Atogepant Found to Significantly Improve Patient-reported Outcomes in Migraine

Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved in 2021 for patients with episodic migraines.

Atogepant (Qulipta; AbbVie) was found to significantly improve patient-reported outcomes (PROs) for functioning in daily social and work activities, emotional impact, physical impairment, and overall effect of migraine headaches, according to results from the phase 3 ADVANCE (NCT02848326) study published online in Neurology.

Atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, was approved in 2021 for patients with episodic migraines based on data from a clinical program that included approximately 2000 patients with episodic migraine, which included the ADVANCE trial. In June, AbbVie submitted a supplemental new drug application to the FDA for atogepant to support the preventive treatment of chronic migraine in adults. The drug has not yet been approved in the United States for the preventive treatment of chronic migraine.

The ADVANCE study included a modified intent-to-treat population of 873 patients with 4-14 migraine days per month who were randomized to receive atogepant 10 mg (n = 214), 30 mg (n = 223), 60 mg (n = 222), or placebo (n = 214). The post-hoc analysis focused on several PROs, including the Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ v2.1), Activity Impairment in Migraine-Diary (AIM-D), and Headache Impact Test-6 (HIT-6).

The study was comprised of a 4-week baseline period, 12-week double-blind treatment period, and 4-week safety follow-up period. Each patient took a once daily, oral dose at approximately the same time each day.

In the mITT population, mean patient age was 41.7 years, and most participants were female (89%) and White (84%). Following 12 weeks of treatment, patients showed statistically significant changes in MSQ v2.1 and clinically meaningful improvements in the impact of migraine on daily social and work-related activities across all atogepant groups relative to placebo (P <.0001 for all). Nominally greater improvements were seen in exploratory MSQ v2.1 end points, including Role Function-Restrictive, Role Function-Preventive, and Emotional Function scores.

Even with similar baseline mean AIM-D domain scores, the 30 mg and 60 mg dosing cohorts displayed statistically significant improvements in mean monthly AIM-D Performance of Daily Activities and Physical Impairment scores over the 12-week treatment period (P ≤ .002). Further, the 10 mg cohort showed improvement across both AIM-D domains, but this was not deemed statistically significant vs placebo.

The mean baseline HIT-5 total scores were similar across cohorts and were reflective of a severe impact of headaches, according to the investigators. Compared with placebo, all atogepant treatment cohorts showed a nominal improvement (P ≤.006) in HIT-6 total score at the earliest point assessed in week 4 and during the double-blind treatment period. The study findings showed a higher proportion of HIT-6 responders with at least a 6-point improvement across all atogepant dose cohorts at weeks 4, 8, and 12 (P ≤.03), with the exception of the atogepant 30 mg cohort at week 4 (P = .07), according to the investigators.

"The early onset of improved functioning is important to patients, as well as payers,” the study authors wrote. "Together, these results reinforce the beneficial effects of atogepant as a promising new treatment for the prevention of migraine."

REFERENCE
Lipton RB, Pozo-Rosich P, Blumenfeld A, et al. Effect of atogepant for preventive migraine treatment on patient-reported outcomes in the randomized, double-blind, phase 3 ADVANCE trial. Neurology. Published online November 17, 2022. doi:10.1212/WNL.0000000000201568

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