MDedge Pediatrics

Israeli officials are reporting a 30% decrease in the effectiveness of the Pfizer/BioNTech vaccine to prevent SARS-CoV-2 infection and mild to moderate cases of COVID-19. At the same time, protection against hospitalization and severe illness remains robust.

The country’s Ministry of Health data cited high levels of circulating Delta variant and a relaxation of public health measures in early June for the drop in the vaccine’s prevention of “breakthrough” cases from 94% to 64% in recent weeks.

However, it is important to consider the findings in context, experts cautioned.

“My overall take on this that the vaccine is highly protective against the endpoints that matter – hospitalization and severe disease,” Anna Durbin, MD, told this news organization.

“I was very pleasantly surprised with the very high efficacy against hospitalization and severe disease – even against the Delta variant,” added Dr. Durbin, professor of medicine at Johns Hopkins University, Baltimore.

Ali Mokdad, PhD, of the Institute for Health Metrics at the University of Washington, Seattle, agreed that the high degree of protection against severe outcomes should be the focus.

“That’s the whole idea. You want to defend against COVID-19. So even if someone is infected, they don’t end up in the hospital or in the morgue,” he said in an interview.

Compared with an earlier report, the efficacy of the Pfizer vaccine against hospitalization fell slightly from 98% to 93%.

“For me, the fact that there is increased infection from the Delta variant after the vaccines such as Pfizer is of course a concern. But the positive news is that there is 93% prevention against severe disease or mortality,” added Dr. Mokdad, who is also professor of global health at University of Washington.

In addition, the absolute numbers remain relatively small. The Ministry of Health data show that, of the 63 Israelis hospitalized with COVID-19 nationwide on July 3, 34 were in critical condition.
 

Unrealistic expectations?

People may have unrealistic expectations regarding breakthrough infections, Dr. Durbin said. “It seems that people are almost expecting ‘sterilizing immunity’ from these vaccines,” she said, explaining that would mean complete protection from infection.

Expectations may be high “because these vaccines have been so effective,” added Dr. Durbin, who is also affiliated with the Johns Hopkins Center for Global Health.

The higher the number of vaccinated residents, the more breakthrough cases will be reported, epidemiologist Katelyn Jetelina, PhD, MPH, assistant professor of epidemiology, human genetics, and environmental sciences at the University of Texas Science Center at Houston, wrote in her “Your Local Epidemiologist” blog.

This could apply to Israel, with an estimated 60% of adults in Israel fully vaccinated and 65% receiving at least one dose as of July 5, Our World in Data figures show.

How the updated figures were reported could be confusing, Dr. Jetelina said. Israel’s Health Minister Chezy Levy noted that “55% of the newly infected had been vaccinated” in a radio interview announcing the results.

“This language is important because it’s very different than ‘half of vaccinated people were infected,’ ” Dr. Jetelina noted.

Israel had a 7-day rolling average of 324 new confirmed COVID-19 cases as of July 5. Assuming 55% of these cases were among vaccinated people, that would mean 178 people experienced breakthrough infections.

In contrast, almost 6 million people in Israel are fully vaccinated. If 55% of them experienced breakthrough infections, the number would be much higher – more than 3 million.

Dr. Jetelina added that more details about the new Israel figures would be helpful, including the severity of COVID-19 among the vaccinated cases and breakdown of infections between adults and children.
 

Next steps

Israeli health officials are weighing the necessity of a third or booster dose of the vaccine. Whether they will reinstate public health measures to prevent spread of COVID-19 also remains unknown.

Going forward, Israel intends to study whether factors such as age, comorbidities, or time since immunization affect risk for breakthrough infections among people vaccinated against COVID-19.

“We want to prevent people from getting hospitalized, seriously ill, and of course, dying. It’s encouraging these vaccines will be able to have a high impact on those outcomes,” Dr. Durbin said. “We just need to get people vaccinated.”
 

A call for better global surveillance

A global surveillance system is a potential solution to track and respond to the growing threat of the Delta variant and other variants of concern, Scott P. Layne, MD, and Jeffery K. Taubenberger, MD, PhD, wrote in a July 7, 2021, editorial in Science Translational Medicine.

One goal, Dr. Layne said in an interview, is to highlight “the compelling need for a new global COVID-19 program of surveillance and offer a blueprint for building it.” A second aim is to promote global cooperation among key advisers and leaders in the G7, G20, and Asia-Pacific Economic Cooperation nations.

“It’s an uphill struggle with superpower discords, global warming, cybersecurity, and pandemics all competing for finite attention,” Dr. Layne said. “However, what other options do we have for taming the so-called forever virus?”

Dr. Mokdad and Dr. Jetelina had no relevant disclosures. Dr. Durban disclosed she was the site primary investigator for the phase 3 AstraZeneca vaccine trial and an investigator on the Pfizer COVID-19 vaccine trial.

A version of this article first appeared on Medscape.com.

Israeli officials are reporting a 30% decrease in the effectiveness of the Pfizer/BioNTech vaccine to prevent SARS-CoV-2 infection and mild to moderate cases of COVID-19. At the same time, protection against hospitalization and severe illness remains robust.

The country’s Ministry of Health data cited high levels of circulating Delta variant and a relaxation of public health measures in early June for the drop in the vaccine’s prevention of “breakthrough” cases from 94% to 64% in recent weeks.

However, it is important to consider the findings in context, experts cautioned.

“My overall take on this that the vaccine is highly protective against the endpoints that matter – hospitalization and severe disease,” Anna Durbin, MD, told this news organization.

“I was very pleasantly surprised with the very high efficacy against hospitalization and severe disease – even against the Delta variant,” added Dr. Durbin, professor of medicine at Johns Hopkins University, Baltimore.

Ali Mokdad, PhD, of the Institute for Health Metrics at the University of Washington, Seattle, agreed that the high degree of protection against severe outcomes should be the focus.

“That’s the whole idea. You want to defend against COVID-19. So even if someone is infected, they don’t end up in the hospital or in the morgue,” he said in an interview.

Compared with an earlier report, the efficacy of the Pfizer vaccine against hospitalization fell slightly from 98% to 93%.

“For me, the fact that there is increased infection from the Delta variant after the vaccines such as Pfizer is of course a concern. But the positive news is that there is 93% prevention against severe disease or mortality,” added Dr. Mokdad, who is also professor of global health at University of Washington.

In addition, the absolute numbers remain relatively small. The Ministry of Health data show that, of the 63 Israelis hospitalized with COVID-19 nationwide on July 3, 34 were in critical condition.
 

Unrealistic expectations?

People may have unrealistic expectations regarding breakthrough infections, Dr. Durbin said. “It seems that people are almost expecting ‘sterilizing immunity’ from these vaccines,” she said, explaining that would mean complete protection from infection.

Expectations may be high “because these vaccines have been so effective,” added Dr. Durbin, who is also affiliated with the Johns Hopkins Center for Global Health.

The higher the number of vaccinated residents, the more breakthrough cases will be reported, epidemiologist Katelyn Jetelina, PhD, MPH, assistant professor of epidemiology, human genetics, and environmental sciences at the University of Texas Science Center at Houston, wrote in her “Your Local Epidemiologist” blog.

This could apply to Israel, with an estimated 60% of adults in Israel fully vaccinated and 65% receiving at least one dose as of July 5, Our World in Data figures show.

How the updated figures were reported could be confusing, Dr. Jetelina said. Israel’s Health Minister Chezy Levy noted that “55% of the newly infected had been vaccinated” in a radio interview announcing the results.

“This language is important because it’s very different than ‘half of vaccinated people were infected,’ ” Dr. Jetelina noted.

Israel had a 7-day rolling average of 324 new confirmed COVID-19 cases as of July 5. Assuming 55% of these cases were among vaccinated people, that would mean 178 people experienced breakthrough infections.

In contrast, almost 6 million people in Israel are fully vaccinated. If 55% of them experienced breakthrough infections, the number would be much higher – more than 3 million.

Dr. Jetelina added that more details about the new Israel figures would be helpful, including the severity of COVID-19 among the vaccinated cases and breakdown of infections between adults and children.
 

Next steps

Israeli health officials are weighing the necessity of a third or booster dose of the vaccine. Whether they will reinstate public health measures to prevent spread of COVID-19 also remains unknown.

Going forward, Israel intends to study whether factors such as age, comorbidities, or time since immunization affect risk for breakthrough infections among people vaccinated against COVID-19.

“We want to prevent people from getting hospitalized, seriously ill, and of course, dying. It’s encouraging these vaccines will be able to have a high impact on those outcomes,” Dr. Durbin said. “We just need to get people vaccinated.”
 

A call for better global surveillance

A global surveillance system is a potential solution to track and respond to the growing threat of the Delta variant and other variants of concern, Scott P. Layne, MD, and Jeffery K. Taubenberger, MD, PhD, wrote in a July 7, 2021, editorial in Science Translational Medicine.

One goal, Dr. Layne said in an interview, is to highlight “the compelling need for a new global COVID-19 program of surveillance and offer a blueprint for building it.” A second aim is to promote global cooperation among key advisers and leaders in the G7, G20, and Asia-Pacific Economic Cooperation nations.

“It’s an uphill struggle with superpower discords, global warming, cybersecurity, and pandemics all competing for finite attention,” Dr. Layne said. “However, what other options do we have for taming the so-called forever virus?”

Dr. Mokdad and Dr. Jetelina had no relevant disclosures. Dr. Durban disclosed she was the site primary investigator for the phase 3 AstraZeneca vaccine trial and an investigator on the Pfizer COVID-19 vaccine trial.

A version of this article first appeared on Medscape.com.

Israeli officials are reporting a 30% decrease in the effectiveness of the Pfizer/BioNTech vaccine to prevent SARS-CoV-2 infection and mild to moderate cases of COVID-19. At the same time, protection against hospitalization and severe illness remains robust.

The country’s Ministry of Health data cited high levels of circulating Delta variant and a relaxation of public health measures in early June for the drop in the vaccine’s prevention of “breakthrough” cases from 94% to 64% in recent weeks.

However, it is important to consider the findings in context, experts cautioned.

“My overall take on this that the vaccine is highly protective against the endpoints that matter – hospitalization and severe disease,” Anna Durbin, MD, told this news organization.

“I was very pleasantly surprised with the very high efficacy against hospitalization and severe disease – even against the Delta variant,” added Dr. Durbin, professor of medicine at Johns Hopkins University, Baltimore.

Ali Mokdad, PhD, of the Institute for Health Metrics at the University of Washington, Seattle, agreed that the high degree of protection against severe outcomes should be the focus.

“That’s the whole idea. You want to defend against COVID-19. So even if someone is infected, they don’t end up in the hospital or in the morgue,” he said in an interview.

Compared with an earlier report, the efficacy of the Pfizer vaccine against hospitalization fell slightly from 98% to 93%.

“For me, the fact that there is increased infection from the Delta variant after the vaccines such as Pfizer is of course a concern. But the positive news is that there is 93% prevention against severe disease or mortality,” added Dr. Mokdad, who is also professor of global health at University of Washington.

In addition, the absolute numbers remain relatively small. The Ministry of Health data show that, of the 63 Israelis hospitalized with COVID-19 nationwide on July 3, 34 were in critical condition.
 

Unrealistic expectations?

People may have unrealistic expectations regarding breakthrough infections, Dr. Durbin said. “It seems that people are almost expecting ‘sterilizing immunity’ from these vaccines,” she said, explaining that would mean complete protection from infection.

Expectations may be high “because these vaccines have been so effective,” added Dr. Durbin, who is also affiliated with the Johns Hopkins Center for Global Health.

The higher the number of vaccinated residents, the more breakthrough cases will be reported, epidemiologist Katelyn Jetelina, PhD, MPH, assistant professor of epidemiology, human genetics, and environmental sciences at the University of Texas Science Center at Houston, wrote in her “Your Local Epidemiologist” blog.

This could apply to Israel, with an estimated 60% of adults in Israel fully vaccinated and 65% receiving at least one dose as of July 5, Our World in Data figures show.

How the updated figures were reported could be confusing, Dr. Jetelina said. Israel’s Health Minister Chezy Levy noted that “55% of the newly infected had been vaccinated” in a radio interview announcing the results.

“This language is important because it’s very different than ‘half of vaccinated people were infected,’ ” Dr. Jetelina noted.

Israel had a 7-day rolling average of 324 new confirmed COVID-19 cases as of July 5. Assuming 55% of these cases were among vaccinated people, that would mean 178 people experienced breakthrough infections.

In contrast, almost 6 million people in Israel are fully vaccinated. If 55% of them experienced breakthrough infections, the number would be much higher – more than 3 million.

Dr. Jetelina added that more details about the new Israel figures would be helpful, including the severity of COVID-19 among the vaccinated cases and breakdown of infections between adults and children.
 

Next steps

Israeli health officials are weighing the necessity of a third or booster dose of the vaccine. Whether they will reinstate public health measures to prevent spread of COVID-19 also remains unknown.

Going forward, Israel intends to study whether factors such as age, comorbidities, or time since immunization affect risk for breakthrough infections among people vaccinated against COVID-19.

“We want to prevent people from getting hospitalized, seriously ill, and of course, dying. It’s encouraging these vaccines will be able to have a high impact on those outcomes,” Dr. Durbin said. “We just need to get people vaccinated.”
 

A call for better global surveillance

A global surveillance system is a potential solution to track and respond to the growing threat of the Delta variant and other variants of concern, Scott P. Layne, MD, and Jeffery K. Taubenberger, MD, PhD, wrote in a July 7, 2021, editorial in Science Translational Medicine.

One goal, Dr. Layne said in an interview, is to highlight “the compelling need for a new global COVID-19 program of surveillance and offer a blueprint for building it.” A second aim is to promote global cooperation among key advisers and leaders in the G7, G20, and Asia-Pacific Economic Cooperation nations.

“It’s an uphill struggle with superpower discords, global warming, cybersecurity, and pandemics all competing for finite attention,” Dr. Layne said. “However, what other options do we have for taming the so-called forever virus?”

Dr. Mokdad and Dr. Jetelina had no relevant disclosures. Dr. Durban disclosed she was the site primary investigator for the phase 3 AstraZeneca vaccine trial and an investigator on the Pfizer COVID-19 vaccine trial.

A version of this article first appeared on Medscape.com.

Although adolescents with acne received different cumulative doses of isotretinoin based on their body mass index, there were no differences in acne clearance, relapse, and most side effects between normal-weight, overweight, and obese individuals, a retrospective cohort study found.

“Oral isotretinoin is among the most effective treatments for acne and is indicated for the treatment of severe acne or when first-line regimens have failed,” Maggie Tallmadge said at the annual meeting of the Society for Pediatric Dermatology. In adolescents with acne, isotretinoin is prescribed at a dose of 0.5-1 mg/kg per day “with the goal of reaching a cumulative dose of 120-150 mg/kg and clinical clearance with durable remission,” she said. “Most providers do not prescribe a daily dose over 80 mg due to perceived increased risk of side effects, including xerosis, cheilitis, liver dysfunction, and acne flare. However, many adolescents weigh over 80 kg and are therefore effectively underdosed, prolonging treatment time and possibly increasing the risk of side effects due to prolonged therapy.”

