Real‐world efficacy, tolerability, and safety of ubrogepant

Abstract

Objective: To assess the real-world efficacy, tolerability, and safety of ubrogepant in a tertiary headache center. Background: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 onabotuli-numtoxinA 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. How to cite this article: Chiang C , Arca KN, Dunn RB, et al. Real-world efficacy, tolerability, and safety of ubrogepant.

Ubrogepant in the Acute Management of Migraine: A Narrative Review

“…12 In the real-world study, 56 patients used ubrogepant while the pain was mild, and ubrogepant was able to abort mild headache attacks reliably for ≥75% of the attacks for 23 (41.1%) patients, as opposed to achieving pain freedom for ≥75% of the attacks for 19.0% patients for all treated attacks, regardless of pain severity. 10 This supports the efficacy of ubrogepant for mild headache attacks, and the general clinical recommendation to treat headache early when the pain is still mild for better treatment efficacy.…”

“…1 The efficacy of ubrogepant was confirmed in a realworld patient experience study conducted in a tertiary headache center, where the majority of patients, 86.6%, had chronic migraine, and had experienced lack of efficacy or intolerance to 7 (median, range 0-34) preventive and 5 (median, range 0-32) acute migraine medications, and 77.5% patients had tried and found ineffective or had intolerance to at least two unique triptans. 10 Based on the results of 106 survey responses, 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 was achieved in 19.0% and 47.6% patients, respectively. Additionally, a total of 31.1% patients in this group reported being "very satisfied" with ubrogepant, 38.7% patients reported being "somewhat satisfied" and 30.2% patients reported "not at all satisfied" with ubrogepant.…”

“…The responses of a standardized questionnaire from 106 patients were analyzed and presented in a previous manuscript. 10 Safety data from the open-label, 52-week extension phase of the ACHIEVE I and ACHIEVE II trials has also been published. 11 The data from the 52-week open extension trial, as well as the real-world patient experience data complements and extends the results from the Phase III clinical trials and provides additional information to address the above limitations.…”

Constipation Caused by Anti-calcitonin Gene-Related Peptide Migraine Therapeutics Explained by Antagonism of Calcitonin Gene-Related Peptide’s Motor-Stimulating and Prosecretory Function in the Intestine

“…As regards the small molecule CGRP receptor antagonists, only one post-approval survey has been published, showing that 4.7% of patients on ubrogepant complained about constipation ( Chiang et al, 2021 ). As described in the previous section of this article, no mention of constipation as an adverse effect was made in the phase 3 trials of ubrogepant.…”

New Generation Gepants: Migraine Acute and Preventive Medications

“…No other predictors of efficacy have been reported, although in a recent study assessing real-world experience, the presence of aura or episodic migraine, a low number of previous failed preventives and positive responses to treatment with onabotulinumtoxinA or monoclonal antibodies targeting the CGRP pathways could predict a good response. However, concomitant treatment with the latter may increase possible adverse events [ 48 ]. The potential role of gepants in sensitization has been recently investigated in a preclinical model of medication overuse headache evoked by sumatriptan, which was administered over more than 10 days.…”