Atogepant linked to rapid reduction of migraine symptoms

Key takeaways:

• Atogepant was associated with a greater reduction in migraine vs. placebo on day 1 in three clinical trials.
• In all three studies, atogepant reduced weekly and monthly migraine days by week 4 vs. placebo.

In three clinical trials, treatment with atogepant relieved migraine symptoms as soon as day 1, with consistent reductions through 4 weeks compared with placebo, according to research published in Neurology.

“With many current drugs to prevent migraine, it takes time to find the right dosage for the individual and it can take weeks or even months for it to be most effective,” Richard B. Lipton, MD, a professor of neurology at Albert Einstein College of Medicine, said in a release related to the study. “Some people give up and stop taking the drugs before they reach this point, plus, many people experience side effects with current treatments.”

Lipton and colleagues evaluated the efficacy of atogepant (Qulipta, AbbVie), an oral calcitonin gene-related peptide, as well as functional outcomes in those with migraine over the first 4 weeks of treatment.

Data were analyzed from three phase 3 clinical trials — ADVANCE, ELEVATE and PROGRESS, all multicenter, randomized, double-blind, placebo-controlled 12-week studies.

ADVANCE and ELEVATE included participants aged 18 to 80 years with at least a 1 year recorded history of episodic migraine along with 4 to 14 migraine days per month (MMDs). Participants in ELEVATE were eligible for inclusion after failing two to four classes of oral preventive migraine medications. Eligible participants for PROGRESS were aged 18 to 80 years with at least a 1 year recorded history of chronic migraine that featured 15 or more days with a headache per month and at least 8 MMDs.

For ADVANCE, enrollees were randomly assigned on a 1:1:1:1 basis to receive once-daily 10 mg, 30 mg, 60 mg atogepant or placebo. For PROGRESS, randomization was 1:1:1 for twice-daily 30 mg, 60 mg atogepant or placebo. In ELEVATE, patients were randomly assigned 1:1 to either once-daily 60 mg atogepant or placebo.

The modified intent-to-treat populations for each respective study were as follows: ADVANCE (atogepant, n = 222; placebo, n = 214); ELEVATE (atogepant, n = 151; placebo, n = 154) and PROGRESS (atogepant, n = 256; placebo, n = 246).

Primary outcomes for the trio of trials included change from baseline in weekly migraine days (WMDs) at weeks 1 through 4 along with MMDs in the same timeframe, concurrent with functional endpoints as measured by the Activity Impairment in Migraine-Diary at weeks 1 through 4, as well as the European Quality-of-Life 5-Dimension 5-Level assessed at weeks 1, 2 and 4.

Across all three studies, results showed atogepant treatment led to greater reductions in the proportion of participants with a migraine by day 1 (OR = 0.39; 95% CI, 0.23–0.67) in ADVANCE, (OR = 0.53; 95% CI 0.29–0.94) in ELEVATE and (OR = 0.63; 95% CI, 0.43–0.93) in PROGRESS.

Data further show that atogepant reduced WMDs on weeks 1 through 4 as well as MMDs in the first 4 weeks, while also boosting AIM-D and EQ-5D-5L scores at all timepoints up to 4 weeks compared with placebo.

Atogepant was also safe and well tolerated across all three trials.

“The analyses reported here demonstrate the early efficacy and functional improvements of atogepant and address a key unmet need of providing preventive treatment options with early benefits across the spectrum of migraine disease state severity,” Lipton and colleagues wrote.

Reference:

New drug to prevent migraine may start working right away. https://www.aan.com/PressRoom/Home/PressRelease/5221. Published Dec. 23, 2024. Accessed Jan. 6, 2025.