USF Health physician-scientist Dr. Juan Carlos Cardet was co-first author for the New England Journal of Medicine article reporting results of the long-awaited PREPARE trial

TAMPA, Fla (Feb. 26, 2022) — Black and Latinx patients suffer disproportionately from asthma, a chronic inflammatory disease with symptoms including shortness of breath, tightness in the chest, coughing, and wheezing. They experience more severe asthma, higher rates of asthma-related emergency department visits and hospitalizations, and approximately double the asthma death rates compared to white patients.

A new approach for managing moderate-to-severe asthma, known as single maintenance and reliever therapy, combines two medications in one inhaler for control of underlying inflammation and quick relief of acute symptoms. While this strategy has gained interest and led to updated guidelines for patients, no studies to date have focused on Black and Latinx populations.

To help address the lack of comparable data for these underrepresented populations, the PREPARE (PeRson EmPowered Asthma RElief) trial enrolled 1,201 Black and Latinx adults (ages 18 to 75)  with moderate-to-severe asthma. The study was conducted November 2017 to April 2021 at 19 sites in the U.S., including the USF Health Morsani College of Medicine, and Puerto Rico. Participants were randomized to one of two groups. In addition to continuing their usual asthma medications, half of the participants (intervention group) received one-time instruction on how to use inhaled corticosteroids whenever they dispensed airway-opening reliever medications via a nebulizer or rescue inhaler. The other half (control group) also continued their usual care (UC) but did not dispense inhaled corticosteroids as needed to treat asthma attacks along with quick-relief medications. All patients had one instructional visit followed by 15 monthly questionnaires.

The PREPARE study demonstrated that this new intervention, called Patient-Activated Reliever-Triggered Inhaled Corticosteroids (PARTICS), substantially reduced severe asthma attacks, improved asthma control and quality of life, and decreased lost days from work or school.

The study results were presented by USF Health physician-scientist Juan Carlos Cardet, MD, MPH, Feb. 26 at the 2022 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) and simultaneously published in The New England Journal of Medicine.

“Despite decades spent trying to find effective solutions to address the health disparities in asthma care, we haven’t made a significant dent in the problem,” said Dr. Cardet, an assistant professor in the USF Health Division of Allergy and Immunology. “The patient-centered PARTICS intervention we investigated works in underrepresented populations with poorly controlled asthma. It’s feasible, low cost, and may be easy to implement and help reduce the burden of complications from asthma if we can bring it to the clinic.”

Dr. Juan Carlos Cardet of the USF Health Morsani College of Medicine’s Allergy and Immunology Division studies better ways to treat poorly controlled asthma, including in underserved populations.

Dr. Cardet was the PREPARE study’s co-first author along with Elliot Israel, MD, the Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research and director of Clinical Research in the Pulmonary and Critical Care Division, Brigham and Women’s Hospital. Thomas Casale, MD, a professor of medicine and pediatrics in the USF Health Division of Allergy and Immunology, helped execute the study as the USF site principal investigator.

Among PREPARE’s key findings:

• The annualized rate of severe asthma exacerbations was 0.69 per patient for participants in the PARTICS+UC group; the rate was 0.82 for the control group.
• Participants in the PARTICS+UC group also showed improved scores for asthma control and quality of life compared to patients in the control group.
• Those in the PARTICS+UC group also missed fewer days of school, work or other usual activities compared to the control group (13.4 versus 16.8 days)

A distinctive aspect of the PREPARE trial was the degree of engagement by patients to help optimize the study. Researchers collaborated with Black and Latinx adults with asthma as well as asthma caregivers — called Patient Partners — who are among the NEJM paper’s coauthors.

Dr. Cardet, working with Dr. Israel worked with other collaborators, designed a symptom-driven treatment approach consistent with what patients wanted; that is, an intervention intended to help control the chronic inflammation of asthma (with an inhaled corticosteroid) at the same time an inhaled reliever medication is delivered to ease severe flare-ups of symptoms.

