American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Virtual

 Sessions this weekend, a late-breaking poster showed just more than half (57%) of pediatric patients with 

 adhered to their controller medication when monitored with a dose-administered feedback device.

, from a team at the Children’s Hospital Colorado, indicates even a high-risk population—who agreed to voluntary treatment monitoring, even—reports asthma controller adherence at a rate close to greater patient population averages.

In the second segment of an interview with 

, study author William Anderson, MD, discussed the concepts of remotely-monitored treatment adherence for asthma, the value of in-person versus telehealth check-ins during the COVID-19 pandemic, and overall thoughts on the virtual AAAAI 2021 sessions.

When doing assessments that involve patients knowingly playing a part of monitored treatment adherence, you would hope for better outcomes from them, in terms of them actually following prescriptions.

But, as you as you alluded to, that's indicative of its own outcome, and the need for better patient confidence in therapy. Would that mean improved education for patients?

 I think it's both education and communication. I think that, for a lot of providers, they don't know exactly what's happening in the home when it comes to taking these medications. And knowing what the rate of the patient's medication adherence is allows them to have that conversation with families to point out, 'Hey, this is the adherence that we're seeing for you. One, do you recognize that that's the only how frequent you're taking your medication? And if so, why is it that you're only taking your medication that often?'

That's where you can really start to analyze some of the barriers that might be present to good medication adherence. Once you've identified those, there's tailoring your treatment options or strategies to what you're learning from the patient.

This broader discussion about remote monitoring and better means of assuring patients are working with confidence of what a prescribing clinician would hope for their treatment. And all that speaks to our current state of isolation and very prioritized in-person care.

But do these findings say anything to value of in-person care—to the idea that it’s something that does help with treatment adherence?

 I can't necessarily say at this point in time whether having less in-person care made a difference one way or the other, because we didn't necessarily look at that in this study. But I will say that it just goes to show the importance of making sure you do continue the continuity of care with these patients. I think that those patients who are not getting routine feedback or are not having these conversations with providers—maybe they are who's more likely start to slip a little bit on taking their medications.

So, if you're able to have those conversations in person, via telehealth, whatever it might be, I think it's just important to make sure that to continue this one way or the other. We don't want to see our patients in a time like COVID be afraid to come into the office, and then we lose them to follow-up, and then their asthma actually gets worse during that time.

So, if you can reach out in terms of an electronic intervention, telehealth, whatever it might be, we certainly want to maintain those on that connection with patients and that care, even during a pandemic.

Is there anything else you would want to add, relative to AAAAI 2021?

 I'm really excited. I'm looking forward to the virtual format. Obviously, it's great that we're able to have the meeting this year. Unfortunately, last year was canceled because of COVID. So, it's hard to believe that it's been a year at this point in time. But it should be a good meeting. Virtual is going to be fantastic, but we're looking forward to the day where we can meet up with our colleagues in-person again, hopefully very soon.

Articles

American Academy of Allergy, Asthma & Immunology

From better education, to remote monitoring and consistent check-ins, clinicians may need to initiate better adherence in their younger, severely ill patients.

What Is Needed to Improve Pediatric Asthma Controller Therapy Adherence

Dupilumab (Dupixent) has showed sustained benefit in health-related quality of life (HRQoL) and symptom burden in patients with 

American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Virtual Sessions

 this week gives hope to possibly nearing the first biologic treatment indicated for the rare disease in the US.

, study author Evan Dellon, MD, MPH, of the Center for Gastrointestinal Biology and Disease, UNC School of Medicine, discussed the burdensome chronic effects of EoE on its varied patient population.

Symptoms can evolve from dysphagia in the young patient population, to esophageal scarring and inflammation which burdens patient swallowing at a younger age.

Though pediatric patients are a particular concern for Dellon and colleagues due to their burdens of pain, regurgitation, food processing failure, and their inability to distinguish between vomiting and EoE symptoms, it’s important for frontline clinicians to remember they’re not the lone at-risk group.

“I think that’s an important point to make—not only for patients that are having dysphagia, but also for providers,” Dellon explained. “Just because you’re seeing a 60-70 year old person who doesn’t fit the young profile, it could still be there.”

