The anti-calcitonin gene-related peptide monoclonal antibody fremanezumab has been shown to reduce migraines compared to placebo, however experts say data is still needed on the long-term safety of the drug class.
The phase III randomised trial involved 875 adults with episodic migraine, in whom multiple medication classes had not previously failed.
From baseline to 12 weeks, mean migraine days per month decreased 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, reported David Dodick, MD, from the Mayo Clinic in Phoenix, and colleagues.
This resulted in 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), they reported in JAMA.
The most common adverse events that led to discontinuation were injection site erythema, injection site induration, diarrhea, anxiety and depression.
“Further research is needed to assess effectiveness against other preventive medications and in patients in whom multiple preventive drug classes have failed and to determine long-term safety and efficacy,” the researchers concluded.
Writing in a linked editorial Dr Elizabeth W. Loder from the Brigham and Women’s Hospital, Harvard Medical School, Boston, and Matthew S, Robbins from the Jack D. Weiler Hospital at the Montefiore Headache Center, Albert Einstein College of Medicine in New York said an important apparent benefit of fremanezumab and other 3 CGRP monoclonal antibodies in development is their low burden of ‘common nuisance adverse events’.