Many patients are prescribed complicated regimens of controller medications to be taken daily, even on days when they experience no need for a fast-acting medication to open their constricted airways,” Dr. Cardet said. “In real life, patients may or may not adhere to that regimen when they’re feeling OK, but they will use their medications when symptoms arise.”

This work was supported by a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (PCS-1504-30283), the Gloria M. and Anthony Simboli Distinguished Chair in Asthma Research Award, grant #K23AI125785 from the National Institute of Allergy and Infectious Diseases (NIAID) and grant #AI-835475 from the American Lung Association (ALA)/American Academy of Allergy, Asthma & Immunology (AAAAI).

Dr. Cardet is a co-investigator for the Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (PrecISE) sponsored by the National Heart, Lung, and Blood Institute (NHLBI). This multisite clinical study, which aims to identify biomarkers to guide development of targeted treatments for severe asthma, is also seeking participants from underrepresented populations.

This week’s New England Journal of Medicine reported results of the pivotal CENTAUR clinical trial; the USF Health ALS Clinic was one of only two sites in Florida for the study

Tampa, FL (Sept. 2, 2020) – Despite two approved medications and at least 100 clinical trials later, an urgent need for new treatments to improve the lives of patients with amyotrophic lateral sclerosis (ALS), a relentlessly progressive and fatal disease, continues to exist.

//www.youtube.com/watch?v=C8O_RVK2UQ0

This week’s New England Journal of Medicine published results of the highly anticipated CENTAUR clinical trial, and included among the study’s coinvestigators was Tuan Vu, MD, professor of neurology at the Morsani College of Medicine and director of the USF Health ALS Clinic.

CENTAUR was a 24-week randomized, double-blind trial Phase 2/3 trial of 137 adults with ALS conducted across 25 top medical centers in the U.S. through the Northeast ALS (NEALS) Consortium. USF Health was one of two Florida sites to evaluate the safety and effect on disease progression of Amylx Pharmaceuticals’ investigational neuroprotective therapy, known as AMX0035. The oral therapy combines two different medicines: sodium phenylbutyrate and taurursodiol.

Using the Revised ALS Functional Rating Scale (ALSFRS-R) to measure daily functions such as the ability to walk, dress independently, self-feed, speak and breathe, the CENTAUR investigators demonstrated that treatment with AMX0035 decreased the rate of decline in patients with ALS compared to those with ALS receiving a placebo. The therapy was generally well tolerated, with similar rates of adverse events reported in the AMX0035 and placebo groups. For more details on the CENTAUR trial, including the open label extension study, and next steps, click here. 

“ALS is likely the end result of several different pathological processes leading to the death of nerve cells in the brain and spinal cord that control voluntary muscle movements — so there is no one treatment solution. To combat this complex neurodegenerative disease we need to target more than one process at the same time,” Dr. Vu said.  “This investigational drug protects motor neurons in a different way than the two currently approved ALS medications (riluzole and edaravone). It was beneficial in slowing disease progression, allowing patients to remain functional for a longer period of time.”

Only two drugs to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, have been approved by the FDA over the last 25 years.

“CENTAUR met its prespecified primary outcome, showing a clinically meaningful and statistically significant treatment benefit on the ALSFRS-R, the most commonly used scale in clinics worldwide to measure function in ALS,” said Sabrina Paganoni, MD, PhD, principal investigator of the CENTAUR trial, investigator at the Sean M. Healey & AMG Center for ALS at Massachusetts General and assistant professor of physical medicine and rehabilitation at Harvard Medical School and Spaulding Rehabilitation Hospital. “These results represent a major milestone for the ALS community, and I am thrilled about the promise of this therapy for people with ALS.”

AMX0035 was the first investigational therapy to demonstrate statistically significant benefit on the prespecified primary outcome in patients with ALS since edaravone, an intravenous drug approved by the U.S. Food and Drug Administration (FDA) in 2017.  The first and only other commercially available drug to treat ALS, riluzole, was FDA approved 25 years ago.

