Efficacy - Chronic Migraine


Study Design

The efficacy and safety of Emgality were evaluated in chronic migraine in a Phase 3 trial1,2

REGAIN was a 3-month, randomized, multicenter, double-blind, placebo-controlled study conducted in the US and 11 other countries1,2

REGAIN: A 3-month, double-blind, placebo-controlled study that enrolled 1113 adult patients with chronic migraine (defined as ≥15 headache days per month with ≥8 migraine days per month). Participants were randomized to receive 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. A subset of patients (15%) continued 1 concomitant migraine preventive medication. Patients with medication overuse headache were allowed to enroll. Patients were excluded if they had 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. The primary endpoint was the mean change from baseline in the number of monthly migraine headache days (MHDs) over the 3-month treatment period.<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.1,3

See Study Design for EVOLVE-1 and EVOLVE-2

Migraine Headache Day (MHD) Reduction Data

For your patients with ≥15 headache days per month,

Emgality delivered significantly more migraine-free days vs placebo1

Emgality demonstrated an average reduction of 4.8 mean MHDs per month vs 2.7 mean MHDs per month with placebo (baseline mean: 19.4 vs 19.6) (p<0.001)1

For your patients with ≥15 headache days 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 3-month treatment period, on average1

Change From Baseline in Monthly MHDs (REGAIN) chart

aLeast-square (LS) means and 95% confidence intervals are presented.
bEarliest post-baseline, prespecified assessment.

REGAIN: -4.1 mean MHDs with Emgality in the first month vs -1.8 mean MHDs with placebo4

See Study Design for REGAIN

See Data for Episodic 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 ≥15 headache days per month,

Assessment of change in the number of monthly MHDs acute medication was used in REGAIN1

Emgality 120 mg was not statistically different from placebo for reduction in mean MHDs with acute medication use, after controlling for multiple comparisons.1

See Study Design for REGAIN

See Data for Episodic 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.

For your patients with ≥15 headache days per month,

Change in monthly MHDs in patients with or without baseline acute medication overuse1,5a

Mean Change From Baseline in the Number of Monthly MHDs in Patients With or Without Baseline Acute Medication Overuse<sup>5a</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 diary6:

  • 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 ≥10 days

Post-hoc repeated measures subgroup analysis of REGAIN data. As this analysis was post hoc, treatment differences observed in this subgroup cannot be regarded as statistically significant. Patients were excluded from the study if they used opioids or barbiturate-containing analgesics >3 times per month for the treatment of pain in more than 2 of the 6 months prior to the study.

See Study Design for REGAIN

See Data for Episodic 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 ≥15 headache days per month,

Emgality reduced monthly MHDs from baseline by at least half in a significantly greater mean percentage of patients: 28% of patients (p<0.001)1

Chronic ≥50% Reduction Months 1 to 3 (REGAIN) chart

ap<0.001 vs placebo.

In REGAIN, Emgality 120 mg was not significantly better than placebo for the mean percentage of patients with ≥75% or 100% reduction from baseline in the number of monthly MHDs over the 3-month treatment period.1

See Study Design for REGAIN

See Data for Episodic Migraine

For your patients with ≥15 headache days per month,

≥50% reduction of mean monthly MHDs from baseline in patients who failed ≥2 preventive treatments1,7

Subgroup Analysis of >=50% Responders in Reduction of Monthly MHDs in Patients Who Failed >=2 Preventive Treatments<sup>7</sup>

Post-hoc analysis of REGAIN. The REGAIN study was not adequately powered nor error-controlled for subgroup analyses. Treatment differences observed in this subgroup 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 Level 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 failed <2 or 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.8

See Study Design for REGAIN

See Data for Episodic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Contraindications

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

Impact of Migraine

For your patients with ≥15 headache days per month,

Assessment of MSQ v2.1 RF-R domain in REGAIN1

Emgality 120 mg was not statistically different from placebo for mean change in MSQ v2.1 RF-R over the 3-month treatment period, after controlling for multiple comparisons.1

See Study Design for REGAIN

See Data for Episodic 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.

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References: 1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Data on File. Lilly USA, LLC. DOF-GZ-US-0019. 3. 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. 4. Data on File. Lilly USA, LLC. DOF-GZ-US-0002. 5. Data on File. Lilly USA, LLC. DOF-GZ-US-0057. 6. Data on File. Lilly USA, LLC. DOF-GZ-US-0024. 7. Data on File. Lilly USA, LLC. DOF-GZ-US-0056. 8. 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