This study aimed to determine whether Atogepant affected patient-reported outcomes in migraine adults.
Migraine is definitely more than just a headache; it’s a neurological condition that can trigger multiple symptoms. It runs in families and impacts people of all ages.
The symptoms of a migraine episode can affect a person’s daily life, including their ability to work or study. Migraine episodes can last for several days and usually occur in stages.
Some people have more than one migraine episode each week, while others only get them occasionally. In addition, migraines can affect people differently; their triggers, severity, symptoms, and frequency can vary.
More than 15% of Americans experienced migraine episodes or severe headaches in the past three months, according to researchers in 2018.
A patient-reported outcome (PRO) assessment is essential when evaluating preventive treatments for migraine.
Atogepant is an oral calcitonin gene-related peptide receptor antagonist indicated for preventing episodic migraines in adults. The researchers examined changes in patient-reported outcomes with the Atogepant drug.
This phase 3, 12-week, multicentre, randomized, double-blinded, placebo-controlled, parallel-group trial (ADVANCE) involved adults with 4-14 migraine days per month who received Atogepant 10, 30, or 60 mg once daily or placebo.
As secondary endpoints, changes from baseline were measured in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role Function-Restrictive (RFR) domain at week 12, as well as mean monthly Performance of Daily Activities and Physical Impairment domains across the 12-week treatment period.
AIM-D Total scores, MSQ-Role Function-Preventive (RFP), and Headache Impact Test-6 (HIT-6) change scores were investigated as exploratory endpoints.
Results of the Study
910 participants were randomized; 873 comprised the modified intent-to-treat population. At week 12, all Atogepant groups demonstrated significantly more improvement in MSQ RFR than placebo, exceeding the minimum clinically meaningful difference (3.2 points).
As a result of Atogepant 30 and 60mg treatment, LSMDs in monthly AIM-D PDA and PI scores improved significantly over the 12-week treatment period, but not for 10mg.
Aim-D outcomes and HIT-6 scores improved significantly with Atogepant 30 and 60mg at the earliest (week 4) and throughout 12-week treatment periods. However, results varied for Atogepant 10mg.
Atogepant significantly improved patient-reported outcomes with 30 and 60mg, including the MSQ-RFR scores and both AIM-D domains. However, as a new migraine prevention treatment, Atogepant showed minor improvements for other MSQ domains and HIT-6.
Atogepant reduced the emotional impact, physical impairment, and overall impact of headaches significantly and clinically meaningfully and in daily social and work-related activities.
Also, this study proves that daily Atogepant is associated with enhanced health-related quality of life measures in patients with 4-14 migraine days per month.
As a result, Atogepant emerges as a favorable new treatment for migraine prevention.