Marco Aguggia (Italy)
Cardinal Massaia Hospital Headache CenterAuthor Of 1 Presentation
LONG TERM (48-WEEKS) EFFECTIVENESS, SAFETY AND TOLERABILITY OF ERENUMAB IN THE PREVENTION OF HIGH-FREQUENCY EPISODIC AND CHRONIC MIGRAINE IN REAL-WORLD: THE EARLY 2 STUDY.
- Cinzia Aurilia (Italy)
Abstract
Background and Aims:
To assess the long-term effectiveness, safety and tolerability of erenumab in a real-world migraine population, looking for putative predictors of responsiveness.
Methods:
In 48-week, multicenter (n=15) longitudinal cohort real life study, all consecutive adult patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) received erenumab 70 mg monthly. Change in monthly migraine days (MMD) at weeks 45-48 compared to baseline was the primary efficacy endpoint. Secondary endpoints encompassed change in monthly analgesic intake (MAI), ≥50%, ≥75%, or 100% response rates, VAS and HIT-6 scores.
Results:
Of the 242 patients treated with >1 dose, 221 received erenumab for >48 weeks. Patients had >3 prior preventive treatments failures. Most subjects received 140 mg. From baseline to weeks 45-48, erenumab reduced MMD by 4.3 days in HFEM and 12.8 in CM. VAS and HIT-6 were decreased by 1.8 and 12.3 in HFEM, and 3.0 and 13.1 in CM. MAI passed from 11 to 5 in HFEM and from 20 to 6 in CM. >50% responders were 56.1% in HFEM and 75.6% in CM, >75% were 31.6% and 44.5%, and 100% responders 8.8% and 1.2% respectively. Erenumab was safe. Responsiveness predictors were allodynia (p=0.009) in HFEM and male gender (p=0.044) and baseline migraine frequency (p=0.001) in CM. Negative predictors in CM were psychiatric comorbidities (p=0.023) and prior treatment failures (p=0.004).
Conclusions:
Long-term erenumab treatment provides sustained effectiveness, safety and tolerability in HFEM or CM patients with >3 prior preventive treatment failures.