Dodick DW, et al. - Fremanezumab (a fully humanized monoclonal antibody that targets calcitonin gene-related peptide) was compared with placebo in preventing episodic migraine with a monthly dosing regimen or a single higher dose. A statistically significant 1.3- to 1.5-day reduction in the mean number of monthly migraine days was noted over a 12-week period after treatment with subcutaneous fremanezumab vs placebo in patients with episodic migraine in whom multiple medication classes had not previously failed.

Methods

• Including a screening visit, 28-day pretreatment period, 12-week treatment period, and final evaluation at week 12, a randomized, double-blind, placebo-controlled, parallel-group trial was performed at 123 sites in 9 countries from March 23, 2016 (first patient randomized) to April 10, 2017.
• Study included subjects aged 18 to 70 years with episodic migraine (6-14 headache days, with at least 4 migraine days, during 28-day pretreatment period), excluding those who had previous treatment failure with two classes of migraine-preventive medication.
• Subcutaneous monthly dosing of fremanezumab (n=290; 225 mg at baseline, week 4, and week 8), a single higher dose of fremanezumab, as intended to support a quarterly dose regimen (n=291; 675 mg of fremanezumab at baseline; placebo at weeks 4 and 8); or placebo (n=294; at baseline, week 4, and week 8) was administered to patients in a randomized 1:1:1 manner.
• Mean change in mean number of monthly migraine days during the 12-week period after the first dose was the primary end point.

Results

• A total of 791 (90.4%) patients completed the trial out of 875 patients who were randomized (mean age, 41.8 [SD, 12.1] years; 742 women [85%]).
• The observed reduction in mean migraine days per month from baseline to 12 weeks was from 8.9 days to 4.9 days in the fremanezumab monthly dosing group, from 9.2 days to 5.3 days in the fremanezumab single-higher-dose group, and from 9.1 days to 6.5 days in the placebo group.
• Researchers noted that this caused a difference with monthly dosing vs placebo of –1.5 days (95% CI, –2.01 to –0.93 days; P < .001) and with single higher dosing vs placebo of –1.3 days (95% CI, –1.79 to –0.72 days; P < .001).
• Injection site erythema (n=3), injection site induration (n=2), diarrhea (n=2), anxiety (n=2), and depression (n=2) were reported as the most common adverse events that led to discontinuation.