Abstract
Background
Effects of galcanezumab, a monoclonal antibody against calcitonin gene-related peptide, on patient satisfaction, health care resource utilization (HCRU), and acute medication use were evaluated in a long-term, open-label study in patients with migraine.
Methods
Patients with episodic (78.9%) or chronic migraine (21.1%) were evaluated in the CGAJ study, an open-label study with 12-month treatment period. Galcanezumab 120 mg (with a loading dose of 240 mg) or 240 mg was administered subcutaneously once a month during treatment period. A self-rated scale, Patient Satisfaction with Medication Questionnaire–Modified (PSMQ-M), was used to measure satisfaction levels. Participants reported HCRU for the previous 6 months at baseline and that which occurred since the patient’s last study visit during treatment period. Acute headache medication use for migraine or headache for the past month was self-reported by participants at baseline and at each monthly visit during treatment period.
Results
At Months 1, 6, and 12, at least 69% of patients treated with galcanezumab responded positively for overall satisfaction, preference over prior treatments, and less impact from side effects. There were within-group reductions from baseline in migraine-specific HCRU (per 100 person-years) with galcanezumab for health care professional visits (173.4 to 59.6), emergency room visits (20.2 to 4.7), and hospital admissions (3.7 to 0.4) during treatment period. Statistically significant reductions in HCRU were observed for some events. There were significant within-group reductions from baseline in mean number of days/month with acute headache medication use for migraine or headache at each monthly visit during treatment period (overall change: −5.1 for galcanezumab 120 mg/240 mg; p<0.001).
Conclusion
Results from this long-term, open-label study suggest that treatment with galcanezumab is likely to lead to high patient satisfaction with treatment as well as meaningful reductions in migraine-specific HCRU and acute headache medication use in people with migraine.
Supplementary materials
Health care resource utilization questions
Since your last visit, did you go to a hospital emergency room for medical care? _____Yes _____No
If yes, how many times did you go to a to a hospital emergency room? ______
How many of these times going to a hospital emergency room were related to your migraine headaches? _______
Since your last visit, were you a patient in a hospital overnight? _____Yes _____No
If yes, how many different times were you a patient in a hospital overnight? _______
➢ How many days in total were you in the hospital for overnight stays? _______
How many of these times, as a patient in a hospital overnight, were related to your migraine headaches? _______
How many days in total, as a patient in a hospital overnight, were related to your migraine headaches? _______
Since your last visit, did you have any other visits with a healthcare professional of any kind (physician of any spe-cialty, nurse, rehabilitation specialist, physical therapist, psychologist, or counselor, urgent care center, etc.)? _____Yes _____No
If yes, how many different times did you visit a healthcare professional? _______
How many of these times, visiting a healthcare professional, were related to your migraine headaches? _______
[For baseline (visit 2) = “In the last 6 months” instead of “since your last visit”]
Table S1 Breakdown of responses to the Patient Satisfaction with Medication Questionnaire–Modified by galcanezumab dose group and visit
Acknowledgments
This work was supported by Eli Lilly and Company, Indianapolis, Indiana, USA. Sriram Govindan, an employee of Eli Lilly Services India Private Limited, Bengaluru, India, provided writing assistance.
Disclosure
JHF, SAF, VLS, DDR, and SKA are full-time employees of Eli Lilly and Company and/or one of its subsidiaries and may hold company stocks. JV received personal fees and nonfinancial support from Teva, personal fees from Novartis, and grants and nonfinancial support from Allergan. The authors report no other conflicts of interest in this work.
Author contributions
JHF contributed to study concept, design, analysis, interpretation of data, and drafting manuscript; SAF to design, analysis, and critical revision of manuscript for intellectual content; VLS to study concept, design, analysis, and critical revision of manuscript for intellectual content; DDR to design, analysis, and critical revision of manuscript for intellectual content; SKA to interpretation of data and critical revision of manuscript for intellectual content; and JV to acquisition and interpretation of data and critical revision of manuscript for intellectual content. All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.