To evaluate differences in treatment courses among normal-weight, overweight, and obese adolescents, and the efficacy and safety of treatment, Ms. Tallmadge, a third-year medical student at the Medical College of Wisconsin, Milwaukee, and colleagues completed a retrospective chart review of 550 dermatology patients at Children’s Wisconsin, also in Milwaukee, who completed at least 2 months of isotretinoin treatment for acne when they were between the ages of 10 and 24, from November 2012 to January 2020. They collected data on age, weight, height, daily dose, cumulative dose, time to acne clearance, side effects, and acne recurrence after treatment, and classified patients as normal weight, overweight, or obese based on their body mass index for age percentile.

Of the 550 patients, 367 (67%) were normal weight, 101 (18%) were overweight, and 82 (15%) were obese. The median age of those in the normal-weight and overweight groups was 16, and was 15 in the obese group.

There was were significant differences in the median cumulative dose in each weight group: 143.7 mg/kg for normal-weight patients, 138.2 mg/kg for overweight patients, and 140.6 mg/kg for obese patients (P < .001).

“Despite achieving different cumulative doses, there was no difference in acne clearance, relapse, and most side effects among the three [body mass index] cohorts,” Ms. Tallmadge said. “Thus, it appears that current treatment strategies may be appropriate for overweight and obese adolescents.”

The proportion of patients with acne clearance did not differ significantly among the three groups of patients: 62% who were in the normal weight range, 60% who were overweight, and 59% who were obese had clearance of facial acne with treatment (P = .84).

Of patients whose treatment course was completed by the time of data collection, the proportion with acne recurrences was similar between the three groups: 25% of normal-weight patients, 27% of overweight patients, and 35% of obese patients (P > .05). Of patients whose treatment course was completed by the time of data collection, there was no significant differences in acne recurrence: 25% of normal-weight patients, 27% of overweight patients, and 35% of obese patients.

However, the proportion of patients reporting headaches differed significantly between the groups: 29% of normal-weight patients, compared with 40% of both overweight and obese patients (P = .035). The researchers also observed a significant positive correlation between increased BMI and increased triglyceride and ALT levels during treatment (P < .001 for both associations), yet no elevations required clinical action.

Funding for the study was provided by the MCW Medical Student Summer Research Program and the American Acne & Rosacea Society.

[email protected]

Although adolescents with acne received different cumulative doses of isotretinoin based on their body mass index, there were no differences in acne clearance, relapse, and most side effects between normal-weight, overweight, and obese individuals, a retrospective cohort study found.

“Oral isotretinoin is among the most effective treatments for acne and is indicated for the treatment of severe acne or when first-line regimens have failed,” Maggie Tallmadge said at the annual meeting of the Society for Pediatric Dermatology. In adolescents with acne, isotretinoin is prescribed at a dose of 0.5-1 mg/kg per day “with the goal of reaching a cumulative dose of 120-150 mg/kg and clinical clearance with durable remission,” she said. “Most providers do not prescribe a daily dose over 80 mg due to perceived increased risk of side effects, including xerosis, cheilitis, liver dysfunction, and acne flare. However, many adolescents weigh over 80 kg and are therefore effectively underdosed, prolonging treatment time and possibly increasing the risk of side effects due to prolonged therapy.”

To evaluate differences in treatment courses among normal-weight, overweight, and obese adolescents, and the efficacy and safety of treatment, Ms. Tallmadge, a third-year medical student at the Medical College of Wisconsin, Milwaukee, and colleagues completed a retrospective chart review of 550 dermatology patients at Children’s Wisconsin, also in Milwaukee, who completed at least 2 months of isotretinoin treatment for acne when they were between the ages of 10 and 24, from November 2012 to January 2020. They collected data on age, weight, height, daily dose, cumulative dose, time to acne clearance, side effects, and acne recurrence after treatment, and classified patients as normal weight, overweight, or obese based on their body mass index for age percentile.

Of the 550 patients, 367 (67%) were normal weight, 101 (18%) were overweight, and 82 (15%) were obese. The median age of those in the normal-weight and overweight groups was 16, and was 15 in the obese group.

There was were significant differences in the median cumulative dose in each weight group: 143.7 mg/kg for normal-weight patients, 138.2 mg/kg for overweight patients, and 140.6 mg/kg for obese patients (P < .001).

“Despite achieving different cumulative doses, there was no difference in acne clearance, relapse, and most side effects among the three [body mass index] cohorts,” Ms. Tallmadge said. “Thus, it appears that current treatment strategies may be appropriate for overweight and obese adolescents.”

The proportion of patients with acne clearance did not differ significantly among the three groups of patients: 62% who were in the normal weight range, 60% who were overweight, and 59% who were obese had clearance of facial acne with treatment (P = .84).

Of patients whose treatment course was completed by the time of data collection, the proportion with acne recurrences was similar between the three groups: 25% of normal-weight patients, 27% of overweight patients, and 35% of obese patients (P > .05). Of patients whose treatment course was completed by the time of data collection, there was no significant differences in acne recurrence: 25% of normal-weight patients, 27% of overweight patients, and 35% of obese patients.

However, the proportion of patients reporting headaches differed significantly between the groups: 29% of normal-weight patients, compared with 40% of both overweight and obese patients (P = .035). The researchers also observed a significant positive correlation between increased BMI and increased triglyceride and ALT levels during treatment (P < .001 for both associations), yet no elevations required clinical action.

Funding for the study was provided by the MCW Medical Student Summer Research Program and the American Acne & Rosacea Society.

[email protected]

Although adolescents with acne received different cumulative doses of isotretinoin based on their body mass index, there were no differences in acne clearance, relapse, and most side effects between normal-weight, overweight, and obese individuals, a retrospective cohort study found.

“Oral isotretinoin is among the most effective treatments for acne and is indicated for the treatment of severe acne or when first-line regimens have failed,” Maggie Tallmadge said at the annual meeting of the Society for Pediatric Dermatology. In adolescents with acne, isotretinoin is prescribed at a dose of 0.5-1 mg/kg per day “with the goal of reaching a cumulative dose of 120-150 mg/kg and clinical clearance with durable remission,” she said. “Most providers do not prescribe a daily dose over 80 mg due to perceived increased risk of side effects, including xerosis, cheilitis, liver dysfunction, and acne flare. However, many adolescents weigh over 80 kg and are therefore effectively underdosed, prolonging treatment time and possibly increasing the risk of side effects due to prolonged therapy.”

To evaluate differences in treatment courses among normal-weight, overweight, and obese adolescents, and the efficacy and safety of treatment, Ms. Tallmadge, a third-year medical student at the Medical College of Wisconsin, Milwaukee, and colleagues completed a retrospective chart review of 550 dermatology patients at Children’s Wisconsin, also in Milwaukee, who completed at least 2 months of isotretinoin treatment for acne when they were between the ages of 10 and 24, from November 2012 to January 2020. They collected data on age, weight, height, daily dose, cumulative dose, time to acne clearance, side effects, and acne recurrence after treatment, and classified patients as normal weight, overweight, or obese based on their body mass index for age percentile.

Of the 550 patients, 367 (67%) were normal weight, 101 (18%) were overweight, and 82 (15%) were obese. The median age of those in the normal-weight and overweight groups was 16, and was 15 in the obese group.

There was were significant differences in the median cumulative dose in each weight group: 143.7 mg/kg for normal-weight patients, 138.2 mg/kg for overweight patients, and 140.6 mg/kg for obese patients (P < .001).

“Despite achieving different cumulative doses, there was no difference in acne clearance, relapse, and most side effects among the three [body mass index] cohorts,” Ms. Tallmadge said. “Thus, it appears that current treatment strategies may be appropriate for overweight and obese adolescents.”

The proportion of patients with acne clearance did not differ significantly among the three groups of patients: 62% who were in the normal weight range, 60% who were overweight, and 59% who were obese had clearance of facial acne with treatment (P = .84).

Of patients whose treatment course was completed by the time of data collection, the proportion with acne recurrences was similar between the three groups: 25% of normal-weight patients, 27% of overweight patients, and 35% of obese patients (P > .05). Of patients whose treatment course was completed by the time of data collection, there was no significant differences in acne recurrence: 25% of normal-weight patients, 27% of overweight patients, and 35% of obese patients.

However, the proportion of patients reporting headaches differed significantly between the groups: 29% of normal-weight patients, compared with 40% of both overweight and obese patients (P = .035). The researchers also observed a significant positive correlation between increased BMI and increased triglyceride and ALT levels during treatment (P < .001 for both associations), yet no elevations required clinical action.

Funding for the study was provided by the MCW Medical Student Summer Research Program and the American Acne & Rosacea Society.

[email protected]

Sublingual immunotherapy (SLIT) emerged over a century ago as a gentler alternative to allergy shots. It uses the same antigens found in allergy shots, delivering them through tablets or drops under the tongue rather than by injecting them into the skin.

Yet injection immunotherapy has been the mainstay of allergy treatment in the United States. Allergy shots are “the bread and butter, keeping the lights on at allergy practices,” said allergist Sakina Bajowala, MD, of Kaneland Allergy and Asthma Center, in the Chicago area. So even “when environmental SLIT showed quite clearly that it had efficacy, people were so slow to adapt.”

SLIT – a daily treatment that builds protection from allergens gradually over years with few side effects – is popular around the globe, particularly for environmental allergies. But only a handful of clinics offer food SLIT. Even though recent trials in peanut-allergic children show that SLIT is far safer than oral immunotherapy and about as effective as the Food and Drug Administration–approved peanut-allergy product and has lasting benefits for toddlers, many allergists lack experience with customized immunotherapies and hesitate to offer an unregulated treatment for which the evidence base is still emerging.
 

Why hasn’t food allergy SLIT caught on?

One issue is that there is scant evidence from randomized, controlled trials. The treatments that clinics offer often hinge on insurance coverage, and increasingly, insurers only cover FDA-approved products. FDA approval requires thousands of patients being enrolled in long, expensive studies to prove the treatment’s merit. In a similar vein, doctors are trained to question methods that lack a strong publication base, for good reason.

Yet SLIT caught the attention of pioneering physicians who were intrigued by this “low-and-slow” immune-modifying approach, despite limited published evidence, and they sought real-world experience.

The late physician David Morris, MD, came across SLIT in the 1960s while searching for alternative ways to help mold-allergic farmers who were suffering terrible side effects from allergy shots. Dr. Morris attended conferences, learned more about sublingual techniques, got board certified in allergy, and opened Allergy Associates of La Crosse (Wis.), in 1970 to offer SLIT as a treatment for food and environmental allergies.

Dr. Morris and colleagues developed a protocol to create custom SLIT drops tailored to individual patients’ clinical histories and allergy test results. The method has been used to treat more than 200,000 patients. It has been used by allergist Nikhila Schroeder, MD, MEng, who learned SLIT methods while treating nearly 1,000 patients at Allergy Associates. In 2018, she opened her own direct-care SLIT practice, Allergenuity Health, in the Charlotte metropolitan area of North Carolina (see part 2 of this series).

Dr. Bajowala’s clinic offers SLIT in addition to oral immunotherapy (OIT). She was encouraged by the recent toddler SLIT data but wondered whether it would translate to a real-world setting. According to her calculations, the published protocol – according to which participants receive up to 4 mg/d over 6 months and continue receiving a daily maintenance dose of 4 mg for 3 years – would cost $10,000 per patient.

With this dosing regimen, the intervention is unaffordable, Dr. Bajowala said. And “there’s no way to make it cheaper because that’s the raw materials cost. It does not include labor or bottles or profit at all. That’s just $10,000 in peanut extract.”

Owing to cost, Dr. Bajowala’s clinic generally uses SLIT as a bridge to OIT. Her food allergy patients receive up to 1 mg/d and remain at that dose for a month or so before transitioning to OIT, “for which the supplies are orders of magnitude cheaper,” she said.

Dr. Schroeder said there is evidence for efficacy at microgram and even nanogram dosing – much lower than used in the recent food SLIT trials. Maintenance doses range from 50 ng/d to 25 mcg/d for environmental SLIT and 4-37 mcg/d for food SLIT, she said. The La Crosse method uses even lower dose ranges.

However, dosing information is not readily available, Dr. Schroeder noted. She has spent years scrutinizing articles and compiling information from allergen extract suppliers – all the while treating hundreds of SLIT patients. “I have had to expend a lot of time and effort,” said Dr. Schroeder. “It’s really hard to explain quickly.”

In the published literature, SLIT dosing recommendations vary widely. According to a 2007 analysis, environmental allergy symptoms improved with doses over a 1,000-fold range. What’s more, success did not scale with increased dosing and seemed to depend more on frequency and duration of treatment.

There are fewer studies regarding food SLIT. The most promising data come from recent trials of peanut-allergic children led by Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill. Still, “I am nervous to tell people to go do this based on 150 kids at one site,” Dr. Kim said. “We need to have a gigantic study across multiple sites that actually confirms what we have found in our single center.”

Because there are few published trials of food SLIT, confusion about which doses are optimal, how early to start, and how long the benefits last will be a barrier for many clinicians, said Douglas Mack, MD, FRCPC, assistant clinical professor in pediatrics at McMaster University, Hamilton, Ont.

Much could be learned from Allergy Associates of La Crosse, Allergenuity Health, and other clinics with SLIT experience involving thousands of patients. But that real-world data are messy and difficult to publish. Plus, it is hard for private allergists to find time to review charts, analyze data, and draft papers alongside seeing patients and running a clinic – especially without students and interns, who typically assist with academic research, Dr. Schroeder said.

Ruchi Gupta, MD, MPH, professor of pediatrics and medicine at Northwestern University, Chicago, and colleagues worked with a La Crosse team 6 or 7 years ago to try to analyze and publish SLIT outcomes for 121 peanut-allergic children who were treated for food and environmental allergies at the Wisconsin clinic. The researchers had hoped to publish an article describing caregiver-reported and clinical outcomes.

Among 73 caregivers who responded to a survey, more than half reported improved eczema, asthma, and environmental allergy symptoms, and virtually all families said SLIT calmed anxieties and minimized fear of allergic reactions. However, the clinical outcomes – skinprick test results, immune changes, and oral food challenges – were not as robust. And the data were incomplete. Some patients had traveled to La Crosse for SLIT drops but underwent skin and blood testing with their local allergist. Compiling records is “so much harder when you’re not doing a prospective clinical trial,” Dr. Gupta said.

The caregiver-reported outcomes were presented as a poster at the 2015 annual meeting of the American College of Allergy, Asthma, and Immunology and the 2016 annual meeting of the Pediatric Academic Society, said Jeff Kessler, MBA, FACHE, who is practice executive at La Crosse. However, with only self-reported data and no convincing lab metrics, the findings were never submitted for publication.

Others are eager to see clearer proof that SLIT works at doses lower than those published in the most recent trials. “If we can get efficacy with lower doses, that means we can increase accessibility, because we can lower the cost,” Dr. Bajowala said.

Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins University, Baltimore, has a pending grant proposal for a multifood trial of SLIT. “It’s a big missing piece,” he said.

Dr. Mack said that in Canada there was “almost an instant change in group think” when the Canadian Society of Allergy and Clinical Immunology published guidelines in support of OIT. With the new guidelines, “people are less concerned about liability. Once they start getting into OIT, I think you’re going to see SLIT coming right along for the ride.”