The NEJM study authors concluded that sodium phenybutyrate/taurursodiol (AMX0035) resulted in slower progression of ALS over 24 weeks as measured by the ALSFRS-R total score, but recommended longer and larger trials to further evaluate the therapy’s effectiveness and safety.

Dr. Tuan Vu, professor of neurology, directs the USF Health ALS Clinic. Below: Dr. Vu performs an electromyography (EMG), one of the tests used to help diagnose ALS.

Zbigniew (Ziggy) Grajzer of Clearwater, Fla, was diagnosed with ALS in November 2019 and began treatment at the USF Health ALS Clinic in February 2020. He takes both edaravone and riluzole and remains hopeful about any steps forward to find new ALS treatments to improve quality of life and maintain independence.  While he was not enrolled in CENTAUR, Grajzer, 69, participates in other ALS clinical trials at the USF Health whenever he can. “It is the only way to find a cure,” he said, “if not in time for me, then to help others in the future.”

Grajzer said he feels fortunate that his ALS appears to be progressing slowly, but acknowledges the struggles of living with a disease that gradually robs an individual’s ability to control muscle movement. He has lost use of his left hand, his legs are weaker, and he tires easily, even walking from one room to another.  “I enjoyed going everywhere, to the beach and the mountains. Now most of what I do is around the house. But at least I can still move, speak, eat, breathe and think, and I’m grateful for that,” he said.

Zbigniew (Ziggy) Grajzer began treatment at the USF Health ALS Clinic earlier this year.

CENTAUR, the recipient of an ALS Accelerated Therapeutics grant, is supported by The ALS Association, ALS Finding a Cure, a program of The Leandro P. Rizzuto Foundation, the Northeast ALS Consortium, Healey Center for ALS at Mass General, and was funded in part by the ALS Ice Bucket Challenge.

ABOUT USF HEALTH ALS CLINIC
The USF Health Amyotrophic Lateral Sclerosis (ALS) Clinic in Tampa, Fla., offers the latest treatment, clinical research opportunities, supportive care and educational resources to help patients, their families and caregivers manage the effects of ALS. The clinic has been recognized by The ALS Association as a Certified Treatment Center of Excellence.

About AMYOTROPHIC LATERAL SCLEROSIS (ALS)
ALS is a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord. Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis, and eventually death. The vast majority of patients with ALS (>90%) have sporadic disease, showing no clear family history. Approximately 6000 people are diagnosed with ALS in the United States every year with an approximately similar number of deaths every year.

ABOUT AMX0035
AMX0035 is an investigational neuroprotective therapy designed to reduce neuronal death and dysfunction. AMX0035 targets endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases.

-Video by Allison Long, USF Health Communications and Marketing

USF Health’s Dr. Juan Carlos Cardet was among the authors of a new multi-site clinical study reported in the New England Journal of Medicine

.

Black children respond differently to step-up asthma therapy than black adolescents and adults, report authors of a major study published Sept. 26 in the New England Journal of Medicine. Among the NEJM authors of the multi-site Best African American Response to Asthma Drugs (BARD) clinical study was Juan Carlos Cardet, MD, MPH, assistant professor in the USF Health Morsani College of Medicine Division of Allergy and Immunology.

Nearly half of black children with poorly controlled asthma (46%) fare better by increasing their dose of inhaled steroid (glucocorticoids) alone, without adding a long-acting beta agonist (LABA), the researchers found. Just as many black children (46%) experience improved asthma control by adding a LABA to their lower-dose inhaled glucocorticoid regimen.

In contrast, black adolescents and adults are more likely to have a superior response by adding a LABA to their inhaled glucocorticoid treatment rather than only escalating (stepping up) the dose of inhaled glucocorticoids, the BARD researchers reported.

Dr. Cardet was an investigator for the BARD study when he was faculty member at Harvard Medical School. At USF Health, he is an investigator for several clinical research networks supported by the National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI), including its Precision Interventions for Severe and/or Exacerbation Prone Asthma (PrecISE) network.

