STAINES-UPON-THAMES, United
Kingdom, Dec. 7, 2019
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a global biopharmaceutical company, today
announced findings on the use of a novel predictive model designed
to more quickly identify infants with infantile spasms (IS), a rare
seizure disorder that typically occurs between three and seven
months of age.1 The study results were reported in
a poster presentation titled, "Clinical Pathways Leading to a
Diagnosis of Infantile Spasms Using a Claims Database," (Poster
#1.209) today during the 2019 Annual Meeting of the American
Epilepsy Society (AES) in Baltimore.
The poster can be accessed here on the company's
website.
Using claims data from 10.8 million patients under two years of
age and input from IS medical experts, researchers developed a
predictive model to identify combinations of factors that may best
predict IS. The deductive model found that two or more symptoms,
including developmental delays, convulsions, dysphagia and cerebral
palsy, coupled with a moderate or high severity emergency
department (ED) visit, were strong predictors for identification of
IS.2
"If we can leverage machine learning algorithms in electronic
medical systems, we may be able to identify those children at
higher risk of developing infantile spasms, with the possibility of
creating alert systems, decreasing time from symptom onset to
diagnosis, and ultimately improving outcomes for this potentially
devastating form of epilepsy," said Dr. Adam L. Numis, pediatric neurologist and
epileptologist, UCSF Benioff Children's Hospital, San Francisco, CA.
Key Findings2
- Deductive models developed to identify the combinations of
variables that predict IS prior to diagnosis and during the
treatment pathway: 557 patients had ≥2 symptoms pertaining to IS –
seizures, developmental delay, lack of eye contact and lack of
muscle tone – and a moderate or high severity ED visit.
- In this group, 55 percent of patients (n=304) had an IS
diagnosis within a median 0.8 months of the triggering event. The
most notable deductive combinations focused on pre-diagnosis of
IS.
Methods2
- The study utilized data from the Symphony Health Integrated
Dataverse database to identify triggers for early identification of
IS patients from medical and pharmacy claims from 10.8 million
patients under 2 years of age between May
2017 and April 2018.
- International Classification of Diseases (ICD) procedure codes
were evaluated to identify the codes most likely to predict a
subsequent diagnosis of IS.
- Researchers also used input from IS medical experts to
determine the clinical, electrographic, radiologic, procedural and
medication variables that may predict IS development.
Study Limitations2
- The use of ICD codes to evaluate IS may not identify all IS
cases.
- The deductive analysis relied on the accuracy of coding for
diagnoses and procedures in the ED.
The analysis was supported by Mallinckrodt.
"We're proud to present this data in support of faster diagnosis
of infants during IS Awareness Week, which seeks to raise awareness
of the subtle signs of IS that are often overlooked and the urgent
need for prompt diagnosis and treatment," said Tunde Otulana, M.D., Chief Medical Officer at
Mallinckrodt. "Mallinckrodt is committed to conducting research
and providing critical services to help caregivers and infants with
IS get the proper diagnosis as quickly as possible to enable
earlier treatment intervention with the goal of improving long-term
outcomes."
About Infantile Spasms
Infantile spasms, sometimes
called West syndrome, is a rare seizure disorder that occurs in
approximately 2,000 to 2,500 infants per year in the U.S., based on
a review of population-based studies of the condition.1
It most commonly occurs in the first year of life, with peak onset
between three and seven months of age.1 Early
identification, diagnosis and treatment of infantile spasms are
essential to help limit lasting effects.3 Children
with infantile spasms generally have one or more of the following
symptoms: a certain type of seizure (called "spasms"), a
disorganized and chaotic brain-wave pattern called hypsarrhythmia
as recorded on an EEG (electroencephalogram), or a failure to meet
developmental milestones.3
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of
multiple wholly owned subsidiaries that develop, manufacture,
market and distribute specialty pharmaceutical products and
therapies. The company's Specialty Brands reportable segment's
areas of focus include autoimmune and rare diseases in specialty
areas like neurology, rheumatology, nephrology, pulmonology and
ophthalmology; immunotherapy and neonatal respiratory critical care
therapies; analgesics and gastrointestinal products. Its Specialty
Generics reportable segment includes specialty generic drugs and
active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution
of important company information, such as press releases, investor
presentations and other financial information. It also uses its
website to expedite public access to time-critical information
regarding the company in advance of or in lieu of distributing a
press release or a filing with the U.S. Securities and
Exchange Commission (SEC) disclosing the same information.
Therefore, investors should look to the Investor Relations page of
the website for important and time-critical information. Visitors
to the website can also register to receive automatic e-mail and
other notifications alerting them when new information is made
available on the Investor Relations page of the website.
CONTACTS
For Trade Media Inquiries
Caren Begun
Green Room Communications
201-396-8551
caren@greenroompr.com
For Financial/Dailies Media Inquiries
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com
Investor Relations
Daniel J.
Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Mallinckrodt, the "M" brand mark and
the Mallinckrodt Pharmaceuticals logo are trademarks of
a Mallinckrodt company. Other brands are trademarks of
a Mallinckrodt company or their respective
owners.
© 2019 Mallinckrodt. US-1902162 12/19
References
1 Wheless J, Gibson P, Rosbeck K, et al. Infantile spasms
(West syndrome): update and resources for pediatricians and
providers to share with parents. BMC Pediatrics. 2012;12(1):108.
doi:10.1186/1471-2431-12-108. Accessed November 20, 2019.
2 Okimoto D, Dandu H, Maru S, Numis A, Panaccio M, Wan, G,
Singh V. Clinical Pathways Leading to a Diagnosis of Infantile
Spasms Using a Claims Database. Poster presented at: 2019 American
Epilepsy Society (AES) Annual Meeting December 6-10, Baltimore, MD.
3 Go CY, Mackay MT, Weiss SK, et al. Evidence-based
guideline update: medical treatment of infantile spasms. Neurology.
2012; 78:1974-1980.
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