New migraine prophylactic for monthly or quarterly injection

Fremanezumab (Ajovy) is a monoclonal antibody licensed for the prophylaxis of migraine in adults who suffer four or more migraine days per month.

Migraine is a leading cause of neurological disability worldwide. | Emily Ciosek/Science Source/SCIENCE PHOTO LIBRARY
Migraine is a leading cause of neurological disability worldwide. | Emily Ciosek/Science Source/SCIENCE PHOTO LIBRARY

Ajovy is administered by subcutaneous injection into the abdomen, thigh or upper arm at a dose of 225mg once a month or 675mg every three months. Concomitant migraine preventive treatment may be continued during initiation of Ajovy if considered necessary by the prescriber.

Pharmacology

Fremanezumab is a humanised monoclonal antibody which binds the calcitonin gene-related peptide (CGRP) ligand to prevent both the α- and β-CGRP isoforms from binding to the CGRP receptor. Although the exact way in which fremanezumab exerts its effect is unknown, CRGP levels have been shown to increase significantly during migraine and return to normal with headache relief.

Clinical studies

The efficacy of fremanezumab was evaluated in two 12-week phase III studies in adults with episodic or chronic migraine, all of whom had at least a 12-month history of migraine (with and without aura) according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.

Episodic migraine

In the 875 patients with episodic migraine were randomised to receive 675mg fremanezumab every three months (n=291), 225mg fremanezumab once a month (n=290), or placebo once a month (n=294), all administered by subcutaneous injection.

Both regimens of fremanezumab demonstrated significant and clinically meaningful improvement in the mean number of monthly migraine days during the 12-week study period (primary efficacy endpoint) compared with placebo (mean change from baseline -3.4 days and -3.7 days for fremanezumab 675mg and 225mg, respectively, versus -2.2 days for placebo; p < 0.001 for both comparisons).

In addition, fremanezumab was associated with significant improvements in key secondary endpoints (achievement of at least 50% reduction from baseline in mean number of monthly migraine days, mean change from baseline in patient-reported Migraine Disability Assessment [MIDAS] score, and mean change from baseline in monthly average number of days of acute headache medicinal product use) compared with placebo.

Chronic migraine

In a 1,130 patients with a history of chronic migraine were randomised to a 675mg fremanezumab starting dose followed by 225mg fremanezumab once a month (n=379), 675mg fremanezumab every three months (n=376) or placebo once a month (n=375), all by subcutaneous injection.

Improvement in the primary efficacy endpoint (mean change from baseline in monthly average number of headache days of at least moderate severity during the 12-week study period) was significantly greater in both fremanzeumab groups compared with placebo (-4.3 days and -4.6 days for the quarterly and monthly fremanezumab regimens, respectively, versus -2.5 days for placebo; p < 0.001 for both comparisons).

Significant improvement in key secondary endpoints was also observed for the fremanezumab groups compared with placebo.

In both studies improvements were observed as early as the first month and were sustained over the treatment period.

Long-term study

The long-term efficacy of fremanezumab was assessed in a 12-month extension study (n=1,890), which included patients from the episodic and chronic migraine studies plus 312 newly enrolled patients.

Efficacy was sustained across the study period with pooled results across the two dosing regimens (225mg monthly or 675mg quarterly) showing a reduction of 6.6 monthly migraine days after 15 months relative to the baselines of the first two studies. The results also showed that 61% of patients in the extension study achieved a 50% response in the last month of the study period.

Fremanezumab was well tolerated in all studies with injection site reactions the most commonly reported adverse effects.

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