Efficacy - Episodic Migraine


Study Design

The efficacy and safety of Emgality were evaluated in two large Phase 3 trials1-3

EVOLVE-1 (North America) and EVOLVE-2 (Global) were 6-month, randomized, multicenter, double-blind, placebo-controlled studies in patients with episodic migraine1-3

EVOLVE-1 and EVOLVE-2: 6-month, double-blind, placebo-controlled studies that enrolled a total of 1773 adult patients with episodic migraine (defined as 4-14 migraine headache days [MHDs] per month). Participants were randomized to once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg.<sup>a</sup> 240 mg is an unapproved dose. Patients were allowed to use acute headache treatments including migraine-specific medications (ie, triptans, ergotamine derivatives), nonsteroidal anti-inflammatory drugs (NSAIDs), and acetaminophen during the study. The studies excluded patients on any other migraine preventive treatment, patients with medication overuse headache, patients with electrocardiogram (ECG) abnormalities compatible with an acute cardiovascular event, and patients with a history of stroke, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. For each study, the primary endpoint was the mean change from baseline in the number of monthly MHDs over Months 1 to 6 in the intent-to-treat study population.<sup>1</sup>

aMSQ v2.1 is a self-administered tool developed to assess the impact of migraine on patients’ health-related quality of life. Areas measured included: relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness. Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.1,5

See Study Design for REGAIN

Migraine Headache Day (MHD) Reduction Data

For your patients with 4-14 MHDs per month,

Emgality delivered significantly more migraine-free days vs placebo1

Emgality prevented up to 4.7 MHDs per month vs up to 2.8 MHDs per month with placebo, on average (p<0.001)1

For your patients with 4-14 MHDs per month,

Emgality reduced mean monthly MHDs in the first month and every following month1

Emgality demonstrated reductions in MHDs in every month of the 6-month treatment period, on average1

Change From Baseline in Monthly MHDs EVOLVE-1 EVOLVE-2 graph

aLeast-square (LS) means and 95% confidence intervals are presented.

bEarliest post-baseline, prespecified assessment.

EVOLVE-1: -3.7 mean MHDs with Emgality in the first month vs -1.7 mean MHDs with placebo6

EVOLVE-2: -3.9 mean MHDs with Emgality in the first month vs -1.2 mean MHDs with placebo6

See Study Design for EVOLVE-1 and EVOLVE-2

See Data for Chronic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Contraindications

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

For your patients with 4-14 MHDs per month,

Emgality significantly reduced the mean number of monthly MHDs that acute medication was used over Months 1 to 6 vs placebo (p<0.001)1

  • EVOLVE-1: -4.0 mean MHDs per month with Emgality (N=210) vs -2.2 mean MHDs per month with placebo (N=425)
  • EVOLVE-2: -3.7 mean MHDs per month with Emgality (N=226) vs -1.9 mean MHDs per month with placebo (N=450)

See Study Design for EVOLVE-1 and EVOLVE-2

SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions

Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.

For your patients with 4-14 MHDs per month,

Change in monthly MHDs in patients with or without baseline acute medication overuse1,7,8a

Mean Change From Baseline in the Number of Monthly MHDs in Patients With or Without Baseline Acute Medication Overuse<sup>1,7,8a</sup>

aMedication overuse was defined as exceeding the following thresholds for total days of use of any of the following drug classes (or medications containing drugs from these classes) per 30-day period of the prospective baseline period as reported in an electronic diary9:

  • Any triptan for ≥10 days
  • Any NSAID or aspirin for ≥15 days
  • Any acetaminophen/paracetamol for ≥15 days
  • Any ergot or ergotamine derivative for ≥10 days
  • Any combination drugs containing 2 or more of the above medication classes for ≥10 days
  • Total days with drug use from at least 2 of the above categories for ≥10 days

Post-hoc repeated measures subgroup analysis of EVOLVE-1 and EVOLVE-2 data. As this analysis was post hoc, treatment differences observed in these subgroups cannot be regarded as statistically significant. Patients were excluded from the studies if they used opioids or barbiturate-containing analgesics >2 times per month for the treatment of pain in more than 2 of the 6 months prior to the study. The studies excluded patients with a diagnosis of medication overuse headache in the preceding 3 months.

See Study Design for EVOLVE-1 and EVOLVE-2

See Data for Chronic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Adverse Reactions

The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

Response rates

For your patients with 4-14 MHDs per month,

Emgality makes it possible for some patients to be totally migraine headache-free for a month1

Emgality demonstrated ≥50%, ≥75%, and 100% reductions in monthly MHDs from baseline for a significantly greater mean percentage of patients vs placebo (p<0.001)1

Mean Percentage of Patients Meeting Defined Levels of Reduction in Monthly MHDs EVOLVE-1 EVOLVE-2 chart

ap<0.001 vs placebo.

>=50% reduction in monthly MHDs from baseline
>=75% reduction in monthly MHDs from baseline
100% reduction in monthly MHDs from baseline

See Study Design for EVOLVE-1 and EVOLVE-2

See Data for Chronic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Contraindications

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

For your patients with 4-14 MHDs per month,

100% reduction of monthly MHDs in at least 1, 2, or 3 months1,10

Percentage of Patients Experiencing 100% Reduction in Monthly MHDs in at Least 1, 2, or 3 Months in the 6-Month Treatment Period Pooled EVOLVE-1 EVOLVE-2 chart

Post-hoc analyses of EVOLVE-1 and EVOLVE-2 pooled data. Results reported are simple calculations of percentages. As these analyses are post hoc, no conclusions of statistical or clinical significance can be drawn.