Dellon also discussed the very diverse EoE care team, which include caregivers from any of allergy, gastroenterology, pediatrics, primary care, nutrition, diet, and pathology. In terms of prescribing a therapy such as dupilumab for EoE, most practices will have the luxury of choice.

“I think allergists are familiar with this medication for other atopic medications, but GI doctors are quite familiar with administering biologics from the inflammatory bowel disease space,” Dellon said.

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How dupilumab is observed to benefit EoE patients—and who may administer the biologic therapy.

Diverse Eosinophilic Esophagitis Symptoms and Care Teams

Tezepelumab, an investigative monoclonal antibody therapy that inhibits the thymic stromal lymphopoietin (TSLP), was associated with clinically meaningful exacerbation reductions among patients with 

 at varied eosinophil counts in new phase 3 data.

Results from the NAVIGATOR trial, presented at the 

, show tezepelumab also reduced the risk of hospitalization or emergency department visits over 52 weeks in treated patients versus placebo.

The newest findings for the subcutaneous novel pathway asthma treatment further evidence its benefit for patients suffering from severe, uncontrolled disease.

, study author Andrew Menzies-Gow, BSc, MBBS, PhD, deputy medical director at the Royal Brompton & Harefield Hospitals, discussed the NAVIGATOR findings, and their preceded research of tezepelumab in this key patient population.

Menzies-Gow also discussed the characteristics of severe, uncontrolled asthma, and how a TSLP inhibitor therapy may significantly influence the disease course.

“The excitement around tezepelumab is really around its unique mechanism of action,” he explained. “With tezepelumab, we’re targeting TSLP—so we’re going upstream, we’re looking at one of the epithelial-derived cytokines, which really drives all the downstream inflammation.”

Menzies-Gow also discussed the pursuit of optimal biologic treatment duration for severe asthma, and how this last year’s greater reliance on monoclonal antibodies in the face of COVID-19 may effect the allergic and inflammatory specialty.

“Looking into the future, the next advance might be moving away from injectable biologics to inhaled biologics,” Menzies-Gow said. “That might be the way forward, to let more people have a biologic.”

The study, “Efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma: results from the phase 3 NAVIGATOR study,” was presented at AAAAI 2021.

An interview on the TSLP inhibitor's effect on exacerbations, hospitalizations, and disease progress over 52-week findings.

Tezepelumab Benefits Severe, Uncontrolled Asthma in Phase 3 NAVIGATOR Findings

New research shows a recently revised diagnostic criteria is sufficient for emergency departments to identify and treat 

The World Allergy Organization (WAO) proposed in 2019 a revision of the anaphylaxis diagnostic criteria proposed in 2006 by the National Institute of Allergy and Infectious Disease/ Food Allergy and Anaphylaxis Network (NIAD/FAAN).

A team, led by Justine M. Ade, MD, Mayo Clinic, assessed the accuracy of the revised clinical criteria in 2019 compared to the original diagnostic criteria in 2006 in data presented during the 

In the cohort study, the researchers identified a stratified sample of 817 patients presenting to an academic Emergency Department between January 2013 and September 2017. The patients included were identified and sampled based on the presence of ICD-9 or ICD-10 codes associated with an emergency department visit that indicated either anaphylaxis, symptoms potentially secondary to anaphylaxis, or an allergic reaction.

The investigators assessed the diagnostic accuracy of the 2 criteria’s by comparison to expert review by an allergist-immunologist or fellow and calculated test characteristics.

Overall, the 2 criteria’s were very similar, with the addition of severe gastrointestinal symptoms especially with non-food allergens and respiratory compromise with bronchospasm or laryngeal involvement added to the 2016 version of the guidelines.

When properly weighed, the sampling represented a cohort of 2191 patients with a median patient age of 42 years old.

The weighted sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the 2006 criteria were 92.6%, 76.9%, 65.3%, and 95.7%, respectively, compared to 93.4%, 72.7%, 61.5%, and 95.9%, respectively for the revised version.

