An interim analysis of an ongoing extension study supports the long-term safety and efficacy of the oral calcitonin gene-related peptide (CGRP) receptor antagonist atogepant (Qulipta) to prevent chronic and episodic migraine.
The data show that 70% of patients treated with atogepant 60 mg daily achieved at least a 50% reduction in monthly migraine days at weeks 13-16 and this was maintained over 48 weeks of treatment.
“This is the first long-term study for assessing the safety and efficacy of a drug belonging to the gepant class, atogepant, used in the prevention of migraine in persons with episodic migraine who did not benefit from several previous preventive treatments or with chronic migraine,” study investigator Cristina Tassorelli, MD, professor and chair of neurology, University of Pavia, Italy, told Medscape Medical News.
“It shows consistency of efficacy over 48 weeks and confirms the known safety profile of atogepant reported in randomized controlled trials, without detecting any new signal with the open-label use over 1 year,” Tassorelli said.
The results were reported at the American Academy of Neurology 2024 annual meeting by Sait Ashina, MD, with the Comprehensive Headache Center at Beth Israel Deaconess Medical Center in Boston.
Novel Longer-Term Data
The extension study includes more than 500 patients who completed the phase 3 PROGRESS or ELEVATE randomized placebo-controlled trials of atogepant 60 mg once daily for prevention of episodic or chronic migraine. It will run for 156 weeks.
Ashina reported safety and tolerability data at 52 weeks of treatment and efficacy data between 13 and 48 weeks of treatment. The mean duration of atogepant exposure was 496.5 days, and the mean number of migraine days at baseline was 14.5.
With atogepant, monthly migraine days improved on average by 8.5 days at weeks 13-16, and this was consistent over 48 weeks, Ashina reported. Similar improvements were observed for monthly headache days and monthly acute medication use days.
In addition, 70% of patients achieved ≥ 50% reduction in monthly migraine days at weeks 13-16, and this was consistent during the 48 weeks of open-label treatment.
Overall safety results were consistent with the known safety profile of atogepant. “A small percentage of subjects (< 6%) discontinue the treatment because of side effects,” Tassorelli told Medscape Medical News.
The most common treatment-emergent adverse events (≥ 5% of participants) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).
As the first report of 1-year atogepant data, the results are “very encouraging” for patients and clinicians, Ashina said in wrapping up his presentation.
Important Advance, but Not Transformative
Reached for comment, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, Florida, noted that “[w]hile the anti-CGRP medications represent an important advancement in migraine treatment, the data suggests they have not necessarily transformed the landscape as dramatically as some may have expected.
“The efficacy of the anti-CGRP drugs appears to be generally similar to previous preventive and mostly genericized treatments, offering modest but meaningful improvements in migraine frequency and severity for many patients,” Lakhan told Medscape Medical News.
“In terms of safety, the anti-CGRPs do seem to have a somewhat cleaner profile compared to earlier migraine preventives, which is certainly a positive. However, the long-term data is still emerging, so the full safety picture is not yet clear,” Lakhan added.
“These medications are also associated with significantly higher overall healthcare costs compared to other treatment approaches. The substantial cost implications, both for patients and the healthcare system, deserve careful consideration as we assess their overall value and role in migraine care going forward,” Lakhan said.
Funding was provided by AbbVie. Several investigators have disclosed financial relationships with the company. Lakhan has no relevant disclosures.