Inhaled glucocorticoids, which reduce airway inflammation, are a first-line therapy to control asthma. When asthma becomes severe and difficult to control, physicians often recommend adding a LABA (long-lasting bronchodilator that relaxes constricted airways) to the inhaled steroid treatment as the gold standard step-up therapy. However, this standard was based on other studies that historically included by too few black people, who suffer higher rates of serious asthma attacks, hospitalizations and asthma-related deaths than white people, Dr. Cardet said.

To address this disparity, two parallel randomized double-blind sequential cross-over BARD trials compared the effectiveness of different doses of inhaled glucocorticoids, with or without the addition of the LABA (salmeterol) in two groups: children ages 5 to 11, and adolescents and adults (ages 12 and older). All 574 participants had at least one grandparent who identified as black and asthma inadequately controlled while on a low dose of inhaled glucocorticoids. A composite measure incorporating frequency of asthma attacks and asthma control days as well as changes in lung function was used to calculate treatment response during each 14-week regimen.

Juan Carlos Cardet, MD, MPH

While several previous retrospective studies suggested otherwise, most of the black adolescents and adults with poorly controlled asthma responded better to adding a LABA to step-up treatment compared to those only receiving increased inhaled steroid doses. This BARD trial finding was similar to that in previous mixed (largely white) population studies – although 20-25% of the black adolescents and adults showed no difference in their responses to these approaches.

“But the black children responded differently. They had an equal chance of responding best to increasing their dose of inhaled steroid as they did to the addition of a long-acting beta agonist,” Dr. Cardet said.

The researchers also found that neither the percentage of African ancestry (evaluated by genotyping) nor baseline biomarkers could predict the response to step-up therapy.

A larger, more simplified trial is needed to determine which step-up therapy option works best for which black children, the researchers wrote, adding that their study demonstrates a need for trials of specific subgroups: “These findings suggest that data cannot be extrapolated from mixed populations to specific subgroups, including those of different ages and races.”

An NIH-funded physician scientist, Dr. Cardet says he is driven to improve asthma therapy through translational research by a family history of the chronic disease and by racial and ethnic disparities in asthma illness and deaths, including in his native Puerto Rican community. He is a co-investigator for the PREPARE Study for PeRson EmPowered Asthma Relief, a multisite trial sponsored by the Patient-Centered Outcomes Research Institute (PCORI), which focuses on African-American, Hispanic and Latino adults. Dr. Cardet is also the local principal investigator for a NHLBI PrecISE grant aiming to identify biomarkers to guide development of targeted treatments for severe asthma.

As the principal investigator for a five-year K23 National Institute of Allergy and Infectious Diseases (NIAID) grant, he has been examining whether higher levels of the gut microbe metabolite enterolactone may benefit asthma control. Dr. Cardet is testing the effects of enterolactone, a plant estrogen with antioxidant and anti-inflammatory properties, in preclinical models of allergic airway inflammation.

The University of South Florida was one of two Florida sites that tested the new immune therapy drug manufactured in Clearwater.

Dr. Thomas Casale, principal investigator for the USF Health arm of the large-scale study testing a new drug for severely peanut-allergic patients, checks study participant Carter Grodi, 16.

TAMPA, Fla. (Nov. 19, 2018) — With the New England Journal of Medicine’s publication yesterday of positive Phase 3 clinical trial results, a breakthrough oral immunotherapy for peanut-allergic children and adolescents is one step closer to becoming the first FDA-approved treatment for this potentially life-threatening food allergy.

The USF Health Morsani College of Medicine, Tampa, Fla., contributed to the long-anticipated PALISADE study reported in NEJM  – the largest randomized clinical trial to date for severely peanut-allergic patients looking for a preventive treatment to protect against accidental, possibly dangerous, exposures to peanuts.

