Our Response to the COVID-19 Pandemic

The COVID-19 pandemic created personal and professional challenges worldwide. Our response to the COVID-19 pandemic, which deeply affected us all, is an example of who we are and our mission in action. The Division of Allergy and Immunology at Cincinnati Children’s strove to overcome these challenges by safely providing clinical care, conducting research, and educating trainees; expanding our telehealth options; and contributing intellectually to the worldwide knowledge of COVID-19. We believe in changing the outcome together.

• COVID-19 Clinical Care and Trial: As the coordinating center of the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR), we assessed how SARS-COV-2 (COVID-19) differentially affects children with eosinophilic gastrointestinal disorders (EGIDs) compared to children without these disorders. This work was part of the larger Human Epidemiology and Response to SARS-CoV-2 (HEROS) study that allows a comparison between children with atopic conditions and children without those conditions. Researchers are in the process of analyzing these results.
• COVID-19 Vaccination: Risma is one of the six allergists nationwide that act as consultants for the Center for Disease Control and Prevention (CDC), Clinical Immunization Safety Assessment (CISA) team. The CISA team evaluates severe allergic reaction (anaphylaxis) reports to the COVID-19 vaccines reported to the Vaccine Adverse Events Reporting System and provides guidance to the CDC regarding potential allergens, at-risk individuals, and recommendations for precautions and contra-indications to vaccination based on allergy history. Risma led a recently published article on this emerging topic.) Learn more about vaccine reactions.
• COVID-19 Publications: We published seven manuscripts about COVID-19 this past year (Lindsley et al. 2020, Ward et al. 2020, Azouz et al. 2021, Hempel et al. 2021, Risma et al. 2021, Mahoney et al. preprint, Jin et al. preprint), including a Journal of Allergy and Clinical Immunology rostrum that is a “call to research” for understanding the mechanisms for allergic reactions to the novel mRNA COVID-19 vaccines (Risma et al. 2021).
• COVID-19 Outreach: This year, due to the COVID-19 pandemic, many of our outreach programs moved to an online format. For instance, in July 2020, the Rothenberg CURED Lab provided a live-streamed “virtual lab day” to provide education about our research to patients and families. In June 2021, the Cincinnati Center for Eosinophilic Disorders hosted our first online camp program for kids with eosinophilic disorders.
• Overcoming COVID-19 Challenges: Our division continues its excellence in clinical care, education and research despite the pandemic.
  • In clinical care, the allergy nursing team received recognition as the 2020 Top Performing Small Division for Outstanding Nursing Patient Family Experience based on a review of the annual experience survey scores and positive comments, highlighting the exceptional feedback the team routinely receives from the patients and families. The team received recognition in a virtual awards ceremony held in February 2021 for making a difference in the lives of so many families and for promoting a positive experience at Cincinnati Children’s. The clinical care team expanded services and outreach, including 934 telemedicine outpatient visits, to provide quality care during challenging times.
  • In education, we continued our excellence in training of graduate students and clinical and research fellows via limited in-person and expanded virtual formats.
  • In research, we garnered 67 publications and eight research awards totaling $1,549,934 dollars in direct funding for fiscal year 2021.

Recognized Excellence of Allergy and Immunology Division Trainees, Fellows and Associates

The Division of Allergy and Immunology is proud of the excellence of its undergraduate and graduate trainees, postdoctoral research, and clinical fellows and associates. Several received recognition for their achievements throughout the year:

