House CallFeb/Mar 2014 Issue

Research Roundup: Drug Treatment, Medications, Anaphylaxis Triggers and More

Women holding pill in hand

Girl looking at pill photo © Lana K/Shutterstock

Celiacs Want Drug Treatment

Two-thirds of celiacs are interested in a drug treatment for celiac disease, say researchers from the Celiac Disease Center at Columbia University. Older adults, men, those who dine out frequently, those dissatisfied with their weight and those concerned about the cost of the gluten-free diet reported greater interest in drug treatment. Additionally, those who didn’t feel their celiac was adequately treated and those reporting a lower quality of life also expressed greater interest in a medication. Key concerns for those not interested in a drug treatment included potential side effects, how well the drug would work and its cost.

Findings were based on a questionnaire sent to celiac support groups in California, Iowa and New York. Data from 365 biopsy-proven celiacs was included in the analysis.

This study is the first time that interest in a drug treatment has been gauged in Americans with celiac, even though work toward such a treatment has been underway for years. It was published in June in Therapeutic Advances in Gastroenterology.

Medications for Celiac Disease

At the 15th International Celiac Disease Symposium held in September in Chicago, updates on several promising drug treatments for celiac disease were presented. Notably, for the first time, a drug, ALV003, has been shown in a clinical study to reduce gluten-induced damage in celiacs on a gluten-free diet. ALV003 is a capsule designed to degrade gluten into fragments too small to trigger an immune response in celiacs. Thirty-four adults with celiac disease took part in the study. They were randomly assigned to take ALV003 or placebo (sugar pill) for six weeks while consuming 2 grams a day of conventional (gluten-containing) breadcrumbs. Eighty-one percent of those taking ALV003 showed little change in their intestinal villi compared to just 39 percent taking the placebo. A late-stage study of ALV003 as a companion to the gluten-free diet is now underway.

Other researchers presented news about BL-7010, an agent that binds to gliadin (the toxic part of gluten), sequestering it until it’s excreted from the body. In early preclinical studies, BL-7010 was found to be safe, well-tolerated and relatively specific to gliadin. This suggests BL-7010 shouldn’t otherwise affect the digestion process or the absorption of vitamins, researchers say. The first study in humans (with celiac disease) is planned soon.

Anaphylaxis Treatment

Researchers from Notre Dame University have made important progress toward the development of a novel treatment for allergic conditions known as type-I hypersensitive allergic reactions. These include certain food allergic reactions that can result in anaphylaxis.

The researchers developed a special molecule, called a heterobivalent inhibitor (HBI), that can be designed to bind to key allergen receptors, blocking the allergen and tamping down or even preventing a reaction. In the study, researchers demonstrated the effectiveness of the HBI molecule using cellular and animal models of allergy. Next, they plan to translate their work into human allergens. However, the molecule must first be engineered for each allergen, such as peanut or egg. If successful, researchers say the molecules could be used together with an EpiPen to reduce the severity of a reaction already taking place. They could also be used if exposure to a serious allergen is likely, such as on an airplane, where peanuts, for example, are widely consumed.

The study was published online in Nature Chemical Biology in October 2013.

Cost of Food Allergy

A new study confirms what families of food allergic children already know: food allergy is expensive. The overall cost of childhood food allergies, which affect approximately 8 percent of U.S. kids, was estimated at nearly $25 billion annually, or $4,184 per child, say researchers from Lurie Children’s Hospital of Chicago and the Northwestern University Feinberg School of Medicine.

Between 2011 and 2012, researchers surveyed 1,643 caregivers of food allergic children to calculate the various medical and out-of-pocket costs associated with food allergy. Of the estimated $25 billion annually, $5 billion was attributed to direct medical costs, including clinician visits, emergency department visits and hospitalizations, while the rest, $20 billion, was borne directly by families. Parents and caregivers identified workplace sacrifices, like reducing hours or even changing or quitting jobs to help care for food allergic children, as key costs. Other significant costs included purchasing specialty allergen-free foods, obtaining extra childcare and paying for special camps or schools.

The study was published in November in JAMA Pediatrics.

Unprepared for Anaphylaxis

As many as 5 percent of Americans have probably experienced anaphylaxis, report researchers at Johns Hopkins University School of Medicine. They randomly surveyed 1,000 U.S. adults by phone about anaphylaxis in their household. The team also surveyed a second group of 1,059 allergy patients to home in on anaphylaxis triggers and treatment. Medications and foods were the most commonly reported triggers, followed closely by insect bites and stings.

Alarmingly, just 42 percent of individuals said they sought treatment (such as calling 911 or going to the hospital) within 15 minutes of anaphylaxis onset and just 11 percent of them utilized self-injected epinephrine. Although most respondents with anaphylaxis reported two or more episodes (almost 20 percent reported five or more), half had never received a prescription for self-injectable epinephrine and 60 percent didn’t currently have epinephrine available.

“Patients do not appear adequately equipped to deal with future episodes,” write the researchers.

This points to the need for public health initiatives to improve anaphylaxis recognition and treatment. The Asthma and Allergy Foundation of America, a non-profit group involved in the study, emphasized that immediate use of a prescription epinephrine auto-injector at the first sign of a severe allergic reaction is the standard-of-care for adults and children.

The study was published online in October in the Journal of Allergy and Clinical Immunology.

Neurologic Effects of Celiac

A study featured at the International Celiac Disease Symposium looked at neurological dysfunction in celiac disease. More than half of the study’s 73 participants—newly diagnosed adults at a celiac clinic in the U.K.—had neurological symptoms. These included frequent and intractable headaches, balance problems and sensory symptoms. White matter abnormalities were spotted in the brain scans of a number of these participants and some had TG6 antibodies. (TG6 antibodies have been linked to neurological dysfunction in celiac disease.) Findings suggest that neurological dysfunction is common in newly diagnosed celiacs, write researchers.

A U.S. study, also featured at ICDS, found that neurocognitive effects like brain fog are common after exposure to gluten in those with celiac disease and non-celiac gluten sensitivity alike. A whopping 89 percent of celiacs and 95 percent of those with non-celiac gluten sensitivity reported experiencing neurocognitive effects due to gluten, specifically, difficulty concentrating, forgetfulness, grogginess, detachment and mental confusion. Symptoms often began 30 minutes to an hour after gluten exposure and lasted several days. Results were based on a preliminary online survey completed by 1,143 individuals with celiac disease and 253 with non-celiac gluten sensitivity. More work is planned.

Senior medical correspondent Christine Boyd lives in Baltimore.

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