68 - Ubrogepant is Effective in the Acute Treatment of Migraine with Mild Pain
Richard Lipton1,2, David Dodick3, Peter Goadsby4, Rami Burstein5, Aubrey Adams6, Jeff Lai7, Sung Yu7, Michelle Finnegan7, Joel Trugman7
1Albert Einstein College of Medicine, Bronx, NY, United States Minor Outlying Islands. 2Montefiore Headache Center, Bronx, NY, United States Minor Outlying Islands. 3Mayo Clinic, Phoenix, AZ, United States Minor Outlying Islands. 4NIHR-Wellcome Trust King's Clinical Research Facility, London, United Kingdom. 5Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, United States Minor Outlying Islands. 6AbbVie, Irvine, CA, United States Minor Outlying Islands. 7AbbVie, Madison, NJ, United States Minor Outlying Islands
Purpose Ubrogepant, approved for the acute treatment of migraine in adults with/without aura, demonstrated efficacy in treating migraine with moderate/severe pain. Clinical guidance recommends treatment when pain is mild, a strategy studied herein for ubrogepant. Methods Phase 3, open-label, 52-week extension trial (NCT02873221). Adults with migraine with/without aura, randomized 1:1:1 to usual care, or in blinded fashion to ubrogepant-50mg or -100mg, treated up to 8 migraine attacks of any pain severity every 4 weeks. Efficacy measures, collected only for ubrogepant, included 2-hour pain freedom and absence of migraine-associated symptoms. Data were analyzed by first treated attack and all treated attacks (averaged for each participant and then across participants; individuals weighted equally). Results Data for 21,454 treated attacks (n=808 participants) are included. Across all treated attacks, pain freedom was achieved in a higher proportion of attacks treated with mild vs moderate/severe pain for ubrogepant-50mg (39% vs 19%; p<0.0001) and ubrogepant-100mg (43% vs 21%; p<0.0001). Absence of photophobia was achieved in an average of 55% vs 34% (both doses; p<0.0001) of attacks with mild vs moderate/severe pain, respectively. Absence of phonophobia was achieved in an average of 64% vs 42% (ubrogepant-50mg; p<0.0001) and 70% vs 45% (ubrogepant-100mg; p<0.0001) of attacks with mild vs moderate/severe pain, respectively. Absence of nausea was achieved in an average of 83% vs 67% (ubrogepant-50mg; p<0.0001) and 82% vs 68% (ubrogepant-100mg; p<0.0001) of attacks with mild vs moderate/severe pain, respectively. First treated attack data were similar. Overall, 10% of participants reported treatment-related adverse events; one considered serious (exacerbation of sinus tachycardia). Conclusions Treating migraine patients with ubrogepant when headaches are mild rather than moderate/severe increases the likelihood of rendering them free of pain and associated symptoms.