USF Health was one of only two Florida sites that tested the safety and effectiveness of the investigational peanut allergy drug, known as AR101.  The biopharmaceutical company Aimmune Therapeutics developed AR101 – tiny, precisely measured amounts of powdered peanut protein held in pull-apart capsules until mixed in food — and makes the drug at its commercial manufacturing plant in Clearwater, Fla.

Aimmune Therapeutics plans to file for FDA approval by the end of this year.  If approved, the therapy could be available for use in children ages 4 to 17 by late 2019.

Tiny precisely measured amounts of powdered peanut protein, the investigational drug AR101 is held in pull-apart capsules until mixed in food.

For the pivotal PALISADE study, researchers at 66 sites across the United States, Canada and Europe evaluated whether gradual, controlled exposure to the substance (peanut proteins) that triggers allergic reactions could desensitize highly allergic children and adolescents, building up tolerance over 6 months and then continuing daily exposure thereafter.

“AR101 significantly improved peanut tolerance and was largely safe,” said USF Health allergist/immunologist Thomas Casale, MD, lead investigator of PALISADE study in Tampa Bay. Dr. Casale was a co-author of the NEJM paper, and serves on Aimmune’s scientific advisory board.  There were some side effects — a few severe, but most were mild to moderate, with gastrointestinal symptoms among the most common, he said.

“With appropriate administration, the AR101 immunotherapy can protect against accidental peanut exposures leading to costly emergency room visits and occasional fatalities,” said Dr. Casale, a professor in USF Health’s Division of Allergy and Immunology. “You still can’t chow down on a bag of peanuts at a baseball game, but it’s the accidental exposures that cause most problems. A treatment option that curtails risk and reduces allergic reactions could alleviate anxiety for these young patients and their parents.”

Currently, strictly avoiding peanuts is the only way to prevent a severe allergic reaction, and refills of costly auto-injectable epinephrine must be kept nearby and given within minutes to counteract hives, swelling of the tongue and throat, difficulty breathing, abdominal cramps and other unpredictable harmful effects. Despite parents’ best efforts, children may be accidentally exposed to peanuts when they swap snacks, consume an unsuspected ingredient in food, use a utensil with microscopic bits of peanut butter, or even inhale peanut particles from shells discarded in an enclosed baseball stadium.

Dr. Casale, a co-author on the New England Journal of Medicine paper, is a professor of medicine in the Division of Allergy and Immunology, USF Health Morsani College of Medicine.

Carolee Grodi is an Ocala, Fla. pharmacist whose 16-year-old son Carter was one of the first participants in USF’s arm of the PALISADE study.

Carter experienced an adverse allergic reaction, including hives, coughing and gasping for air, after eating a small peanut butter cracker as a toddler. His mother has been vigilant about screening any type of peanut or peanut product out of his diet ever since. So vigilant that Carter had virtually no other allergic reactions as he grew, and Carolee Grodi worried that as an increasingly social teen faced with peer pressure her son might not think about the risks.

“Accidental ingestion of peanuts was a constant worry whenever we went out to eat, or he attended a birthday party,” Grodi said. “Although this treatment is not a cure, it definitely helps guard against accidental exposure and offers our family some peace of mind.”

Even though Carter experienced sweating and mild nausea in reaction to his initial PALISADE peanut challenge (all carefully monitored for safety), he was eager to participate in helping test the new peanut allergy immune therapy.

“I wanted to see if I could build immunity so I wouldn’t have to worry so much about getting sick if someone with peanut butter on their hands bumps into me, or always have to be so cautious with every food label reading, ‘May contain peanuts’” he said.  “From my perspective, it’s been an extra layer of protection.”

The clinical research unit cart stocks auto-injectable epinephrine that can be administered to counteract severe allergic reactions.

In early November Carter was on a 300 mg. daily maintenance dose of AR101 – equivalent to one peanut – which he mixes with his food of choice, applesauce. He is now part of an Aimmune extended safety study.

