INDIANAPOLIS, Oct. 9, 2020 /PRNewswire/ -- Nearly 80% of people
taking calcitonin gene-related peptide monoclonal antibodies (CGRP
mAbs) for the preventive treatment of migraine reported their
migraine as "better" overall since starting their medication,
according to a web-based population survey. Close to two-thirds
(62.6%) said they also used an additional recommended migraine
preventive medication with their CGRP mAbs. Eli Lilly and Company
(NYSE: LLY) announced today the results, which are among the first
real-world, population-based, patient-reported outcomes from people
using CGRP mAbs as a migraine preventive treatment and suggest
these novel medications lead to improvement in how patients
perceive their migraine. The latest findings from Lilly's
OVERCOME study are being presented virtually at the
18th Migraine Trust International Symposium (MTIS 2020).
"It is very encouraging that nearly 4 out of 5 people in the
survey taking a CGRP monoclonal antibody felt better and reported
their migraine had improved," said Sait Ashina, M.D.,
Department of Neurology and Department of Anesthesia, Critical Care
and Pain Medicine, and Harvard Medical School, Beth Israel
Deaconess Medical Center, and scientific advisor to the OVERCOME
study. "It is also notable that the OVERCOME survey reported the
clinically meaningful distinction between individuals who reported
no change in their migraine with those who said their migraine
worsened. This distinction can enhance conversations between the
healthcare provider and the patient regarding treatment
expectations when considering the use of these novel migraine
preventive medications."
Patient's Assessment of Their Migraine After Taking a CGRP
mAb for Preventive Treatment
Of the 586 people who reported using a CGRP mAb for the
preventive treatment of migraine in the past three months, 79.2%
reported perception of their migraine as "better," 11.3% indicated
"no change" and 9.6% said it was "worse." These findings were
relatively consistent across groups: 80.3% (0-3 headache days per
month), 80.8% (4-7 headache days per month), 79.8% (8-14 headache
days per month) and 74.6% (≥15 headache days per month). Data
was obtained from participants in Q4 2019 and represented 2.8% of
the 20,782 participants in the U.S. OVERCOME 2019 survey. Patients'
perception of improvement in their migraine were measured using the
Patient Global Impression of Improvement (PGI-I) scale. PGI-I
responses were categorized as better, no change, or worse.
Use of Additional Recommended Migraine Preventive
Medication
Among respondents who used a CGRP mAb in the previous 3 months,
62.6% used an additional recommended migraine preventive
medication. This finding is consistent with the 2018 position
statement of the American Headache Society (AHS) on integrating new
migraine treatments into clinical practice and with patients'
existing treatment plans.
"Given the AHS position statement and these exciting results
that people reported their migraine as 'better' overall after
taking novel CGRPs mAbs, Lilly believes the new data informs HCPs
of the role CGRP mAbs can play as part of a comprehensive treatment
plan for migraine," said Michael Cobas Meyer, M.D., vice
president, global medical affairs, bio-medicines, Eli Lilly and
Company.
Use of an additional migraine preventive medication was
generally higher for patients with more frequent migraine headache
days per month: 56.8% (0-3 headache days per month), 64.6% (4-7
headache days per month), 70.9% (8-14 headache days per month) and
70.2% (≥15 headache days per month). Recommended preventive
medications for migraine were defined by the guidelines of the
American Academy of Neurology (AAN) as well as the AHS position
statement, and included topiramate, divalproex sodium/valproate
sodium, metoprolol, propranolol, timolol, atenolol, nadolol,
amitriptyline, nortriptyline, venlafaxine, duloxetine and
onabotulinumtoxinA.
"We are pleased to share the latest insights from OVERCOME,
which will enroll 100,000 people with migraine from around the
globe and make it the largest population-based study of its kind by
including U.S. patients who are studied over time. OVERCOME is
focused on assessing the unmet needs of patients with migraine and
how novel therapies, including the class of CGRP monoclonal
antibodies, are influencing migraine treatment and patient-reported
outcomes in this unprecedented era of treatment innovation for
migraine," said Michael Cobas Meyer. "At Lilly we believe it's
important to go beyond controlled clinical trials to better
understand how patients manage their migraine including medicines
in real life, and how they report the impact on their outcomes. We
believe these insights will be useful for patients and healthcare
providers when discussing treatment."
For additional information, read about Lilly's commitment to go
beyond clinical trials to advance findings for migraine here.
About the OVERCOME Study
The Observational Survey of
the Epidemiology, Treatment
and Care of Migraine (OVERCOME)
study aims to further understand the unmet needs of those with
migraine by assessing the burden of migraine experienced by people
living with the disease, identify barriers to the appropriate
treatment of migraine, and assess how the introduction of novel
treatment options may influence delivery of migraine care and
outcomes.
OVERCOME is a prospective, web-based patient survey and will
enroll 100,000 individuals with migraine from regions across the
globe. U.S. OVERCOME will enroll more than 60,000 individuals with
migraine using a prospective, multi-cohort, longitudinal study
design to follow U.S. population samples with migraine for two
years following their enrollment. In addition, nearly 40,000
individuals with migraine from other regions across the globe will
complete a cross-sectional survey. In parallel, OVERCOME will also
include 24,000 people who did not have migraine, providing a unique
perspective about how migraine is perceived by those who do not
have the disease. OVERCOME began enrollment in Q4 2018.
About the U.S. OVERCOME Scientific Advisory Board
The U.S. OVERCOME study is being conducted by Kantar on behalf
of Eli Lilly and Company with expert guidance provided by some of
the leading voices in migraine research today, including:
- Richard B. Lipton, M.D., (Study Chair), Department of
Neurology, Albert Einstein College of Medicine and
Director, Montefiore Headache Center, Montefiore Health System
- Sait Ashina, M.D., Department of
Neurology and Department of Anesthesia, Critical Care and Pain
Medicine, and Harvard Medical School, Beth Israel Deaconess
Medical Center
- Dawn C. Buse, Ph.D., Department
of Neurology, Albert Einstein College of Medicine,
Clinical Health Psychology Doctoral Program of
the Ferkauf Graduate School of Psychology, Yeshiva University
- Susan Hutchinson, M.D., Orange
County Migraine and Headache Center
- Michael L. Reed, Ph.D.,
President, Vedanta Research
- Robert E. Shapiro, M.D.,
Department of Neurological Sciences, Larner College of
Medicine, University of Vermont
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at lilly.com and lilly.com/newsroom.
P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about the OVERCOME study and its assessment of the unmet
needs of patients with migraine and the use of novel therapies,
including the class of CGRP monoclonal antibodies, and reflects
Lilly's current beliefs. There are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee that future study
results will be consistent with the results to date or that Lilly
will receive additional regulatory approvals. For further
discussion of these and other risks and uncertainties, see Lilly's
most recent respective Form 10-K and Form 10-Q filings with
the United States Securities and Exchange Commission. Except
as required by law, Lilly undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
© Lilly USA, LLC 2020. All
rights reserved
Refer to:
|
Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly
Bio-Medicines)
|
|
Kevin
Hern; hern_kevin_r@lilly.com; 317-277-1838 (Investor
Relations)
|
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