Treatment with fremanezumab, the fully humanized IgG2?a monoclonal antibody that selectively targets calcitonin gene-related peptide, significantly reduced the number of headache or migraine days experienced before therapy. These findings, from a pooled analysis of phase 3 trials, were presented at Psych Congress 2020, held virtually from September 10 to 13, 2020.
Patients (N=368) with chronic migraine, as defined by ³15 days per month of moderate to severe headache, and concurrent depression, as defined by a Patient Health Questionnaire (PHQ-9) score ³10, were included in the international, multicenter, randomized, double-blind, placebo-controlled studies. Participants. were randomly assigned in a 1:1:1 ratio to receive monthly (n=130; fremanezumab 675 mg the first month followed by fremanezumab 225 mg for 2 months), quarterly (n=131; fremanezumab 675 mg the first month followed by placebo for 2 months, or placebo (n=107) injections.
A difference among treatment and placebo groups was observed after the first month of treatment. The mean decrease in the number of days with migraine among participants in the monthly treatment group was 4.3 (P <.001) and in the quarterly group was 4.6 (P <.0001); these decreases were statistically significant compared with the decrease reported by the placebo group (1.5 days).
The decrease in the number of days with migraine remained significant over the duration of the study. The mean decrease reported by placebo recipients was 1.9 (standard deviation [SD], 0.63) days compared with participants who received monthly (4.9 days; SD, 0.59; P <.001) and quarterly (4.6 days; SD, 0.56; P <.001) injections.
Similarly, the average number of days with a moderate to severe headache decreased after a single treatment (placebo: 1.2 days vs monthly: 4.9 days; P <.0001 or quarterly: 5.0 days; P <.0001). Over the entire study duration, the placebo group reported an average of 1.7 (SD, 0.59) fewer days with headache compared with participants who received monthly (5.2 days; SD, 0.56; P <.02) or quarterly (4.6 days; SD, 0.53; P <.02) treatments.
A limitation of this study was that these data were from a subset of individuals from 2 separate studies. Although the studies were of similar design, some bias may have been introduced.