The efficacy and safety of
ubrogepant for the acute treatment of
migraine were established in phase 3 randomized controlled trials. However, there is no real-world data of patient experience with
ubrogepant in a population in which the majority of patients have chronic
migraine, multiple prior unsuccessful treatments, complex medical comorbidities, and concurrent use of other
migraine-specific medications.
METHOD: This was a post-market cohort study conducted at Mayo Clinic Arizona. All patients prescribed
ubrogepant were tracked and contacted 1-3 months after the prescription to answer a list of standardized questions. Demographic information and additional
headache history were obtained from chart review.
RESULTS: We obtained eligible questionnaire responses from 106 patients. Chronic
migraine accounted for 92/106 (86.8%) of the population. Complete
headache freedom (from mild/moderate/severe to no
pain) and
headache relief (from moderate/severe to mild/no
pain or mild to no
pain) for ≥75% of all treated attacks at 2 hours after taking
ubrogepant were achieved in 20/105 (19.0%) and 50/105 (47.6%) patients, respectively. A total of 33/106 (31.1%) patients reported being "very satisfied" with
ubrogepant. Adverse events were reported in 42/106 (39.6%) patients, including
fatigue in 29/106 (27.4%), dry mouth in 8/106 (7.5%),
nausea/
vomiting in 7/106 (6.6%),
constipation in 5/106 (4.7%),
dizziness in 3/106 (2.8%), and other adverse events in 7/106 (6.6%). Predictive factors for being a "good responder" to
ubrogepant, defined as
headache relief for ≥75% of all treated attacks at 2 hours after taking
ubrogepant, included
migraine with aura, episodic
migraine, <5 prior unsuccessful preventive or acute treatment trials. Additionally, prior treatment responses to a CGRP
monoclonal antibody and
onabotulinumtoxinA injections are predictive of treatment responses and patient satisfaction to
ubrogepant. For the 62/106 (58.5%) patients concurrently using a CGRP
monoclonal antibody, there was no difference in the "good responder" rate or adverse event rate compared to those who were not on a CGRP
monoclonal antibody, though the rate of moderate, as opposed to mild adverse events was higher, 11/62 (47.8%) versus 3/44 (17.6%), p = 0.048. Additionally, 16 patients had a history of significant cardiovascular or
cerebrovascular diseases. No severe adverse events were reported in any patient.
CONCLUSION: Our study confirms and extends the efficacy profile and tolerability of
ubrogepant in a real-world tertiary
headache clinic and identifies factors that may predict efficacy. Adverse event rates were higher than reported in clinical trials. Further studies are needed to confirm these findings and to evaluate the long-term efficacy and safety of
ubrogepant.