Galcanezumab

Additional information

Migraine is twice as common in women as in men [1-3]. In a Swedish population-based study the one-year prevalence was 9.5% in men and 16.7 % in women [4] which is slightly lower than three months prevalence reported from the US [1].

Among adults with migraine, sex and gender differences were found in a cross-sectional longitudinal internet-based study (11 049 women, 4 084 men). Compared with men, women had significantly higher amount of monthly headache days, were more likely to have been diagnosed with migraine and to report headache-related disability and cutaneous allodynia. Among prescription medication users, women took more triptans than men, while men were more likely to take opioids and, besides oral formulations, use nasal spray and injectable medication. Men also used more daily oral preventive medication than women [5].

Women who have migraine with aura have an increased risk of ischemic stroke compared to women without migraine [6]. A prospective controlled study showed that in patients with active migraine, female sex was significantly associated with the risk of ischemic stroke [7].

It should be noted that most studies include more women than men, and the low number of men included can affect the ability to make statistically significant analyses.

Pharmacokinetics and dosing

A pooled population pharmacokinetic analysis (1 515 women, 375 men) showed that the pharmacokinetics of galcanezumab did not differ between men and women [8] and no sex differentiation in dosing has been recommended by the pharmaceutical company [9, 10].

Effects

No differences in migraine treatment effects of galcanezumab, between men and women, were shown in the pivotal studies according to the product information [9-12]. In a pivotal phase III study of galcanezumab in patients with chronic cluster headache, a pre-specified subgroup analysis was published in the supplemental information that showed that the treatment effect did not differ significantly based on patient’s sex [13]. Galcanezumab is currently not registered for the indication cluster headache in Europe [14].

Adverse effects

The incidence of side effects were similar in men and women according to the pharmaceutical company [10, 11].

EPAR Public assessment report [12] states that galcanezumab has a potential of negative impact on bone mass, which may be of certain interest in post-menopausal women with underlying osteoporosis.

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).