CGRP Monoclonal Antibodies Associated With Improved Migraine Prevention, Patient-Reported Outcomes

October 13, 2020

The largest real-world study of patient-reported outcomes in people with migraine demonstrated the positive benefits that the CGRP mAbs drug class has had on migraine.

Newly published data from Eli Lilly’s OVERCOME study showed that nearly 80% of patients who treated their migraine with calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) self-reported their migraine as “better” overall since starting treatment.

The findings, which were presented at the 18th Migraine Trust International Symposium, October 3–9, 2020, are among the first real-world, population-based, patient-reported outcomes from people using CGRP mAbs as migraine preventive treatment. The data suggest that these novel medications lead to improvement in how patients perceive their migraine.

“It is very encouraging that nearly 4 out of 5 people in the survey taking a CGRP monoclonal antibody felt better and reported their migraine had improved,” Sait Ashina, MD, of the department of neurology and department of anesthesia, Critical Care and Pain Medicine, and Harvard Medical School, Beth Israel Deaconess Medical Center, said in a statement.

OVERCOME is a prospective, web-based patient survey that will enroll 100,000 individuals with migraine from regions across the globe. The newly published data was obtained from participants in Q4 2019 and represented 2.8% of the 20,782 participants in the US OVERCOME 2019 survey, which will ultimately include more than 60,000 individuals with migraine followed for 2 years.

Among a cohort of 586 people using CGRP mAbs for migraine prevention, 79.2% reported perception of their migraine as “better,” 11.3% indicated “no change” and 9.6% said it was “worse.” The amount of headache days per month did not influence the results of migraine perception. In fact, 80.3% of those with 0 to 3 headache days per month, 80.8% with 4 to 7 headache days per month, 79.8% with 8 to 14 headache days per month, and 74.6% with ≥15 headache days per month reported their migraine perception as “better.”

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Ashina, who is also scientific advisor to the OVERCOME study, added that “it is also notable that the OVERCOME survey reported the clinically meaningful distinction between individuals who reported no change in their migraine with those who said their migraine worsened. This distinction can enhance conversations between the healthcare provider and the patient regarding treatment expectations when considering the use of these novel migraine preventive medications.”

Nearly 63% of patients reported the use of an additional recommended migraine preventive medication. Investigators noted that this finding is consistent with the 2018 position statement of the American Headache Society on integrating new migraine treatments into clinical practice and with patients’ existing treatment plans.

Michael C. Meyer, MD, vice president, global medical affairs, biomedicines, Eli Lilly, said in a statement, “given the [American Headache Society] position statement and these exciting results that people reported their migraine as ‘better’ overall after taking novel CGRPs mAbs, Lilly believes the new data informs HCPs of the role CGRP mAbs can play as part of a comprehensive treatment plan for migraine.”

The results showed that a greater number of people with more headache days per month used an additional migraine preventive medication. Specifically, 56.3% of those with 0 to 3 headache days per month, 64.6% with 4 to 7 headache days per month, 70.9% of those with 8 to 14 headache days per month, and 70.2% with ≥15 headache days per month used an additional migraine preventive medication.

Topiramate, divalproex sodium/valproate sodium, metoprolol, timolol, atenolol, nadolol, amitriptyline, nortriptyline, venlafaxine, duloxetine, and onabotunlinumtoxinA were among the recommended preventive medications for migraine as defined by the guidelines of the American Academy of Neurology.

Additional data on the other 40,000 individuals with migraine in the US OVERCOME cohort will be recorded in a cross-sectional survey. Notably, investigators will also assess a cohort of 24,000 people who did not have migraine in attempt to provide a unique perspective about how migraine is perceived by those who do not have the disease.

The use of CGRPs has been well documented as a novel and effective treatment for chronic migraine. Fred Cohen, MD, internal medicine resident physician in the department of medicine at Montefiore Health System, recently sat down with NeurologyLive to discuss the combined use of CGRP medications and onabotulinumtoxinA (Botox) to optimize migraine prevention in patients who have inadequate response to Botox alone. Click below to watch the interview.

REFERENCE
Lilly’s OVERCOME study reveals nearly 80% of people reported improvement in their migraine since starting a CGRP monoclonal antibody for preventive treatment. News release. Eli Lilly. October 9, 2020. Accessed October 13, 2020. https://www.prnewswire.com/news-releases/lillys-overcome-study-reveals-nearly-80-of-people-reported-improvement-in-their-migraine-since-starting-a-cgrp-monoclonal-antibody-for-preventive-treatment-301149147.html