“Despite a select number of cases that may be missed by one criteria or both, the revised NIAID/FAAN clinical criteria have test characteristics very similar to the original NIAID/FAAN criteria and are therefore likely to be useful for the diagnosis of anaphylaxis in the ED,” the authors wrote.

Advocating for better treatment of anaphylaxis and food allergies has been a staple of past AAAAI meetings.

Last year, Dennis K. Ledford, MD, University of South Florida College of Medicine and Division of Allergy and Immunology, explained in an interview with 

Ledford was set to present during a session on anaphylaxis during surgery when the conference was cancelled because of COVID-19, making it 1 of the first medical conferences to be impacted by the pandemic.

“It was to increase awareness of the problem of anaphylaxis around anesthesia or surgery because it's not terribly common, but surgery is a common process,” Ledford said. “And it can be misinterpreted where low blood pressure, for example, is due to the anesthesia and not an anaphylactic reaction.”

Validation of the revised National Institute of Allergy and Infectious Disease / Food Allergy and Anaphylaxis Network Diagnostic Criteria in Emergency Department Patients

In data presented during AAAAI 21, researchers compared the 2006 and 2016 versions of the diagnostic criteria proposed by the NIAD/FAAN. 

Revised Anaphylaxis Diagnostic Guidelines Seen as an Improvement

 this week showed continued benefit of dupilumab (Dupixent) for the treatment of the gastrointestinal inflammatory disease 

The new data, presented by Evan Dellon, MD, MPH, of the Center for Gastrointestinal Biology and Disease at the UNC School of Medicine, contribute to a half-decade of promising research development into treating the rare disease.

 during AAAAI 2021, it contributes toward caring for a patient population without many, if any, available drugs.

“Right now in the US, there’s still a huge need for EoE treatments,” Dellon explained. “There’s still nothing approved in the US, and only one drug approved in Europe and Canada right now, which is topical steroids.”

The new phase 3 outcomes build on recent phase 2 research for dupilumab, an interleukin 4 and 13 (IL-4; IL-13) targeting monoclonal antibody with indicated benefit across a spectrum of inflammatory disease. As Dellon explained, EoE pathogenesis involves cytokine inflammation similar to that of atopic dermatitis—for which dupilumab is already approved as a treatment.

“It seems to be a very potent anti-inflammatory approach for EoE, and it’s reasonably high up in the inflammatory cascade,” he explained. “So you theoretically see a nice downstream effect on the inflammatory effector cells.”

Perspective on how the interleukin-targeting biologic has unique benefit for the rare, under-resourced disease.

Dupilumab for Eosinophilic Esophagitis

Masks have become a key mitigation piece in the fight to stop the spread of COVID-19.

However, there is some concern regarding the use of masks for individuals with 

A team, led by Marissa Hodges, MD, Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan, assessed the safety of mask use at rest for asthma patients in data presented at the 

The US Centers for Disease Control and Prevention (CDC) currently recommends masks be worn in public settings and around members of different households for individuals 2 years and older, including asthma patients.

The study included 223 adult and pediatric patients attending appointments at the Michigan Medicine Allergy clinic between September 10, 2020 and October 23, 2020, 46% (n = 102) of which reported having asthma. Each patient voluntarily completed a survey reflecting their demographics, asthma diagnosis and perceived control, and mask type worn.

The researchers performed a pulse oximetry reading on the masked patient with respondents reporting their continuous duration of ask use prior to the measurement. They completed a descriptive analysis of frequencies and proportions to examine the data.

) ranged between 93-100% among the patient subgroup with asthma, unchanged from the SpO

After adjusting for gender, race, mask type used, or duration of mask use, the oxygen saturation did not change, with asthma patients who reported their perceived level of control (n = 100) having a similar mean SpO

 levels in patients with or without asthma, regardless of mask type worn, duration of mask use, or demographics,” the authors wrote.”SpO

 levels did not differ between those with perceived well-controlled and somewhat-controlled asthma.”

While mask use has dramatically increased in the general population since the beginning of the pandemic, many believe a high percentage of the population will continue to wear masks in public spaces even after the pandemic concludes to reduce the risk of influenza and other transmittable diseases.

The researchers believe the study could be used as a tool to prove to concerned asthma patients on the safety of masks.

