Galcanezumab provides substantial QoL benefits for patients with migraine

The CGRP* inhibitor galcanezumab reduces migraine headache days, leading to improvements in function and potential elimination of migraine-related disability, according to a post hoc analysis.

“Migraine causes considerable disease-related disability and negatively impacts the health-related quality of life (HRQoL) of patients,” said the researchers. Moreover, the between-attack limitations (ie, interictal burden) happen even on symptom-free days, thus compounding the ictal burden of migraine. [Headache 2008;48:430-441; J Headache Pain 2019;20:41]

Given these detrimental effects, the objective of preventive migraine treatment is not confined to reducing the attack frequency; it is also imperative to improve function and decrease disability. [Cephalalgia 2002;22:491-512; Neuropsychiatr Dis Treat 2013;9:709-720] “[As such,] treatment of migraine should address not only the headache pain, nausea, and heightened sensitivities associated with a migraine attack, but also the impact that migraine attacks have on the daily activities of a patient with migraine,” they stressed.

“[Our findings] demonstrate that patients with higher response rates for migraine headache days are also experiencing greater improvements in HRQoL [with galcanezumab],” said the researchers.

This analysis utilized data from three similar phase III studies: EVOLVE-1, EVOLVE-2, and REGAIN. Both EVOLVE studies (n=1,773) evaluated patients with episodic migraine (EM), while REGAIN (n=1,113) saw those with chronic migraine (CM). Participants were randomized 1:1:2 to receive either SC galcanezumab 120 or 240 mg, or placebo, once monthly for 6 months (EVOLVE studies) or 3 months (REGAIN). [Headache 2020;60:2304-2319]

At baseline, most participants (60 percent and 82 percent in the respective EM and CM studies) had relatively high levels of migraine-related disability, as reflected by the mean MIDAS** scores (33.1 [severe] and 67.2 [very severe], respectively).

As migraine headache day response levels improved, so did the mean changes in MSQ*** scores for all three domains (p<0.001 across all studies). The greatest observed mean changes were for the MSQ role function-restrictive domain in participants who experienced a ≥75-percent reduction in monthly migraine headache days (36.0 and 46.5 points for EM and CM studies, respectively).

In the EVOLVE studies, more galcanezumab vs placebo recipients reported improvements in all 14^# MSQ item scores (p<0.001 for both galcanezumab doses across all items), with therapeutic gains ranging from 10 to 20 percent. At 6 months, more galcanezumab vs placebo recipients reported little or no migraine-related disability (50.6 percent [120 mg] and 51.3 percent [240 mg] vs 33.3 percent [placebo]; p<0.001 for both).

REGAIN also saw more galcanezumab vs placebo recipients with improvements in all MSQ item scores, with therapeutic gains ranging between 3 and 16 percent. At 3 months, there were also more galcanezumab vs placebo recipients who had little or no migraine-related disability (19.7 percent vs 13.9 percent; p=0.045 [120 mg] and 20.9 percent vs 13.9 percent; p=0.017 [240 mg]).

“These findings are highly relevant given that more than half of all patients with migraine have moderate-to-severe disability due to migraine, and the average patient reports a reduction in work productivity due to migraine of 10.2 work-equivalent days per year,” the researchers explained.

“[Our] findings … are important because the previous examination of the relationship between reduction in migraine headache days and improvement in patient functioning did not look beyond what is achieved with a 50-percent reduction in migraine headache days,” they continued. “The current study went beyond the 50-percent response rate, and showed that further gains in function could be realized when a response of ≥75 percent is achieved.”

However, the 3-month treatment duration in REGAIN might be insufficient to see significant gains. Caution is also warranted in interpreting the findings owing to the post hoc nature of the study. The results may also not be applicable to the general migraine population as the cohorts were only confined to participants in the three trials.

“[Nonetheless, knowing] that achieving higher migraine headache day response rates equates to a meaningful increase in a patient’s ability to function provides evidence for healthcare providers and patients that they should continue to strive for greater reductions in monthly migraine headache days,” the researchers concluded.