Lundbeck highlights AAN 2026 data showing real-world improvements in migraine-related cognitive symptoms with VYEPTI® (eptinezumab-jjmr)
Lundbeck has presented new real-world data from its ongoing INFUSE study at the American Academy of Neurology Annual Meeting 2026, offering fresh insights into the broader burden of migraine—particularly cognitive symptoms that have historically been underrecognized in both research and clinical care. The six-month interim findings highlight how treatment with VYEPTI may help improve not only migraine frequency but also the often-debilitating cognitive issues commonly described by patients as “brain fog.”
Migraine is widely understood as a complex neurological disorder that extends far beyond episodic headache pain. While clinical trials and treatment strategies have traditionally focused on reducing the frequency and severity of headaches, patients frequently report a constellation of additional symptoms that significantly impair their daily functioning. Among these, cognitive difficulties—such as trouble concentrating, impaired decision-making, and mental cloudiness—are some of the most disruptive yet least systematically studied aspects of the disease.
The INFUSE study seeks to address this gap by capturing patient-reported outcomes in a real-world setting, offering a more comprehensive understanding of how migraine affects individuals’ lives. Unlike controlled clinical trials, real-world studies provide insights into how therapies perform in routine clinical practice, reflecting a broader and more diverse patient population. In this context, the six-month interim analysis of INFUSE places a particular emphasis on cognitive symptoms and their response to preventive treatment.
According to Amaal Starling, M.D., a neurologist at Mayo Clinic and an author of the study, migraine is a highly individualized condition characterized by fluctuating symptoms, varying levels of disability, and significant impacts on quality of life. She noted that many patients describe “brain fog” as one of the most challenging aspects of their condition, often interfering with work productivity, social interactions, and even basic daily tasks. Despite its prevalence, this symptom has received relatively little attention in traditional clinical research.
The INFUSE data presented at AAN 2026 aim to shift that perspective by highlighting the importance of evaluating migraine holistically. At baseline, the study population—comprising individuals with a high burden of disease—reported substantial cognitive impairment. A significant proportion of participants described symptoms such as difficulty making decisions (reported as moderately to extremely bothersome by 64.7 percent), challenges with reading comprehension (60.0 percent), difficulty performing complex tasks (62.6 percent), and brain fog, including trouble concentrating, finding words, and maintaining mental clarity (82.1 percent). These findings underscore the pervasive nature of cognitive dysfunction in migraine and its impact on patients’ everyday lives.
Following treatment with VYEPTI, a preventive therapy indicated for adults with migraine, patients reported meaningful improvements across these cognitive domains. After six months of treatment—corresponding to two doses of the therapy—more than half of the participants experienced improvements in individual cognitive symptoms compared to baseline. Notably, some patients began to report improvements as early as seven days after initiating treatment, suggesting a relatively rapid onset of benefit.
These results are particularly significant given the study population, which included individuals who continued to experience a high disease burden despite prior treatment with anti-calcitonin gene-related peptide (anti-CGRP) therapies. This indicates that VYEPTI may offer additional benefits even for patients who have not achieved adequate symptom control with other preventive options.
The findings also highlight the importance of incorporating patient-reported outcomes into clinical decision-making. Traditional clinical endpoints, such as reduction in monthly migraine days, provide valuable information but may not fully capture the aspects of disease that matter most to patients. By focusing on cognitive symptoms and quality of life, the INFUSE study offers a more patient-centered perspective on treatment effectiveness.
Damian Fiore, Vice President of U.S. Medical Affairs Neurology at Lundbeck, emphasized that these real-world data provide deeper insight into managing the full spectrum of migraine burden. He noted that understanding and addressing cognitive symptoms can help clinicians make more informed treatment decisions and set more comprehensive goals for patient care. The company views these findings as part of a broader effort to redefine expectations for preventive migraine therapy and improve overall standards of care.
VYEPTI (eptinezumab-jjmr) is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP), a molecule known to play a key role in the pathophysiology of migraine. By inhibiting CGRP activity, the therapy helps prevent migraine attacks before they begin. It is administered via intravenous infusion and is approved for the preventive treatment of migraine in adults. However, like all medications, it carries certain risks and is contraindicated in patients with serious hypersensitivity to its components, with reported reactions including anaphylaxis and angioedema.
The broader implications of the INFUSE study extend beyond the specific therapy being evaluated. They point to a growing recognition within the medical community that migraine is a multifaceted condition requiring equally multifaceted treatment approaches. Cognitive symptoms, in particular, represent an area of unmet need that warrants greater attention in both research and clinical practice.
In addition to the cognitive-focused analysis, Lundbeck is presenting further data on VYEPTI at AAN 2026, including studies examining its effectiveness in patients who have failed one or more prior anti-CGRP preventive treatments, as well as its impact on interictal periods—the time between migraine attacks—and overall quality of life. These additional analyses contribute to a more comprehensive understanding of how the therapy may benefit patients across different clinical scenarios.
The emphasis on real-world evidence reflects a broader trend in healthcare toward more personalized and patient-centered care. By capturing the lived experiences of patients, studies like INFUSE can help bridge the gap between clinical trial data and everyday practice. This approach not only enhances the relevance of research findings but also supports the development of treatment strategies that align more closely with patient needs and priorities.
For individuals living with migraine, the potential to alleviate cognitive symptoms represents a meaningful advancement. Brain fog and related issues can be just as disabling as the headache itself, affecting professional performance, interpersonal relationships, and overall well-being. Addressing these symptoms can therefore have a profound impact on patients’ quality of life.
As the understanding of migraine continues to evolve, the integration of therapies that target both physical and cognitive aspects of the disease will likely become increasingly important. The data presented by Lundbeck at AAN 2026 suggest that VYEPTI may play a role in this paradigm shift, offering benefits that extend beyond traditional measures of efficacy.
Looking ahead, further research will be needed to confirm these findings and explore their long-term implications. Larger studies and longer follow-up periods could provide additional insights into the durability of cognitive improvements and their relationship to other clinical outcomes. Nonetheless, the current results represent an important step toward a more holistic approach to migraine management.
In summary, the six-month interim data from the INFUSE study highlight the significant burden of cognitive symptoms in migraine and demonstrate the potential for VYEPTI to address these challenges in a real-world setting. By emphasizing patient-reported outcomes and focusing on aspects of disease that matter most to individuals, the study contributes to a more comprehensive understanding of migraine and its treatment—one that prioritizes not only symptom reduction but also meaningful improvements in daily life.
About VYEPTI
VYEPTI® (eptinezumab-jjmr) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. VYEPTI was deliberately developed for administration by IV infusion to deliver 100 percent of the medication into the bloodstream at the end of the infusion.
The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials; episodic migraine in PROMISE-1 and chronic migraine in PROMISE-2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9 percent of patients treated with VYEPTI discontinued treatment due to adverse reactions.
VYEPTI offers patients with migraine a preventive treatment administered as one 30-minute IV infusion 4 times a year (every three months). The recommended dosage is 100 mg, and some patients may benefit from a dosage of 300 mg. Dosing should be based on the guidance in the Prescribing Information and Patient Information.
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