• Susie Min, a medical student summer researcher, won second place for her poster "Molecular Diagnosis of Eosinophilic Esophagitis from a Single Esophageal Biopsy" in the 10th Annual Research and Service Symposium at the University of Cincinnati (UC) on Friday, November 6th. This year, we appreciate UC providing a virtual forum for the Medical Student Summer Research Program (MSSRP) poster judging. Ting Wen, PhD, and Marc Rothenberg, MD, PhD, mentor Min. Min represented the division at the annual National Student Research Forum (NSRF) in Galveston, TX.
• Rahul Sandella, a medical student summer researcher, won second place for his poster "The Effects of Adiposity on Disease and Symptom Severity in Eosinophilic Esophagitis" in the 10th Annual Research and Service Symposium at University of Cincinnati on Friday, November 6th. Vincent A. Mukkada, MD, and Kara Kliewer, RD, PhD, mentor Sandella.
• Simin Zhang, MD, a third-year clinical fellow of the Allergy / Immunology Fellowship Program, is researching the roles of mast cells in eosinophilic esophagitis and received an award for first place in clinical research for her project “Clinical Significance of Mast Cell Density in GI Biopsies in Patients Presenting for Evaluation of Gastrointestinal Mast Cell Disorders” presented at the 10th Annual Department of Internal Medicine Research Symposium at the University of Cincinnati.
• Katharine Guarnieri, MD, a first-year research fellow of the Advanced Research Training Fellowship Program, contributed one publication under the mentorship of Michelle Lierl, MD, co-developed a protocol for egg oral immunotherapy for the division and achieved EPIC Physician Builder Certification. Guarnieri has three main areas of research and associated research mentors: 1) Collaborating with the Food Allergy Research & Education (FARE) to characterize individuals with food allergy with and without eosinophilic esophagitis, mentored by Sandra Andorf, PhD, and Marc E. Rothenberg, MD, PhD; 2) Evaluating the impact of eosinophilic esophagitis disease activity on asthma measures in children with comorbid eosinophilic esophagitis and asthma, mentored by Sandy Durrani, MD; and 3) Characterizing amoxicillin-associated reactions presenting to the emergency department, mentored by Kimberly A. Risma, MD, PhD.
• Steven Proper, DO, PhD, a second-year research fellow of the Advanced Research Training Fellowship Program, contributed two publications under the mentorship of Jonathan A. Bernstein, MD,  and Gurjit Khurana Hershey, MD, PhD, and is researching the impact of environmental exposures on skin barrier function in atopic dermatitis under the mentorship of Nurit Azouz, PhD.
• A special thank you to Stephanie L. Ward, MD, for her continued leadership in educational mentorship of medical students with the University of Cincinnati, including becoming the Chair for the fellowship Clinical Competency Committee of Cincinnati Children’s for Accreditation Council for Graduate Medical Education (ACGME).
• A special thank you to Risma for her continued leadership in educational mentorship of Allergy / Immunology fellows and as leader of the Allergy / Immunology Fellowship Program and co-director of the Advanced Research Training Fellowship Program. Risma also received the 2020 Clinical Care Achievement Award for formalizing and expanding inpatient and outpatient services to address unmet needs for children with drug allergies.

New Faculty: Nurit Azouz, PhD

The division welcomes Azouz as a faculty member. Azouz researches allergic diseases and the mechanisms by which protease–protease inhibitor imbalance promotes barrier breaches and loss of immunologic tolerance in the development of allergic diseases. A breakdown of immunologic tolerance appears to be a key feature in allergic diseases. The mechanisms underlying the break of tolerance are not well understood and involve a combination of environmental and genetic factors. The epithelium is the first line of defense against potential insults, providing a physical barrier between the host and the external environment. Clinical observations of atopic or allergic march supports the importance of epithelial integrity in the development of allergic disease, which is the natural history or typical progression of allergic diseases that often begin early in life. These include atopic dermatitis (eczema), food allergy, allergic rhinitis (hay fever) and asthma. At a barrier breach, harmless antigens may encounter immune cells, potentially leading to production of a danger signal and priming a break in immune tolerance and an allergic response. The Azouz Lab investigates the function and regulation of proteases in host defense and in the onset and propagation of inflammatory and allergic diseases and focuses on deciphering the role of proteases and their inhibitors in the epithelium as part of homeostatic and surveillance mechanisms. As loss of protease inhibitors and alterations of proteolytic activity lead to tissue damage and may exert a paramount signal in the development of inflammatory diseases, the Azouz Lab also focuses on deciphering the molecular mechanisms that disrupt the balance between proteases and protease inhibitors and developing strategies for controlling proteolytic activity as an approach to treat immune diseases.

Approaching Immune Mechanisms with Systems Biology and Omics Data

Artem Barski, PhD, garnered two new awards in fiscal year 2021 to fund research using or developing multi-omics techniques to investigate allergic mechanisms. A National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID) R01 co-led by Barski and Emily R. Miraldi, PhD, of the Divisions of Immunobiology and Biomedical Informatics, supports “An experimentally refined, dynamic gene regulatory network model of T-cell memory” with the goal of using single-cell RNA and ATAC sequencing data to develop a dynamic gene regulatory model explaining rapid recall response in memory T cells. Furthermore, Barski uses a NIH / National Human Genome Research Institute Home (NHGRI) R41 Phase I Small Business Technology Transfer (via Datirium, LLC) to commercialize SciDAP.com, a next-generation data analysis platform for user-friendly yet reproducible analysis of big data. Learn more about the Barski Lab.

