions include exercise and multidisciplinary rehabilitation. Once the interventions become inadequate or if CLBP persists, it is recommended to use non-steroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacological treatments and duloxetine and tramadol as second-line treatments. Stronger opioids are an option only if patients fail the afore-mentioned treatments and if the potential benefits outweigh the risks, noted the lead researchers.
The phase 2/3, double-blind, placebo-controlled study involved patients aged 35 years and older with an inadequate response, or intolerance to, NSAIDs and opioids. Participants were randomized to receive either 6 mg or 9 mg of subcutaneous fasinumab every 4 weeks, or 9 mg of intravenous fasinumab every 8 weeks, or a placebo. The primary endpoint was the change in average daily low back pain intensity (LBPI) numeric rating score from baseline to week 16.
“Significant pain improvement was maintained over 16 weeks for both fasinumab 9 mg groups, but not for 6 mg,” Paula Dakin, MBChB, and colleagues wrote. “Further studies will be needed to determine whether the robust efficacy shown at week 8 is sustained for longer durations at lower doses.”
Long-term use of both NSAIDs and opioids is limited by tolerability issues and adverse effects, such as gastrointestinal bleeding, cardiovascular events, and the potential for abuse and dependence. Hence, fasinumab, being a fully human monoclonal antibody. is a better option to reduce the side-effects and bring down pain in OA patients.