PainRelief.com Interview with:
Dulanji K. Kuruppu, MD
Medical Advisor, Migraine & Headache Disorders
US Medical Affairs
Eli Lilly and Company
LTC-South, Indianapolis IN 46221 U.S.A.
PainRelief.com: What is the background for this study?
Response: Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and is approved for the preventive treatment of migraine and for the treatment of episodic cluster headache in adults. The CONQUER study assessed the efficacy and safety of galcanezumab in 462 adults with episodic or chronic migraine who previously did not benefit from 2 to 4 standard-of-care migraine preventive medication categories. This study consisted of a 3-month double-blind, placebo-controlled period (months 1-3) followed by an open-label period (months 4-6). The primary endpoint, which was the mean change from baseline in the number of monthly migraine headache days for galcanezumab vs placebo over months 1-3, was met. In this post-hoc analysis, we assessed onset of effect of galcanezumab in the CONQUER population.
PainRelief.com: What are the main findings?
Response: Results of this post-hoc analysis showed that galcanezumab treatment reduced mean monthly migraine headache days beginning at month 1 and this benefit persisted throughout the study. Reduction in weekly migraine headache days in galcanezumab-treated patients began at week 1 and continued during the remaining weeks of month 1. Additionally, a lower percentage of patients had a migraine headache on the first day after galcanezumab treatment and during each subsequent day of week 1 compared to placebo.
PainRelief.com: What should readers take away from your report?
Response: These post-hoc results showed that in patients who previously had not benefited from 2 to 4 standard-of-care migraine preventive medication categories, galcanezumab demonstrated early onset of effect at month 1. Further, fewer patients treated with galcanezumab had a migraine headache on the first day after initial treatment compared to placebo. Therefore, galcanezumab may be an effective treatment option for patients who did not benefit from 2 to 4 prior preventive treatment categories.
PainRelief.com: What recommendations do you have for future research as a result of this work?
Response: Migraine is a neurologic disease that impacts more than 30 million Americans and is the third most prevalent illness in the world and leading cause of disability for people under age 50. Many patients are not on appropriate preventive treatment and often discontinue or switch therapy due to inadequate efficacy or safety/tolerability. It is important to consider what patients prioritize in their migraine treatment when selecting a medication and developing future treatments.
PainRelief.com: Is there anything else you would like to add?
Response: The safety profile of galcanezumab was also assessed in the CONQUER study, and results were consistent with the safety profile observed in the galcanezumab pivotal trials. It is important to keep in mind that post-hoc analyses have limitations, and no definitive conclusions should be drawn. This study was funded by Eli Lilly and Company who manufactures galcanezumab. We are grateful for all participants, investigators, and personnel involved in the CONQUER study. We are pleased that galcanezumab may help patients with such significant unmet need who have not benefited from 2 to 4 prior standard-of-care preventive treatment categories.
- Emgality (galcanezumab-gnlm) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.
- Schwedt TJ, Kuruppu DK, Dong Y, et al. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain. 2021;22(15).
- Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343-349.
- GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390:1211-1259.
- Ford JH, Jackson J, Milligan G, et al. A real-world analysis of migraine: a cross-sectional study of disease burden and treatment patterns. Headache. 2017;57(10):1532-1544.
Schwedt, T.J., Kuruppu, D.K., Dong, Y. et al. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain 22, 15 (2021). https://doi.org/10.1186/s10194-021-01230-w
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