VYEPTI® SIGNIFICANTLY REDUCED MONTHLY MIGRAINE DAYS
VS. PLACEBO IN PATIENTS WITH EPISODIC MIGRAINE (PROMISE 1 TRIAL) AND IN PATIENTS WITH CHRONIC MIGRAINE (PROMISE 2 TRIAL)
(Primary endpoint chronic migraine: Reduction in mean MMD from baseline; Vyepti® -7.7, placebo -5.6, p<0.0001; difference from placebo = -2; CI95% [-2.9, -1.2])1,2
(Primary endpoint episodic migraine: Reduction in mean MMD from baseline; Vyepti® -3.9, placebo -3.2, p=0.0182; difference from placebo = -0.7; CI95% [-1.3, -0.1])1,3
Vyepti® (eptinezumab for injection) is indicated for the prevention of migraine in adults who have at least 4 migraine days per month. Vyepti® should be prescribed by healthcare professionals experienced in the diagnosis and treatment of migraine.
ONE 30-MINUTE IV INFUSION EVERY 12 WEEKS
coordinated by the
Reduction in mean MMD from baseline
MIGRAINE RESPONDER RATES
CHRONIC MIGRAINE – PROMISE-2 TRIAL
≥75% MMD reduction from baseline was achieved in 27% of patients taking Vyepti® vs. 15% of patients taking placebo1,2 (Key secondary endpoint)
Adapted from Product Monograph
≥50% MMD reduction from baseline was achieved in 58% of patients taking Vyepti® vs. 39% of patients taking placebo1,2 (Key secondary endpoint)
Adapted from Product Monograph
EPISODIC MIGRAINE – PROMISE-1 TRIAL
≥75% MMD reduction from baseline was achieved in 31% of patients taking Vyepti® vs. 20% of patients taking placebo1,3 (Key secondary endpoint)
Adapted from Product Monograph
MEDICATION OVERUSE HEADACHE (MOH) AND CHRONIC MIGRAINE DATA1,4
CHRONIC MIGRAINE – PROMISE-2 TRIAL
- A total of 431 patients (40%) with a dual diagnosis of chronic migraine and MOH were included in the study
Treatment difference observed for the reduction of MMDs:1,4
- -3 MMDs between Vyepti® 100 mg and placebo
- Overuse of triptans, ergotamine, or combination analgesics >10 days/month OR
- Acetaminophen, acetylsalicylic acid, or NSAID ≥15 days/month
MOH diagnosis:
MMD=monthly migraine day
*A parallel-group, double-blind, placebo-controlled global trial to evaluate the efficacy and safety of Vyepti® for the preventive treatment of chronic migraine (defined as ≥15 to ≤26 headache days, of which ≥8 were assessed as migraine days) in adults. A total of 1,072 patients were randomized and received placebo (n=366), eptinezumab 100 mg (n=356), or eptinezumab 300 mg (n=350) every 12 weeks for 24 weeks (2 infusions). The primary endpoint was the change from baseline in MMD over weeks 1-12. Key secondary endpoints included migraine responder rates defined as the proportion of patients achieving ≥75% reduction in migraine days over weeks 1-4 and 1-12.
†A parallel-group, double-blind, placebo-controlled global trial to evaluate the efficacy and safety of Vyepti® for the preventive treatment of episodic migraine in adults (defined as ≥4 and ≤14 headache days of which at least 4 had to be migraine days during the 28-day screening period) in adults. A total of 888 patients were randomized and received placebo (n=222), Vyepti® 30 mg (n=223), Vyepti®100 mg (n=221), or Vyepti®300 mg (n=222) every 12 weeks for 48 weeks (4 infusions). Patients were allowed to use concurrent acute migraine or headache medications, including migraine-specific medications (e.g., triptans, ergotamine derivatives), during the trial. Regular use (greater than 7 days per month) of other treatments for the prevention of migraine was not allowed. The key secondary efficacy endpoints were 75% migraine responder rate over weeks 1-4, 75% migraine responder rate over weeks 1-12, 50% migraine responder rate over weeks 1-12, and percentage of patients with a migraine on the day after dosing.
‡Migraine responder rates were defined as the proportion of patients achieving ≥75% or ≥50% reduction from baseline in monthly migraine days during the specified time frame.
- Vyepti® Product Monograph. Lundbeck Canada Inc.
- Lipton RB, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377.
- Ashina M, et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254.
- Diener HC, et al. Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication overuse headache: Subgroup analysis of PROMISE-2. Headache. 2021;61:125-136.
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