Unique Training and Research Opportunity for Rare Conditions

Schwartz is a physician-scientist with the Division of Allergy and Immunology and the Cincinnati Center of Eosinophilic Disorders, where he provides clinical care for patients with eosinophilic disease. Schwartz has research training in basic and translation science with expertise in innate immune function and eosinophil biology. His research focuses on understanding how allergic progenitor cells participate in the pathophysiology of eosinophilic gastrointestinal disease, with a goal of advancing our understanding of disease mechanisms to identify potential novel therapeutic targets and biomarkers for disease monitoring. He works with Rothenberg investigating eosinophilic esophagitis. EoPs are lineage–committed CD34+ progenitor cells that primarily reside in the bone marrow but can mobilize into the peripheral blood during allergic immune responses and accumulate at sites of allergic inflammation. There is a significant increase in EoP levels in the peripheral blood of patients with active EoE, and levels can differentiate active disease from inactive disease with high sensitivity, suggesting that EoP levels could serve as a potential disease biomarker. The functional significance of mobilized EoPs remains unclear, but these cells could propagate local tissue inflammation through in situ proliferation and maturation and secretion of inflammatory cytokines. Schwartz received a training grant by the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) for his project focused on further evaluating the potential role for EoP levels as a peripheral blood biomarker for disease activity and elucidating the extent to which the recruitment of these cells into the inflamed esophageal tissue contribute to local inflammation. “The CEGIR training program provides support for junior faculty to receive specialty training in eosinophilic gastrointestinal disease, where they can develop the skills necessary to make future contributions that will improve our understanding and eventual management of these disorders. CEGIR offers a unique training environment where young investigators can participate in the conversations between clinicians, scientists and patient advocacy groups and learn how these collaborations ultimately advance patient care,” says Schwartz. Learn more about the Schwartz Lab.

Binational Collaborative Eosinophilic Esophagitis Research

Eosinophilic esophagitis (EoE) is an emerging, chronic, allergic disease with dramatic and continuous increases in prevalence in nearly all regions of the world, including the USA, Europe and Israel. EoE has one of the lowest qualities of life, likely because of the restricted diets, chronic pain, relapsing nature and need for recurrent endoscopies. The Binational Science Foundation (BSF)’s Regular Grants Program awarded Ariel Munitz, PhD, of Tel Aviv University, Israel and Rothenberg of Cincinnati Children’s grant funding to investigate the roles of the type 1 and type 2 interleukin 4 (IL-4) receptors in EoE and define the relative contribution of IL-4 and IL-13 to EoE pathogenesis via the type 2 IL-4 receptor. This collaborative research project is an exciting opportunity to better understand disease pathogenesis and develop more effective, mechanism-based precision therapy. Learn more about the Rothenberg CURED Lab.

Regulation of Gastrointestinal Eosinophils

Eosinophilic esophagitis (EoE) is a chronic, allergic inflammatory esophageal disease characterized clinically by esophageal dysfunction (vomiting, pain, dysphagia, and food impaction); histologically by esophageal eosinophilia, epithelial hyperplasia, and dilated intercellular spaces associated with impaired barrier function; and by a high degree of heritability. Evidence is accumulating that the causal genes at two identified risk loci are CAPN14 (encoding for calpain 14) and TSLP (encoding for thymic stromal lymphopoietin). In addition to identifying the role of the two genetic risk loci (2p23 and 5q22), genome-wide association studies (GWAS) implicate numerous other suggestive loci. Despite these advances, the causal gene variants and / or genomic pathways for EoE pathogenesis remain largely unclear. Rothenberg received an R01 award to further investigate the regulation of gastrointestinal eosinophils and will leverage a GWAS approach, followed by genetic and biological validation, to uncover central processes involved in disease pathoetiology with a focus on the interface of adaptive and innate immunity. The limitations of current EoE therapy compounded with the fact that no FDA-approved drug exists for EoE treatment highlight the significance of this grant, which focuses on developing a better understanding of the genetic and mechanistic basis of disease pathogenesis, with particular focus on genes involved in epithelial cell function. The immediate significance of this study is its potential to uncover the primary genetic and mechanistic bases of EoE, which will likely provide the rationale for better diagnostics and therapeutic strategies, such as biological agents targeting novel pathways that emerge from genetic association (e.g., CAPN14 and TSLP).