Wear a Mask! Masks Don’t Affect Oxygen Saturation in Patients with Asthma,

Recently, investigators from the Canadian Thoracic Society (CTS) made a number of recommendations regarding asthma management and 

, including the use of popular drug classes including inhaled corticosteroids (ICSs), nebulizers, and biologics among patients at risk of contracting the virus.

As they noted in their advisory, patients with asthma are actually not at greater risk of contracting SARS-CoV-2 infection.

However, it is possible asthma may be linked to a higher risk of severe illness of death due to COVID-19 illness.

Though patients with asthma have not been overrepresented in multinational assessments of COVID-19 patients suffering from severe illness, the Chinese Center for Disease Control and Prevention has reported a greater-than-average fatality rate among patients with comorbid, chronic respiratory disease. Asthma has not been evaluated by the organization as an independent risk factor.

Oxygen saturation levels similar for both asthma patients and non-asthma patients following mask use. 

Masks Deemed Safe for Asthma Patients

Sustained unresponsiveness, a pivotal, sought-after benchmark in allergic immunotherapy research, may be achievable with early initiation of peanut sublingual immunotherapy designed to desensitize children with 

In late-breaking data presented during the 

American Academy of Allergy & Immunology (AAAAI) 2021 Virtual Sessions

, a team of North Carolina and Texas investigators reported findings showing a dozen toddlers to have undergone sublingual immunotherapy for a peanut allergy were able to pass a sustained unresponsiveness food challenge after 3 years of care.

The 12 peanut-allergic children were also part of a treatment arm which achieved a median peanut tolerance of 4433 mg.

Led by Edwin Kim, MD, MS, of the University of North Carolina School of Medicine, investigators randomized peanut-allergic children aged 1-4 years old with a positive peanut-specific immunoglobulin E (IgE) and skin prick test (SPT) 1:1 to either 4 mg daily peanut protein sublingual immunotherapy or placebo for a study duration of 36 months.

Patient peanut allergy was confirmed by a food challenge prior to baseline.

The younger patient population was a deliberate choice by the investigators. Though previous research has indicated potential benefit in overall desensitization of peanut allergy when sublingual immunotherapy is initiated at younger ages, no safety nor efficacy data has been described in toddler-aged children.

In fact, AR101 (PALFORZIA), the first oral peanut protein immunotherapy approved by the US Food and Drug Administration (FDA) for desensitizing pediatric peanut allergy, is currently indicated in patients aged 4-17 years old.

Kim and colleagues assessed allergy desensitization by way of double-blind, placebo-controlled food challenge with 4333 mg peanut protein. Sustained unresponsiveness was defined as identical food challenge success after discontinuing sublingual immunotherapy for 3 months.

Patients and their families recorded their dosing compliance and any observed adverse events on home diaries shared with investigators.

At total of 50 participants were randomized at 2 academic centers. Median patient age was 2.2 years old, with the treatment and placebo arms having similar demographics in gender, race, ethnicity, atopic history, peanut SPT, and qualifying food challenge results.

Among the 36 participants (19 treatment; 17 placebo) to complete the desensitization food challenge, cumulative median tolerated dose increased from 143 mg to 4443 mg in the immunotherapy group. Among the placebo group, median tolerated dose increased from 43 mg to 143 mg (

Fourteen immunotherapy participants passed the desensitization double-blind, placebo-controlled food challenge; another 12 passed the sustained unresponsiveness mark. Comparatively, 0 and 2 placebo participants achieved such marks, respectively.

Mean peanut SPT had decreased from 10 mm to 3.25 mm in peanut immunotherapy participants, versus an increase from 11.5 mm to 12 mm with placebo (

 <.0001). Cumulatively, 1031 immunotherapy doses were associated with patient-reported symptoms, versus 629 placebo doses.

In highlighting the significance of the outcomes, Kim and colleagues noted the need for continued assessment of such an early initiation of sublingual peanut immunotherapy in such a young population of peanut-allergic patients.

“Significant desensitization was observed with peanut sublingual immunotherapy in peanut-allergic toddlers when compared to placebo with a strong potential for sustained unresponsiveness,” they concluded. “Peanut sublingual immunotherapy may be a promising treatment option for early intervention in peanut allergy.”