See Study Design for EVOLVE-1 and EVOLVE-2

For your patients with 4-14 MHDs per month,

≥50% reduction of mean monthly MHDs for Months 1 to 3 and Months 4 to 61,11

≥50% Reduction in Monthly MHDs in Months 1-3 and Months 4-6 chart

Post-hoc analysis of EVOLVE-1 and EVOLVE-2. No conclusions of statistical or clinical significance can be drawn. The mean monthly percentage of patients meeting response criteria during Months 1 to 3 and Months 4 to 6 of the double-blind treatment phase was estimated using generalized linear repeated measures models.

See Study Design for EVOLVE-1 and EVOLVE-2

For your patients with 4-14 MHDs per month,

≥50% reduction of monthly MHDs in preventive-naïve patients and patients who failed ≥1 or ≥2 preventives1,12-14

Subgroup Analysis of >=50% Responders in Reduction of Monthly MHDs in Preventive Naïve and Prior Preventive Treatment Exposed<sup>12-14</sup>

Post-hoc analysis of EVOLVE-1 and EVOLVE-2 pooled data. The studies were not adequately powered nor error-controlled for subgroup analyses. Treatment differences observed in these subgroups cannot be regarded as statistically significant. Patients were excluded from the study if they had failed to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months). Failure to respond due to tolerability issues was not considered an exclusion criterion. Migraine preventive treatments are defined as Level A and B of the American Academy of Neurology’s Evidence-based Guideline Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults as well as botulinum toxin A or B. Assignment to the subgroup of patients who were naïve, failed ≥1, and failed ≥2 individual preventive medications was based on patient report of previous discontinuation of a migraine preventive due to lack of efficacy, suboptimal efficacy, or intolerability.15

See Study Design for EVOLVE-1 and EVOLVE-2

See Data for Chronic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions

Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.

Patient Global Impression of Severity Data

For your patients with 4-14 MHDs per month,

Patients reported a significantly greater reduction in the severity of their disease with Emgality, on average, over Months 4 to 6 (p=0.002)1,4

Mother Daughter Lifestyle image
Emgality significantly improved patients’ impression of the severity of their disease vs placebo, on average, over Months 4 to 6 (p=0.002)<sup>4</sup> graphic
  • EVOLVE-1: Mean change from baseline in PGI-S score was -1.59 for Emgality vs -1.27 for placebo. LS mean difference: -0.32 (p=0.002)a
  • EVOLVE-2: Mean change from baseline in PGI-S score was -1.22 for Emgality vs -0.94 for placebo. LS mean difference: -0.29 (p=0.002)a

Mean change from baseline in the PGI-S score over Months 4 to 6.4

aEVOLVE-1: Emgality 120 mg (N=189), placebo (N=377); EVOLVE-2: Emgality 120 mg (N=213), placebo (N=396).

See Study Design for EVOLVE-1 and EVOLVE-2

Impact of Migraine

For your patients with 4-14 MHDs per month,

Emgality significantly reduced the impact of migraine on daily activities1

Patients completed the RF-R domain of the MSQ v2.1, a functional impact tool1,5

MSQ v2.1 is a self-administered tool developed to assess the impact of migraine on patients’ health-related quality of life.1,5

  • Areas measured included: relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness
  • Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities
32.4 points image
  • In EVOLVE-1, Emgality demonstrated a mean improvement of 32.4 points from baseline (N=189) vs 24.7 points with placebo (N=377) over Months 4 to 6 (baseline: 51.4 points vs 52.9 points) (p<0.001)1
28.5 points image
  • In EVOLVE-2, Emgality demonstrated a mean improvement of 28.5 points from baseline (N=213) vs 19.7 points with placebo (N=396) over Months 4 to 6 (baseline: 52.5 points vs 51.4 points) (p<0.001)1

See Study Design for EVOLVE-1 and EVOLVE-2

SELECT IMPORTANT SAFETY INFORMATION
Adverse Reactions

The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

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References: 1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018:75(9):1080-1088. 3. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. 4. Data on File. Lilly USA, LLC. DOF-GZ-US-0001. 5. Bagley CL, Rendas-Baum R, Maglinte GA, et al. Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine. Headache. 2012;52:409-421. 6. Data on File. Lilly USA, LLC. DOF-GZ-US-0002. 7. Data on File. Lilly USA, LLC. DOF-GZ-US-0092. 8. Data on File. Lilly USA, LLC. DOF-GZ-US-0091. 9. Data on File. Lilly USA, LLC. DOF-GZ-US-0024. 10. Data on File. Lilly USA, LLC. DOF-GZ-US-0010. 11. Data on File. Lilly USA, LLC. DOF-GZ-US-0012. 12. Data on File. Lilly USA, LLC. DOF-GZ-US-0025. 13. Data on File. Lilly USA, LLC. DOF-GZ-US-0015. 14. Data on File. Lilly USA, LLC. DOF-GZ-US-0016. 15. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults. Neurology. 2012;78:1337-1345.

Indication and Important Safety Information
Indication

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.

Important Safety Information

CONTRAINDICATIONS
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.


ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.


Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the pen and prefilled syringe.


GZ HCP ISI 27SEP2018