Specialized Care for Food Allergy in Infancy

Devonshire is the initiator and leader of a specialized Beginning Introduction To Allergens Early (BITE) Clinic for the prevention, early identification and management of food allergy in infancy. The BITE Clinic sees infants who may be at high risk for food allergies or who already have food allergies. Devonshire’s research investigating the molecular signature from CD4+ T cells in infants with clinically reactive peanut allergy versus infants with peanut tolerance receives support from a KL2 Research Scholar Award from the Center for Clinical and Translational Science and Training (CCTST) at the University of Cincinnati. Resulting data will aid in developing tools to predict risk of peanut allergy in infants and expand our knowledge of food allergy in the understudied infant population. Durrani is making key progress in developing early infant food allergy screening for in-clinic use. Learn more about the Devonshire Lab.

Transition and Adult Primary Immune Deficiency Program

Cincinnati Children’s is a worldwide leader in the diagnosis and treatment of primary immune deficiency diseases. With the recognition of more immune deficiency diseases in adults, there is an eventual need for children with primary immune deficiencies to transition to adult care providers. To fill these important care needs, Erinn S. Kellner, MD, founded the Transition and Adult Primary Immune Deficiency Program, which focuses on the complex needs of adults and adolescents with primary immune deficiencies and basic, translational and clinical research to understand the mechanisms of different immune deficiencies and how they may change over time. The Transition and Adult Primary Immune Deficiency Program collaborates with adult subspecialty services at the University of Cincinnati and the Cincinnati Children’s Diagnostic Immunology Laboratory and Immune Deficiency and Histiocytosis Program. Learn more about the Kellner Lab.

Risma Awarded Clinical Care Achievement Award for Drug Allergy Program

Risma received the 2020 Clinical Care Achievement Award for formalizing and expanding inpatient and outpatient services to address unmet needs for children with drug allergies. Risma is an extraordinary clinician whose innovation led to the creation of the Drug Allergy Program, launched in 2019, at Cincinnati Children’s. The Drug Allergy Program diagnoses and treats drug allergies in children in the Greater Cincinnati area and in patients referred nationally. An important aspect of the program is “de-labeling” drug allergies by testing children for a clinical reaction to the drug in a controlled setting. For instance, recent studies show that 95% of children labeled as having an “allergy” to amoxicillin do not have a clinical reaction when re-exposed to it through testing. Delabeling drug allergies prevents use of alternative drugs that may cost more, have more side effects, or contribute to increased antibiotic resistance in our communities. The Penicillin Allergy Testing Services (PATS) team of the Drug Allergy Program received an invitation to share awareness about this topic on the Cincinnati Children’s Young & Healthy Podcast, launched in June 2021, for their fifth episode. Since launching the Drug Allergy Program, Risma enhanced perioperative anaphylaxis testing by adding documentation flowsheets, note templates and note writer capacity to the EPIC electronic medical record system and is pursuing opportunities for building a new clinical registry for drug allergies. Her leadership impacts the promotion of the next generation of physicians in the allergy and immunology field. This Clinical Care Achievement Award is most deserving and demonstrates appreciation for her immense dedication, talents and contributions.

Food Allergy Program

The Food Allergy Program, led by Assa’ad improves the lives of patients with food allergies and their family members by providing expert care, innovative treatments and cutting-edge research. In addition to providing patient services, engaging in clinical trials and leading the field in improving oral immunotherapy protocols, the Food Allergy Program receives the support of two key research awards, is a Food Allergy Research & Education (FARE) Clinical Research Center of Distinction and the FARE Clinical Network Biobank and Biomarker Discovery Center and has published 10 publications in fiscal year 2021. These publications include a consensus report of the 2019 FARE Food Allergy Summit (Pepper, Assa’ad, et al.), peanut oral immunotherapy (Guarnieri, et al.) and peanut oral immunotherapy clinical trial research (Fleischer et al.), food allergy in infancy (Devonshire and Lin), food allergy bullying and disparity research (Brown, et al.), oral food challenges (Assa’ad) and national and international food allergy guideline development (Mennini, et al.). The Food Allergy Program works to increase awareness of food allergy therapies; for instance, Durrani and Justin Schwartz, MD, PhD, co-presented “Food Oral Immunotherapy 101: An introduction to a Novel Therapy for Food Allergy” at Cincinnati Children’s Pediatric Grand Rounds. Furthermore, the oral immunotherapy clinic expanded to offer this therapy for non-peanut food allergies.