The shift will be slower in the United States, which has 20 times as many practicing allergists as Canada. Nevertheless, “I totally think SLIT has a place at the table,” Dr. Mack said. “I hope we start to see more high-quality data and people start to use it and experiment with it a bit and see how it works.”

A version of this article first appeared on Medscape.com. This is part three of a three-part series. Part one is here. Part two is here.

Sublingual immunotherapy (SLIT) emerged over a century ago as a gentler alternative to allergy shots. It uses the same antigens found in allergy shots, delivering them through tablets or drops under the tongue rather than by injecting them into the skin.

Yet injection immunotherapy has been the mainstay of allergy treatment in the United States. Allergy shots are “the bread and butter, keeping the lights on at allergy practices,” said allergist Sakina Bajowala, MD, of Kaneland Allergy and Asthma Center, in the Chicago area. So even “when environmental SLIT showed quite clearly that it had efficacy, people were so slow to adapt.”

SLIT – a daily treatment that builds protection from allergens gradually over years with few side effects – is popular around the globe, particularly for environmental allergies. But only a handful of clinics offer food SLIT. Even though recent trials in peanut-allergic children show that SLIT is far safer than oral immunotherapy and about as effective as the Food and Drug Administration–approved peanut-allergy product and has lasting benefits for toddlers, many allergists lack experience with customized immunotherapies and hesitate to offer an unregulated treatment for which the evidence base is still emerging.
 

Why hasn’t food allergy SLIT caught on?

One issue is that there is scant evidence from randomized, controlled trials. The treatments that clinics offer often hinge on insurance coverage, and increasingly, insurers only cover FDA-approved products. FDA approval requires thousands of patients being enrolled in long, expensive studies to prove the treatment’s merit. In a similar vein, doctors are trained to question methods that lack a strong publication base, for good reason.

Yet SLIT caught the attention of pioneering physicians who were intrigued by this “low-and-slow” immune-modifying approach, despite limited published evidence, and they sought real-world experience.

The late physician David Morris, MD, came across SLIT in the 1960s while searching for alternative ways to help mold-allergic farmers who were suffering terrible side effects from allergy shots. Dr. Morris attended conferences, learned more about sublingual techniques, got board certified in allergy, and opened Allergy Associates of La Crosse (Wis.), in 1970 to offer SLIT as a treatment for food and environmental allergies.

Dr. Morris and colleagues developed a protocol to create custom SLIT drops tailored to individual patients’ clinical histories and allergy test results. The method has been used to treat more than 200,000 patients. It has been used by allergist Nikhila Schroeder, MD, MEng, who learned SLIT methods while treating nearly 1,000 patients at Allergy Associates. In 2018, she opened her own direct-care SLIT practice, Allergenuity Health, in the Charlotte metropolitan area of North Carolina (see part 2 of this series).

Dr. Bajowala’s clinic offers SLIT in addition to oral immunotherapy (OIT). She was encouraged by the recent toddler SLIT data but wondered whether it would translate to a real-world setting. According to her calculations, the published protocol – according to which participants receive up to 4 mg/d over 6 months and continue receiving a daily maintenance dose of 4 mg for 3 years – would cost $10,000 per patient.

With this dosing regimen, the intervention is unaffordable, Dr. Bajowala said. And “there’s no way to make it cheaper because that’s the raw materials cost. It does not include labor or bottles or profit at all. That’s just $10,000 in peanut extract.”

Owing to cost, Dr. Bajowala’s clinic generally uses SLIT as a bridge to OIT. Her food allergy patients receive up to 1 mg/d and remain at that dose for a month or so before transitioning to OIT, “for which the supplies are orders of magnitude cheaper,” she said.

Dr. Schroeder said there is evidence for efficacy at microgram and even nanogram dosing – much lower than used in the recent food SLIT trials. Maintenance doses range from 50 ng/d to 25 mcg/d for environmental SLIT and 4-37 mcg/d for food SLIT, she said. The La Crosse method uses even lower dose ranges.

However, dosing information is not readily available, Dr. Schroeder noted. She has spent years scrutinizing articles and compiling information from allergen extract suppliers – all the while treating hundreds of SLIT patients. “I have had to expend a lot of time and effort,” said Dr. Schroeder. “It’s really hard to explain quickly.”

In the published literature, SLIT dosing recommendations vary widely. According to a 2007 analysis, environmental allergy symptoms improved with doses over a 1,000-fold range. What’s more, success did not scale with increased dosing and seemed to depend more on frequency and duration of treatment.

There are fewer studies regarding food SLIT. The most promising data come from recent trials of peanut-allergic children led by Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill. Still, “I am nervous to tell people to go do this based on 150 kids at one site,” Dr. Kim said. “We need to have a gigantic study across multiple sites that actually confirms what we have found in our single center.”

Because there are few published trials of food SLIT, confusion about which doses are optimal, how early to start, and how long the benefits last will be a barrier for many clinicians, said Douglas Mack, MD, FRCPC, assistant clinical professor in pediatrics at McMaster University, Hamilton, Ont.

Much could be learned from Allergy Associates of La Crosse, Allergenuity Health, and other clinics with SLIT experience involving thousands of patients. But that real-world data are messy and difficult to publish. Plus, it is hard for private allergists to find time to review charts, analyze data, and draft papers alongside seeing patients and running a clinic – especially without students and interns, who typically assist with academic research, Dr. Schroeder said.

Ruchi Gupta, MD, MPH, professor of pediatrics and medicine at Northwestern University, Chicago, and colleagues worked with a La Crosse team 6 or 7 years ago to try to analyze and publish SLIT outcomes for 121 peanut-allergic children who were treated for food and environmental allergies at the Wisconsin clinic. The researchers had hoped to publish an article describing caregiver-reported and clinical outcomes.

Among 73 caregivers who responded to a survey, more than half reported improved eczema, asthma, and environmental allergy symptoms, and virtually all families said SLIT calmed anxieties and minimized fear of allergic reactions. However, the clinical outcomes – skinprick test results, immune changes, and oral food challenges – were not as robust. And the data were incomplete. Some patients had traveled to La Crosse for SLIT drops but underwent skin and blood testing with their local allergist. Compiling records is “so much harder when you’re not doing a prospective clinical trial,” Dr. Gupta said.

The caregiver-reported outcomes were presented as a poster at the 2015 annual meeting of the American College of Allergy, Asthma, and Immunology and the 2016 annual meeting of the Pediatric Academic Society, said Jeff Kessler, MBA, FACHE, who is practice executive at La Crosse. However, with only self-reported data and no convincing lab metrics, the findings were never submitted for publication.

Others are eager to see clearer proof that SLIT works at doses lower than those published in the most recent trials. “If we can get efficacy with lower doses, that means we can increase accessibility, because we can lower the cost,” Dr. Bajowala said.

Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins University, Baltimore, has a pending grant proposal for a multifood trial of SLIT. “It’s a big missing piece,” he said.

Dr. Mack said that in Canada there was “almost an instant change in group think” when the Canadian Society of Allergy and Clinical Immunology published guidelines in support of OIT. With the new guidelines, “people are less concerned about liability. Once they start getting into OIT, I think you’re going to see SLIT coming right along for the ride.”

The shift will be slower in the United States, which has 20 times as many practicing allergists as Canada. Nevertheless, “I totally think SLIT has a place at the table,” Dr. Mack said. “I hope we start to see more high-quality data and people start to use it and experiment with it a bit and see how it works.”

A version of this article first appeared on Medscape.com. This is part three of a three-part series. Part one is here. Part two is here.

Sublingual immunotherapy (SLIT) emerged over a century ago as a gentler alternative to allergy shots. It uses the same antigens found in allergy shots, delivering them through tablets or drops under the tongue rather than by injecting them into the skin.

Yet injection immunotherapy has been the mainstay of allergy treatment in the United States. Allergy shots are “the bread and butter, keeping the lights on at allergy practices,” said allergist Sakina Bajowala, MD, of Kaneland Allergy and Asthma Center, in the Chicago area. So even “when environmental SLIT showed quite clearly that it had efficacy, people were so slow to adapt.”

SLIT – a daily treatment that builds protection from allergens gradually over years with few side effects – is popular around the globe, particularly for environmental allergies. But only a handful of clinics offer food SLIT. Even though recent trials in peanut-allergic children show that SLIT is far safer than oral immunotherapy and about as effective as the Food and Drug Administration–approved peanut-allergy product and has lasting benefits for toddlers, many allergists lack experience with customized immunotherapies and hesitate to offer an unregulated treatment for which the evidence base is still emerging.
 

Why hasn’t food allergy SLIT caught on?

One issue is that there is scant evidence from randomized, controlled trials. The treatments that clinics offer often hinge on insurance coverage, and increasingly, insurers only cover FDA-approved products. FDA approval requires thousands of patients being enrolled in long, expensive studies to prove the treatment’s merit. In a similar vein, doctors are trained to question methods that lack a strong publication base, for good reason.

Yet SLIT caught the attention of pioneering physicians who were intrigued by this “low-and-slow” immune-modifying approach, despite limited published evidence, and they sought real-world experience.

The late physician David Morris, MD, came across SLIT in the 1960s while searching for alternative ways to help mold-allergic farmers who were suffering terrible side effects from allergy shots. Dr. Morris attended conferences, learned more about sublingual techniques, got board certified in allergy, and opened Allergy Associates of La Crosse (Wis.), in 1970 to offer SLIT as a treatment for food and environmental allergies.

Dr. Morris and colleagues developed a protocol to create custom SLIT drops tailored to individual patients’ clinical histories and allergy test results. The method has been used to treat more than 200,000 patients. It has been used by allergist Nikhila Schroeder, MD, MEng, who learned SLIT methods while treating nearly 1,000 patients at Allergy Associates. In 2018, she opened her own direct-care SLIT practice, Allergenuity Health, in the Charlotte metropolitan area of North Carolina (see part 2 of this series).

Dr. Bajowala’s clinic offers SLIT in addition to oral immunotherapy (OIT). She was encouraged by the recent toddler SLIT data but wondered whether it would translate to a real-world setting. According to her calculations, the published protocol – according to which participants receive up to 4 mg/d over 6 months and continue receiving a daily maintenance dose of 4 mg for 3 years – would cost $10,000 per patient.

With this dosing regimen, the intervention is unaffordable, Dr. Bajowala said. And “there’s no way to make it cheaper because that’s the raw materials cost. It does not include labor or bottles or profit at all. That’s just $10,000 in peanut extract.”

Owing to cost, Dr. Bajowala’s clinic generally uses SLIT as a bridge to OIT. Her food allergy patients receive up to 1 mg/d and remain at that dose for a month or so before transitioning to OIT, “for which the supplies are orders of magnitude cheaper,” she said.

Dr. Schroeder said there is evidence for efficacy at microgram and even nanogram dosing – much lower than used in the recent food SLIT trials. Maintenance doses range from 50 ng/d to 25 mcg/d for environmental SLIT and 4-37 mcg/d for food SLIT, she said. The La Crosse method uses even lower dose ranges.

However, dosing information is not readily available, Dr. Schroeder noted. She has spent years scrutinizing articles and compiling information from allergen extract suppliers – all the while treating hundreds of SLIT patients. “I have had to expend a lot of time and effort,” said Dr. Schroeder. “It’s really hard to explain quickly.”

In the published literature, SLIT dosing recommendations vary widely. According to a 2007 analysis, environmental allergy symptoms improved with doses over a 1,000-fold range. What’s more, success did not scale with increased dosing and seemed to depend more on frequency and duration of treatment.

There are fewer studies regarding food SLIT. The most promising data come from recent trials of peanut-allergic children led by Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill. Still, “I am nervous to tell people to go do this based on 150 kids at one site,” Dr. Kim said. “We need to have a gigantic study across multiple sites that actually confirms what we have found in our single center.”

Because there are few published trials of food SLIT, confusion about which doses are optimal, how early to start, and how long the benefits last will be a barrier for many clinicians, said Douglas Mack, MD, FRCPC, assistant clinical professor in pediatrics at McMaster University, Hamilton, Ont.

Much could be learned from Allergy Associates of La Crosse, Allergenuity Health, and other clinics with SLIT experience involving thousands of patients. But that real-world data are messy and difficult to publish. Plus, it is hard for private allergists to find time to review charts, analyze data, and draft papers alongside seeing patients and running a clinic – especially without students and interns, who typically assist with academic research, Dr. Schroeder said.

Ruchi Gupta, MD, MPH, professor of pediatrics and medicine at Northwestern University, Chicago, and colleagues worked with a La Crosse team 6 or 7 years ago to try to analyze and publish SLIT outcomes for 121 peanut-allergic children who were treated for food and environmental allergies at the Wisconsin clinic. The researchers had hoped to publish an article describing caregiver-reported and clinical outcomes.

Among 73 caregivers who responded to a survey, more than half reported improved eczema, asthma, and environmental allergy symptoms, and virtually all families said SLIT calmed anxieties and minimized fear of allergic reactions. However, the clinical outcomes – skinprick test results, immune changes, and oral food challenges – were not as robust. And the data were incomplete. Some patients had traveled to La Crosse for SLIT drops but underwent skin and blood testing with their local allergist. Compiling records is “so much harder when you’re not doing a prospective clinical trial,” Dr. Gupta said.

The caregiver-reported outcomes were presented as a poster at the 2015 annual meeting of the American College of Allergy, Asthma, and Immunology and the 2016 annual meeting of the Pediatric Academic Society, said Jeff Kessler, MBA, FACHE, who is practice executive at La Crosse. However, with only self-reported data and no convincing lab metrics, the findings were never submitted for publication.

Others are eager to see clearer proof that SLIT works at doses lower than those published in the most recent trials. “If we can get efficacy with lower doses, that means we can increase accessibility, because we can lower the cost,” Dr. Bajowala said.

Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins University, Baltimore, has a pending grant proposal for a multifood trial of SLIT. “It’s a big missing piece,” he said.

Dr. Mack said that in Canada there was “almost an instant change in group think” when the Canadian Society of Allergy and Clinical Immunology published guidelines in support of OIT. With the new guidelines, “people are less concerned about liability. Once they start getting into OIT, I think you’re going to see SLIT coming right along for the ride.”

The shift will be slower in the United States, which has 20 times as many practicing allergists as Canada. Nevertheless, “I totally think SLIT has a place at the table,” Dr. Mack said. “I hope we start to see more high-quality data and people start to use it and experiment with it a bit and see how it works.”

A version of this article first appeared on Medscape.com. This is part three of a three-part series. Part one is here. Part two is here.

With degrees in electrical engineering and computer science from the Massachusetts Institute of Technology, Nikhila Schroeder, MD, MEng, brings a problem-solving mindset to medicine.

Being a doctor means having to “figure out all aspects of [a patient’s] situation and do my best to come up with an answer,” said Dr. Schroeder, who founded Allergenuity Health, a solo allergy practice in Huntersville, N.C., with her husband James, who serves as practice executive. It’s “being a medical detective for your patient.”

