FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Subcutaneous injections of fremanezumab, a humanized monoclonal antibody, reduced headache frequency, compared with placebo, in patients with chronic migraine, according to results of a randomized, double-blind, placebo-controlled trial.
Beneficial effects of fremanezumab were seen within 4 weeks of the initial treatment, according to Stephen D. Silberstein, MD , director of the Jefferson Headache Center at Thomas Jefferson University, Philadelphia, and his coauthors.
The results suggest fremanezumab “was effective for preventive treatment of chronic migraine” in this phase 3 trial , wrote Dr. Silberstein and his colleagues ( N Engl J Med. 2017;377[22]:2113-22 ).
“Expert opinion has been that patients with chronic migraine should receive preventive treatment,” they wrote. “However, these treatments may be underused, not adhered to, associated with side effects, or ineffective.”
Fremanezumab targets calcitonin gene-related peptide, which is “involved in central and peripheral pathophysiological events of migraine,” according to the investigators.
The trial comprised 1,130 patients with chronic migraine, defined as occurring at least 8 days per month and headache of any severity at least 15 days per month. They were randomly assigned to receive fremanezumab on a planned quarterly regimen (a single dose at baseline, followed by placebo injections at weeks 4 and 8), fremanezumab monthly (a single dose at baseline, followed by lower doses at weeks 4 and 8), or matching placebo.
For the 12-week period after the first dose, the average number of headache days per month dropped by 4.3 from a baseline mean of 13.2 in the group of patients receiving treatment quarterly, and by 4.6 from a baseline of 12.8 in patients on monthly treatment, compared with a reduction of only 2.5 from a baseline of 13.3 in the placebo-treated patient group (P less than .001 for both fremanezumab groups vs. placebo).
Migraine days also declined significantly more among patients receiving quarterly and monthly fremanezumab by 12 weeks (from a mean of 16.2 to 11.3 and from 16.0 to 11.0, respectively) when compared with placebo (from 16.4 to 13.2; P less than .001 for both comparisons).
The number of patients experiencing a reduction of at least 50% in average number of headache days was higher in both fremanezumab groups at 38% for the quarterly dosing and 41% for monthly dosing, compared with placebo at 18% (P less than .001 for comparisons of fremanezumab to placebo).
Injection site pain was the most common adverse event in the trial, occurring in 30% and 26% of the fremanezumab quarterly and monthly groups, respectively, and 28% of the placebo group, according to the reported data.
Serious adverse events occurred in 1% of patients in the quarterly treatment group, 2% of the monthly group, and 2% of the placebo group, the data showed.
An ongoing extension of the trial will provide “further insights” on the safety and efficacy of treating chronic migraine with fremanezumab over a longer term, the investigators said.
Teva Pharmaceuticals funded the study. Dr. Silberstein and some of his coauthors reported receiving consulting fees from Teva and others. Many coauthors were employees of Teva.
