Qulipta Treatment for Migraine Shows Potential for Immediate Efficacy

Treatment of migraine with Qulipta (atogepant; AbbVie, Chicago, IL) demonstrated early efficacy and functional improvements within the first 4 weeks, according to data published in Neurology. Additionally, people who received Qulipta had a reduced likelihood of experiencing a migraine within their first week of treatment.

In the study, researchers analyzed results from the ADVANCE (NCT03777059; N=910) phase 3 clinical trial conducted in the United States, the ELEVATE (NCT04740827; N=315) phase 3 clinical trial in North America and Europe, and the PROGRESS (NCT03855137; N=778) phase 3 clinical trial conducted in North America, Europe, and East Asia. The 3 randomized clinical trials included adults with a history of either episodic migraine (ADVANCE and ELEVATE) or chronic migraine (PROGRESS) who were treated with Qulipta or placebo, each with the same primary endpoint of change from baseline in mean monthly migraine days (MMDs) across 12 weeks. The analysis in the study published in Neurology assessed only participants who received placebo or Qulipta 60 mg.

At day 1, after adjusting for factors that may affect the rate of migraine, the following results were reported:

• In the ADVANCE study, people who received Qulipta were 61% less likely to have a migraine compared with placebo.
• In ELEVATE, people who received Qulipta were 47% less likely to have a migraine compared with placebo.
• In PROGRESS, people who received Qulipta were 37% less likely to have a migraine compared with placebo.

Additional key findings from weeks 1-4 include the following:

• In ADVANCE and ELEVATE, Qulipta-treated participants showed 1 fewer day with migraine per week on average compared with >.5 fewer days for those treated with placebo.
• In PROGRESS, Qulipta-treated participants showed ~1.5 fewer average migraine days per week compared with ~1 fewer day for those who received placebo.
• Treatment with Qulipta was associated with fewer MMDs in the first 4 weeks of treatment compared with placebo across all 3 studies.
• Participants who received Qulipta showed improved functional and quality-of-life outcomes as early as week 1, with results consistent across each of the phase 3 trials.

“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,” said Study Author Richard B. Lipton, MD, of Albert Einstein College of Medicine and Fellow of the American Academy of Neurology. “Some people give up and stop taking the drugs before they reach this point. Plus, many people experience side effects with current treatments. Developing a drug that works both effectively and quickly is critical.”