Real World Efficacy, Tolerability and Safety of Ubrogepant
Chia-Chun Chiang1, Karissa Arca2, Rachel Dunn4, Marlene Girardo3, Jaxon Quillen3, David Dodick2, Amaal Starling2
1Neurology, Mayo Clinic, 2Neurology, 3Biostatistics, Mayo Clinic Arizona, 4Mayo Clinic Alix School of Medicine
Objective:

To assess the real-world efficacy, tolerability and safety of ubrogepant in a tertiary headache center.

Background:

Ubrogepant was approved by the FDA in December 2019 for the acute treatment of migraine. There is currently no real-world data of ubrogepant use in a population with chronic migraine, multiple prior unsuccessful acute treatments, and concurrent use of CGRP monoclonal antibodies (mAbs).

Design/Methods:

This was a cohort study conducted at Mayo Clinic Arizona. All patients prescribed ubrogepant were contacted within three months to answer a list of standardized questions.

Results:

Eligible questionnaire responses were obtained from 106 patients, in which 92(86.8%) had chronic migraine, and 78(74%) had tried at least three triptans. Complete headache freedom and headache relief for ≥75% of all treated attacks at 2 hours after taking ubrogepant was achieved in 20(19.1%) and 50(47.6%) patients, respectively. Thirty-three (31.1%) patients were “very satisfied” with ubrogepant. Adverse events (AE) were reported in 42(39.6%) patients, including fatigue in 29(27.4%), dry mouth in 8(7.5%), nausea/vomiting in 7(6.6%), constipation in 5(4.7%), dizziness in 3(2.8%), and other AEs in 7(6.6%). Predictive factors for being a “good responder”, 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, and successful responses to a CGRP mAb and onabotulinumtoxinA injections. For the 62 (58.5%) patients concurrently using a CGRP mAb, there was no difference in the “good responder” rate or AE rate compared to those who were not on a CGRP mAb, though the rate of AEs that were rated as moderate was higher, 11(47.8%) vs 3(17.6%), p=0.048.

Conclusions:

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.