Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: results from the COURAGE Study.
| Title: | Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: results from the COURAGE Study. |
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| Authors: | Manack Adams A; AbbVie, 2525 Dupont Dr, Irvine, CA, 92612, USA. aubrey.adams@abbvie.com.; Hutchinson S; Orange County Migraine and Headache Center, Irvine, CA, USA.; Engstrom E; OPEN Health, Bethesda, MD, USA.; Ayasse ND; OPEN Health, Bethesda, MD, USA.; Serrano D; OPEN Health, Bethesda, MD, USA.; Davis L; Kolvita Family Medical Group, Mission Viejo, CA, USA.; Sommer K; AbbVie, 2525 Dupont Dr, Irvine, CA, 92612, USA.; Contreras-De Lama J; AbbVie, 2525 Dupont Dr, Irvine, CA, 92612, USA.; Lipton RB; Albert Einstein College of Medicine, Bronx, NY, USA. |
| Source: | The journal of headache and pain [J Headache Pain] 2023 Aug 03; Vol. 24 (1), pp. 102. Date of Electronic Publication: 2023 Aug 03. |
| Publication Type: | Observational Study; Journal Article |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 100940562 Publication Model: Electronic Cited Medium: Internet ISSN: 1129-2377 (Electronic) Linking ISSN: 11292369 NLM ISO Abbreviation: J Headache Pain Subsets: MEDLINE |
| Imprint Name(s): | Publication: [2018]- : [London, United Kingdom] : BioMed Central; Original Publication: Milano : Springer Verlag Italia, c2000- |
| MeSH Terms: | Botulinum Toxins, Type A*/therapeutic use ; Migraine Disorders*/drug therapy ; Migraine Disorders*/prevention & control ; Courage*; Pain/drug therapy ; Humans ; Prospective Studies ; Personal Satisfaction ; Treatment Outcome ; Pyridines ; Pyrroles |
| Abstract: | Background: Individuals using onabotulinumtoxinA as a preventive migraine treatment often use acute treatments for breakthrough attacks. Data on real-world effectiveness of the small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant in combination with onabotulinumtoxinA are limited.; Methods: COURAGE, a prospective, multiple attack, observational study, evaluated the real-world effectiveness of ubrogepant (50 or 100 mg) for acute treatment of migraine in people receiving onabotulinumtoxinA, an anti-CGRP monoclonal antibody (mAb), or both. This analysis focused only on onabotulinumtoxinA users. The Migraine Buddy app was used to identify eligible participants and track response to treated attacks. For each ubrogepant-treated attack, meaningful pain relief (MPR) and return to normal function (RNF) at 2 and 4 h post-dose over 30 days was assessed. MPR was defined as a level of relief that is meaningful to the participant, usually occurring before the pain is all gone. After 30 days, satisfaction was reported on a 7-point scale and overall acute treatment optimization was evaluated using the migraine Treatment Optimization Questionnaire-4 (mTOQ-4).; Results: This analysis included 122 participants who received ubrogepant and onabotulinumtoxinA and reported on 599 ubrogepant-treated attacks. Following the first ubrogepant-treated attack, MPR was achieved in 53.3% of participants 2 h post-dose and in 76.2% of participants 4 h post-dose. RNF was achieved in 25.4% of participants 2 h post-dose and in 45.9% of participants 4 h post-dose. MPR and RNF results were similar across up to 10 ubrogepant-treated attacks. After 30 days, satisfaction with ubrogepant in combination with onabotulinumtoxinA was reported by 69.8% of participants and acute treatment optimization (defined as mTOQ-4 score ≥ 4) was achieved in 77.6%.; Conclusions: In this prospective real-world effectiveness study, ubrogepant treatment in onabotulinumtoxinA users with self-identified migraine was associated with high rates of MPR and RNF at 2 and 4 h as well as satisfaction and acute treatment optimization. Although the lack of a contemporaneous control group limits causal inference, these findings demonstrate the feasibility of using a novel, app-based design to evaluate the real-world effectiveness and satisfaction of treatments.; (© 2023. Springer-Verlag Italia S.r.l., part of Springer Nature.) |
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| Contributed Indexing: | Keywords: Chronic migraine; OnabotulinumtoxinA; Ubrogepant |
| Substance Nomenclature: | EC 3.4.24.69 (Botulinum Toxins, Type A); AD0O8X2QJR (ubrogepant); 0 (Pyridines); 0 (Pyrroles) |
| Entry Date(s): | Date Created: 20230803 Date Completed: 20230807 Latest Revision: 20260127 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC10399003 |
| DOI: | 10.1186/s10194-023-01622-0 |
| PMID: | 37537578 |
| Database: | MEDLINE |
Observational Study; Journal Article