Results from the CONQUER study1,2
A study of patients with episodic or chronic migraine who experienced 2-4 prior preventive category failures1,2
In a study of patients with episodic or chronic migraine who experienced 2-4 prior preventive category failures,
Emgality reduced mean monthly MHDs1,2
Emgality prevented significantly more mean monthly MHDs vs placebo over Months 1 to 31a:
- 4.1 with Emgality vs 1.0 with placebo (baseline: 13.4 vs 13.0)
ap<.0001 vs placebo.
bLS means and 95% confidence intervals are presented.
Mean change from baseline in monthly MHDs over Months 1 to 3 in CONQUER1,2b:
- The mean change from baseline at Month 1 for Emgality loading dose 240 mg (N=232) was -4.0 vs -0.7 for placebo (N=230)
- The mean change from baseline at Month 2 for Emgality 120 mg was -4.0 vs -1.1 for placebo
- The mean change from baseline at Month 3 for Emgality 120 mg was -4.4 vs -1.3 for placebo
No formal hypothesis testing was conducted to evaluate treatment difference in mean monthly MHD reduction at each month.
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.
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
Patients taking Emgality reported improvement in the interictal burden of migraine as assessed by the MIBS-4.
aLS means are presented.
bNominal p-value ≤0.001 vs placebo.
Mean reduction from baseline in MIBS-4 scores at Month 3 in CONQUER (baseline: 5.3 vs 5.6), respectively4a:
Mean change from baseline in MIBS-4 score for Emgality 120 mg (N=232) was -1.8b vs -0.8 with placebo (N=230)2
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 failures1a
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 failuresa
- 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.