68 - Ubrogepant is Effective in the Acute Treatment of Migraine with Mild Pain

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.