Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain Versus Moderate or Severe Pain

Abstract

ObjectiveTo examine the efficacy of ubrogepant in the treatment of migraine with mild versus moderate or severe pain.MethodsPhase-3, open-label, dose-blinded, 52-week extension trial. Adults with migraine were randomized 1:1:1 (usual care, ubrogepant-50mg, or ubrogepant-100mg). Participants treated up to 8 migraine attacks of any pain intensity every 4 weeks. Efficacy outcomes (only collected for ubrogepant) included 2-hour pain freedom (2hPF), freedom from associated symptoms, and from disability. A generalized linear mixed model with binomial distribution and logit link function was used to assess the influence of baseline pain intensity on treatment outcomes in this post hoc analysis.ResultsData for 19,291 attacks from 808 participants are included. 2hPF rates were higher for attacks treated when pain was mild versus moderate or severe: ubrogepant-50mg (47.1% versus 23.6%; OR[95%CI]=2.89[2.57,3.24] and ubrogepant-100mg (55.2% versus 26.1%; 3.50[3.12, 3.92]; P<.0001 both doses). Rates of freedom from photophobia, phonophobia, and nausea 2 hours post-treatment were also significantly higher following treatment of mild versus moderate or severe pain (P<0.001 all symptoms, both doses). At 2-hours, the proportion of attacks with normal function was more than double for both doses of ubrogepant (P<0.001). The most common adverse event was upper respiratory tract infection (∼11% both doses). Serious adverse events were reported by 2% in ubrogepant-50mg and 3% in ubrogepant-100mg.Conclusion:Relative to attacks treated with moderate or severe pain, treatment with ubrogepant during mild pain resulted in significantly higher rates of freedom from pain, freedom from associated symptoms, and achieving normal function two hours after administration.(Funded by Allergan plc [prior to acquisition by AbbVie]; ClinicalTrials.govNCT02873221)Classification of Evidence:This study provides Class III evidence that ubrogepant, 50 mg or 100 mg, used by adults when migraine headache is mild as compared to when migraine headache is moderate to severe increases the probability of freedom from migraine headache pain, migraine associated symptoms, and disability 2 hours later.