Food Allergy Biobank and Biomarker Discovery Center and Clinical Research Center of Distinction

Cincinnati Children’s received a significant grant with the expectation to boost research to benefit patients with a food allergy. The Food Allergy Program at Cincinnati Children’s received a grant from the Food Allergy Research & Education (FARE) organization to house the FARE Clinical Network Biobank and Biomarker Discovery Center. According to FARE, about 32 million Americans live with food allergy, leaving them at risk for mild to severe allergic reactions. Amal Assa’ad, MD, leads the Food Allergy Program at Cincinnati Children’s. “The establishment of the FARE Research and Clinical Network is a visionary initiative to move forward the research and clinical care for patients and families with food allergies,” says Assa’ad, professor of pediatrics in the Division of Allergy and Immunology and principal investigator for the FARE Clinical Network Biobank and Biomarker Discovery Center at Cincinnati Children’s, a FARE Clinical Research Center of Distinction. This will be the first and only biobank solely dedicated to food allergy, Assa’ad says. “It brings together the experience of the Cincinnati Children’s Discover Together Biobank in supporting national research networks and the expertise of biomarker researchers at the Cincinnati Children’s Research Foundation and the Division of Allergy and Immunology in innovation and discovery to form a strong and collaborative infrastructure for the FARE Network,” Assa’ad says. The FARE Clinical Network is a nationwide coalition of 50 academic, research and clinical centers dedicated to providing food allergy patients with access to cutting-edge prevention, diagnosis, care and clinical trials. The new center will be in charge of developing of critical biorepository infrastructure necessary to carry out the FARE Clinical Network mission, says Rothenberg, director of the Division of Allergy and Immunology at Cincinnati Children’s. “We will serve as a tactical hub for biospecimens, as well as a key participant in the design and implementation of food allergy–related biomarker and translational research,” Rothenberg says. The new FARE biobank at Cincinnati Children’s is a collaborative effort with the Division of Biostatistics and Epidemiology and the Discover Together Biobank. “We are very excited to leverage our existing biobanking infrastructure and knowledge to facilitate the establishment of the (FARE Clinical Network’s) Biobank and Biomarker Discovery Center,” says Mike Pauciulo, director of the Discover Together Biobank. “We look forward to this resource having a large impact on food allergy research into the future.” Read more about the Food Allergy Program, Assa’ad Lab, Research Horizon’s blog post, and FARE’s announcement.

Director Co-chairs the Rare Diseases Clinical Research Network Steering Committee

Rothenberg is the co-chair of the Rare Diseases Clinical Research Network (RDCRN) Steering Committee. Rothenberg joins Jennifer Puck, MD, and Andrea Gropman, MD, in leading the RDCRN Steering Committee. Rothenberg is the principal investigator for the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) of the RDCRN and director of the Cincinnati Center for Eosinophilic Disorders at Cincinnati Children’s. Rothenberg’s research focuses on molecular analysis of allergic inflammation, primarily on the molecular pathogenesis of eosinophilic gastrointestinal disorders (EGIDs). The Rothenberg CURED Lab takes a multi-disciplinary approach including the development of preclinical murine models: genetics, genomics, molecular immunology and biochemistry. The laboratory includes several broad research areas and objectives, including the epigenetic and genetic basis of allergic disease and responses, immunopathogenesis of allergic inflammation, impaired barrier function, pathogenesis of EGIDs, precision and predictive medicine and proteases and protease inhibitors in inflammation. Nationally, Rothenberg leads CEGIR, which dedicates itself to improving the lives of individuals with EGIDs through innovative research, clinical expertise and education via collaborations between scientists, health care providers, patients and professional organizations. Read the RDCRN announcement.

Cincinnati Center for Eosinophilic Disorders

Cincinnati Children’s is a worldwide leader in the diagnosis, treatment and research of eosinophilic disorders. Rothenberg established the Cincinnati Center for Eosinophilic Disorders (CCED) in 2001. It was the first of its kind to focus solely on these complex medical conditions in children and adults. Today, patients with eosinophilic disorders travel from all over the country and different parts of the world to receive comprehensive care at Cincinnati Children’s. Our specialists engage in extensive research efforts to enhance the understanding of these disorders, fuel the development of novel therapies and find a cure. This year Mukkada received the “2020 Top Pediatric Provider Award” at Cincinnati Children’s. This is an amazing, well-deserved accomplishment, reflecting not only his outstanding clinical care, but also a great team with the CCED. In fiscal year 2021, the CCED published 39 publications on eosinophilic disorders, initiated physician training for transnasal endoscopy (TNE) to establish TNE practice at Cincinnati Children’s and had 16 ongoing basic, clinical and translational studies.

