A study depicted that in migraine subjects, fremanezumab (monthly and quarterly) displayed sustained improvements in headache days, monthly migraine days, and headache-associated disability for up to 12 months. Fremanezumab also displayed good tolerability.

A randomized, phase III, 52-week, parallel-group, multicenter, double-blind trial was carried out to investigate the extended-term safety, efficacy, and tolerability of fremanezumab, a fully-humanized monoclonal antibody approved for the preventive therapy of migraine.

This trial assessed fremanezumab monthly or quarterly in adult patients suffering from chronic migraine or episodic migraine. Safety and tolerability were determined by monitoring of adverse events, immunogenicity testing, systematic local injection-site assessments (immediately and one hour after injection), and laboratory/vitals assessments. The pre-specified exploratory assessments incorporated alteration from baseline in the (i) monthly number of migraine days, (ii) days with any acute headache medication use, and (ii) headache days of at least moderate severity. Alteration in headache-linked disability (6-item Headache Impact Test scores) from baseline was also estimated.

Of 1,890 patients (1110 with chronic migraine, 780 with episodic migraine) recruited, 551 and 559 subjects with chronic migraine were administered quarterly and monthly dosing; 394 and 386 subjects with episodic migraine were administered quarterly or monthly, respectively. The most frequently noted noxious events were injection-site reactions (erythema 26%, induration 33%, pain 31%). Fremanezumab lowered monthly migraine days and headache days of at least moderate severity (from baseline to 12 months), as shown in the following table:

A decline in any acute headache medicine usage and headache-linked disability were also sustained over 12 months. Thus, fremanezumab offers a vital therapy option for episodic or chronic patients as it minimizes their pain and disability while improving their quality of life.