Eptinezumab achieved 82.3% ≥50% and 51.6% ≥75% migraine response over 48 weeks in real-world patients.
Background
Long-term real-world data on the effectiveness of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) for migraine prevention, especially beyond 24 weeks, remains limited. This gap is particularly critical for patients suffering from high-frequency episodic migraine (HFEM) or chronic migraine (CM) who have failed multiple prior preventive treatments. Eptinezumab, an intravenous anti-CGRP mAb, offers a distinct administration profile, and understanding its sustained efficacy and super-response rates in complex, real-world populations is essential for optimizing treatment strategies.
Study Design
The EMBRACEIII study was a prospective, multicenter, observational study enrolling 261 adults with HFEM or CM who had experienced ≥3 prior preventive treatment failures. Participants received eptinezumab 100 mg intravenously every 12 weeks, with an optional dose escalation to 300 mg after week 12 if response was inadequate. Co-primary endpoints were ≥50% and ≥75% reductions in monthly migraine/headache days (MMD/MHD) at weeks 45-48 compared to baseline. Secondary endpoints included changes in monthly analgesic intake (MAI), pain intensity (NRS), and migraine-related disability (HIT-6, MIDAS, MIBS-4).
Results
Among the 261 patients, 124 completed ≥48 weeks of treatment. At week 48, the response rates were notably high: ≥50% reduction in MMD/MHD was achieved by 82.3% of patients, while a ≥75% super-response was observed in 51.6%. A 100% response rate was achieved by 9.7% of patients. All secondary endpoints demonstrated significant improvements (p < 0.001) from baseline. Monthly migraine/headache days decreased by -15.5, monthly analgesic intake by -14.9, and NRS pain intensity by -3.3. Migraine impact scores also improved significantly: HIT-6 by -20.6, MIDAS by -74, and MIBS-4 by -4.3. Furthermore, 94.8% of patients reported global treatment improvement via PGI-C. Dose escalation to 300 mg occurred in 69.4% of patients, with those receiving ≥3 doses of 300 mg achieving comparable outcomes.
At week 48, 82.3% of patients achieved a ≥50% reduction in monthly migraine/headache days, with 51.6% achieving a ≥75% super-response.
Key Findings
- At week 48, 82.3% of patients achieved a ≥50% reduction in monthly migraine/headache days.
- A ≥75% super-response rate was observed in 51.6% of patients at week 48.
- Monthly migraine/headache days significantly decreased by -15.5 from baseline (
p < 0.001). - 94.8% of patients reported global treatment improvement via the
PGI-Cquestionnaire. - Dose escalation to 300 mg occurred in 69.4% of patients, maintaining comparable outcomes.
Why It Matters
Eptinezumab demonstrates sustained, high-level efficacy in real-world settings for difficult-to-treat migraine patients, including those with multiple prior treatment failures. This long-term, observational data provides crucial evidence supporting its use and the benefit of dose escalation for individuals with chronic or high-frequency episodic migraine. The significant improvements across multiple patient-reported outcomes, including pain, disability, and global impression of change, suggest a substantial positive impact on quality of life. This reinforces eptinezumab as a valuable option in the therapeutic arsenal, particularly for those who have exhausted other preventive strategies, offering a clear protocol for initial dosing and potential escalation.
eptinezumab
migraine
chronic-migraine
hfem
cgrp-inhibitor
real-world-evidence