Yet, during her training, Dr. Schroeder found that market-driven health care makes it hard to practice medicine with a patient’s best interest foremost. Procedures for diagnosing and treating disease cater to insurance companies’ reimbursement policies. “You wind up having to tailor your care to whatever insurance will cover,” she said.

Insurers, in turn, look for evidence from large, peer-reviewed studies to prove that a treatment works. Many physicians hesitate to offer therapies that aren’t covered by insurance, for both liability and financial reasons. So treatment tends to be limited to those options that were rigorously vetted in long, costly, multisite trials that are difficult to conduct without a corporate sponsor.

This is why there is still only one licensed treatment for people with food allergies – a set of standardized peanut powder capsules (Palforzia) that was approved by the Food and Drug Administration in early 2020 for peanut-allergic children aged 4-17 years. A small but growing number of allergists offer unapproved oral immunotherapy (OIT) using commercial food products to treat allergies to peanuts and other foods.

Even fewer allergists treat food allergy patients with another immune-modifying treatment, sublingual immunotherapy (SLIT), which delivers allergens through liquid drops held for several minutes under the tongue. Since 2018, Allergenuity Health, which offers SLIT to treat food and environmental allergies, has provided care to more than 400 patients. More than a third have come from out of state.

The clinic uses a direct-care approach. Rather than taking insurance, the clinic offers a monthly billing program that includes tests, SLIT bottles, and access to Dr. Schroeder via phone, email, or text. “I’m only contracted with the patient, and my only focus is the patient,” Dr. Schroeder said in an interview.
 

Unforgettable day

Allergy was not on Dr. Schroeder’s radar in medical school. She wanted to be a surgeon. But she loved working with children, so she did a pediatrics residency at the University of Virginia Children’s Hospital in Charlottesville. There Dr. Schroeder started seeing kids with eczema and allergies. While covering a friend’s clinic shift in 2010, she was thrust into an emergency. A family who didn’t speak English had just brought in their screaming 6-month-old baby, red and puffy with hives. “We didn’t know what was going on with this child,” Dr. Schroeder said. “Somehow I was elected to go in there.”

All of a sudden, things got quiet. Yet the baby was still screaming, mouth wide open. Dr. Schroeder had learned about anaphylaxis but had never witnessed it – until that day. The baby›s airways swelled so much that the crying became hoarse and soft. After working with a nurse to administer epinephrine, Dr. Schroeder saw something equally unforgettable: The baby’s heart rate soared, but within minutes the hives and swelling subsided and smiles returned. “It was incredible how quickly things changed,” Dr. Schroeder said. The baby had a reaction to rice, an uncommon allergen.

Dr. Schroeder stayed at UVA 2 more years to complete an allergy and immunology fellowship. She learned to diagnose food allergies but became frustrated having to tell patients they had little recourse but to avoid the food and to check in every year or 2. “I was, like, aren’t we specialists? Shouldn’t we have a little more expertise and maybe see if there are ways we could change this?” Dr. Schroeder said.

During those years, allergy shots were the only form of immunotherapy being taught to fellows. At clinic, Dr. Schroeder served as backup to the nurses when someone reacted to shots. She was troubled that some patients needed epinephrine to stop asthma attacks caused by injections they had received as treatment. The idea of injecting substances under the skin seemed akin to vaccination – where “you want to aggravate the immune system, you want it to get revved up, you want to build it up to fight,” she said. “But that’s not what you want for allergy. You want to tone it down. It didn’t really, to be honest, make a lot of sense to me.”

Dr. Schroeder started digging and asking questions. How does the immune system decide what is safe? Which cells and molecules communicate these decisions? She thought about babies and how they “learn” by putting stuff into their mouths. “If we don’t tolerate most of what we take in there, we wouldn’t survive,” Dr. Schroeder said. “It makes a lot of sense that a lot of tolerance begins with cells of the mouth.”

Dr. Schroeder discussed these concepts with her attendings. “They were all, like, no, there’s really no good evidence for that,” she said. But at some point, someone mentioned sublingual immunotherapy, and Schroeder came across Allergy Associates of La Crosse (Wis.).

The clinic’s late founder, David Morris, MD, learned about SLIT in the 1960s as an alternative option for farmers who suffered terrible side effects from injection immunotherapy they received to treat their mold allergies. Dr. Morris attended conferences, learned more about sublingual techniques – at times seeking advice from European allergists who offered SLIT – and became board certified in allergy before opening the La Crosse clinic in 1970. According to the clinic, more than 200,000 patients with environmental and food allergies have been treated with its SLIT protocol.

Dr. Schroeder was shocked to discover that this clinic had existed for 40 years, yet “I, as an allergist, had heard nothing about them,” she said.

Toward the end of her fellowship, OIT was becoming more well known. But she felt its risks were often downplayed. After years of talking with food allergy patients, Schroeder realized that most didn’t actually care about eating peanut butter sandwiches or sesame or walnuts. “Often I would hear, through tears: ‘I just want my child to be able to sit with their friends at lunch, to not be put at this other table, to not feel so isolated,’ ” she said. What mattered most to many families was gaining enough protection to not feel anxious about participating in social activities involving food.

Dr. Schroeder had a growing sense that SLIT – given its ease, safety, and sensible route of allergen delivery – seemed more useful. She wanted to learn more.

Her mentors urged her to stay in academia instead. “They were, like, you have a good academic reputation. You’re a solid thinker. You’re great at what you do. Do the traditional stuff,” Dr. Schroeder said.

Despite these admonitions, Dr. Schroeder left academia and took a job at La Crosse after completing her allergy fellowship. Determined to see whether SLIT could be effective, “I decided in the end, you know what, I have to go do this,” she said. “I need to know, and the only way I’m going to know is to do it, because no one was giving me good information.”

Before treating anyone with SLIT, Dr. Schroeder tried it herself – as a La Crosse patient. Growing up with severe eczema, eye swelling, and chronic nasal congestion leading to sinus infections, “I myself was a severely allergic person,” she said. Within several months, Dr. Schroeder saw dramatic improvement in her symptoms – “a night and day difference.” She experienced some mouth tingling, one of SLIT’s most common side effects, but found it “very tolerable, very mild.”

Allergenuity Health doesn’t aim to promote SLIT as the best treatment, said Dr. Schroeder, who has helped some families use avoidance or OIT as a better option. “An initial evaluation is always about proper diagnosis and education about all the treatment options available. Really, the point is education – be a detective for them and figure out what’s going on, be honest about what we know and what we don’t know, and give them the tools to figure out how to proceed.”

A version of this article first appeared on Medscape.com. This is part two of a three-part series. Part one is here. Part three is here.

With degrees in electrical engineering and computer science from the Massachusetts Institute of Technology, Nikhila Schroeder, MD, MEng, brings a problem-solving mindset to medicine.

Being a doctor means having to “figure out all aspects of [a patient’s] situation and do my best to come up with an answer,” said Dr. Schroeder, who founded Allergenuity Health, a solo allergy practice in Huntersville, N.C., with her husband James, who serves as practice executive. It’s “being a medical detective for your patient.”

Yet, during her training, Dr. Schroeder found that market-driven health care makes it hard to practice medicine with a patient’s best interest foremost. Procedures for diagnosing and treating disease cater to insurance companies’ reimbursement policies. “You wind up having to tailor your care to whatever insurance will cover,” she said.

Insurers, in turn, look for evidence from large, peer-reviewed studies to prove that a treatment works. Many physicians hesitate to offer therapies that aren’t covered by insurance, for both liability and financial reasons. So treatment tends to be limited to those options that were rigorously vetted in long, costly, multisite trials that are difficult to conduct without a corporate sponsor.

This is why there is still only one licensed treatment for people with food allergies – a set of standardized peanut powder capsules (Palforzia) that was approved by the Food and Drug Administration in early 2020 for peanut-allergic children aged 4-17 years. A small but growing number of allergists offer unapproved oral immunotherapy (OIT) using commercial food products to treat allergies to peanuts and other foods.

Even fewer allergists treat food allergy patients with another immune-modifying treatment, sublingual immunotherapy (SLIT), which delivers allergens through liquid drops held for several minutes under the tongue. Since 2018, Allergenuity Health, which offers SLIT to treat food and environmental allergies, has provided care to more than 400 patients. More than a third have come from out of state.

The clinic uses a direct-care approach. Rather than taking insurance, the clinic offers a monthly billing program that includes tests, SLIT bottles, and access to Dr. Schroeder via phone, email, or text. “I’m only contracted with the patient, and my only focus is the patient,” Dr. Schroeder said in an interview.
 

Unforgettable day

Allergy was not on Dr. Schroeder’s radar in medical school. She wanted to be a surgeon. But she loved working with children, so she did a pediatrics residency at the University of Virginia Children’s Hospital in Charlottesville. There Dr. Schroeder started seeing kids with eczema and allergies. While covering a friend’s clinic shift in 2010, she was thrust into an emergency. A family who didn’t speak English had just brought in their screaming 6-month-old baby, red and puffy with hives. “We didn’t know what was going on with this child,” Dr. Schroeder said. “Somehow I was elected to go in there.”

All of a sudden, things got quiet. Yet the baby was still screaming, mouth wide open. Dr. Schroeder had learned about anaphylaxis but had never witnessed it – until that day. The baby›s airways swelled so much that the crying became hoarse and soft. After working with a nurse to administer epinephrine, Dr. Schroeder saw something equally unforgettable: The baby’s heart rate soared, but within minutes the hives and swelling subsided and smiles returned. “It was incredible how quickly things changed,” Dr. Schroeder said. The baby had a reaction to rice, an uncommon allergen.

Dr. Schroeder stayed at UVA 2 more years to complete an allergy and immunology fellowship. She learned to diagnose food allergies but became frustrated having to tell patients they had little recourse but to avoid the food and to check in every year or 2. “I was, like, aren’t we specialists? Shouldn’t we have a little more expertise and maybe see if there are ways we could change this?” Dr. Schroeder said.

During those years, allergy shots were the only form of immunotherapy being taught to fellows. At clinic, Dr. Schroeder served as backup to the nurses when someone reacted to shots. She was troubled that some patients needed epinephrine to stop asthma attacks caused by injections they had received as treatment. The idea of injecting substances under the skin seemed akin to vaccination – where “you want to aggravate the immune system, you want it to get revved up, you want to build it up to fight,” she said. “But that’s not what you want for allergy. You want to tone it down. It didn’t really, to be honest, make a lot of sense to me.”

Dr. Schroeder started digging and asking questions. How does the immune system decide what is safe? Which cells and molecules communicate these decisions? She thought about babies and how they “learn” by putting stuff into their mouths. “If we don’t tolerate most of what we take in there, we wouldn’t survive,” Dr. Schroeder said. “It makes a lot of sense that a lot of tolerance begins with cells of the mouth.”

Dr. Schroeder discussed these concepts with her attendings. “They were all, like, no, there’s really no good evidence for that,” she said. But at some point, someone mentioned sublingual immunotherapy, and Schroeder came across Allergy Associates of La Crosse (Wis.).

The clinic’s late founder, David Morris, MD, learned about SLIT in the 1960s as an alternative option for farmers who suffered terrible side effects from injection immunotherapy they received to treat their mold allergies. Dr. Morris attended conferences, learned more about sublingual techniques – at times seeking advice from European allergists who offered SLIT – and became board certified in allergy before opening the La Crosse clinic in 1970. According to the clinic, more than 200,000 patients with environmental and food allergies have been treated with its SLIT protocol.

Dr. Schroeder was shocked to discover that this clinic had existed for 40 years, yet “I, as an allergist, had heard nothing about them,” she said.

Toward the end of her fellowship, OIT was becoming more well known. But she felt its risks were often downplayed. After years of talking with food allergy patients, Schroeder realized that most didn’t actually care about eating peanut butter sandwiches or sesame or walnuts. “Often I would hear, through tears: ‘I just want my child to be able to sit with their friends at lunch, to not be put at this other table, to not feel so isolated,’ ” she said. What mattered most to many families was gaining enough protection to not feel anxious about participating in social activities involving food.

Dr. Schroeder had a growing sense that SLIT – given its ease, safety, and sensible route of allergen delivery – seemed more useful. She wanted to learn more.

Her mentors urged her to stay in academia instead. “They were, like, you have a good academic reputation. You’re a solid thinker. You’re great at what you do. Do the traditional stuff,” Dr. Schroeder said.

Despite these admonitions, Dr. Schroeder left academia and took a job at La Crosse after completing her allergy fellowship. Determined to see whether SLIT could be effective, “I decided in the end, you know what, I have to go do this,” she said. “I need to know, and the only way I’m going to know is to do it, because no one was giving me good information.”

Before treating anyone with SLIT, Dr. Schroeder tried it herself – as a La Crosse patient. Growing up with severe eczema, eye swelling, and chronic nasal congestion leading to sinus infections, “I myself was a severely allergic person,” she said. Within several months, Dr. Schroeder saw dramatic improvement in her symptoms – “a night and day difference.” She experienced some mouth tingling, one of SLIT’s most common side effects, but found it “very tolerable, very mild.”

Allergenuity Health doesn’t aim to promote SLIT as the best treatment, said Dr. Schroeder, who has helped some families use avoidance or OIT as a better option. “An initial evaluation is always about proper diagnosis and education about all the treatment options available. Really, the point is education – be a detective for them and figure out what’s going on, be honest about what we know and what we don’t know, and give them the tools to figure out how to proceed.”

A version of this article first appeared on Medscape.com. This is part two of a three-part series. Part one is here. Part three is here.

With degrees in electrical engineering and computer science from the Massachusetts Institute of Technology, Nikhila Schroeder, MD, MEng, brings a problem-solving mindset to medicine.

Being a doctor means having to “figure out all aspects of [a patient’s] situation and do my best to come up with an answer,” said Dr. Schroeder, who founded Allergenuity Health, a solo allergy practice in Huntersville, N.C., with her husband James, who serves as practice executive. It’s “being a medical detective for your patient.”

Yet, during her training, Dr. Schroeder found that market-driven health care makes it hard to practice medicine with a patient’s best interest foremost. Procedures for diagnosing and treating disease cater to insurance companies’ reimbursement policies. “You wind up having to tailor your care to whatever insurance will cover,” she said.

Insurers, in turn, look for evidence from large, peer-reviewed studies to prove that a treatment works. Many physicians hesitate to offer therapies that aren’t covered by insurance, for both liability and financial reasons. So treatment tends to be limited to those options that were rigorously vetted in long, costly, multisite trials that are difficult to conduct without a corporate sponsor.

This is why there is still only one licensed treatment for people with food allergies – a set of standardized peanut powder capsules (Palforzia) that was approved by the Food and Drug Administration in early 2020 for peanut-allergic children aged 4-17 years. A small but growing number of allergists offer unapproved oral immunotherapy (OIT) using commercial food products to treat allergies to peanuts and other foods.

Even fewer allergists treat food allergy patients with another immune-modifying treatment, sublingual immunotherapy (SLIT), which delivers allergens through liquid drops held for several minutes under the tongue. Since 2018, Allergenuity Health, which offers SLIT to treat food and environmental allergies, has provided care to more than 400 patients. More than a third have come from out of state.

The clinic uses a direct-care approach. Rather than taking insurance, the clinic offers a monthly billing program that includes tests, SLIT bottles, and access to Dr. Schroeder via phone, email, or text. “I’m only contracted with the patient, and my only focus is the patient,” Dr. Schroeder said in an interview.
 