At the start of the one-year PALISADE study, all 496 highly allergic participants, ages 4 to 17, tolerated a challenge test of no more than 30 mg. of peanut protein (equal to one-tenth of a peanut kernel) before experiencing symptoms. At the exit challenge, more than 67 percent of patients receiving active treatment (AR101) tolerated at least a single dose of 600 mg. of peanut protein – equal to 2 peanuts – compared to 4 percent of those receiving placebo. Half of the active treatment participants could eat a 1,000 mg dose — equal to 3 to 4 peanuts — in the exit food challenge.

USF Health continues to participate in ongoing studies to learn more about dosing of AR101 and long-term safety and effectiveness of peanut allergy immunotherapy, which may need to be maintained for years.

Up to 2.5 percent of children in the U.S. have been diagnosed with a peanut allergy, according to the American College of Allergy, Asthma and Immunology, with the incidence continuing to rise in the pediatric population.

-Photos by Torie M. Doll, USF Health Communications and Marketing

USF Health professor Dr. Richard Lockey helping develop rare blood disorder drug

Asphyxiation is a frightening experience, not just for the sufferer, but also for those who’ve witnessed someone’s inability to breathe.

University of South Florida professor Dr. Richard Lockey is working to prevent some people from ever facing that life-threatening attack.

He’s involved in a study recently published in the New England Journal of Medicine testing a first-of-its kind medication for those with hereditary angioedema and a C1 inhibitor deficiency. The rare blood disorder causes spontaneous swelling in various parts of the body, which could be deadly if it occurs in areas such as the tongue or larynx.

Richard Lockey, MD

Lanadelumab is a monoclonal antibody administered by injection every two weeks, helping patients avoid asphyxiation and costly trips to the emergency room, allowing them to live a full life. Previously, up to 20 percent died before the age of 20. Existing long-term preventive treatments can cause serious side effects for a significant percentage of patients.

Thirty-seven patients from across the country participated in the multisite, double-blind, placebo-controlled clinical trial (Phase 1).  Dr. Lockey says in this early study lanadelumab was almost 100 percent effective, with minimal side effects. The drug works by inhibiting the enzyme kallikrein, blocking a cascade of molecular processes leading to angioedema.

“If this disease is in your family and you inherit the gene, we can give you this monoclonal antibody every two weeks to prevent attacks (of spontaneous swelling) from occurring,” said Dr. Lockey, director of the Division of Allergy and Immunology in the USF Health Morsani College of Medicine Department of Internal Medicine.  “It can enable people to live a normal life.”

Once the study is complete, researchers hope to win FDA approval, stocking pharmacy shelves in the next couple years.

About 10,000 people are diagnosed with hereditary angioedema.

– Story by Tina Meketa, USF Communications

Tampa, FL (April 10, 2014) — Patients with severe allergies to stings from bees, wasps, hornets, fire ants and other insects should seriously consider immunotherapy, the recommended standard treatment that can prevent life-threatening reactions, concludes an article co-authored by internationally-recognized allergists/immunologists from the University of South Florida (USF) and the University of North Carolina (UNC) at Chapel Hill. 

The clinical practice article, featured in today’s New England Journal of Medicine, also recommends learning to carry and self-administer an auto-injectable syringe containing epinephrine, which counteracts the allergic reaction to insect venom, at the earliest signs of an acute response.

The paper was written by lead author Thomas B. Casale, MD, professor of medicine in the Division of Allergy and Immunology, USF Health Morsani College of Medicine, and A. Wesley Burks, MD, chairman of the Department of Pediatrics, UNC School of Medicine.

It describes the case of 24-year-old woman who reported being stung on her upper lip while drinking from a can of soda at a picnic, and within 5 minutes experiencing a cascade of reactions including swollen lips, light-headedness, difficulty swallowing, flushing and hives. She was rushed to a local emergency department, where she was treated, observed and discharged with injectable epinephrine.  The article provides a review of strategies for managing allergies to stinging insects.

