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EXPLORING VYEPTI®
(eptinezumab-jjmr):
A CHRONIC MIGRAINE
CASE STUDY

Patient case courtesy of and used with permission from:
Charles Argoff, MD
Professor of Neurology and Director of the Comprehensive Pain Center Albany Medical Center, Albany, NY

This case study is presented in compliance with HIPAA privacy rules. Individual results may vary.

Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information and Patient Information or go to VYEPTIhcp.com. © 2021 Lundbeck. All rights reserved. VYEPTI is a trademark of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-100454v2

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DIGITAL PATIENT CASE STUDY: CHRONIC MIGRAINE
Objectives
1

Discover the treatment journey of a patient with chronic migraine and their experience with VYEPTI® (eptinezumab-jjmr)

2

Learn about the safety and efficacy of VYEPTI by examination of clinical trial findings

Click here for INSTRUCTIONS on how to navigate

INDICATION

VYEPTI is indicated for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS

Hypersensitivity reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, have occurred with VYEPTI in clinical trials. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.

ADVERSE REACTIONS

The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.

For more information, please see the Full Prescribing Information and Patient Information or go to VYEPTIhcp.com.

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DIGITAL PATIENT CASE STUDY: CHRONIC MIGRAINE
Instructions
1.
This is a self-guided exploration of a real patient case
2.
Please navigate through the case by clicking on the tabs and the subtabs across the top of each page, or by using the forward and backward arrows to the right and left of each page
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
Patient Presentation
46-year-old female
Current diagnosis Chronic Migraine, 10 years
Baseline mean monthly migraine days (MMD) 22
Baseline mean acute medication days per month 22
Age at initial diagnosis 17 (initial diagnosis of migraine)
BMI 27.8
Comorbidities Hyperlipidemia, hypothyroidism, vitamin D deficiency, GERD
Patient goals of treatment Reduce the impact the disease has on job attendance and ability to work (2 jobs). Wants to be able to go to nursing school as well.
BMI, body mass index; GERD, gastroesophageal reflux disorder.
Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
Please click above to learn about treatment history
Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
Patient Treatment History
AGE 17-36
Prior to Specialist Referral
AGE 36-44AGE 44-46
After Chronic Migraine (CM) Diagnosis Under Specialist Care
Acute migraine Various OTC
and prescription
analgesics, triptan
Preventive migraine Beta blocker,
anticonvulsant
Concomitant
Baseline
MMD
22
Triptans
Previous plus
antidepressant,
neurotoxin
Proton-pump inhibitor,
thyroid hormone
treatment, multivitamin
Patient MMD
went down to
~10
Triptan
Previous plus
anti-CGRP mAbs
Proton-pump inhibitor,
hormone treatment,
multivitamin
Patient MMD
went down to
8
CGRP, calcitonin gene-related peptide; mAbs, monoclonal antibodies; MMD, monthly migraine days; OTC, over the counter.
Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
Current Treatments
46-year-old female
Acute migraine medication use Gepant as abortive only
Preventive migraine medication use VYEPTI, botulinum toxin
Concomitant medication use Proton-pump inhibitor, hormone treatment, multivitamin
Patient has received 2 doses of VYEPTI® (eptinezumab-jjmr) 100 mg

There is currently no evidence that supports the safe and effective use of gepants, botulinum toxins, and VYEPTI concomitantly.
Patients with any use of botulinum toxins were excluded in the VYEPTI clinical trials.

Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
Please click the sub-tabs or use the forward arrow to navigate through the clinical data
PROMISE-2 was a phase 3 clinical trial that studied the efficacy and safety of intravenously administered VYEPTI® (eptinezumab-jjmr) in patients with chronic migraine1,2*
In the VYEPTI clinical trials, both the 100 mg and 300 mg doses of eptinezumab-jjmr were efficacious and well tolerated for migraine prevention compared to placebo. However, the trials were not designed to test for differences between the two therapeutic doses. The recommended dosage is 100 mg administered by IV infusion every 3 months. Some patients may benefit from a dosage of 300 mg administered by IV infusion every 3 months. Dosing should be based on the physician’s evaluation of specific patient needs.
MMD, monthly migraine days; mo, month; RR, responder rate.
*Chronic migraine was defined as ≥15 to ≤26 headache days, of which ≥8 were migraine days.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
Study Design2*
Primary
Outcome
End of
Study
Week -4
IV Treatments:
0
12
32
Screening
(28 days)
Randomization
Placebo (n=366)
VYEPTI® (eptinezumab-jjmr) 100 mg (n=356)
VYEPTI® (eptinezumab-jjmr) 300 mg (n=350)
*During the 28-day screening period, patients experienced ≥15 to ≤26 headache days, of which ≥8 were migraine days.
In the VYEPTI clinical trials, both the 100 mg and 300 mg doses of eptinezumab-jjmr were efficacious and well tolerated for migraine prevention. However, the trials were not designed to test for differences between the two therapeutic doses. The recommended dosage is 100 mg administered by IV infusion every 3 months. Some patients may benefit from a dosage of 300 mg administered by IV infusion every 3 months. Dosing should be based on the physician’s evaluation of specific patient needs.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
Primary1,2*†
Change from baseline in MMD (Months 1-3)
FDA Approved Label Analyses1‡
Percentage of subjects with a migraine from Day -1 (day prior to infusion) to Day 7
Select Key Secondary1-3*†
  • ≥50% MRR (Months 1-3)
  • ≥75% MRR (Months 1-3)
  • Percentage of subjects with a migraine on the day after dosing
  • Reduction in migraine prevalence from baseline to Week 4
Other Secondary3†
  • 100% MRR (Months 1-3)
  • Migraine responder rates for time periods other than Months 1-3
  • Mean change from baseline in MMD (Months 4-6)
MMD, monthly migraine days; MRR, migraine responder rate.
*Primary and key secondary endpoints are hierarchical. †One month was defined as 28 consecutive days. ‡Analysis based on observed data.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
Baseline Characteristics2*†
VYEPTI® (eptinezumab-jjmr)
100 mg 300 mg Placebo
Patients, n 356 350 366
Mean age, y (SD) 41.0 (11.7) 41.0 (10.4) 39.6 (11.3)
Mean BMI, kg/m2 (SD) 26.4 (5.0) 26.2 (5.0) 27.0 (5.6)
Female, % 86.2 89.7 88.8
Mean duration of migraine diagnosis at baseline, y (SD) 18.3 (12.2) 19.0 (11.5) 17.0 (11.6)
Mean duration of CM at baseline, y (SD) 11.6 (11.7) 12.4 (11.2) 11.6 (10.9)
Medication overuse headache diagnosis, n (%) 139 (39.0) 147 (42.0) 145 (39.6)
Mean migraine days/mo (SD)‡ 16.1 (4.6) 16.1 (4.8) 16.2 (4.6)
Mean headache days/mo (SD) 20.4 (3.1) 20.4 (3.2) 20.6 (2.99)
Baseline triptan use, n (%)
≥33% of days 124 (34.8) 125 (35.7) 116 (31.7)
<33% of days 231 (64.9) 225 (64.3) 250 (68.3)
BMI, body mass index; CM, chronic migraine; SD, standard deviation.
*Full analysis population; mean electronic diary–reported migraine and headache characteristics during the 28-day screening period. †When looking at baseline characteristics of 100 mg versus placebo and 300 mg versus placebo, no differences were identified to specify which patients may benefit from 300 mg. ‡Migraine days were defined as any day with a headache that met the migraine definition as outlined in the International Classification of Headache Disorders, 3rd edition (beta version).
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
After the first dose, VYEPTI® (eptinezumab-jjmr) significantly reduced mean monthly migraine days
