Study Finds Reduction in Mean Monthly Migraine Days With Atogepant

New data from the pivotal phase 3 PROGRESS trial found a reduction in mean monthly migraine days among patients administered atogepant (Qulipta; AbbVie).

The PROGRESS trial is evaluating atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the prevention of chronic migraine in adults. The trial met its primary endpoint of a statistically significant reduction from baseline in mean monthly migraine days compared to placebo, for both the 60 mg once daily and 30 mg twice daily doses, across the 12-week treatment period.

Chronic migraine is a debilitating neurological disease in which patients experience headaches on 15 or more days per month for more than 3 months. At least 8 days per month must include symptoms of a migraine headache. In the PROGRESS study, 778 patients with at least a 1-year history of chronic migraine were randomized into 1 of 3 treatment groups to receive atogepant or placebo.

Across the 12-week treatment period, based on the modified intent-to-treat (mITT) population, patients in the atogepant 60 mg daily and 30 mg twice daily treatment arms of the study experienced a decrease of 6.88 and 7.46 monthly migraine days, respectively, compared to patients in the placebo arm, who experienced a decrease of 5.05 monthly migraine days.

Based on the European Union-focused off-treatment hypothetical estimand (OTHE) population, patients in the 60 mg daily and 30 mg twice-daily arms experienced a decrease of 6.75 and 7.33 monthly migraine days, respectively, compared to a decrease of 5.09 in the placebo arm. According to the study, these findings demonstrated that treatment with atogepant resulted in statistically significant improvements in all secondary endpoints for both efficacy analysis populations.

A key secondary endpoint of the study measured the proportion of patients who achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. Based on the mITT population, researchers found that 41% in the 60 mg once-daily group and 42.7% in the 30 mg twice-daily arm achieved at least a 50% reduction, compared to 26% of patients in the placebo arm.

In the OTHE population, 40.1% and 42.1% of patients, respectively, achieved at least a 50% reduction compared to 26.5% of patients in the placebo arm.

“We know that no 2 migraine patients are alike, so it is important for health care providers to have a variety of treatment options,” said Michael Severino, MD, vice chairman and president of AbbVie, in a press release.

The overall safety profile of the phase 3 PROGRESS study was consistent with findings of previous studies in an episodic migraine population. According to the study findings, the most common adverse events (AEs) reported with a frequency of 5% or more in at least 1 atogepant treatment arm, and greater than placebo, were constipation and nausea. Most of these AEs were mild or moderate in severity and did not lead to discontinuation.

No hepatic safety issues were identified, and serious AEs occurred in 2.7% of patients with atogepant 60 mg daily and 1.6% of patients with atogepant 30 mg twice daily, compared to 1.2% of patients with placebo. None of these treatment-emergent AEs were assessed as treatment-related by the investigator.

These data build on results from the phase 3 ADVANCE study, which evaluated atogepant as a preventive treatment for episodic migraine. Based on the results of the phase 3 PROGRESS trial, AbbVie intends to submit a supplemental New Drug Application to the FDA for the expanded use of atogepant to include the preventive treatment of chronic migraine.

REFERENCE

AbbVie Announces Positive Phase 3 Atogepant (Qulipta) Data for the Preventive Treatment of Chronic Migraine. News release. AbbVie; March 10, 2022. Accessed March 25, 2022. https://news.abbvie.com/article_display.cfm?article_id=12413