Fremanezumab May Have Long-Term Efficacy as a Prophylactic for Chronic Migraine
Fremanezumab is a fully humanized monoclonal antibody raised against calcitonin gene-related peptide.
|The following article is part of conference coverage from the PAINWeek 2018 conference in Las Vegas, Nevada. Clinical Pain Advisor's staff will be reporting breaking news associated with research conducted by leading experts in pain medicine. Check back for the latest news from PAINWeek 2018.|
LAS VEGAS — Fremanezumab treatment may be efficacious in reducing the number of monthly headache days in the long-term in people with chronic migraine, according to a preliminary study presented during the 2018 PAINWeek conference, held September 4-8.
Previous studies have shown the safety and efficacy of fremanezumab, a fully humanized monoclonal antibody raised against calcitonin gene-related peptide, for migraine prophylaxis over a period of 3 months. The present randomized multicenter, parallel-group double-blind study sought to assess the long-term effects of fremanezumab on acute headache medication use, response rates, and disability in adult patients with chronic migraine (n=1110) over 52 weeks of therapy, as well as the medication's tolerability and safety. Study participants took the Headache Impact Test (HIT-6) to assess migraine-related disability.
They were then randomly assigned to receive a monthly dose of fremanezumab (starting dose, 675 mg; maintenance dose, 225 mg), or a quarterly dose of 675 mg fremanezumab, with a placebo injection on non-fremanezumab months to maintain blinding. Primary end points were >50% reduction in the average number of moderate or worse headache days per month, change from baseline of the average number of days on which acute headache medications were used, and changes in HIT-6 scores from baseline.
At month 6, 56% of patients receiving monthly fremanezumab achieved ≥50% reduction in the average number of monthly moderate or worse headache days per month compared with 51% of patients in the quarterly dosing group. Study participants receiving monthly and quarterly fremanezumab resorted to acute headache medications 5.8 and 5.2 fewer days, respectively, compared with baseline levels. HIT-6 disability scores were reduced by 8.1 and 6.9 points in participants in the monthly and quarterly dosing groups, respectively, compared with baseline levels. Both groups met the minimally important difference criteria established for reductions in HIT-6 scores.
”Efficacy and disability data from this interim analysis indicated that the level of efficacy observed at month 1 of this study was maintained during the remainder of the study,” concluded the study authors.
McAllister P, Yeung P, Cohen J, Gandhi S, Yang R, Aycardi E. Long-term impact of fremanezumab on response rates, acute headache medication use, and disability in patients with chronic migraine: interim results of a one-year study. Poster 89. Presented at: Pain Week 2018; September 4-8, 2018; Las Vegas, Nevada. doi:10.1080/00325481.2018.1512253
For more coverage of PAINWeek 2018, click here.