Silberstein SD, et al. - Two dosing regimens of fremanezumab, a humanized monoclonal antibody targeting calcitonin gene–related peptide (CGRP), were compared with placebo for the prevention of chronic migraine. In this 12-week trial, it was observed that those who were treated with fremanezumab vs placebo for preventing chronic migraine, had a lower frequency of headache. It was also noted that injection-site reactions to the drug were common.

Methods

• Researchers performed this phase 3 trial, wherein, patients with chronic migraine (defined as headache of any duration or severity on ≥15 days per month and migraine on ≥8 days per month) were randomly assigned in a 1:1:1 ratio to receive fremanezumab quarterly (a single dose of 675 mg at baseline and placebo at weeks 4 and 8), fremanezumab monthly (675 mg at baseline and 225 mg at weeks 4 and 8), or matching placebo.
• Via subcutaneous injection, both fremanezumab and placebo were administered.
• The mean change from baseline in the average number of headache days (defined as days in which headache pain lasted ≥4 consecutive hours and had a peak severity of at least a moderate level or days in which acute migraine–specific medication [triptans or ergots] was used to treat a headache of any severity or duration) per month during the 12 weeks after the first dose was the primary end point.

Results

• Researchers enrolled a total of 1130 patients, of these, 376 were randomly assigned to fremanezumab quarterly, 379 to fremanezumab monthly, and 375 to placebo.
• Data demonstrated that the mean number of baseline headache days (as defined above) per month was 13.2, 12.8, and 13.3, respectively.
• They also noted that the least-squares mean (±SE) reduction in the average number of headache days per month was 4.3±0.3 with fremanezumab quarterly, 4.6±0.3 with fremanezumab monthly, and 2.5±0.3 with placebo (P<0.001 for both comparisons with placebo).
• In the fremanezumab-quarterly group, 38% patients exhibited a reduction of at least 50% in the average number of headache days per month, while 41% in the fremanezumab-monthly group and 18% in the placebo group (P<0.001 for both comparisons with placebo) exhibited such a reduction.
• In addition, occurrence of abnormalities of hepatic function was reported in 5 patients in each fremanezumab group (1%) and 3 patients in the placebo group (<1%).