The study, “Safety and efficacy of peanut sublingual immunotherapy in toddler-aged peanut-allergic children,” was presented at AAAAI 2021.

Late-breaking data show allegic children as young as 1-4 years old may have sustained benefit from daily peanut protein exposure.

Sublingual Immunotherapy May Provide Peanut Allergy Desensitization in Toddlers

 showed an inconsistent—and even seasonally-influenced—pattern of pediatric patient adherence to controller therapy for 

The research, presented by William Anderson, MD, of the Children’s Hospital Colorado and University of Colorado School of Medicine, showed a near 50% adherence to controller therapy among pediatric severe asthma patients who were remotely monitored for their care via a Propeller Health device.

 regarding the data, Anderson discussed the trial’s makeup and outcome, its contribution to currently understood patterns of pediatric asthma adherence, and the influence of factors including COVID-19 and the summer season on asthmatic care monitoring and adherence among children.

What is the known history of pediatric asthma patient adherence to controller therapy?

 We know that when it comes to approaching patients who either have difficult-to-control or severe asthma, the one of the very first steps is to check to make sure that patients are adhering to the controller therapy. Because it does provide us great guidance to know, 'Do we need to be stepping up for therapy if they're poorly controlled, or potentially do we need to be addressing barriers to why they're not taking their medication?' And that could be the reason why they're poorly controlled.

So historically, the way that we've been monitoring the adherence is either through medication refills, insurance claims, or using a dose count on the back of the medication. However, all of those have their own limitations associated with it. So for example, a patient might still have medication, but they never use it. You can think that they're taking it, but they're really not. So one thing that this technology and this kind of advancement allows us to do is get a real-time objective feedback of how they're doing and taking their medication.

Could you share bit more detail into this device?

 For our project, we use the Propeller Health device. These are monitors that are attached to patient rescue and controller medication. And they provide real-time objective data on when a patient takes their medication. So there ends up being a timestamp associated when patients use their medications, and both the patient as well as the care team have access to this information. So we can trend their adherence over time, and then also provide feedback to the patient, depending on what we're seeing with the stack.

How well-equipped is such a device in US asthma care right now?

 This is a relatively new device. It's been around for actually the last several years. But these technologies are still gaining incorporation to clinical practice. So. a lot of them initially started in the research setting and are now moving towards clinical practice. So we are, to my knowledge, one of the few pediatric severe asthma clinics in the country that are using this on a routine basis with our patient population.

The first thought that comes to mind is the utility of such a device at a time when in-person care is very minimal due to COVID-19. With a pediatric population, it's very pivotal that we assure they're gaining confidence and trust in the use of their controller medication for asthma, especially at-risk patients at a time when we're monitoring this respiratory-affecting virus.

Were there heightened stakes into this level of remote adherence and monitoring research?

 Certainly, one of the things that COVID-19 has done is it's really propelled forward the use of this kind of more remote monitoring or home-based technology, knowing that patients cannot always make it into the office. So having this data really helps benefit our patients and care for them beyond just that in-person or telehealth clinic encounter. 

We can really follow up with them on more consistently outside of our standard clinic setting in this way. And I will say that this technology is obviously one aspect of that. You're also seeing this happen with home spirometry as another way that patients and providers are trying to monitor their asthma management.

Could you tell us more on the study's findings?

 This was a study that was conducted in our multi-disciplinary asthma clinic. So this is a clinic for patients with either difficult-to-control or severe asthma. Patients are typically referred to this clinic if they have had recurrent hospitalizations, or emergency room visits, or they still do not have good asthma control despite guidelines-based therapy. So at the start, we're working with definitely a higher-risk population. And this clinic is being staffed by allergy, pulmonology, nurse care coordinators, and social work, as well as speech therapy and nutrition as needed. So certainly, a comprehensive team environment. And what we wanted to do with this technology is just really understand what are the adherence patterns of our patients? Are they taking their medications or not?