Unforgettable day

Allergy was not on Dr. Schroeder’s radar in medical school. She wanted to be a surgeon. But she loved working with children, so she did a pediatrics residency at the University of Virginia Children’s Hospital in Charlottesville. There Dr. Schroeder started seeing kids with eczema and allergies. While covering a friend’s clinic shift in 2010, she was thrust into an emergency. A family who didn’t speak English had just brought in their screaming 6-month-old baby, red and puffy with hives. “We didn’t know what was going on with this child,” Dr. Schroeder said. “Somehow I was elected to go in there.”

All of a sudden, things got quiet. Yet the baby was still screaming, mouth wide open. Dr. Schroeder had learned about anaphylaxis but had never witnessed it – until that day. The baby›s airways swelled so much that the crying became hoarse and soft. After working with a nurse to administer epinephrine, Dr. Schroeder saw something equally unforgettable: The baby’s heart rate soared, but within minutes the hives and swelling subsided and smiles returned. “It was incredible how quickly things changed,” Dr. Schroeder said. The baby had a reaction to rice, an uncommon allergen.

Dr. Schroeder stayed at UVA 2 more years to complete an allergy and immunology fellowship. She learned to diagnose food allergies but became frustrated having to tell patients they had little recourse but to avoid the food and to check in every year or 2. “I was, like, aren’t we specialists? Shouldn’t we have a little more expertise and maybe see if there are ways we could change this?” Dr. Schroeder said.

During those years, allergy shots were the only form of immunotherapy being taught to fellows. At clinic, Dr. Schroeder served as backup to the nurses when someone reacted to shots. She was troubled that some patients needed epinephrine to stop asthma attacks caused by injections they had received as treatment. The idea of injecting substances under the skin seemed akin to vaccination – where “you want to aggravate the immune system, you want it to get revved up, you want to build it up to fight,” she said. “But that’s not what you want for allergy. You want to tone it down. It didn’t really, to be honest, make a lot of sense to me.”

Dr. Schroeder started digging and asking questions. How does the immune system decide what is safe? Which cells and molecules communicate these decisions? She thought about babies and how they “learn” by putting stuff into their mouths. “If we don’t tolerate most of what we take in there, we wouldn’t survive,” Dr. Schroeder said. “It makes a lot of sense that a lot of tolerance begins with cells of the mouth.”

Dr. Schroeder discussed these concepts with her attendings. “They were all, like, no, there’s really no good evidence for that,” she said. But at some point, someone mentioned sublingual immunotherapy, and Schroeder came across Allergy Associates of La Crosse (Wis.).

The clinic’s late founder, David Morris, MD, learned about SLIT in the 1960s as an alternative option for farmers who suffered terrible side effects from injection immunotherapy they received to treat their mold allergies. Dr. Morris attended conferences, learned more about sublingual techniques – at times seeking advice from European allergists who offered SLIT – and became board certified in allergy before opening the La Crosse clinic in 1970. According to the clinic, more than 200,000 patients with environmental and food allergies have been treated with its SLIT protocol.

Dr. Schroeder was shocked to discover that this clinic had existed for 40 years, yet “I, as an allergist, had heard nothing about them,” she said.

Toward the end of her fellowship, OIT was becoming more well known. But she felt its risks were often downplayed. After years of talking with food allergy patients, Schroeder realized that most didn’t actually care about eating peanut butter sandwiches or sesame or walnuts. “Often I would hear, through tears: ‘I just want my child to be able to sit with their friends at lunch, to not be put at this other table, to not feel so isolated,’ ” she said. What mattered most to many families was gaining enough protection to not feel anxious about participating in social activities involving food.

Dr. Schroeder had a growing sense that SLIT – given its ease, safety, and sensible route of allergen delivery – seemed more useful. She wanted to learn more.

Her mentors urged her to stay in academia instead. “They were, like, you have a good academic reputation. You’re a solid thinker. You’re great at what you do. Do the traditional stuff,” Dr. Schroeder said.

Despite these admonitions, Dr. Schroeder left academia and took a job at La Crosse after completing her allergy fellowship. Determined to see whether SLIT could be effective, “I decided in the end, you know what, I have to go do this,” she said. “I need to know, and the only way I’m going to know is to do it, because no one was giving me good information.”

Before treating anyone with SLIT, Dr. Schroeder tried it herself – as a La Crosse patient. Growing up with severe eczema, eye swelling, and chronic nasal congestion leading to sinus infections, “I myself was a severely allergic person,” she said. Within several months, Dr. Schroeder saw dramatic improvement in her symptoms – “a night and day difference.” She experienced some mouth tingling, one of SLIT’s most common side effects, but found it “very tolerable, very mild.”

Allergenuity Health doesn’t aim to promote SLIT as the best treatment, said Dr. Schroeder, who has helped some families use avoidance or OIT as a better option. “An initial evaluation is always about proper diagnosis and education about all the treatment options available. Really, the point is education – be a detective for them and figure out what’s going on, be honest about what we know and what we don’t know, and give them the tools to figure out how to proceed.”

A version of this article first appeared on Medscape.com. This is part two of a three-part series. Part one is here. Part three is here.

For the 32 million people in the United States with food allergies, those who seek relief beyond constant vigilance and EpiPens face a confusing treatment landscape. In January 2020, the Food and Drug Administration approved an oral immunotherapy product (Palforzia) for peanut-allergic children. Yet the product’s ill-timed release during a pandemic and its black-box warning about the risk for anaphylaxis has slowed uptake.

A small number of allergists offer home-grown oral immunotherapy (OIT), which builds protection by exposing patients to increasing daily doses of commercial food products over months. However, as with Palforzia, allergic reactions are common during treatment, and the hard-earned protection can fade if not maintained with regular dosing.

An alternate approach, sublingual immunotherapy (SLIT), delivers food proteins through liquid drops held in the mouth – a site rich in tolerance-inducing immune cells. In a 2019 study of peanut-allergic children aged 1-11 years, SLIT offered a level of protection on par with Palforzia while causing considerably fewer adverse events. And at the 2021 annual meeting of the American Academy of Allergy, Asthma and Immunology, researchers reported that SLIT produced stronger, more durable benefits in toddlers aged 1-4.

Sublingual immunotherapy is “a bunch of drops you put under your tongue, you hold it for a couple minutes, and then you’re done for the day,” said Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, who led the two recent studies. For protecting against accidental ingestions, SLIT “is pushing pretty close to what OIT is able to provide but seemingly with a superior ease of administration and safety profile.”

Many parents don’t necessarily want their allergic kids to be able to eat a peanut butter sandwich – but do want them to be able to safely sit at the same lunch table and attend birthday parties with other kids. SLIT achieves this level of protection about as well as OIT, with fewer side effects.

Still, because of concerns about the treatment’s cost, unclear dosing regimens, and lack of FDA approval, very few U.S. allergists – likely less than 5% – offer sublingual immunotherapy to treat food allergies, making SLIT even less available than OIT.
 

Concerns about SLIT

One possible reason: Success is slower and less visible for SLIT. When patients undergo OIT, they build up to dosing with the actual food. “To a family who has a concern about their kid reacting, they can see them eating chunks of peanut in our office. That is really encouraging,” said Douglas Mack, MD, FRCPC, an allergist with Halton Pediatric Allergy and assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont.

On the other hand, ingestion isn’t the focus for SLIT, so progress is harder to measure using metrics in published trials. After holding SLIT drops under the tongue, some patients spit them out. If they swallow the dose, it’s a vanishingly small amount. Immune changes that reflect increasing tolerance, such as a decrease in IgE antibodies, tend to be more gradual with SLIT than with OIT. And because SLIT is only offered in private clinics, such tests are not conducted as regularly as they would be for published trials.

But there may be a bigger factor: Some think earlier trials comparing the two immunotherapy regimens gave SLIT a bad rap. For example, in studies of milk- and peanut-allergic children conducted in 2011 and 2014, investigators concluded that SLIT was safer and that OIT appeared to be more effective. However, those trials compared SLIT with OIT using a much higher dose (2,000 mg) than is used in the licensed product (300 mg).

Over the years, endpoints for food allergy treatment trials have shifted from enabling patients to eat a full serving of their allergen to merely raising their threshold to guard against accidental exposures. So in those earlier articles, “we would probably write the discussion section differently now,” said Corinne Keet, MD, PhD, first author on the 2011 milk study and an associate professor of pediatrics at Johns Hopkins University, Baltimore.

Indeed, “when you compare [SLIT] to Palforzia or other studies of low-dose OIT (300 mg/d), they look equal in terms of their efficacy,” said senior author Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins. Yet, “I’m afraid we had a major [negative] impact on pharma’s interest in pursuing SLIT.”

Without corporate funding, it’s nearly impossible to conduct the large, multisite trials required for FDA approval of a treatment. And without approved products, many allergists are reluctant to offer the therapy, Dr. Wood said. It “makes your life a lot more complicated to be dabbling in things that are not approved,” he noted.

But at least one company is giving it a go. Applying the SLIT principle of delivering food allergens to tolerance-promoting immune cells in the mouth, New York–based Intrommune Therapeutics recently started enrolling peanut-allergic adults for a phase 1 trial of its experimental toothpaste.

Interest in food-allergy SLIT seems to be growing. “I definitely think that it could be an option for the future,” said Jaclyn Bjelac, MD, associate director of the Food Allergy Center of Excellence at the Cleveland Clinic. “Up until a few months ago, it really wasn’t on our radar.”

On conversations with Dr. Kim, philanthropists and drug developers said they found the recent data on SLIT promising, yet pointed out that food SLIT protocols and products are already in the public domain – they are described in published research using allergen extracts that are on the market. They “can’t see a commercial path forward,” Dr. Kim said in an interview. “And that’s kind of where many of my conversations end.”

Although there are no licensed SLIT products for food allergies, between 2014 and 2017, the FDA approved four sublingual immunotherapy tablets to treat environmental allergies – Stallergenes-Greer’s Oralair and ALK’s Grastek for grass pollens, ALK’s Odactra for dust mites, and ALK’s Ragwitek for short ragweed.

SLIT tablets work as well as allergy shots (subcutaneous immunotherapy) for controlling environmental allergy symptoms, they have a better safety profile, according to AAAAI guidelines, and they can be self-administered at home, which has made them a popular option globally. “Our European colleagues have used sublingual immunotherapy much more frequently than, for example, in the U.S.,” said Kari Nadeau, MD, PhD, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

Use of SLIT is also increasing in the United States, especially as FDA-approved products become available. In a 2019 survey, the percentage of U.S. allergists who said they were offering sublingual treatment for environmental allergies increased from 5.9% in 2007 to 73.5% in 2019. However, only 11.2% reported extensive SLIT use; the remainder reported some (50.5%) or little (38.3%) use.

As noted above, considerably fewer U.S. allergists use SLIT to treat food allergies. Similarly, a 2021 survey of allergists in Canada found that only 7% offered food sublingual immunotherapy; more than half reported offering OIT.

One practice, Allergy Associates of La Crosse (Wis.), has offered SLIT drops for food and environmental allergies for decades. Since the clinic opened in 1970, more than 200,000 people have been treated with its protocol. Every patient receives customized sublingual drops – “exactly what they’re allergic to, exactly how allergic they are, and then we build from there,” said Jeff Kessler, MBA, FACHE, practice executive at Allergy Associates of La Crosse. “Quite frankly, it’s the way immunotherapy should be done.

A version of this article first appeared on Medscape.com. This is part one of a three-part series. Part two is here. Part three is here.

For the 32 million people in the United States with food allergies, those who seek relief beyond constant vigilance and EpiPens face a confusing treatment landscape. In January 2020, the Food and Drug Administration approved an oral immunotherapy product (Palforzia) for peanut-allergic children. Yet the product’s ill-timed release during a pandemic and its black-box warning about the risk for anaphylaxis has slowed uptake.

A small number of allergists offer home-grown oral immunotherapy (OIT), which builds protection by exposing patients to increasing daily doses of commercial food products over months. However, as with Palforzia, allergic reactions are common during treatment, and the hard-earned protection can fade if not maintained with regular dosing.

An alternate approach, sublingual immunotherapy (SLIT), delivers food proteins through liquid drops held in the mouth – a site rich in tolerance-inducing immune cells. In a 2019 study of peanut-allergic children aged 1-11 years, SLIT offered a level of protection on par with Palforzia while causing considerably fewer adverse events. And at the 2021 annual meeting of the American Academy of Allergy, Asthma and Immunology, researchers reported that SLIT produced stronger, more durable benefits in toddlers aged 1-4.

Sublingual immunotherapy is “a bunch of drops you put under your tongue, you hold it for a couple minutes, and then you’re done for the day,” said Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, who led the two recent studies. For protecting against accidental ingestions, SLIT “is pushing pretty close to what OIT is able to provide but seemingly with a superior ease of administration and safety profile.”

Many parents don’t necessarily want their allergic kids to be able to eat a peanut butter sandwich – but do want them to be able to safely sit at the same lunch table and attend birthday parties with other kids. SLIT achieves this level of protection about as well as OIT, with fewer side effects.

Still, because of concerns about the treatment’s cost, unclear dosing regimens, and lack of FDA approval, very few U.S. allergists – likely less than 5% – offer sublingual immunotherapy to treat food allergies, making SLIT even less available than OIT.
 

Concerns about SLIT

One possible reason: Success is slower and less visible for SLIT. When patients undergo OIT, they build up to dosing with the actual food. “To a family who has a concern about their kid reacting, they can see them eating chunks of peanut in our office. That is really encouraging,” said Douglas Mack, MD, FRCPC, an allergist with Halton Pediatric Allergy and assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont.

On the other hand, ingestion isn’t the focus for SLIT, so progress is harder to measure using metrics in published trials. After holding SLIT drops under the tongue, some patients spit them out. If they swallow the dose, it’s a vanishingly small amount. Immune changes that reflect increasing tolerance, such as a decrease in IgE antibodies, tend to be more gradual with SLIT than with OIT. And because SLIT is only offered in private clinics, such tests are not conducted as regularly as they would be for published trials.

But there may be a bigger factor: Some think earlier trials comparing the two immunotherapy regimens gave SLIT a bad rap. For example, in studies of milk- and peanut-allergic children conducted in 2011 and 2014, investigators concluded that SLIT was safer and that OIT appeared to be more effective. However, those trials compared SLIT with OIT using a much higher dose (2,000 mg) than is used in the licensed product (300 mg).

Over the years, endpoints for food allergy treatment trials have shifted from enabling patients to eat a full serving of their allergen to merely raising their threshold to guard against accidental exposures. So in those earlier articles, “we would probably write the discussion section differently now,” said Corinne Keet, MD, PhD, first author on the 2011 milk study and an associate professor of pediatrics at Johns Hopkins University, Baltimore.

Indeed, “when you compare [SLIT] to Palforzia or other studies of low-dose OIT (300 mg/d), they look equal in terms of their efficacy,” said senior author Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins. Yet, “I’m afraid we had a major [negative] impact on pharma’s interest in pursuing SLIT.”

