Ubrogepant Sustains Efficacy, Safety in Combination With OnabotulinumtoxinA

At 2- and 4-hours post dose, return to normal function was achieved by 30.1% and 52.1% of participants for their first 10 ubrogepant-treated attacks.

Results from the COURAGE study, a real-world, prospective, observational trial, showed that ubrogepant (Ubrelvy; AbbVie) is a safe and effective acute therapy to treat breakthrough migraine attacks while in combination with onabotulinumtoxinA.1

Presented at the 2022 American Headache Society (AHS) Annual Scientific Meeting, June 9-11, in Denver, Colorado, 53.3% and 76.2% of ubrogepant-treated participants achieved meaningful pain relief (MPR), defined as a reduction of headache pain to a meaningful degree or remaining pain-free, at 2- and 4-hours post dose, respectively. Lead author Richard B. Lipton, MD, director, Edwin S. Lowe Chair in Neurology, vice-chair, Saul R. Korey Department of Neurology, and director, Montefiore Headache Center, and colleagues concluded that further research is needed on the effectiveness of ubrogepant in combination with other preventatives.

Using the Migraine Buddy application, the study collected data on the first ubrogepant-treated attack and first 10 ubrogepant-treated attacks in a cohort of 122 participants who used the combination approach. Those included in the analysis had at least 3 migraine attacks in the previous 30 days, had treated at least 3 prior attacks with ubrogepant, and were concurrently taking an anticalcitonin gene-related peptide (CGRP) monoclonal antibody, onabotulinumtoxinA, or both as migraine preventive treatment.

READ MORE: The MiCOAS Project and the Importance of Patient-Reported Outcomes in Migraine

Most of the cohort were females (95.9%), White (92.2%), and had Migraine Disability Assessment grades of IVb (70.5%), considered very severe. Patients included in the study received either 50 mg ubrogepant (44.3%; n = 55) or 100 mg ubrogepant (55.7%; n = 68) and a median of 9 attacks (interquartile range, 6-12) per respondent were recorded.

At 2- and 4-hours post dose, return to normal function (RNF) was achieved in 25.4% and 45.9% of ubrogepant-treated participants, respectively. For the first 10 ubrogepant-treated attacks, MPR was achieved in 44.8% of attacks at 2 hours and 72.9% of attacks at 4 hours post dose. Similarly, RNF was achieved by 30.1% and 52.1% at 2- and 4-hours post dose, respectively, for the first 10 ubrogepant treated attacks.

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 CGRP antagonist for this indication. Since then, it has been further examined in several analyses, including the real-world, observational, cross-sectional UNIVERSE study. In that study, the therapy was associated with a high satisfaction of pain relief in patients who switched following prior treatment failure, demonstrated by 91.7% of those who reported that they were likely to continue ubrogepant.2

In the UNIVERSE analysis, investigators looked at a subgroup of patients (n = 264; 87.4%) who switched to ubrogepant due to their prior treatment’s lack of efficacy. More than one-third (35.6%) of the subgroup had chronic migraine and more than half (55.9%) previously tried at least 3 triptans. At 2-, 4-, and 24-hours post dose, 76.1%, 83.3%, and 78.4% of patients, respectively, reported satisfaction with ubrogepant for achieving pain relief.

In total, 85.2% of ubrogepant-treated patients reported satisfaction with the ability to think clearly and 84.8% were reportedly satisfied with their return to normal function. In addition to a large majority of patients claiming they were likely to continue treatment, an analysis of prior and concurrent acute medication revealed reduced use of opioids (–28%), barbiturates (–25%), ergots (–15%), nonsteroidal anti-inflammatory drugs (–38%), and other acute medication classes (–37%).

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1. Lipton RB, Engstrom E, Serrano D, et al. Real-world effectiveness of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA preventive: results from the COURAGE study.
2. Shewale AR, Poh W, Reed ML, et al. Real-world effectiveness of ubrogepant among participants with prior treatment failure: subgroup analysis from the UNIVERSE study. Presented at: AAN Annual Meeting; April 2-7, 2022; Seattle, WA, and virtual. Abstract 1167