Mean change from baseline in MMD, Months 1-3 (Primary Endpoint)1,2*
Although 300 mg is an available and approved dose, 100 mg is the recommended dose. Therefore, for the remainder of the presentation, we will be focusing only on 100 mg data.
MMD, monthly migraine days.
*One month was defined as 28 consecutive days. †Analysis of covariance model used to test for difference among treatment groups.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
Approximately 60% of Patients Experienced ≥50% Fewer Monthly Migraine Days For Months 1–61,2,4*
50% migraine responder is defined as a subject achieving ≥50% reduction from baseline in migraine days averaged over each of the 1-month intervals.
QUIZClick here
*One month was defined as 28 consecutive days. †Stratified Cochran–Mantel–Haenszel test used for statistical analysis. ‡This is a prespecified secondary endpoint, not adjusted for multiplicity.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
What is the recommended dose for
VYEPTI® (eptinezumab-jjmr)?
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
Over 1 in 3 Patients Experienced ≥75% Fewer Migraine Days After the Second Dose1,2,4*
75% migraine responder is defined as a subject achieving ≥75% reduction from baseline in migraine days averaged over each of the 1-month intervals.
*One month was defined as 28 consecutive days. †Stratified Cochran–Mantel–Haenszel test used for statistical analysis. ‡This is a prespecified secondary endpoint, not adjusted for multiplicity.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
Patients Who Were Migraine-Free for a Month or More With VYEPTI: 100% Responder Rates3,4* (Other Secondary Endpoints†)
100% responder rate was calculated as the average percentage of patients with 100% migraine response for any given 4-week study month during the respective dosing interval.
*Data shown were calculated by averaging the subjects. †These are prespecified secondary endpoints, not adjusted for multiplicity.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
VYEPTI® (eptinezumab-jjmr) Demonstrated a Sustained Reduction of MMD Through Month 61,3*
(Other Secondary)†
Baseline: ~16.1 Migraine Days/Months
VYEPTI demonstrated migraine improvement of ~50% reduction from baseline at every 4-week interval through month 63†‡
QUIZClick here
MMD, monthly migraine days.
*One month was defined as 28 consecutive days. †This is a prespecified endpoint, but not prespecified analyses. ‡Migraine improvement was calculated from the percent change from baseline; percentage for VYEPTI 100 mg range from 47%–54%, and placebo range from 30%–39%.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
True or False?In the PROMISE-2 trial, VYEPTI® (eptinezumab-jjmr) demonstrated a
sustained reduction of monthly migraine days through month 6.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
% of Patients with a Migraine Attack From Day -1 to Day 71
(FDA Approved Label Analysis)
VYEPTI® (eptinezumab-jjmr) demonstrated a treatment benefit in the first 7 days and as early as Day 1 post IV administration*
FDA, Food and Drug Administration; SE, standard error.
*Data represent mean percent of patients based on observed data.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
Adverse Reactions Occurring in Two Pivotal Phase 3 Trials of Over 1700 Patients
The most common adverse reactions occurring with an incidence of ≥2% for VYEPTI® (eptinezumab-jjmr) and ≥2% greater than placebo during the PROMISE-1 and PROMISE-2 studies1
VYEPTI 100 mg
(n=579)		 VYEPTI 300 mg
(n=574)		 Placebo
(n=588)
Nasopharyngitis 6% 8% 6%
Hypersensitivity reactions* 1% 2% 0%
*Hypersensitivity reactions includes multiple related adverse event terms, such as hypersensitivity, pruritus, and flushing/hot flush that occurred on the day of dosing.
1.9% of patients treated with VYEPTI® (eptinezumab-jjmr) discontinued treatment due to adverse events
Overall safety was evaluated in 2076 patients with migraine who received at least 1 dose of VYEPTI, representing 1615 patient-years of exposure.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
PROMISE-2 clinical trial demonstrates that VYEPTI® (eptinezumab-jjmr)