Without corporate funding, it’s nearly impossible to conduct the large, multisite trials required for FDA approval of a treatment. And without approved products, many allergists are reluctant to offer the therapy, Dr. Wood said. It “makes your life a lot more complicated to be dabbling in things that are not approved,” he noted.

But at least one company is giving it a go. Applying the SLIT principle of delivering food allergens to tolerance-promoting immune cells in the mouth, New York–based Intrommune Therapeutics recently started enrolling peanut-allergic adults for a phase 1 trial of its experimental toothpaste.

Interest in food-allergy SLIT seems to be growing. “I definitely think that it could be an option for the future,” said Jaclyn Bjelac, MD, associate director of the Food Allergy Center of Excellence at the Cleveland Clinic. “Up until a few months ago, it really wasn’t on our radar.”

On conversations with Dr. Kim, philanthropists and drug developers said they found the recent data on SLIT promising, yet pointed out that food SLIT protocols and products are already in the public domain – they are described in published research using allergen extracts that are on the market. They “can’t see a commercial path forward,” Dr. Kim said in an interview. “And that’s kind of where many of my conversations end.”

Although there are no licensed SLIT products for food allergies, between 2014 and 2017, the FDA approved four sublingual immunotherapy tablets to treat environmental allergies – Stallergenes-Greer’s Oralair and ALK’s Grastek for grass pollens, ALK’s Odactra for dust mites, and ALK’s Ragwitek for short ragweed.

SLIT tablets work as well as allergy shots (subcutaneous immunotherapy) for controlling environmental allergy symptoms, they have a better safety profile, according to AAAAI guidelines, and they can be self-administered at home, which has made them a popular option globally. “Our European colleagues have used sublingual immunotherapy much more frequently than, for example, in the U.S.,” said Kari Nadeau, MD, PhD, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

Use of SLIT is also increasing in the United States, especially as FDA-approved products become available. In a 2019 survey, the percentage of U.S. allergists who said they were offering sublingual treatment for environmental allergies increased from 5.9% in 2007 to 73.5% in 2019. However, only 11.2% reported extensive SLIT use; the remainder reported some (50.5%) or little (38.3%) use.

As noted above, considerably fewer U.S. allergists use SLIT to treat food allergies. Similarly, a 2021 survey of allergists in Canada found that only 7% offered food sublingual immunotherapy; more than half reported offering OIT.

One practice, Allergy Associates of La Crosse (Wis.), has offered SLIT drops for food and environmental allergies for decades. Since the clinic opened in 1970, more than 200,000 people have been treated with its protocol. Every patient receives customized sublingual drops – “exactly what they’re allergic to, exactly how allergic they are, and then we build from there,” said Jeff Kessler, MBA, FACHE, practice executive at Allergy Associates of La Crosse. “Quite frankly, it’s the way immunotherapy should be done.

A version of this article first appeared on Medscape.com. This is part one of a three-part series. Part two is here. Part three is here.

For the 32 million people in the United States with food allergies, those who seek relief beyond constant vigilance and EpiPens face a confusing treatment landscape. In January 2020, the Food and Drug Administration approved an oral immunotherapy product (Palforzia) for peanut-allergic children. Yet the product’s ill-timed release during a pandemic and its black-box warning about the risk for anaphylaxis has slowed uptake.

A small number of allergists offer home-grown oral immunotherapy (OIT), which builds protection by exposing patients to increasing daily doses of commercial food products over months. However, as with Palforzia, allergic reactions are common during treatment, and the hard-earned protection can fade if not maintained with regular dosing.

An alternate approach, sublingual immunotherapy (SLIT), delivers food proteins through liquid drops held in the mouth – a site rich in tolerance-inducing immune cells. In a 2019 study of peanut-allergic children aged 1-11 years, SLIT offered a level of protection on par with Palforzia while causing considerably fewer adverse events. And at the 2021 annual meeting of the American Academy of Allergy, Asthma and Immunology, researchers reported that SLIT produced stronger, more durable benefits in toddlers aged 1-4.

Sublingual immunotherapy is “a bunch of drops you put under your tongue, you hold it for a couple minutes, and then you’re done for the day,” said Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, who led the two recent studies. For protecting against accidental ingestions, SLIT “is pushing pretty close to what OIT is able to provide but seemingly with a superior ease of administration and safety profile.”

Many parents don’t necessarily want their allergic kids to be able to eat a peanut butter sandwich – but do want them to be able to safely sit at the same lunch table and attend birthday parties with other kids. SLIT achieves this level of protection about as well as OIT, with fewer side effects.

Still, because of concerns about the treatment’s cost, unclear dosing regimens, and lack of FDA approval, very few U.S. allergists – likely less than 5% – offer sublingual immunotherapy to treat food allergies, making SLIT even less available than OIT.
 

Concerns about SLIT

One possible reason: Success is slower and less visible for SLIT. When patients undergo OIT, they build up to dosing with the actual food. “To a family who has a concern about their kid reacting, they can see them eating chunks of peanut in our office. That is really encouraging,” said Douglas Mack, MD, FRCPC, an allergist with Halton Pediatric Allergy and assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont.

On the other hand, ingestion isn’t the focus for SLIT, so progress is harder to measure using metrics in published trials. After holding SLIT drops under the tongue, some patients spit them out. If they swallow the dose, it’s a vanishingly small amount. Immune changes that reflect increasing tolerance, such as a decrease in IgE antibodies, tend to be more gradual with SLIT than with OIT. And because SLIT is only offered in private clinics, such tests are not conducted as regularly as they would be for published trials.

But there may be a bigger factor: Some think earlier trials comparing the two immunotherapy regimens gave SLIT a bad rap. For example, in studies of milk- and peanut-allergic children conducted in 2011 and 2014, investigators concluded that SLIT was safer and that OIT appeared to be more effective. However, those trials compared SLIT with OIT using a much higher dose (2,000 mg) than is used in the licensed product (300 mg).

Over the years, endpoints for food allergy treatment trials have shifted from enabling patients to eat a full serving of their allergen to merely raising their threshold to guard against accidental exposures. So in those earlier articles, “we would probably write the discussion section differently now,” said Corinne Keet, MD, PhD, first author on the 2011 milk study and an associate professor of pediatrics at Johns Hopkins University, Baltimore.

Indeed, “when you compare [SLIT] to Palforzia or other studies of low-dose OIT (300 mg/d), they look equal in terms of their efficacy,” said senior author Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins. Yet, “I’m afraid we had a major [negative] impact on pharma’s interest in pursuing SLIT.”

Without corporate funding, it’s nearly impossible to conduct the large, multisite trials required for FDA approval of a treatment. And without approved products, many allergists are reluctant to offer the therapy, Dr. Wood said. It “makes your life a lot more complicated to be dabbling in things that are not approved,” he noted.

But at least one company is giving it a go. Applying the SLIT principle of delivering food allergens to tolerance-promoting immune cells in the mouth, New York–based Intrommune Therapeutics recently started enrolling peanut-allergic adults for a phase 1 trial of its experimental toothpaste.

Interest in food-allergy SLIT seems to be growing. “I definitely think that it could be an option for the future,” said Jaclyn Bjelac, MD, associate director of the Food Allergy Center of Excellence at the Cleveland Clinic. “Up until a few months ago, it really wasn’t on our radar.”

On conversations with Dr. Kim, philanthropists and drug developers said they found the recent data on SLIT promising, yet pointed out that food SLIT protocols and products are already in the public domain – they are described in published research using allergen extracts that are on the market. They “can’t see a commercial path forward,” Dr. Kim said in an interview. “And that’s kind of where many of my conversations end.”

Although there are no licensed SLIT products for food allergies, between 2014 and 2017, the FDA approved four sublingual immunotherapy tablets to treat environmental allergies – Stallergenes-Greer’s Oralair and ALK’s Grastek for grass pollens, ALK’s Odactra for dust mites, and ALK’s Ragwitek for short ragweed.

SLIT tablets work as well as allergy shots (subcutaneous immunotherapy) for controlling environmental allergy symptoms, they have a better safety profile, according to AAAAI guidelines, and they can be self-administered at home, which has made them a popular option globally. “Our European colleagues have used sublingual immunotherapy much more frequently than, for example, in the U.S.,” said Kari Nadeau, MD, PhD, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

Use of SLIT is also increasing in the United States, especially as FDA-approved products become available. In a 2019 survey, the percentage of U.S. allergists who said they were offering sublingual treatment for environmental allergies increased from 5.9% in 2007 to 73.5% in 2019. However, only 11.2% reported extensive SLIT use; the remainder reported some (50.5%) or little (38.3%) use.

As noted above, considerably fewer U.S. allergists use SLIT to treat food allergies. Similarly, a 2021 survey of allergists in Canada found that only 7% offered food sublingual immunotherapy; more than half reported offering OIT.

One practice, Allergy Associates of La Crosse (Wis.), has offered SLIT drops for food and environmental allergies for decades. Since the clinic opened in 1970, more than 200,000 people have been treated with its protocol. Every patient receives customized sublingual drops – “exactly what they’re allergic to, exactly how allergic they are, and then we build from there,” said Jeff Kessler, MBA, FACHE, practice executive at Allergy Associates of La Crosse. “Quite frankly, it’s the way immunotherapy should be done.

A version of this article first appeared on Medscape.com. This is part one of a three-part series. Part two is here. Part three is here.

Suicide-risk screening may identify cases that typically fall through the cracks during depression screening, new research suggests.

The study, published in Pediatrics, found that the Ask Suicide-Screening Questions (ASQ) identified 2.2% of additional cases compared with those screened for any type of depression or other mental illnesses, and 8.3% of additional cases compared with those who screened positive for major depressive disorder.

About 3.2% of U.S. children between the ages of 3 and 17 have been diagnosed with depression, according to the Centers for Disease Control and Prevention. The American Academy of Pediatrics and the U.S. Preventive Services Task Force recommends that all teens be routinely screened for depression. However, there’s no specific recommendation that adolescents should also be screened for suicide in addition to depression screening.

The study highlights the high baseline rates of depression and suicide risk and the need for pediatric practices to plan for them and develop strategies about how they’re going to provide follow-up care, including treatment for suicidal teens.

“We began this project because we were concerned that we might be missing teens with increased risk of suicide by screening only for depression,” study author Alex Kemper, MD, said in an interview. “Our goal with this project was really to compare standard depression screening tools that we’ve used for a long time with a suicide-specific instrument just to see if we would identify additional cases with a suicide-risk instrument.”

Dr. Kemper and colleagues collected data from 803 mostly Medicaid-enrolled adolescents across 12 primary care practices. The subjects were between the ages of 12 and 20 years, with no recent history of depression or self-harm, who were screened with the Patient Health Questionnaire–9 Modified for Adolescents (PHQ-9A) and ASQ. For the study, two PHQ-9A screening strategies were evaluated: screening for any type of depression or other mental illness (positive on any item) or screening for major depressive disorder.

In addition, the researchers found that 56.4% of patients had a positive PHQ-9A screen for any type of depression and 24.7% had a positive PHQ-9A screen for major depressive disorder. Meanwhile, 21.1% of the population received a positive screen result. Of those who responded on the PHQ-9A that they did not have suicidal thoughts in the past month, 13.2% had a positive ASQ result.

Dr. Kemper, division chief of primary care pediatrics at Nationwide Children’s Hospital and professor of pediatrics at the Ohio State University, both in Columbus, said the suicide-risk screening questions were more direct and clear than were the two suicide questions included in the PHQ-9A screening.

For example, the PHQ-9A includes the following suicide-risk questions: “Has there been a time in the past month when you have had serious thoughts about ending your life?” and “Have you EVER, in your WHOLE LIFE, tried to kill yourself or made a suicide attempt?” The teen can respond with “not at all,” “several days,” “more than half the days” or “nearly every day.”

Meanwhile, the ASQ questionnaire focuses on a more narrow time period and includes questions such as “In the past few weeks, have you wished you were dead?” and “Have you ever tried to kill yourself?” Teens respond by answering “yes” or “no.”

“So I think the difference is by asking questions that are really direct and very clear about suicide risk, you end up identifying more cases than this kind of general question about thoughts of killing yourself,” Dr. Kemper explained. “It makes sense when you think about where adolescents are in terms of their development, that the more specific you [are], the more likely you are to find what you’re looking for.”

Kelly Curran, MD, who was not involved in the study, said that because some of the ASQ questions “overlap” with the suicide-risk questions on the PHQ-9A, she didn’t expect the ASQ to identify more positive cases.

However, Dr. Curran said it is possible for suicidal teens to fall through the cracks during a depression screening because some of them may not self-identify as depressed.

“I don’t think we often think about the importance of linguistics or how something is asked,” said Dr. Curran, associate professor in the department of pediatrics at the University of Oklahoma, Oklahoma City.

“So asking [teens] these kind of direct questions about suicide may pick up on these cases of people who don’t necessarily have the insight into their sadness or their general kind of thought process.”

Dr. Kemper said he hopes the study would encourage pediatricians to adopt depression screening if they’re not already doing it and to think about whether they should implement suicide-risk screening in their practice. The study also highlights the importance of following up after a positive screening.

“There are a lot of teens who have depression or increased suicide risk that you wouldn’t identify if you didn’t screen, and a key aspect of any kind of screening is that you need to be prepared to provide follow-up care after a positive screening,” he explained.

Study limitations include the fact that the subjects were recruited from a single health care system that serves mostly urban and low-income communities, and that the study was not designed to determine test accuracy.

Dr. Kemper and Dr. Curran indicated that they have no financial disclosures.
 

Suicide-risk screening may identify cases that typically fall through the cracks during depression screening, new research suggests.

The study, published in Pediatrics, found that the Ask Suicide-Screening Questions (ASQ) identified 2.2% of additional cases compared with those screened for any type of depression or other mental illnesses, and 8.3% of additional cases compared with those who screened positive for major depressive disorder.

About 3.2% of U.S. children between the ages of 3 and 17 have been diagnosed with depression, according to the Centers for Disease Control and Prevention. The American Academy of Pediatrics and the U.S. Preventive Services Task Force recommends that all teens be routinely screened for depression. However, there’s no specific recommendation that adolescents should also be screened for suicide in addition to depression screening.

The study highlights the high baseline rates of depression and suicide risk and the need for pediatric practices to plan for them and develop strategies about how they’re going to provide follow-up care, including treatment for suicidal teens.

“We began this project because we were concerned that we might be missing teens with increased risk of suicide by screening only for depression,” study author Alex Kemper, MD, said in an interview. “Our goal with this project was really to compare standard depression screening tools that we’ve used for a long time with a suicide-specific instrument just to see if we would identify additional cases with a suicide-risk instrument.”

Dr. Kemper and colleagues collected data from 803 mostly Medicaid-enrolled adolescents across 12 primary care practices. The subjects were between the ages of 12 and 20 years, with no recent history of depression or self-harm, who were screened with the Patient Health Questionnaire–9 Modified for Adolescents (PHQ-9A) and ASQ. For the study, two PHQ-9A screening strategies were evaluated: screening for any type of depression or other mental illness (positive on any item) or screening for major depressive disorder.