“Stinging insects are the number one cause of venomous deaths in the United States,” Dr. Casale said. With snakes the venom itself kills, but with stinging insects you can die from anaphylaxis, the severe systemic allergic reaction to the venom.”

When most people are stung by an insect, the reaction is typically localized – some redness, itching and swelling at the site of the sting.  Cold compresses, cortisone cream and/or oral antihistamines can help ease these bothersome symptoms.

However, up to about 4 percent of the population is allergic to the venom of a stinging insect. For these adults and children, the more rapid the onset of symptoms of anaphylaxis, the more severe the reaction tends to be.

“So, if you are stung by an insect and develop any acute symptoms, especially getting lightheaded, short of breath or breaking out in hives, immediately seek emergency treatment,” Dr. Casale said.  “The sooner you treat acute symptoms, the less likely you are to have a catastrophic event like death.”

Lead author Dr. Thomas Casale is a professor in the USF Health Morsani College of Medicine Division of Allergy and Immunology.

Adults or children who have had a severe allergic reaction to an insect sting should be referred to an allergist/immunologist for diagnostic testing and consideration of immunotherapy, the authors say.  Immunotherapy involves a series of injections that expose the patient in a medically-controlled environment to tiny amounts of venom.   The therapy is intended to stimulate the immune system to build up tolerance over time to the venom, helping to prevent severe allergic reactions to a future insect sting. Immunotherapy is a process that takes several years, although for those at higher risk, maintenance doses may need to continue indefinitely.

Immunotherapy for insect stings “reduces the risk of having another severe systemic allergic reaction from more than 60 percent to about 5 percent,” Dr. Casale said.

With spring pollination in bloom and summertime heat approaching, it’s prime time for stinging insects to encroach on outdoor activities.  The allergy experts provide some prevention strategies for those with venom allergies, including:

–         Avoid gardens and keep outdoor areas free of exposed garbage that draws insects.

–         Wear closed-toe shoes and avoid going barefoot when outdoors.   Yellow jackets may build nests in the ground and fire ant mounds are popping up underfoot.

–         Don’t wear brightly colored clothing, perfumes, lotions or scented soaps that make you a more attractive target.

–         Cover food and drink at picnics.  The case scenario of the woman being stung while drinking from a soda can is not uncommon. “Yellow jackets, especially, will fly inside the can and sting when a person drinks,” Dr. Casale said. “It’s better to drink from a cup, where you can see what you’re drinking.”

–         Make sure you or a child’s caregiver is educated about how and when to use an epinephrine auto-injector, and bring it with you whenever there is a chance of a sting. Don’t leave the auto-injector on car dashboards or other hot places, because heat and sunlight breaks down the epinephrine.

                                                                                                  -USF Health-
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu

Peter Mouton was a co-author of the research showing that brain irregularities indicate prenatal origin of autism

March 27, 2014 — A new study published today in the New England Journal of Medicine suggests that brain abnormalities in children with autism can be traced back to prenatal development.

A team at the USF Health Byrd Alzheimer’s Institute led by Peter Mouton, PhD, a professor in the USF Health Morsani College of Medicine’s Department of Pathology and Cell Biology, worked with principal investigator Eric Courchesne, PhD, and colleagues at the University of California San Diego (UCSD) on the study.

Previously published research led by USCD neuroscientist Courchesne was also done in collaboration with Dr. Mouton’s group; that study reported an overabundance of neurons in the prefrontal cortex of children with autism — 60 to 70 percent more than in age-matched controls.

The current study analyzed postmortem brain tissue from children with and without autism, all between ages 2 and 15.

Blinded stereology analyses by USF Health quantified the densities of neurons (brain cells) inside and outside patches in the cerebral cortex of the brains from autistic children, and compared these to the same regions in brains from non-affected children. The researchers found a highly disorganized pattern of neurons in the cerebral cortex of children with autism.

“Since the number and pattern of neurons is set by the time of birth in humans, these findings confirm that autism starts before birth,” Dr. Mouton said.  “Secondly, our study points directly to genetic mutations that regulate the normal pattern of cortical brain cells as the likely cause of autism.”

