PDF: COURAGE
(2024)Objective
To evaluate the real-world effectiveness, satisfaction, and treatment optimization of ubrogepant for acute migraine when used with anti-CGRP monoclonal antibodies, with or without onabotulinumtoxinA.
Study Summary
• Meaningful pain relief was achieved in ~80% at 4 hours post-dose
• Over 70% of users were satisfied with treatment
Intervention
App-based, prospective observational study using Migraine Buddy over 30 days; included patients using ubrogepant (50 or 100 mg) with anti-CGRP mAbs, with/without onabotulinumtoxinA.
Inclusion Criteria
• US adults using Migraine Buddy app
• ≥3 migraines in past 30 days
• Previous use of ubrogepant and anti-CGRP mAb or onabotulinumtoxinA
Study Design
Arms: Two arms: (1) Ubrogepant + anti-CGRP mAb, (2) Ubrogepant + anti-CGRP mAb + onabotulinumtoxinA
Patients per Arm: 245 and 69
Outcome
• RNF at 4h: 55.5% (mAb only), 55.1% (mAb + Botox)
• Satisfaction: 72.7% (mAb only), 68.8% (combo)
• mTOQ-4 ≥4: ~80% in both groups
Bottom Line
Ubrogepant demonstrated high real-world effectiveness, functional recovery, and user satisfaction when used with anti-CGRP mAbs, with or without Botox.
Major Points
- Ubrogepant was effective for acute migraine in patients who had prior inadequate response to triptans.
- Pain freedom at 2h: 21.8% (ubrogepant 50mg) and 18.5% (100mg) vs 10.0% (placebo).
- Absence of MBS at 2h: 36.1% (50mg) and 38.9% (100mg) vs 25.5% (placebo).
- Post-hoc analysis of the ACHIEVE trials focusing on triptan-insufficient responders.
- Supports CGRP receptor antagonist as effective alternative after triptan failure.
- Both doses effective — consistent with overall ACHIEVE trial results.
- Ubrogepant: oral small-molecule CGRP receptor antagonist (gepant class).
- AEs: nausea (2-4%), somnolence (1-2%). Well tolerated.
- Important clinical question: gepants fill treatment gap for triptan non-responders.
- Published Headache 2021. AbbVie/Allergan.
Study Design
- Study Type
- Prospective, observational, app-based study
- Randomization
- No
- Blinding
- Unblinded
- Sample Size
- 314
- Follow-up
- 30 days
- Centers
- 1
- Countries
- USA
Primary Outcome
Definition: Meaningful Pain Relief (MPR) at 2 and 4 hours
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| MPR 4h: 80.4% (mAb only), 84.1% (combo) | - (mAb only: 75–85%; combo: 73–91%) |
Limitations & Criticisms
- App-based self-report introduces potential bias
- No placebo or control arm
- Short duration (30 days)
- Migraine diagnosis not confirmed by a clinician
- Limited generalizability to users without app access or digital literacy
Citation
Neurol Ther. 2024;13:69–83. doi:10.1007/s40120-023-00556-8