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The functional impact of migraine during and between attacks can be measured using the Migraine-Specific Quality-of-Life Questionnaire (MSQ)1-3

The MSQ RF-R is a valid measure of the functional impact of migraine1,2

This tool consists of 7 questions that assess how migraine limits the social and work-related activities of patients. Patient responses are rated on a 100-point scale, with 0 points being most impacted and 100 points being least impacted.1,2

The questions of the RF-R domain of the MSQ v2.1 include1:

  • Have migraines interfered with how well you dealt with family, friends, and others who are close to you?
  • Have migraines interfered with your leisure time activities, such as reading or exercising?
  • Have you had difficulty in performing work or daily activities because of migraine symptoms?
  • Did migraines keep you from getting as much done at work or at home?
  • Did migraines limit your ability to concentrate on work or daily activities?
  • Have migraines left you too tired to do work or daily activities?
  • Have migraines limited the number of days you felt energetic?

For patients with 4-14 MHDs per month,

Emgality significantly improved patients' migraine-specific quality of life during and in between attacks2,3

EVOLVE-1 study data, mean improvement in MSQ v2.1 RF-R scores graph

Baseline: 51.4 points vs 52.9 points

Patients on Emgality experienced a statistically significant improvement in the functional impact of migraine over Months 4 to 6.3

Mean improvement from baseline in MSQ RF-R scores for Emgality 120 mg (N=189) was 32.4 points vs 24.7 points with placebo (N=377) over Months 4 to 6. Baseline values for Emgality and placebo were 51.4 vs 52.9 points, respectively.

Evolve 2 mean improvement in MSQ v2.1 RF-R scores

Baseline: 52.5 points vs 51.4 points

ap<0.001 vs placebo.

Mean improvement from baseline in MSQ RF-R scores for Emgality 120 mg (N=213) was 28.5 points vs 19.7 points with placebo (N=396) over Months 4 to 6. Baseline values for Emgality and placebo were 52.5 vs 51.4 points, respectively.

  • In REGAIN, statistical significance vs placebo was not observed after controlling for multiple comparisons for mean change in MSQ v2.1 RF-R3

See study designs for EVOLVE-1 and EVOLVE-2 and REGAIN.

References:

  1. 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.
  2. 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;59:756-774.
  3. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.

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