We ended up enrolling about 20 patients. It was a small, more pilot study. But we enrolled 20 patients in this study, and we gave them that Propeller Health device—they volunteer to do this. And the patients were aware that they had access to the data, we had access to the data, and that we would provide them feedback on their adherence overall. And then we calculated their adherence as a seven-day rolling average. And then we also tried to break it down based on seasonal trends, as well to see if there's any difference with that. 

So overall, for our patients, we found that their mean adherence was about 57%. So a little over 50% of the time, they ended up taking their medication. The total duration study was about 203 days as the median. And patients were using primarily combination ICS-LABA therapy, with one patient just being on ICS therapy alone.

We did find that patients usually started with a higher adherence, and then had a drop over time. And in general for our population, at about 160 days is where they kind of settled into their baseline where they then remained for the remainder of the study. Overall, in terms of the seasons, we found that the during the summer months, there was an increase in the frequency of patients who had very low adherence, 0-25%. So essentially, during the school year, there was really no significant differences in their adherence patterns but they did drop in their adherence over the summer—which could potentially be secondary to some of the loss of structure that comes with the school year.

Our conclusions for this study was that despite being a high-risk population, voluntarily signing up for this program and providing adherence feedback, their overall adherence was only about 57%. Now, I will say we had hoped that it would be higher than that. But actually, when you look at other studies that look at real-world adherence patterns in patients, this is actually a pretty good adherence. It's comparable to, if not higher than some other real-world studies.

So overall, what we're recognizing from this is that it's really important, obviously, to recognize what is the adherence patterns for your patient so that if they are not adherent to the medication, we need to see why that might be the case. Is that because they feel like the medications aren't working for them? Is it because they don't have? It doesn't work with their schedule? Are they having side effects for the medication? What could it potentially be?

And then on the flip side, for those patients who are very adherent to the medications, and they're still not well-controlled—those are the ones we really need to target, in terms of escalating their therapy, and especially for those most severe patients, they might be a good candidate for biologics. And, as you're probably aware, the biologics are a very expensive medication. So it's important to know that you're targeting the right patient population to use these medications.

The study, “Objective Controller Medication Adherence Patterns in Pediatric Patients with Asthma in a High-Risk Multidisciplinary Asthma Clinic,” was presented at AAAAI 2021.

An interview with a Children's Hospital Colorado investigator on new remote-monitoring research into children's adherence trends.

Study: Pediatric Adherence to Drugs Treating Severe Asthma is About 57%

Since discovering the airways and lungs are the primary sites of 

 entry, replication, and damage researchers have attempted to administer and test drugs in these regions for efficacy.

However, trials testing oral hydroxychloroquine (oHCQ) have produced mixed results, despite having some antiviral activity in vitro (EC

A team, led by Ohad Bentur, The Rockefeller University, tested the hypothesis that aerosolized HCQ sulfate (aHCQ) is tolerable, safe, and rapidly achieves high respiratory tissue concentrations while minimizing systemic toxicity.

In the phase 1 study, aHCQ was administered with an Aerogen nebulizer to healthy volunteers to assess the overall tolerability, safety, and pharmacokinetics.

Overall, there were 10 volunteers randomized to receive either a placebo (n = 2) or aHCQ (20 mg, n = 2; 50 mg, n = 6).

All 10 patients completed the inhalation, while 6 of the 8 HCQ patients had adverse events, all of which were mild (75% transient dysgeusia; 25% dizziness).

 and FVC were essentially unchanged from baseline after 15-360 minutes and 1 and 7 days, while QT segments were minimally changed from baseline (maximum change 34 msec) after 1-6 hours and 1 and 7 days, all of which were 

Pharmacokinetics of 50 mg—Area Under the Blood Curve 0-24 hours post-inhalation was 377 

 127 ng* hr/mL, while less than 15% of the patients reported for oHCQ 200 mg.

In addition, pharmacokinetic modeling predicted initial epithelial lining fluid concentrations in excess of reported EC

s, and peak respiratory tissue concentration of 0.5 mM, decreasing to 0.01 mM at 24 hours as HCQ slowly releases into the blood.

“aHCQ was safe, well-tolerated, and appears to be sequestered in respiratory tissues,” the authors wrote. “Administering aHCQ at a fraction of oral dosing may rapidly achieve respiratory tract concentrations sufficient to inhibit SARS-CoV-2.”

 was 1 of the first potential drugs tested for efficacy against COVID-19.