FDA Approved Mepolizumab for Hypereosinophilic Syndrome After Decades of Research

The U.S. Food and Drug Administration (FDA) approved the drug Nucala (mepolizumab) to treat hypereosinophilic syndrome (HES). HES is a life-threatening group of blood disorders involving high levels of eosinophils, a type of white blood cell that plays an important role in the immune system. Over time, these overly high levels of eosinophils, called eosinophilia, enter tissues and organs and cause damage. Until now, the use of high doses of corticosteroids to lower eosinophil levels and prevent damage to organs. However, disease flares still happen, and these disease flares cause dangerous damage to the body. This milestone of FDA approval of mepolizumab for treating HES led many within the eosinophilic community to look back on the decades-long journey to this achievement, including Bill H., a former patient who first received this drug in the early 2000s at Cincinnati Children’s (Read about Bill’s journey). At the time, Rothenberg was beginning to study the effects of the anti–interleukin 5 (IL-5) mepolizumab to treat eosinophilic disorders. Bill became a patient and saw positive results soon after. “I became a participant in the initial phase I/II study of mepolizumab in 2002-2003. I immediately found a dramatic and rapid effect on my health and well-being. My eosinophil count returned to normal, my breathing improved, and I was able to reduce dependency on steroids,” he said. Rothenberg recalls his participation in the initial clinical study of the drug in 2002. A competitive grant that Rothenberg received from the FDA’s Office of Orphan Product Development supported the study. At the time, he was hoping to find new therapeutic options for individuals like Bill with HES. “Early research in our division pioneered the first usage of mepolizumab in patients with HES through an open-label, FDA-sponsored study in which patients with HES were intravenously infused with mepolizumab at Cincinnati Children's,” said Rothenberg. “A striking drop in their blood eosinophil levels was found. These findings prompted the prolonged development pathway of mepolizumab for HES.” The drug mepolizumab targets interleukin 5, a chemical produced by the body that acts as a growth factor for eosinophils and that Rothenberg studies in the research lab as part of his long-standing work to decipher mechanisms of eosinophilia and treat eosinophilic diseases. “Despite delays, it is truly rewarding to see this treatment now approved for HES,” says Rothenberg.

Diversity Initiative of Multicenter Consortium on Eosinophilic Disorders

Led by Rothenberg and Glenn Furuta, MD, the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) continues to further research and develop clinical expertise, train clinical investigators, pilot clinical research projects and provide access to information related to eosinophilic gastrointestinal disorders (EGIDs) for basic and clinical researchers, physicians, patients and the lay public. The belief is that allergic hypersensitivity to certain foods and an over-accumulation in the gastrointestinal tract of white blood cells, called eosinophils, trigger chronic inflammatory conditions. Eosinophilic disorders can cause a variety of gastrointestinal complaints, including reflux-like symptoms, vomiting, difficulty swallowing, tissue scarring, fibrosis, the formation of strictures, diarrhea, abdominal pain and failure to grow in childhood. CEGIR receives funding from the Rare Diseases Clinical Research Network (RDCRN) and comprises researchers from 16 institutions and three major patient advocacy groups, including the Campaign Urging Research for Eosinophilic Disease (CURED), American Partnership for Eosinophilic Disorders (APFED), and the Eosinophilic Family Coalition (EFC). Notably, CEGIR has initiated a diversity committee, which is very active (>30 members) and has become exemplary for the RDCRN. The Diversity Committee has a number of research and education objectives, which are actively underway. The Diversity Committee also generated this diversity vision statement for CEGIR read at the beginning of all biweekly meetings: “CEGIR actively promotes a culture of diversity and inclusivity in its membership, its innovative research studies and its educational initiatives”.

Industry Clinical Trials

The Division of Allergy and Immunology at Cincinnati Children’s believes that research is the hope for future clinical advances in care and treatment. In fiscal year 2021, there were three newly initiated clinical trials in the division. Assa’ad leads a trial investigating oral immunotherapy: 1) “A Multicenter Open-Label, Long Term-Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in A Prior AR 101 Study” with Aimmune Therapeutics, Inc. (ClinicalTrials.gov Identifier: NCT03292484). Durrani leads two investigating eosinophilic esophagitis (EoE) and eosinophilic gastritis: 1) "A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Adult and Adolescent Patients with Active Eosinophilic Esophagitis" with Allakos, Inc. (ClinicalTrials.gov Identifier: NCT04322708) and 2) "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis Who Have an Inadequate Response with, Lost Response to, or Were Intolerant to Standard Therapies" with Allakos, Inc. (ClinicalTrials.gov Identifier: NCT04322604).