In addition, the researchers found that 56.4% of patients had a positive PHQ-9A screen for any type of depression and 24.7% had a positive PHQ-9A screen for major depressive disorder. Meanwhile, 21.1% of the population received a positive screen result. Of those who responded on the PHQ-9A that they did not have suicidal thoughts in the past month, 13.2% had a positive ASQ result.

Dr. Kemper, division chief of primary care pediatrics at Nationwide Children’s Hospital and professor of pediatrics at the Ohio State University, both in Columbus, said the suicide-risk screening questions were more direct and clear than were the two suicide questions included in the PHQ-9A screening.

For example, the PHQ-9A includes the following suicide-risk questions: “Has there been a time in the past month when you have had serious thoughts about ending your life?” and “Have you EVER, in your WHOLE LIFE, tried to kill yourself or made a suicide attempt?” The teen can respond with “not at all,” “several days,” “more than half the days” or “nearly every day.”

Meanwhile, the ASQ questionnaire focuses on a more narrow time period and includes questions such as “In the past few weeks, have you wished you were dead?” and “Have you ever tried to kill yourself?” Teens respond by answering “yes” or “no.”

“So I think the difference is by asking questions that are really direct and very clear about suicide risk, you end up identifying more cases than this kind of general question about thoughts of killing yourself,” Dr. Kemper explained. “It makes sense when you think about where adolescents are in terms of their development, that the more specific you [are], the more likely you are to find what you’re looking for.”

Kelly Curran, MD, who was not involved in the study, said that because some of the ASQ questions “overlap” with the suicide-risk questions on the PHQ-9A, she didn’t expect the ASQ to identify more positive cases.

However, Dr. Curran said it is possible for suicidal teens to fall through the cracks during a depression screening because some of them may not self-identify as depressed.

“I don’t think we often think about the importance of linguistics or how something is asked,” said Dr. Curran, associate professor in the department of pediatrics at the University of Oklahoma, Oklahoma City.

“So asking [teens] these kind of direct questions about suicide may pick up on these cases of people who don’t necessarily have the insight into their sadness or their general kind of thought process.”

Dr. Kemper said he hopes the study would encourage pediatricians to adopt depression screening if they’re not already doing it and to think about whether they should implement suicide-risk screening in their practice. The study also highlights the importance of following up after a positive screening.

“There are a lot of teens who have depression or increased suicide risk that you wouldn’t identify if you didn’t screen, and a key aspect of any kind of screening is that you need to be prepared to provide follow-up care after a positive screening,” he explained.

Study limitations include the fact that the subjects were recruited from a single health care system that serves mostly urban and low-income communities, and that the study was not designed to determine test accuracy.

Dr. Kemper and Dr. Curran indicated that they have no financial disclosures.
 

Suicide-risk screening may identify cases that typically fall through the cracks during depression screening, new research suggests.

The study, published in Pediatrics, found that the Ask Suicide-Screening Questions (ASQ) identified 2.2% of additional cases compared with those screened for any type of depression or other mental illnesses, and 8.3% of additional cases compared with those who screened positive for major depressive disorder.

About 3.2% of U.S. children between the ages of 3 and 17 have been diagnosed with depression, according to the Centers for Disease Control and Prevention. The American Academy of Pediatrics and the U.S. Preventive Services Task Force recommends that all teens be routinely screened for depression. However, there’s no specific recommendation that adolescents should also be screened for suicide in addition to depression screening.

The study highlights the high baseline rates of depression and suicide risk and the need for pediatric practices to plan for them and develop strategies about how they’re going to provide follow-up care, including treatment for suicidal teens.

“We began this project because we were concerned that we might be missing teens with increased risk of suicide by screening only for depression,” study author Alex Kemper, MD, said in an interview. “Our goal with this project was really to compare standard depression screening tools that we’ve used for a long time with a suicide-specific instrument just to see if we would identify additional cases with a suicide-risk instrument.”

Dr. Kemper and colleagues collected data from 803 mostly Medicaid-enrolled adolescents across 12 primary care practices. The subjects were between the ages of 12 and 20 years, with no recent history of depression or self-harm, who were screened with the Patient Health Questionnaire–9 Modified for Adolescents (PHQ-9A) and ASQ. For the study, two PHQ-9A screening strategies were evaluated: screening for any type of depression or other mental illness (positive on any item) or screening for major depressive disorder.

In addition, the researchers found that 56.4% of patients had a positive PHQ-9A screen for any type of depression and 24.7% had a positive PHQ-9A screen for major depressive disorder. Meanwhile, 21.1% of the population received a positive screen result. Of those who responded on the PHQ-9A that they did not have suicidal thoughts in the past month, 13.2% had a positive ASQ result.

Dr. Kemper, division chief of primary care pediatrics at Nationwide Children’s Hospital and professor of pediatrics at the Ohio State University, both in Columbus, said the suicide-risk screening questions were more direct and clear than were the two suicide questions included in the PHQ-9A screening.

For example, the PHQ-9A includes the following suicide-risk questions: “Has there been a time in the past month when you have had serious thoughts about ending your life?” and “Have you EVER, in your WHOLE LIFE, tried to kill yourself or made a suicide attempt?” The teen can respond with “not at all,” “several days,” “more than half the days” or “nearly every day.”

Meanwhile, the ASQ questionnaire focuses on a more narrow time period and includes questions such as “In the past few weeks, have you wished you were dead?” and “Have you ever tried to kill yourself?” Teens respond by answering “yes” or “no.”

“So I think the difference is by asking questions that are really direct and very clear about suicide risk, you end up identifying more cases than this kind of general question about thoughts of killing yourself,” Dr. Kemper explained. “It makes sense when you think about where adolescents are in terms of their development, that the more specific you [are], the more likely you are to find what you’re looking for.”

Kelly Curran, MD, who was not involved in the study, said that because some of the ASQ questions “overlap” with the suicide-risk questions on the PHQ-9A, she didn’t expect the ASQ to identify more positive cases.

However, Dr. Curran said it is possible for suicidal teens to fall through the cracks during a depression screening because some of them may not self-identify as depressed.

“I don’t think we often think about the importance of linguistics or how something is asked,” said Dr. Curran, associate professor in the department of pediatrics at the University of Oklahoma, Oklahoma City.

“So asking [teens] these kind of direct questions about suicide may pick up on these cases of people who don’t necessarily have the insight into their sadness or their general kind of thought process.”

Dr. Kemper said he hopes the study would encourage pediatricians to adopt depression screening if they’re not already doing it and to think about whether they should implement suicide-risk screening in their practice. The study also highlights the importance of following up after a positive screening.

“There are a lot of teens who have depression or increased suicide risk that you wouldn’t identify if you didn’t screen, and a key aspect of any kind of screening is that you need to be prepared to provide follow-up care after a positive screening,” he explained.

Study limitations include the fact that the subjects were recruited from a single health care system that serves mostly urban and low-income communities, and that the study was not designed to determine test accuracy.

Dr. Kemper and Dr. Curran indicated that they have no financial disclosures.
 

Obesity, atopic dermatitis, psychiatric disease, and arthritis are the most common comorbidities among infants, children, and adolescents with psoriasis, while predictors of moderate to severe disease include morphology, non-White race, and culture-confirmed infection.

Those are among the key findings from a retrospective analysis of pediatric psoriasis patients who were seen at the University of California, San Francisco, over a 24-year period.

“Overall, our data support prior findings of age- and sex-based differences in location and morphology and presents new information demonstrating associations with severity,” presenting study author Carmel Aghdasi said during the annual meeting of the Society for Pediatric Dermatology. “We provide evidence of the increased use of systemic and biologic therapies over time, an important step in ensuring pediatric patients are adequately treated.”

To characterize the demographics, clinical features, comorbidities, and treatments, and to determine predictors of severity and changes in treatment patterns over 2 decades in a large cohort of pediatric psoriasis patients, Ms. Aghdasi, a 4th-year medical student at the University of California, San Francisco, and colleagues retrospectively evaluated the records of 754 pediatric patients up to 18 years of age who were seen at UCSF for psoriasis from 1997 to 2021. They collected demographic, clinical, familial, comorbidity, and treatment data and divided the cohort into two groups by date of last visit.

Group 1 consisted of 332 patients whose last visit was between 2001 and 2011, while the second group included 422 patients whose last visit was between 2012 and 2021. The researchers also divided the cohort into three age groups: infants (0-2 years of age), children (3-12 years of age), and adolescents (13-18 years of age).

Slightly more than half of the patients (55%) were female and 67% presented between ages 3 and 12. (Seventy-four patients were in the youngest category, 0-2 years, when they presented.) The average age of disease onset was 7 years, the average age at presentation to pediatric dermatology was 8.8 years, and 37% of the total cohort were overweight or obese. The top four comorbidities were being overweight or obese (37%), followed by atopic dermatitis (19%), psychiatric disease (7%), and arthritis (4%).

Plaque was the most common morphology (56%), while the most common sites of involvement were the head and neck (69%), extremities (61%), and trunk (44%). About half of the cohort (51%) had mild disease, 15% had culture-confirmed infections (9% had Streptococcal infections), and 66% of patients reported itch as a symptom.

The researchers observed that inverse psoriasis was significantly more common in infants and decreased with age. Anogenital involvement was more common in males and in those aged 0-2, while head and neck involvement was more common in females. Nail involvement was more common in childhood.

Topical therapy was the most common treatment overall and by far the most common among those in the 0-2 age category. “Overall, phototherapy was used in childhood and adolescents but almost never in infancy,” Ms. Aghdasi said. “Looking at changes in systemic treatment over time, conventional systemic use increased in infants and children and decreased in adolescents. Biologic use increased in all ages, most notably in children aged 3-12 years old.”

Multivariate regression analyses revealed that the following independent variables predicted moderate to severe psoriasis: adolescent age (adjusted odds ratio, 1.9; P = .03), guttate morphology (aOR, 2.2; P = .006), plaque and guttate morphology (aOR, 7.6; P less than .001), pustular or erythrodermic morphology (aOR, 5; P = .003), culture-confirmed infection (aOR, 2; P = .007), Black race (aOR, 3.3; P = .007), Asian race (aOR, 1.8; P = .04, and Hispanic race (aOR, 1.9; P = .03).

“Further analysis is needed to elucidate the influence of race on severity and of the clinical utility of infection as a marker of severity,” Ms. Aghdasi said. “Interestingly, we did not find that obesity was a marker of severity in our cohort.”

In an interview, senior study author Kelly M. Cordoro, MD, professor of dermatology and pediatrics at UCSF, noted that this finding conflicts with prior studies showing an association between obesity and severe psoriasis in children.

[email protected]

Obesity, atopic dermatitis, psychiatric disease, and arthritis are the most common comorbidities among infants, children, and adolescents with psoriasis, while predictors of moderate to severe disease include morphology, non-White race, and culture-confirmed infection.

Those are among the key findings from a retrospective analysis of pediatric psoriasis patients who were seen at the University of California, San Francisco, over a 24-year period.

“Overall, our data support prior findings of age- and sex-based differences in location and morphology and presents new information demonstrating associations with severity,” presenting study author Carmel Aghdasi said during the annual meeting of the Society for Pediatric Dermatology. “We provide evidence of the increased use of systemic and biologic therapies over time, an important step in ensuring pediatric patients are adequately treated.”

To characterize the demographics, clinical features, comorbidities, and treatments, and to determine predictors of severity and changes in treatment patterns over 2 decades in a large cohort of pediatric psoriasis patients, Ms. Aghdasi, a 4th-year medical student at the University of California, San Francisco, and colleagues retrospectively evaluated the records of 754 pediatric patients up to 18 years of age who were seen at UCSF for psoriasis from 1997 to 2021. They collected demographic, clinical, familial, comorbidity, and treatment data and divided the cohort into two groups by date of last visit.

Group 1 consisted of 332 patients whose last visit was between 2001 and 2011, while the second group included 422 patients whose last visit was between 2012 and 2021. The researchers also divided the cohort into three age groups: infants (0-2 years of age), children (3-12 years of age), and adolescents (13-18 years of age).

Slightly more than half of the patients (55%) were female and 67% presented between ages 3 and 12. (Seventy-four patients were in the youngest category, 0-2 years, when they presented.) The average age of disease onset was 7 years, the average age at presentation to pediatric dermatology was 8.8 years, and 37% of the total cohort were overweight or obese. The top four comorbidities were being overweight or obese (37%), followed by atopic dermatitis (19%), psychiatric disease (7%), and arthritis (4%).

Plaque was the most common morphology (56%), while the most common sites of involvement were the head and neck (69%), extremities (61%), and trunk (44%). About half of the cohort (51%) had mild disease, 15% had culture-confirmed infections (9% had Streptococcal infections), and 66% of patients reported itch as a symptom.

The researchers observed that inverse psoriasis was significantly more common in infants and decreased with age. Anogenital involvement was more common in males and in those aged 0-2, while head and neck involvement was more common in females. Nail involvement was more common in childhood.

Topical therapy was the most common treatment overall and by far the most common among those in the 0-2 age category. “Overall, phototherapy was used in childhood and adolescents but almost never in infancy,” Ms. Aghdasi said. “Looking at changes in systemic treatment over time, conventional systemic use increased in infants and children and decreased in adolescents. Biologic use increased in all ages, most notably in children aged 3-12 years old.”

Multivariate regression analyses revealed that the following independent variables predicted moderate to severe psoriasis: adolescent age (adjusted odds ratio, 1.9; P = .03), guttate morphology (aOR, 2.2; P = .006), plaque and guttate morphology (aOR, 7.6; P less than .001), pustular or erythrodermic morphology (aOR, 5; P = .003), culture-confirmed infection (aOR, 2; P = .007), Black race (aOR, 3.3; P = .007), Asian race (aOR, 1.8; P = .04, and Hispanic race (aOR, 1.9; P = .03).

“Further analysis is needed to elucidate the influence of race on severity and of the clinical utility of infection as a marker of severity,” Ms. Aghdasi said. “Interestingly, we did not find that obesity was a marker of severity in our cohort.”

In an interview, senior study author Kelly M. Cordoro, MD, professor of dermatology and pediatrics at UCSF, noted that this finding conflicts with prior studies showing an association between obesity and severe psoriasis in children.

[email protected]

Obesity, atopic dermatitis, psychiatric disease, and arthritis are the most common comorbidities among infants, children, and adolescents with psoriasis, while predictors of moderate to severe disease include morphology, non-White race, and culture-confirmed infection.

Those are among the key findings from a retrospective analysis of pediatric psoriasis patients who were seen at the University of California, San Francisco, over a 24-year period.

“Overall, our data support prior findings of age- and sex-based differences in location and morphology and presents new information demonstrating associations with severity,” presenting study author Carmel Aghdasi said during the annual meeting of the Society for Pediatric Dermatology. “We provide evidence of the increased use of systemic and biologic therapies over time, an important step in ensuring pediatric patients are adequately treated.”

To characterize the demographics, clinical features, comorbidities, and treatments, and to determine predictors of severity and changes in treatment patterns over 2 decades in a large cohort of pediatric psoriasis patients, Ms. Aghdasi, a 4th-year medical student at the University of California, San Francisco, and colleagues retrospectively evaluated the records of 754 pediatric patients up to 18 years of age who were seen at UCSF for psoriasis from 1997 to 2021. They collected demographic, clinical, familial, comorbidity, and treatment data and divided the cohort into two groups by date of last visit.