delivers robust and sustained efficacy
VYEPTI is proven to reduce monthly migraine days2*
Change from baseline (Months 1-3) for 100 mg=7.7‡, 300 mg=8.2‡, and placebo=5.6
During months 4-6, over 1 in 3 patients experienced at least 75% fewer monthly migraine days4*†
75% Responders 100 mg=26.7% Dose 1‡, 39.3% Dose 2; 300 mg=33.1% Dose 1‡, 43.1% Dose 2; and placebo=15% Dose 1, 23.8% Dose 2
VYEPTI was well tolerated. The most common adverse reactions occurring in two pivotal phase 3 trials of over 1700 patients were nasopharyngitis and hypersensitivity reactions1§
Nasopharyngitis 100 mg=6%, 300 mg=8%, placebo=6%; hypersensitivity reactions 100 mg=1%, 300 mg=2%, placebo=0%
*VYEPTI 100 mg n=356; VYEPTI 300 mg n=350; Placebo n=366. †This is a prespecified endpoint, but not prespecified analyses. ‡p<0.001. §100 mg n=579; 300 mg n=574; placebo n=588.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
Please click above to learn about patient response to treatment
Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
Patient Response Summary
Baseline (at chronic migraine diagnosis)
Baseline [immediately prior to VYEPTI® (eptinezumab-jjmr)]
After VYEPTIDose 1 (months 1-3)
Mean migraine days per month 22 8 5
Mean headache days per month >22 8 5
Mean acute medication days per month 22 9 <5
Patient Goals of Treatment
Patient-reported Outcomes With More Migraine-free Days
Work without headache, enjoy home life without migraine, be able to go to nursing school, and reduce use of oral medications
  • Within week 1: no headache for 3 consecutive days
  • By month 2: weaned off oral preventive medications*
  • Reportedly not missing any work due to migraine
  • Considering attending nursing school
*Patient was taking a beta blocker, a tricyclic antidepressant, and an anticonvulsant immediately prior to initiating VYEPTI.
Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
Patient Response Summary
Baseline (at chronic
migraine diagnosis)
Baseline [immediately prior to VYEPTI®
(eptinezumab-jjmr)]
After VYEPTIDose 1
(months 1-3)
After VYEPTIDose 2
(months 4-6)
Mean migraine days per month 22 8 5 2
Mean headache days per month >22 8 5 2
Mean acute medication days per month 22 9 <5 2
Patient Goals of Treatment
Patient-reported Outcomes With More Migraine-free Days
Work without headache, enjoy home life without migraine, be able to go to nursing school, and reduce use of oral medications
  • Treatment with VYEPTI resulted in fewer monthly migraine days
  • Enrolled in nursing school
  • Migraine not interfering with work duties
  • Has not reported any side effects thus far
Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
Patient’s ADVERSE REACTIONS, 46-year-old female
Patient did not report any adverse reactions after either infusion of
VYEPTI® (eptinezumab-jjmr)
Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
PATIENT SUMMARY, 46-year-old female
  • Treatment with VYEPTI® (eptinezumab-jjmr) resulted in fewer monthly migraine days
  • Weaned off oral preventive medications
  • Views migraine as manageable
  • Enrolled in nursing school
  • Has not reported any side effects thus far
This concludes the case study. Thank you for your interest.For more information or to locate an infusion center near you, please visit…
www.VYEPTIhcp.com
Patient case used with permission from Charles Argoff, MD. Individual results may vary.
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.
DIGITAL PATIENT CASE STUDY
46-year-old female
Living with migraine for 29 years
  1. VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  2. Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020;94(13):e1365-e1377.
  3. Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  4. Silberstein S, Diamond M, Hindiyeh NA, et al. Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy–2) study. J Headache Pain. 2020;21(1):120.
Patient case used with permission from Charles Argoff, MD. Individual results may vary..
Please see Important Safety Information on page 2.
For more information, please see the Full Prescribing Information including Patient Information at VYEPTIhcp.com.