Migraine impact measures
Learn more about the impact of migraine1-4
Migraine-related disability1 Daily functioning2 Impact between attacks3,4SELECT IMPORTANT SAFETY INFORMATION
Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Migraine Disability Assessment (MIDAS) 50% response rate5a
In patients with 4-14 MHDs per month6
Up to 80% of patients on Emgality saw their migraine-related disability CUT IN HALF OR MORE5a
Most patients taking Emgality achieved a ≥50% decrease in disability based on MIDAS total scoreb (disability days) from baseline at Month 6 vs up to 56% of patients on placebo.5a
EVOLVE-1: For MIDAS total scoreb, the percentage of patients meeting the definition of 50% response at Month 6 (model estimated rate) in the Emgality 120 mg (N=210) treatment group was 80.3% compared with the placebo group (N=425), which was 54.8%.5
EVOLVE-2: For MIDAS total scoreb, the percentage of patients meeting the definition of 50% response at Month 6 (model estimated rate) in the Emgality 120 mg (N=226) treatment group was 73.0% compared with the placebo group (N=450), which was 55.6%.5
aThere was no adjustment for multiplicity in the treatment comparisons. No conclusions of statistical significance can be drawn from this data.5
bMigraine Disability Assessment (MIDAS) was designed to quantify headache-related disability over the last 3 months and consists of 5 items that reflect the number of days reported as missed work or school, reduced productivity at work or school, missed household work, reduced productivity at home, and missed family or social events. The total score was calculated by taking the sum of those 5 items. A higher value is indicative of greater disability and scores range from 0 to 270. The MIDAS score can be higher than the actual number of lost headache days if more than one domain of activity is affected on the same day.7-9
See study design for EVOLVE-1, EVOLVE-2.
SELECT IMPORTANT SAFETY INFORMATION
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.
Migraine Disability Assessment (MIDAS) total score5c,d
In patients with 4-14 MHDs per month6
AT MONTH 6,
patients on Emgality had an improvement from baseline in
MIDAS TOTAL SCOREc OF 21 (DISABILITY DAYS)5d
On average, at Month 6, patients on Emgality had an improvement from baseline in MIDAS total scorec of 21 (disability days) vs 12-15 for those on placebo.5d
Change from baseline in MIDAS total scorec at Month 65
EVOLVE-1: Emgality 120 mg (N=210) LS mean change from baseline of -21.2 (baseline total mean of 32.9) vs placebo (N=425) LS mean change from baseline of -14.9 (baseline total mean of 31.8)
EVOLVE-2: Emgality 120 mg (N=226) LS mean change from baseline of -21.2 (baseline total mean of 30.9) vs placebo (N=450) LS mean change from baseline of -12.0 (baseline total mean of 34.3)
cMigraine Disability Assessment (MIDAS) was designed to quantify headache-related disability over the last 3 months and consists of 5 items that reflect the number of days reported as missed work or school, reduced productivity at work or school, missed household work, reduced productivity at home, and missed family or social events. The total score was calculated by taking the sum of those 5 items. A higher value is indicative of greater disability and scores range from 0 to 270. The MIDAS score can be higher than the actual number of lost headache days if more than one domain of activity is affected on the same day.7-9
dThere was no adjustment for multiplicity in the treatment comparisons. No conclusions of statistical significance can be drawn from this data.5
LS=least-square; MHD=migraine headache day; MIDAS=Migraine Disability Assessment.
See MIDAS Questionnaire.
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.
References
- Stewart WF, Lipton RB, Kolodner K, et al. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain. 2000;88(1):41-52.
- 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(3):409-421.
- Speck, RM, Shalhoub H, Wyrwich KW, et al. Psychometric validation of the Role Function Restrictive domain of the Migraine Specific Quality-of-Life Questionnaire Version 2.1 electronic patient-reported outcome in patients with episodic and chronic migraine. Headache. 2019;59(5):756-774.
- 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(5):422-435.
- Ford JH, Ayer DW, Zhang Q, et al. Two randomized migraine studies of galcanezumab: effects on patient functioning and disability. Neurology. 2019;93(5):e508-e517.
- Emgality. Prescribing Information. Lilly USA, LLC.
- Lipton RB, Stewart WF, Sawyer J, et al. Clinical utility of an instrument assessing migraine disability: the Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2001;41(9):854-861.
- Stewart WF, Lipton RB, Dowson AJ, et al. Development and testing of the Migraine Disability Assessment (MIDAS) questionnaire to assess headache-related disability. Neurology. 2001;56(Suppl 1):S20-S28.
- Blumenfeld AM, Bloudek LM, Becker WJ, et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache. 2013;53(4):644-655.