Dose-Dependent Weight Reductions Observed With Atogepant
In the open-label extension where the highest dose of atogepant (Qulipta; AbbVie) was observed, 24.1% of participants had at least 7% weight loss compared with 14.7% of those on standard of care.
Atogepant (Qulipta; AbbVie), an oral, calcitonin gene-related peptide (CGRP) receptor antagonist FDA-approved for the prevention of migraine, was found to be associated with dose-dependent decreases in body weight, according to new post-hoc data from the phase 3 ADVANCE study (NCT02848326).1
Presented at the
ADVANCE was a phase 3 trial that included 873 patients with episodic migraine who were randomized 1:1:1:1 to receive a once-daily dose of oral atogepant (10 mg, 30 mg, or 60 mg) or placebo for 12 weeks. Led by
In ADVANCE, 3.2% of those on placebo demonstrated at least 7% weight loss compared with 4.1%, 2.7%, and 5.7% for the atogepant 10-, 30-, and 60-mg groups, respectively. In contrast, weight gains of at least 7% were found in 2.3%, 1.8%, and 0.0% of those in the respective atogepant groups and 2.7% of those on placebo.
The analysis also included data from the open-label, 52-week extension, which randomized patients 1:1 to either standard of care or once-daily atogepant 60 mg. Here, Dodick et al observed LS mean percentage change of +0.19 for body fat after 52 weeks on standard of care vs –1.57 for those in the highest dose atogepant group (P =.0003). In comparison, 14.7% of those on standard of care had at least 7% weight loss compared with 24.1% of those on atogepant 60 mg. Weight gains of at least 7% were observed in 12.6% and 7.3% of those on standard of care or atogepant 60 mg, respectively.
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After the American Academy of Neurology Annual Meeting, April 2-7, 2022, where similar results from ADVANCE were also presented, NeurologyLive® spoke with Jessica Ailani, MD, director, MedStar Georgetown Headache Center, on the Mind Moments™ podcast, about these data. Ailani, who presented the data at AHS 2022, noted that the body weight decrease observed not usually a concern for women, who make up the majority of patients with migraine. She called the results surprising, but good, news.
"We don't really have any other preventive treatment that does this outside of topiramate, and most of the time, patients are coming in asking for anything that doesn't cause weight gain. They say, ‘as long as it doesn't cause weight gain, I'm going to be okay with it,’” she said. “Just to give us a frame of reference, about 10% of people will lose about 10% of their body weight on topiramate. That's the average that we're looking at, with a similar preventive medication treatment regimen, for people for with migraine. In patients who are starting atogepant, at 60 mg daily for migraine prevention, we tell them that they can have a decrease of body weight, but that is usually a small amount of body weight. It's also important to realize that this was seen across the spectrum. If a person was on the smaller side or on had a larger BMI where they could lose weight, and then the longer they were on it, the more likely they would lose weight."
Ailani noted that the individuals who were on atogepant for 52 weeks were more likely to lose slightly more weight than those that remained on it only for 3 months. She said that the underlying process for this weight loss was still being investigated, as it did not appear to be correlated with response or the CGRP-focused mechanism of action.
"I think this is a fascinating area, and personally, for someone who's a clinician very interested in science, this just shows us that these drugs do have other targets, especially the oral agents, and that's probably might have some meaning and how they're working for migraine as well,” Ailani said. “It's really opened up this whole area of, ‘Oh my goodness, look, there's something else going on.’ What does that actually mean about this drug, and what else it could possibly be doing? Is this something that's unique to atogepant, or are we going to see it with other products? It wasn't seen with rimegepant, but that is dosed every other day. So, is it unique to dosing? Is it unique to dosing regimen? We may see it with other future gepants, so I think it's something for us to watch."
In the
Although approved for episodic migraine, the preventive recently met its primary end point in a phase 3 study evaluating patients with chronic migraine (CM).
REFERENCES
1. Dodick DW, Hay DL, Walker CS, et al. Decrease in body weight with once-daily atogepant for the preventive treatment of migraine: a post hoc analysis. Presented at: AHS Annual Meeting, 2022; June 9-12; IOR-11
2. Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. NEJM. 2021; 385:695-706. doi:10.1056/NEJMoa2035908
3. AbbVie announces positive phase 3 atogepant (Qulipta) data for preventive treatment of chronic migraine. News release. AbbVie. March 10, 2022. Accessed June 14, 2022. https://news.abbvie.com/news/press-releases/abbvie-announces-positive-phase-3-atogepant-qulipta-data-for-preventive-treatment-chronic-migraine.htm
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