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Atogepant Improves QoL, Function in Adults with Chronic, Episodic, Treatment-Resistant Migraine
An analysis of patient reported outcome measures from 3 pivotal phase 3 RCTs of atogepant 60 mg demonstrates efficacy across functional domains as well as for migraine prevention.
Atogepant 60 mg taken daily improved quality of life, daily functioning and headache-related impairment among adults with migraine, including both low- and high-frequency episodic migraine, chronic migraine, and migraine resistant to up to 4 preventive treatments, according to a new analysis of 3 pivotal phase 3 clinical trials with the oral calcitonin gene related peptide (CGRP) antagonist, or gepant.1
The findings, published December 8, in the journal Cephalalgia, were based on patient reported outcome measures (PROMS) from the ADVANCE2 (NCT03777059), PROGRESS3 (NCT03855137) and ELEVATE4 (NCT04740827) trials, which evaluated the efficacy of atogepant 60 mg from baseline to week 12 for prevention of migraine.
Reduction of migraine frequency is a critical benchmark for treatment efficacy required by regulatory agencies. However, the functional impact of migraine extends beyond the number of headache days to sensory, cognitive, and emotional dimensions, lead author Christopher Gottschalk, MD, professor and chief, division of general neurology; director, fellowship program, Headache & Facial Pain Center, Yale Medicine, and colleagues wrote. The growing use of validated PROMS allows investigators to collect health data that are not fully captured by conventional metrics and evaluate treatment effects in these critical domains.
For the current analysis, Gottschalk et al assessed the effect of atogepant 60 mg vs placebo on 3 routinely used and complementary measures of migraine related QoL and functioning among the different populations of individuals with migraine enrolled in the 3 randomized controlled trials mentioned. Although there is some overlap among the instruments, each quantifies distinct domains:
- Migraine-Specific Quality of Life questionnaire version 2.1 (MSQv2.1)
- Headache Impact Test-6 (HIT-6)
- Activity Impairment in Migraine–Diary (AIM-D)
The ADVANCE trial focused evaluated atogepant 60 mg in participants with low-frequency episodic migraine (4 to 8 monthly migraine days MMD) and high-frequency episodic migraine with 8 to 12 MMD. In the PROGRESs trial, participants experienced chronic migraine and in ELEVATE atogepant 60 mg was evaluated in adults with episodic migraine in individuals who previously failed 2 to 4 classes of oral preventive treatments.
FINDINGS
Compared with placebo, participants who received atogepant had a greater change from baseline to week 12 in the MSQv2.1 Role Function-Restrictive domain scores (P < .05). This was seen in ADVANCE for low-frequency episodic migraine (least squares mean difference, 12.0; 95% CI, 6.0 to 18.0) and high-frequency episodic migraine (9.9; 95% CI, 3.4 to 16.4), as well as in PROGRESS (6.2; 95% CI, 2.5 to 9.8) and ELEVATE (17.7; 95% CI, 13.1 to 22.3).
The change from baseline to week 12 was also greater for atogepant-treated participants on HIT-6 total scores in all 3 trials: ADVANCE for low-frequency episodic migraine (-4.7; 95% CI, -6.7 to -2.7) and high-frequency episodic migraine (-3.4; 95% CI, -5.5 to -1.2); PROGRESS (-2.8; 95% CI, -4.1 to -1.4), and ELEVATE (-6.5; 95% CI, -8.3 to -4.7).
Investigators reported parallel findings for scores on the AIM-D from baseline to week 12 for atogepant vs placebo: ADVANCE (low-frequency episodic migraine: -2.3; 95% CI, -3.9 to -0.7; high-frequency episodic migraine: -4.5; 95% CI, -6.9 to -2.2), PROGRESS (-3.4; 95% CI, 5.3 to -1.5), and ELEVATE (-4.7; 95% CI, -6.4 to -3.1).
“The present analysis expands on earlier findings by demonstrating that atogepant also improved QoL, headache-related impairment and daily functioning among people with [episodic migraine] failed by prior preventive treatment, as well as those with [high-frequency episodic migraine], who are at risk of transformation to [chronic migraine] in the absence of effective treatment,” investigators wrote. “These PROM data are an important complement to the efficacy and safety data underpinning the American Headache Society's endorsement of atogepant and other [calcitonin gene-related peptide]- targeted agents as first-line preventive migraine treatments and reflect the rapid improvement in well-being for patients who respond to atogepant.”
“These results demonstrate the value of preventive treatment with atogepant for reducing migraine-attributed impacts on multiple aspects of daily life, health, and well-being across the spectrum of people with migraine,” authors concluded.
Atogepant (Qulipta; Abbvie) is approved in the US and indicated for the preventive treatment of migraine in adults.
