Fremanezumab reduces migraine days
Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, significantly reduces the number of migraine days in patients with chronic migraine (CM) or episodic migraine (EM), according to the FOCUS* study presented at AHS 2019.
This phase III, international, double-blind, parallel-group trial evaluated 838 adults diagnosed with CM or EM (aged ≤50 years) with previous inadequate responses to 2–4 classes of preventive treatments. Participants were randomized in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab, either monthly** (n=283) or quarterly*** (n=276), or monthly placebo (n=278) for 12 weeks. [AHS 2019, abstract IOR08]
At baseline, the mean number of migraine days was 14.1 days for those assigned to monthly or quarterly fremanezumab and 14.3 days for those in the placebo group.
Significantly more patients treated with monthly or quarterly fremanezumab achieved a ≥50 percent reduction in monthly average number of migraine days compared with placebo at 4 weeks (36 and 38 percent, respectively, vs 10 percent; p<0.0001) and within 12 weeks after the first dose (34 percent in each group vs 9 percent; p<0.0001).
More fremanezumab recipients also experienced a reduction of ≥75 percent in monthly average number of migraine days than the placebo recipients at 4 weeks (14 percent for both the monthly and quarterly dose vs 2 percent; p<0.0001) and within 12 weeks after the first dose (12 percent vs 2 percent; p<0.0001 for the monthly dose and 8 percent vs 2 percent; p<0.005 for the quarterly dose).
A greater proportion of patients on monthly and quarterly fremanezumab sustained ≥50 percent reduction in the monthly average number of migraine days between the first 4 and 12 weeks of treatment (19 percent for monthly and 20 percent for quarterly vs 3 percent; p<0.0001) compared with placebo.
“[This] … study of fremanezumab was the first and largest study of a migraine preventive treatment in adults with both CM and EM,” said investigator Dr Egilius Spierings from MedVadis Research in Boston, Massachusetts, US, who presented the study.
“Monthly or quarterly fremanezumab treatment resulted in clinically meaningful and statistically significant reductions in migraine days … [among] patients with EM or CM ... Given the multiple previous preventive treatment failures in these patients, response rates reported here suggest [that] fremanezumab offers an effective treatment opportunity in this potentially more difficult-to-treat migraine population,” Spierings noted.
*FOCUS: An efficacy and safety study of fremanezumab in adults with migraine
**Monthly dosage: CM (month 1: 675 mg, months 2–3: 225 mg); EM (months 1–3: 225 mg)
***Quarterly dosage: CM or EM (month 1: 675 mg, months 2–3: placebo)