Results from the CONQUER study^1,2

A study of patients with episodic or chronic migraine who experienced 2-4 prior preventive category failures^1,2

The burden of migraine in between attacks can be measured using the Migraine Interictal Burden Scale-4 (MIBS-4)³

MIBS-4 is a self-administered 4-item questionnaire. Patients are asked to answer statements related to the burden of migraine in between attacks.³

Each item response ranges from never to most or all of the time. Responses are summed for a total score ranging from 0 to 12.³

Statements on the MIBS-4 include⁴:

“BETWEEN HEADACHE ATTACKS OR AT TIMES WHEN I DO NOT HAVE A HEADACHE...”

My headaches affect my work or school at times when I do not have a headache
I worry about planning social or leisure activities because I might have a headache
My headaches impact my life at times when I do not have a headache
At times when I do not have a headache, I feel helpless because of my headaches

Another Secondary Endpoint

In a study of patients with episodic and chronic migraine who experienced 2-4 prior preventive category failures,

Emgality showed significant improvement in the burden of migraine in between attacks⁴

Chart showing mean change from baseline in monthly MHDs over Months 1 to 3 in CONQUER — Mean reduction from baseline in MIBS-4 scores at Month 3 in CONQUER.^4a

Emgality 120 mg (N=232) demonstrated a -1.8^b mean change from baseline in MIBS-4 scores vs -0.8 with placebo (N=230)²

^aLS means are presented.
^bNominal p-value ≤0.001 vs placebo.

See study design for CONQUER

Statistical significance does not imply clinically meaningful difference. Change in MIBS-4 from baseline to Month 3 was evaluated using an ANCOVA model controlling for prespecified effects. For missing MIBS-4 score at Month 3 (9 in placebo, 8 in Emgality 120 mg) LOCF was used. There was no adjustment for multiplicity in the treatment comparisons using the MIBS-4.³

ANCOVA=analysis of covariance; LOCF=last observation carried forward; LS=least-square; MIBS-4=Migraine Interictal Burden Scale-4.

SELECT IMPORTANT SAFETY INFORMATION

Contraindications

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

A study of patients with episodic or chronic migraine who experienced 2-4 prior preventive category failures^1a

CONQUER was a Phase 3 study with a 3-month, double-blind phase¹:

Enrolled 462 adult patients with episodic migraine (58%) or chronic migraine (42%)
Eligible patients were 18-75 years of age
Patients had a history of 2-4 standard-of-care preventive category failures^a
The prior preventive categories were propranolol or metoprolol, topiramate, valproate or divalproex, amitriptyline, flunarizine, candesartan, and botulinum toxin A or B (if taken for chronic migraine)
Of the patients enrolled, about 58% had 2 preventive treatment failures, 30% had 3 preventive treatment failures, and 10% had 4 preventive treatment failures in the previous 10 years

^aFailure was defined as discontinuation over the previous 10 years due to inadequate efficacy (after at least 2 months at maximum tolerated dose) or safety/tolerability reasons, or both.¹

Double-blind treatment phase¹

3-month randomized, double-blind phase (N=462)
- Patients were randomized to receive once-monthly placebo or Emgality 120 mg, after an initial loading dose of 240 mg

The primary endpoint during the double-blind phase was¹:

LS mean change from baseline in the number of monthly MHDs in the total population (episodic and chronic) over Months 1 to 3

Key secondary endpoints during the double-blind phase were¹:

Mean percentage of patients with ≥50% reduction from baseline in the number of monthly MHDs over Months 1 to 3
Mean percentage of patients with ≥75% reduction from baseline in the number of monthly MHDs over Months 1 to 3
Mean percentage of patients with 100% reduction from baseline in the number of monthly MHDs over Months 1 to 3
Mean change from baseline in the MSQ v2.1 RF-R score at Month 3

Another secondary endpoint was³:

Mean change from baseline in MIBS-4 scores at Month 3

The study excluded patients with¹:

A lifetime history of cluster headache or migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and migraine with brainstem aura
History of head or neck injury within 6 months before screening
History of traumatic head injury associated with significant change in the quality or frequency of headaches
Presence of acute cardiovascular events or serious cardiovascular risk, or both, based on ECG results during the screening visit
Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months before screening
Hepatic disease based on liver tests
Serious or unstable medical or psychiatric condition

ECG=electrocardiogram; LS=least-square; MHD=migraine headache day; MIBS-4=Migraine Interictal Burden Scale-4; MSQ v2.1=Migraine-Specific Quality of Life version 2.1; RF-R=Role Function-Restrictive.

References:

Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19:814-825.
Data on File. Lilly USA, LLC. DOF-GZ-US-0182.
Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84:422-435.
García-Azorín D, Ford J, Buse DC, et al. Changes in work productivity and interictal burden: results from randomized, double-blind study evaluating galcanezumab in adults with treatment resistant migraine (CONQUER). Presented at: 17th Asian Oceanian Congress of Neurology (AOCN 2021); Taipei, Taiwan; April 1-4, 2021.

INDICATIONS

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the:

Preventive treatment of migraine
Treatment of episodic cluster headache

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, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. 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 device.

GZ HCP ISI 10DEC2019

Results from the CONQUER study1,2

Emgality reduced mean monthly MHDs1,2

Another Secondary Endpoint

A study of patients with episodic or chronic migraine who experienced 2-4 prior preventive category failures1a

Results from the CONQUER study^1,2

Emgality reduced mean monthly MHDs^1,2

A study of patients with episodic or chronic migraine who experienced 2-4 prior preventive category failures^1a