Ubrogepant Shows Efficacy for Patients With Chronic and Episodic Migraine

Chia-Chun Chiang, MD

Preliminary results from a real-world study evaluating ubrogepant (Ubrelvy; Allergen), lasmiditan (Reyvow; Eli Lilly), and rimegepant (Nurtec ODT; Biohaven) in patients with chronic and episodic migraine revealed that ubrogepant showed significant efficacy with regard to pain freedom and headache relief at 2 hours post-dose.

The data, which at time of presentation only included survey results for ubrogepant, showed that 39 of the 57 (68%) respondents reported that ubrogepant had completely aborted headache pain in 2 hours. Among the 57 respondents, 81% reported suffering from chronic migraine. The survery results for rimegepant and lasmiditan are still under analysis.

The study was presented virtually at the 2020 American Headache Society (AHS) Annual Scientific Meeting, June 13, 2020, by Chia-Chun Chiang, MD, a neurologist at Mayo Clinic in Scottsdale, Arizona, and colleagues. The focus of the study was to asses real-world efficacy, tolerability, and safety of the 3 newly FDA-approved medications in patients with episodic and chronic migraine. The study used a structured questionnaire with approximately 15 questions that was administered to patients who had been prescribed one of the treatments for 1 to 3 months.

Using the RedCap database, frequency of ubrogepant use since its prescription was 5 (3.5) days per month, with a range of 1 to 16 days per month. In total, 32% reported that they were very satisfied with the treatment, 34% said somewhat satisfied, and 34% reported not satisfied at all. The respondents included 49 women and 8 men, with an average age of 47.3 (19 to 83) years old. Chronic migraine was the diagnosis in 48 (81%) patients, migraine with aura in 25 (44%), and migraine without aura in 32 (56%) patients.

The results also showed that 18 (32%) patients experienced headache freedom at 2 hours after taking the treatment for 1 or more attacks. Notably, 7 (12%) patients said ubrogepant consistently provided complete headache freedom at 2 hours. In addition to abortion of headache, Chiang and colleagues measured headache relief, from moderate or severe to mild or no pain, within 2 hours of administration. They found that 16 (27%) patients claimed it never reduced pain in 2 hours, 41 (73%) reported pain relief for 1 or more attacks, and 16 (27%) patients said ubrogepant always provided pain relief.

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Fatigue was among the most commonly reported adverse events (AE), reported by 22% of patients. Overall, 74% of AEs were reported as mild and 26% as moderate. Other AEs included nausea (7%), dry mouth (7%), constipation (2%) and others (3%).

The researchers concluded that, “systematically collecting, analyzing, and reporting real-world efficacy and tolerability data for newly FDA-approved acute migraine medications ubrogepant, rimegepant, and lasmiditan will provide important clinical evidence that will supplement results from placebo-controlled trials and inform decision-making in clinical practice.”

Ubrogepant was approved for the acute treatment of migraine with or without aura by the FDA in December 2019, making it the first-in-class oral calcitonin gene-related peptide (CGRP) antagonist for this indication.²

The researchers did not indicate when survey data on lasmiditan or rimegepant would be released.

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REFERENCES

1. Chiang C, Starling AJ, Dodick DW. Real world efficacy, tolerability and safety of ubrogepant, rimegepant, and lasmiditan. Headache. 2020;60(S1 suppl). 1—156. doi: 10.1111/head.13854

2. FDA approves new treatment for adults with migraine. News release. FDA. December 23, 2019. Accessed June 15, 2020. fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-migraine