The study was supported in part by the National Institute of Mental Health.

Over the last five years, Courchesne and colleagues have worked with Mouton, a NIMH grantee, who has developed computerized stereology systems to accurately and efficiently count brain cells in an unbiased manner.  For neuropathology studies, Mouton uses a computerized stereology system developed and patented by his company, the Stereologer Resource Center.

Article citation:
Rich Stoner, PhD; Maggie L. Chow, PhD; Maureen P. Boyle, PhD; Susan M. Sunkin, Ph.D;  Peter R. Mouton, PhD;  Subhojit Roy, MD, PhD;  Anthony Wynshaw-Boris, MD, PhD;  Sophia A. Colamarino, PhD, EdS; Lein, PhD, and Eric Courchesne, PhD;  “Patches of Disorganization in the Neocortex of Children with Autism,” N Engl J Med 2014; 370:1209-1219, March 27, 2014.

Watch VIDEO of USF Health’s Peter Mouton speaking about stereology:

//www.youtube.com/watch?v=P2s3qdshowY

Photo by Eric Younghans, USF Health Communications

         –Study results published in recent New England Journal of Medicine-

A recent New England Journal of Medicine article reporting that upper airway stimulation reduces the severity of obstructive sleep apnea included the USF Health Morsani College of Medicine as a site in the international clinical study.

Tapan Padhya, MD, professor and director of the Division of Head and Neck Oncology and co-director of the multidisciplinary USF ENT Sleep and Snoring Clinic, was one of the investigators for the trial conducted at 22 leading medical centers across the United States and Europe.

Dr. Padhya led the USF arm of the Stimulation Therapy for Apnea Reduction (STAR) Trial at Tampa General Hospital, and was among the authors of the study results published Jan. 9 in the NEJM.

Tapan Padhya, M.D, led the USF-TGH arm of the international sleep apnea stimulation therapy study.

The researchers tested an implantable device delivering mild electronic stimulation to the upper airway during sleep to prevent the tongue from collapsing and obstructing the airway.  The Inspire Upper Airway Stimulation device was implanted in patients who were unable to accept or adhere to sleep apnea treatment with a bedside machine known as CPAP, which provides continuous positive airway pressure to keep upper airways open.

The alternative therapy worked well in reducing interruptions in sleep, alleviating the symptoms of obstructive sleep apnea including snoring and daytime drowsiness, and improving quality of life.

While several options – including a various upper airway surgeries and custom-made removable oral appliances – area available for treating sleep apnea, CPAP has been the gold standard treatment for people with moderate to severe sleep apnea.  But, its effectiveness depends on patient compliance, and some people have trouble adjusting to sleeping with system’s face mask and head strap, so adherence to the regimen can be poor.

“CPAP is still the gold standard,” Dr. Padhya said, “but this (implantable device) technology is an extremely effective treatment option for a broad swath of patients who are unable to use or won’t tolerate the mask.”

The technology for the Inspire  implant is similar to that used in cardiac pacemakers.  The system is designed to be permanent with a change of the stimulator’s battery every seven to nine years.

The study published in NEJM “definitely addresses a sweet spot for research to benefit the undertreated sleep apnea population,” said Dr. Padhya, adding that USF was one of the top sites in the country for recruiting study participants.

“Our participation in a study at this level highlights the value of the academic partnership between USF Health and TGH in collaborating to address important research questions with applications for advances in patient care.”

More than 18 million Americans suffer from obstructive sleep apnea, characterized by repeat episodes of upper airway collapse during sleep in which patients frequently stop breathing for a minute or longer.  The sleep disorder can lead to daytime sleepiness, depression, weight gain, industrial accidents, reduced productivity and diminished quality of life.

Dr. Tapan Padhya, right, and Dr. David Smith, chair of the USF Health Morsani College of Medicine’s Department of Surgery, operate on a patient with obstructive sleep apnea.