CHRONIC MIGRAINE RESULTS
≥15 to ≤26 headache days per month, of which ≥8 were migraine days.1 One month was defined as 28 consecutive days.2
Primary endpoint
After a single dose of VYEPTI 100 mg, patients had 23 fewer migraine days, on average, over 3 months1*
Chronic migraine—Primary endpoint: Mean change from baseline in mean MMD (Months 1-3)1
*Calculated by multiplying the mean change from baseline in mean MMD by 3 months.1
†p<0.001 vs placebo.1
‡Analysis of covariance model used to test for difference between treatment groups.2
MMD, monthly migraine days.
VYEPTI was also studied in patients with episodic migraine.
POWERFUL
≥50% response: Months 1-3
~58% of patients on VYEPTI experienced at least 50% fewer migraine days during Months 1-31*
Chronic migraine—≥50% migraine responder rate (Months 1-3)1
*One month was defined as 28 consecutive days.2
†p<0.001 vs placebo; stratified Cochran-Mantel-Haenszel test used for statistical analysis.2
VYEPTI was also studied in patients with episodic migraine.
POWERFUL
≥50% response: Months 1-6
During the first 6 months of treatment, over 3 in 5 patients experienced at least 50% fewer migraine days3*
Chronic migraine—≥50% migraine responder rate3-6
*One month was defined as 28 consecutive days.2
†These are prespecified endpoints, not adjusted for multiplicity.3,4
‡p<0.001 vs placebo; stratified Cochran-Mantel-Haenszel test used for statistical analysis.2
VYEPTI was also studied in patients with episodic migraine.
POWERFUL
≥75% response: Months 1-3
~27% of patients on VYEPTI experienced at least 75% fewer migraine days during Months 1-31*
Chronic migraine—≥75% migraine responder rate (Months 1-3)1
*One month was defined as 28 consecutive days.2
†p<0.001 vs placebo; stratified Cochran-Mantel-Haenszel test used for statistical analysis.2
VYEPTI was also studied in patients with episodic migraine.
POWERFUL
≥75% response: Months 1-6
After the second dose, ~40% of patients experienced at least 75% fewer migraine days6*
Chronic migraine—≥75% migraine responder rate1,6
*One month was defined as 28 consecutive days.2
†p<0.001 vs placebo; stratified Cochran-Mantel-Haenszel test used for statistical analysis.2
‡This is a prespecified secondary endpoint, not adjusted for multiplicity.1
VYEPTI was also studied in patients with episodic migraine.
POWERFUL
≥75% response: Month 1
Over 30% of patients experienced at least 75% fewer migraine days after one month2*
Chronic migraine—≥75% migraine responder rate (Month 1)2
*One month was defined as 28 consecutive days.2
†p<0.001 vs placebo; stratified Cochran-Mantel-Haenszel test used for statistical analysis.2
75% migraine responder rate at Month 1 was a key secondary endpoint.2
VYEPTI was also studied in patients with episodic migraine.
POWERFUL
Migraine-free for a month or more
More than a third of patients were migraine-free for a month or more with VYEPTI7*
Chronic migraine—100% migraine responder rate7†
*One month was defined as 28 consecutive days.2
†100% responder rate was a prespecified secondary endpoint but not prespecified analyses. Therefore, no definitive conclusions should be drawn.2
‡VYEPTI 100 mg: n=356; placebo: n=366.1
VYEPTI was also studied in patients with episodic migraine.
POWERFUL
100% response: Months 1-6
Almost 3X as many patients on VYEPTI were migraine-free at Month 1 vs placebo7*
Chronic migraine—100% migraine responder rate4,7
*One month was defined as 28 consecutive days.2
†These are prespecified secondary endpoints, not adjusted for multiplicity.3,4
‡Calculated by averaging the subjects’ 100% responder status.4,7
VYEPTI was also studied in patients with episodic migraine.
FAST
Early benefit
VYEPTI: Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion1
Chronic migraine—Percentage of patients with a migraine from Day –1 (day prior to infusion) to Day 71
Data represent mean percent of patients based on observed data.1
SE, standard error.
VYEPTI was also studied in patients with episodic migraine.
