While childhood allergic disease is often diagnosed a few years after birth, recent science indicates that some root causes of disease may initiate early in life.1 Pregnancy and early childhood years, therefore, provide a unique window for detecting disease risk and intervening to induce healthy development and prevent disease.
Enter the Healthy Baby Initiative (HBI), a strategic, cross-sector effort through the World Without Disease Accelerator (WWDA), aligned with the group’s vision of advancing prevention, interception, and curative solutions, including early childhood conditions, to inhibit chronic disease in later childhood and adulthood. Richard Insel, M.D., Global Head, HBI, leads the group that was formed in February 2019.
Which diseases does the HBI focus on, and why is early childhood an important window for targeting these conditions?
Richard Insel (RI): The HBI has been initially focused on the prevention, interception, and cure of atopic dermatitis, food allergy, and celiac disease. According to the World Allergy Organization, the prevalence of allergic diseases has continued to rise in the industrialized world for more than 50 years.2 In the U.S., 9.6 million children under the age of 18 are affected by atopic dermatitis, and one-third have moderate to severe disease.3,4,5 Food allergy afflicts 32 million individuals in the U.S., including one in 13 children.6,7,8 Additionally, about 40 percent of food allergic children have a history of severe reactions, and a high proportion of children are allergic to more than one food.9
These diseases often develop during the first two years and set the stage for the rest of a child’s life. Moreover, these diseases often develop into other conditions over time. For instance, a child with atopic dermatitis is at high risk to develop a food allergy later in childhood. This phenomenon is called the atopic march. Some food allergies, such as peanut allergy usually last lifelong.
Presently, there are no known cures for the diseases we’re focusing on, and the treatments that are commonly recommended for children are strict diets for food allergy or celiac disease, and topical ointments and creams for atopic dermatitis. Management of these chronic conditions can be time-consuming and burdensome for children and their caregivers, and in some cases allergic conditions can be dangerous or even deadly.
How is the HBI working toward prevention and interception of these diseases?
RI: The WWDA brings together expertise through internal and external collaborations to accelerate science, understand the root causes of disease, detect risk of disease, and develop transformational novel solutions. Our current HBI projects are in collaboration with Evolve BioSystems, Kaleido Biosciences, FARE, and Monash University.
First, we are collaborating with Evolve BioSystems, a company that has developed a unique gut probiotic for infants based on infant microbiome research, for a proof-of-concept clinical trial in infants at risk for developing atopic dermatitis. The trial will evaluate the effectiveness of Evolve’s gut probiotic, Evivo® (B. infantis EVC001), in reducing the risk of atopic dermatitis in the first year of life. The trial is expected to be completed in 2022.
Second, as part of a research agreement with Kaleido Biosciences, a clinical-stage healthcare company, we are working to identify a prebiotic that can alter the infant gut microbiome to promote healthy immune training. Our hope is that by driving specific microbiome composition and function, we can impact the onset of childhood allergies and other immune, and metabolic conditions.
Third, in collaboration with FARE (Food Allergy Research and Education), the world’s largest private funder of food allergy research, we will be co-funding a biomarker research grant focused on identifying and validating novel food allergy biomarkers relevant to detection of risk or prediction of severity of food allergy or prognosis and potential for clinical response to therapy for food allergies.
Lastly, our multi-year research collaboration with Monash University aims to better understand the role of the immune system in celiac disease, identify new diagnostic approaches, characterize patient heterogeneity, and decipher the role of the gut microbiome in the disease.
Why is this work important for patients and caregivers, and why is it special to you?
RI: I am trained in pediatrics and believe the essence of pediatric medicine is prevention. In the 20th century, the industry was very effective in the development of vaccines to prevent childhood infectious diseases. I believe that in the 21st century we will develop safe and effective approaches for the prevention and interception of non-communicable diseases such as allergic diseases, autoimmune diseases such as type 1 diabetes and celiac disease and even obesity and cancer.
The burden that childhood allergic diseases place on children and their families can be overwhelming. For example, children with atopic dermatitis often suffer from poor sleep due to constant itching and scratching, and children with food allergy or celiac disease must alter their diet to avoid possible life-threatening reactions and damage to the intestine. These diseases can also cause lifelong psychological and social burdens that start at a young age and remain with an individual throughout his or her life.
Within the WWDA we’re taking a unique approach, leveraging cross-sector internal J&J assets with external innovation to prevent and intercept disease in a way not many healthcare companies have tried. It is a privilege to help catalyze a paradigm shift from today’s diagnose-and-treat model to one of prediction and preemption – to improve the lives of children and their caregivers.
REFERENCES
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2 Pawankar R, Walkter Canonica G, Holgate S, Lockey R. World Allergy Organization. White Book on Allergy 2011-2012 Executive Summary.
3 Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema prevalence in the United States: data from the 2003 National Survey of Children’s Health. J Invest Dermatol. 2011;131(1):67-73.
4 Silverberg JI, Simpson EL. Association between severe eczema in children and multiple comorbid conditions and increased healthcare utilization. Pediatr Allergy Immunol. 2013;24(5):476-486.
5 Silverberg JI, Simpson EL. Associations of childhood eczema severity: a US population-based study. Dermatitis. 2014;25(3):107-114.
6 Gupta RS, Warren CM, Smith BM, Jiang J, Blumenstock JA, Davis MM, Schleimer RP, Nadeau KC. Prevalence and Severity of Food Allergies Among US Adults. JAMA Network Open 2019; 2(1):e185630.doi:10.1001/jamanetworkopen.2018.5630.
7 United States Census Bureau Quick Facts (2015 and 2016 estimates).
8 Gupta RS, Warren CM, Smith BM, Blumenstock JA, Jiang J, Davis MM, Nadeau KC. The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics 2018; 142(6):e20181235.
9 Gupta, R, et al. The Prevalence, Severity and Distribution of Childhood Food Allergy in the United States. Pediatrics 2011; 10.1542/ped.2011-0204.