Late last year, researchers found in a study of 479 patients hospitalized with respiratory symptoms of COVID-19, the treatment ultimately did not improve clinical outcomes.

In the study, patients were assigned to receive hydroxychloroquine or a placebo, with 242 in the group assigned to receive 400 mg of hydroxychloroquine twice daily for 2 doses, then 200 mg twice daily for 8 doses, and 237 assigned to receive a placebo.

They were assessed 14 days after randomization based on a 7-point scale ranging from death to discharge. No significant difference was reported between the two groups (median [interquartile range] score, 6 [4-7] vs 6 [4-7]; adjusted odds ratio, 1.02 [95% confidence interval, 0.73 to 1.42]). At 28 days, 25 patients in each group (10.4% of the hydroxychloroquine group and 10.6% of the placebo group) had died.

The study, “Phase 1 Randomized Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate – A Potential Treatment for COVID-19,” was published online by 

Trials testing hydroxychloroquine against COVID-19 have produced mixed results.

Early Phase Trial Results Positive for HCQ Against COVID-19

New guidelines have increased the number of parents who introduce their children at 12 months to the peanut in order to avoid any potential 

Researchers in the past have found in randomized, controlled-trials the early introduction of the peanut has shown evidence it could prevent peanut allergies.

A team, led by Victoria Soriano, BSc, Murdoch Children’s Research Institute/University of Melbourne/Centre for Food and Allergy Research (CFAR) Australia, evaluated the change in peanut allergy prevalence following changes to infant feeding practices since a pair of population-based studies conducted 10 years apart led to changes in infant feeding practices in 2016.

The research was presented in a late-breaking poster at the 

American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Annual Meeting

The researchers recruited a population-based sample of 1933 infants at 12 months old between 2018-2019 and compared the data to a sample of 5276 infants recruited 10 years early between 2007-2011. The investigators used the same sampling frame and methods and collected questionnaires on demographic and infant feeding data.

Each infant in the study sensitized underwent skin prick tests and food challenges and the investigators compared the prevalence between the 2 cohorts using direct standardization and marginal effects models. The data was adjusted for known risk factors for food allergy—parent’s country of birth, family history of allergy, dog ownership, and number of siblings.

Overall, the adjusted peanut allergy prevalence in 2018-2019 was 2.6% (95% CI, 1.9-4.0%). This was lower than the 3.1% (95% CI, 2.6-3.6%) found in the 2007-2011 cohort.

After making a further adjustment for eczema, the investigators found little difference (2.7%; 95% CI, 2.1-3.2%).

For the current study, 77.7% (95% CI, 75.7-79,5%) of infants consumed peanuts before 12 months. Of this subgroup, 2.6% were peanut allergic, compared to 4.8% of the infants who avoided peanuts until they were older than 12 months (

“We showed a 16% decrease in peanut allergy following earlier introduction of peanut; however, the prevalence of peanut allergy was still high despite the majority of infants consuming peanut within the first year,” the authors wrote.

Since the COVID-19 pandemic began, clinicians have opted for a new system of 

 introduction for infant patients at risk of developing peanut allergies.

Prior to initiation of the virtual programs infants were screened for eligibility in a private-practice allergist setting using the telehealth platform Doxy.me.

Patients were eligible if they had physician-diagnosed severe eczema, physician diagnosed egg allergy, SPT≥3 mm or ≥0.35 kU/L without prior ingestion, perceived high-risk by caregiver, or had caregiver anxiety to introduce a particular food.

During this first consultation, parents or guardians were informed about the risks and benefits of either prolonging peanut avoidance until the first in-person visit or participating in the virtually-support food introduction process.

If they chose to proceed with the program, then consent was obtained, and they were prescribed an epinephrine autoinjector and rupatadine.

The study, “Has the Prevalence of Peanut Allergy Changed Following Earlier Introduction of Peanut? The Early Nuts Study,” was published online by 

The adjusted allergy prevalence in recent years was 2.6% in infants who have been introduced to peanuts at 12 months.

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