FAST
Day 1 reduction
Day 1: 50% reduction in the percentage of patients experiencing a migraine2
Chronic migraine—Migraine incidence was reduced by 50.3% on Day 1 vs 27.1% with placebo2*
†p<0.001 vs placebo; stratified Cochran-Mantel-Haenszel test used for statistical analysis.2
‡Weeks 1-4: Key secondary endpoint repeated measure used for statistical analysis (p<0.001 vs placebo).3,4
DAY 1
VYEPTI is the only preventive anti-CGRP to have demonstrated significant reduction in migraine incidence as soon as Day 1.1,5
CGRP, calcitonin gene-related peptide.
VYEPTI was also studied in patients with episodic migraine.
SUSTAINED
Improvement through Month 6
Reduced mean monthly migraine days by ~50% through Month 6 vs 30-39% with placebo4*†
Chronic migraine—Mean change from baseline in mean MMD1
*This is a prespecified endpoint, but not prespecified analyses.4
†Calculated from the percent change from baseline; percentages for VYEPTI range from 47-54%.4
MMD, monthly migraine days.
VYEPTI was also studied in patients with episodic migraine.
SUSTAINED
Reduction through Month 6
Reduced acute medication use by 50% over 6 months6,8*
In patients with CM and MOH,† VYEPTI 100 mg reduced acute medication days from 20.6 to 10.6 days/month (vs 19.8 to 14.0 days/month for placebo), and for CM patients use decreased from 6.6 to 3.2 days/month (vs 6.2 to 4.0 days/month for placebo) (Months 4-6).
*Total acute migraine medication days is the sum of triptan, ergotamine, opioid, barbiturate, simple analgesic, and combination analgesic days of use.
†Post-hoc subpopulation analysis is exploratory in nature. MOH defined using ICHD-3 diagnostic criteria. MOH solely associated with opioids or barbiturates was excluded.
CM, chronic migraine; ICHD-3, International Classification of Headache Disorders, third edition; MOH, medication overuse headache.
PRO: PGIC at Months 1 and 6
Nearly half of patients felt that their migraine status was much or very much improved as early as Month 14
Chronic migraine—Patient-reported outcome: Change from baseline in PGIC4,9
PGIC comprises a single question concerning the patient’s impression of the overall change in their disease status compared to baseline, ranging from “very much improved” to “worse.” “Worse” includes “minimally worse,” “much worse,” and “very much worse.”4,9
This is a prespecified secondary endpoint but not prespecified analyses. Therefore, no definitive conclusions should be drawn.4
PGIC, Patient Global Impression of Change; PRO, patient-reported outcome.
PRO: PGIC at Month 1
Nearly half of patients felt that their migraine status was much or very much improved as early as Month 14
Chronic migraine—Change from baseline in PGIC (Month 1)4
PGIC comprises a single question concerning the patient’s impression of the overall change in their disease status compared to baseline, ranging from “very much improved” to “worse.” “Worse” includes “minimally worse,” “much worse,” and “very much worse.”4,9
This is a prespecified secondary endpoint but not prespecified analyses. Therefore, no definitive conclusions should be drawn.4
PGIC, Patient Global Impression of Change; PRO, patient-reported outcome.
Episodic Results
4 to 14 headache days per month, of which ≥4 were migraine days.1†
Over 20% of patients experienced at least 75% fewer migraine days during Months 1-3 (22.2% vs 16.2% with placebo, not significant)1†
Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion1‡
Reduced mean monthly migraine days by ~50% through Month 6 (vs 28-42% with placebo)1,4§¶
*Data from VYEPTI 100 mg dose groups.1
†One month was defined as 28 consecutive days.4
‡Data represent mean percent of patients based on observed data.1
§This is a prespecified endpoint but not prespecified analyses.4
¶Calculated from the percent change from baseline; percentages for VYEPTI range from 43-55%.4
Chronic Results
≥15 to ≤26 headache days per month, of which ≥8 were migraine days.1†
~27% of patients on VYEPTI experienced at least 75% fewer migraine days during Months 1-3 (26.7% vs 15% with placebo, p<0.001)1†
Early benefit seen within the first 7 days, and as soon as Day 1 post-infusion1‡
Reduced mean monthly migraine days by ~50% through Month 6 (vs 30-39% with placebo)1,4§¶
*Data from VYEPTI 100 mg dose groups.1
†One month was defined as 28 consecutive days.2
‡Data represent mean percent of patients based on observed data.1
§This is a prespecified endpoint but not prespecified analyses.1
¶Calculated from the percent change from baseline; percentages for VYEPTI range from 47-54%.4
