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.
References:
Safety Information
Indication & clinical use:
PrVyepti® (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.
No data are available in the pediatric population (<18 years of age). Therefore, Vyepti® is not authorized for pediatric use.
The safety and efficacy of Vyepti® has not been established in geriatric patients (≥65 years of age). The clinical study program of Vyepti® did not include sufficient numbers of these patients to determine whether they respond differently from younger patients.
Most serious warnings and precautions:
Hypersensitivity reactions: Serious hypersensitivity reactions, including angioedema, urticaria, rash and anaphylactic reactions have been reported with the CGRP-class products including Vyepti®. These reactions may develop within minutes of the infusion. If a serious hypersensitivity reaction occurs, administration of Vyepti® should be discontinued immediately and appropriate therapy initiated.
Other relevant warnings and precautions:
• Patients with cardiovascular diseases
• Patients with diabetes or morbid obesity
• Patients with hereditary fructose intolerance (HFI)
• Hepatic insufficiency
• Patients with HIV, Hepatitis B and C
• Patients with autoimmune disorder
• Patients with neurological disorder
• Renal insufficiency
• Fertility
• Pregnancy
• Breastfeeding
For more information:
Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-586-2325.
