News Release

Mallinckrodt Presents Data on a Novel Predictive Model to Identify Infants at Risk for Infantile Spasms (IS) at the 2019 Annual Meeting of the American Epilepsy Society (AES)

-- Predictive model based on claims data from 10.8 million infant patients and input from IS medical experts finds strongest predictors for identifying infants at risk for IS include presence of at least two symptoms and a moderate or high severity emergency department visit --


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.


  • 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

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

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© 2019 Mallinckrodt. US-1902162 12/19



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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