Group 1 consisted of 332 patients whose last visit was between 2001 and 2011, while the second group included 422 patients whose last visit was between 2012 and 2021. The researchers also divided the cohort into three age groups: infants (0-2 years of age), children (3-12 years of age), and adolescents (13-18 years of age).

Slightly more than half of the patients (55%) were female and 67% presented between ages 3 and 12. (Seventy-four patients were in the youngest category, 0-2 years, when they presented.) The average age of disease onset was 7 years, the average age at presentation to pediatric dermatology was 8.8 years, and 37% of the total cohort were overweight or obese. The top four comorbidities were being overweight or obese (37%), followed by atopic dermatitis (19%), psychiatric disease (7%), and arthritis (4%).

Plaque was the most common morphology (56%), while the most common sites of involvement were the head and neck (69%), extremities (61%), and trunk (44%). About half of the cohort (51%) had mild disease, 15% had culture-confirmed infections (9% had Streptococcal infections), and 66% of patients reported itch as a symptom.

The researchers observed that inverse psoriasis was significantly more common in infants and decreased with age. Anogenital involvement was more common in males and in those aged 0-2, while head and neck involvement was more common in females. Nail involvement was more common in childhood.

Topical therapy was the most common treatment overall and by far the most common among those in the 0-2 age category. “Overall, phototherapy was used in childhood and adolescents but almost never in infancy,” Ms. Aghdasi said. “Looking at changes in systemic treatment over time, conventional systemic use increased in infants and children and decreased in adolescents. Biologic use increased in all ages, most notably in children aged 3-12 years old.”

Multivariate regression analyses revealed that the following independent variables predicted moderate to severe psoriasis: adolescent age (adjusted odds ratio, 1.9; P = .03), guttate morphology (aOR, 2.2; P = .006), plaque and guttate morphology (aOR, 7.6; P less than .001), pustular or erythrodermic morphology (aOR, 5; P = .003), culture-confirmed infection (aOR, 2; P = .007), Black race (aOR, 3.3; P = .007), Asian race (aOR, 1.8; P = .04, and Hispanic race (aOR, 1.9; P = .03).

“Further analysis is needed to elucidate the influence of race on severity and of the clinical utility of infection as a marker of severity,” Ms. Aghdasi said. “Interestingly, we did not find that obesity was a marker of severity in our cohort.”

In an interview, senior study author Kelly M. Cordoro, MD, professor of dermatology and pediatrics at UCSF, noted that this finding conflicts with prior studies showing an association between obesity and severe psoriasis in children.

[email protected]

Most of us are familiar with the good news: In recent weeks, rates of COVID-19 infection and death have plummeted in California, falling to levels not seen since the early days of the pandemic. The average number of new COVID infections reported each day dropped by an astounding 98% from December to June, according to figures from the California Department of Public Health.

And bolstering that trend, nearly 70% of Californians 12 and older are partially or fully vaccinated.

But state health officials are still reporting nearly 1,000 new COVID cases and more than 2 dozen COVID-related deaths per day. So, where does COVID continue to simmer in California? And why?

An analysis of state data shows some clear patterns at this stage of the pandemic: As vaccination rates rose across the state, the overall numbers of cases and deaths plunged. But within that broader trend are pronounced regional discrepancies. Counties with relatively low rates of vaccination reported much higher rates of COVID infections and deaths in May and June than counties with high vaccination rates.

There were about 182 new COVID infections per 100,000 residents from May 1 to June 18 in California counties where fewer than half of residents age 12 and older had received at least one vaccine dose, CDPH data show. By comparison, there were about 102 COVID infections per 100,000 residents in counties where more than two-thirds of residents 12 and up had gotten at least one dose.

“If you live in an area that has low vaccination rates and you have a few people who start to develop a disease, it’s going to spread quickly among those who aren’t vaccinated,” said Rita Burke, PhD, assistant professor of clinical preventive medicine at the University of Southern California, Los Angeles. Dr. Burke noted that the highly contagious Delta variant of the coronavirus now circulating in California amplifies the threat of serious outbreaks in areas with low vaccination rates.

The regional discrepancies in COVID-related deaths are also striking. There were about 3.2 COVID-related deaths per 100,000 residents from May 1 to June 18 in counties where first-dose vaccination rates were below 50%. That is almost twice as high as the death rate in counties where more than two-thirds of residents had at least one dose.

While the pattern is clear, there are exceptions. A couple of sparsely populated mountain counties with low vaccination rates – Trinity and Mariposa – also had relatively low rates of new infections in May and June. Likewise, a few suburban counties with high vaccination rates – among them Sonoma and Contra Costa – had relatively high rates of new infections.

“There are three things that are going on,” said George Rutherford, MD, a professor of epidemiology and biostatistics at the University of California, San Francisco. “One is the vaccine – very important, but not the whole story. One is naturally acquired immunity, which is huge in some places.” A third, he said, is people still managing to evade infection, whether by taking precautions or simply by living in areas with few infections.

As of June 18, about 67% of Californians age 12 and older had received at least one dose of COVID vaccine, according to the state health department. But that masks a wide variance among the state’s 58 counties. In 14 counties, for example, fewer than half of residents 12 and older had received a shot. In 19 counties, more than two-thirds had.

The counties with low vaccination rates are largely rugged and rural. Nearly all are politically conservative. In January, about 6% of the state’s COVID infections were in the 23 counties where a majority of voters cast ballots for President Donald Trump in November. By May and June, that figure had risen to 11%.

While surveys indicate politics plays a role in vaccine hesitancy in many communities, access also remains an issue in many of California’s rural outposts. It can be hard, or at least inconvenient, for people who live far from the nearest medical facility to get two shots a month apart.

“If you have to drive 30 minutes out to the nearest vaccination site, you may not be as inclined to do that versus if it’s 5 minutes from your house,” Dr. Burke said. “And so we, the public health community, recognize that and have really made a concerted effort in order to eliminate or alleviate that access issue.”

Many of the counties with low vaccination rates had relatively low infection rates in the early months of the pandemic, largely thanks to their remoteness. But, as COVID reaches those communities, that lack of prior exposure and acquired immunity magnifies their vulnerability, Dr. Rutherford said. “We’re going to see cases where people are unvaccinated or where there’s not been a big background level of immunity already.”

As it becomes clearer that new infections will be disproportionately concentrated in areas with low vaccination rates, state officials are working to persuade hesitant Californians to get a vaccine, even introducing a vaccine lottery.

But most persuasive are friends and family members who can help counter the disinformation rampant in some communities, said Lorena Garcia, DrPH, an associate professor of epidemiology at the University of California, Davis. Belittling people for their hesitancy or getting into a political argument likely won’t work.

When talking to her own skeptical relatives, Dr. Garcia avoided politics: “I just explained any questions that they had.”

“Vaccines are a good part of our life,” she said. “It’s something that we’ve done since we were babies. So, it’s just something we’re going to do again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Most of us are familiar with the good news: In recent weeks, rates of COVID-19 infection and death have plummeted in California, falling to levels not seen since the early days of the pandemic. The average number of new COVID infections reported each day dropped by an astounding 98% from December to June, according to figures from the California Department of Public Health.

And bolstering that trend, nearly 70% of Californians 12 and older are partially or fully vaccinated.

But state health officials are still reporting nearly 1,000 new COVID cases and more than 2 dozen COVID-related deaths per day. So, where does COVID continue to simmer in California? And why?

An analysis of state data shows some clear patterns at this stage of the pandemic: As vaccination rates rose across the state, the overall numbers of cases and deaths plunged. But within that broader trend are pronounced regional discrepancies. Counties with relatively low rates of vaccination reported much higher rates of COVID infections and deaths in May and June than counties with high vaccination rates.

There were about 182 new COVID infections per 100,000 residents from May 1 to June 18 in California counties where fewer than half of residents age 12 and older had received at least one vaccine dose, CDPH data show. By comparison, there were about 102 COVID infections per 100,000 residents in counties where more than two-thirds of residents 12 and up had gotten at least one dose.

“If you live in an area that has low vaccination rates and you have a few people who start to develop a disease, it’s going to spread quickly among those who aren’t vaccinated,” said Rita Burke, PhD, assistant professor of clinical preventive medicine at the University of Southern California, Los Angeles. Dr. Burke noted that the highly contagious Delta variant of the coronavirus now circulating in California amplifies the threat of serious outbreaks in areas with low vaccination rates.

The regional discrepancies in COVID-related deaths are also striking. There were about 3.2 COVID-related deaths per 100,000 residents from May 1 to June 18 in counties where first-dose vaccination rates were below 50%. That is almost twice as high as the death rate in counties where more than two-thirds of residents had at least one dose.

While the pattern is clear, there are exceptions. A couple of sparsely populated mountain counties with low vaccination rates – Trinity and Mariposa – also had relatively low rates of new infections in May and June. Likewise, a few suburban counties with high vaccination rates – among them Sonoma and Contra Costa – had relatively high rates of new infections.

“There are three things that are going on,” said George Rutherford, MD, a professor of epidemiology and biostatistics at the University of California, San Francisco. “One is the vaccine – very important, but not the whole story. One is naturally acquired immunity, which is huge in some places.” A third, he said, is people still managing to evade infection, whether by taking precautions or simply by living in areas with few infections.

As of June 18, about 67% of Californians age 12 and older had received at least one dose of COVID vaccine, according to the state health department. But that masks a wide variance among the state’s 58 counties. In 14 counties, for example, fewer than half of residents 12 and older had received a shot. In 19 counties, more than two-thirds had.

The counties with low vaccination rates are largely rugged and rural. Nearly all are politically conservative. In January, about 6% of the state’s COVID infections were in the 23 counties where a majority of voters cast ballots for President Donald Trump in November. By May and June, that figure had risen to 11%.

While surveys indicate politics plays a role in vaccine hesitancy in many communities, access also remains an issue in many of California’s rural outposts. It can be hard, or at least inconvenient, for people who live far from the nearest medical facility to get two shots a month apart.

“If you have to drive 30 minutes out to the nearest vaccination site, you may not be as inclined to do that versus if it’s 5 minutes from your house,” Dr. Burke said. “And so we, the public health community, recognize that and have really made a concerted effort in order to eliminate or alleviate that access issue.”

Many of the counties with low vaccination rates had relatively low infection rates in the early months of the pandemic, largely thanks to their remoteness. But, as COVID reaches those communities, that lack of prior exposure and acquired immunity magnifies their vulnerability, Dr. Rutherford said. “We’re going to see cases where people are unvaccinated or where there’s not been a big background level of immunity already.”

As it becomes clearer that new infections will be disproportionately concentrated in areas with low vaccination rates, state officials are working to persuade hesitant Californians to get a vaccine, even introducing a vaccine lottery.

But most persuasive are friends and family members who can help counter the disinformation rampant in some communities, said Lorena Garcia, DrPH, an associate professor of epidemiology at the University of California, Davis. Belittling people for their hesitancy or getting into a political argument likely won’t work.

When talking to her own skeptical relatives, Dr. Garcia avoided politics: “I just explained any questions that they had.”

“Vaccines are a good part of our life,” she said. “It’s something that we’ve done since we were babies. So, it’s just something we’re going to do again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Most of us are familiar with the good news: In recent weeks, rates of COVID-19 infection and death have plummeted in California, falling to levels not seen since the early days of the pandemic. The average number of new COVID infections reported each day dropped by an astounding 98% from December to June, according to figures from the California Department of Public Health.

And bolstering that trend, nearly 70% of Californians 12 and older are partially or fully vaccinated.

But state health officials are still reporting nearly 1,000 new COVID cases and more than 2 dozen COVID-related deaths per day. So, where does COVID continue to simmer in California? And why?

An analysis of state data shows some clear patterns at this stage of the pandemic: As vaccination rates rose across the state, the overall numbers of cases and deaths plunged. But within that broader trend are pronounced regional discrepancies. Counties with relatively low rates of vaccination reported much higher rates of COVID infections and deaths in May and June than counties with high vaccination rates.

There were about 182 new COVID infections per 100,000 residents from May 1 to June 18 in California counties where fewer than half of residents age 12 and older had received at least one vaccine dose, CDPH data show. By comparison, there were about 102 COVID infections per 100,000 residents in counties where more than two-thirds of residents 12 and up had gotten at least one dose.

“If you live in an area that has low vaccination rates and you have a few people who start to develop a disease, it’s going to spread quickly among those who aren’t vaccinated,” said Rita Burke, PhD, assistant professor of clinical preventive medicine at the University of Southern California, Los Angeles. Dr. Burke noted that the highly contagious Delta variant of the coronavirus now circulating in California amplifies the threat of serious outbreaks in areas with low vaccination rates.

The regional discrepancies in COVID-related deaths are also striking. There were about 3.2 COVID-related deaths per 100,000 residents from May 1 to June 18 in counties where first-dose vaccination rates were below 50%. That is almost twice as high as the death rate in counties where more than two-thirds of residents had at least one dose.

While the pattern is clear, there are exceptions. A couple of sparsely populated mountain counties with low vaccination rates – Trinity and Mariposa – also had relatively low rates of new infections in May and June. Likewise, a few suburban counties with high vaccination rates – among them Sonoma and Contra Costa – had relatively high rates of new infections.

“There are three things that are going on,” said George Rutherford, MD, a professor of epidemiology and biostatistics at the University of California, San Francisco. “One is the vaccine – very important, but not the whole story. One is naturally acquired immunity, which is huge in some places.” A third, he said, is people still managing to evade infection, whether by taking precautions or simply by living in areas with few infections.

As of June 18, about 67% of Californians age 12 and older had received at least one dose of COVID vaccine, according to the state health department. But that masks a wide variance among the state’s 58 counties. In 14 counties, for example, fewer than half of residents 12 and older had received a shot. In 19 counties, more than two-thirds had.

The counties with low vaccination rates are largely rugged and rural. Nearly all are politically conservative. In January, about 6% of the state’s COVID infections were in the 23 counties where a majority of voters cast ballots for President Donald Trump in November. By May and June, that figure had risen to 11%.

While surveys indicate politics plays a role in vaccine hesitancy in many communities, access also remains an issue in many of California’s rural outposts. It can be hard, or at least inconvenient, for people who live far from the nearest medical facility to get two shots a month apart.

“If you have to drive 30 minutes out to the nearest vaccination site, you may not be as inclined to do that versus if it’s 5 minutes from your house,” Dr. Burke said. “And so we, the public health community, recognize that and have really made a concerted effort in order to eliminate or alleviate that access issue.”

Many of the counties with low vaccination rates had relatively low infection rates in the early months of the pandemic, largely thanks to their remoteness. But, as COVID reaches those communities, that lack of prior exposure and acquired immunity magnifies their vulnerability, Dr. Rutherford said. “We’re going to see cases where people are unvaccinated or where there’s not been a big background level of immunity already.”

As it becomes clearer that new infections will be disproportionately concentrated in areas with low vaccination rates, state officials are working to persuade hesitant Californians to get a vaccine, even introducing a vaccine lottery.

But most persuasive are friends and family members who can help counter the disinformation rampant in some communities, said Lorena Garcia, DrPH, an associate professor of epidemiology at the University of California, Davis. Belittling people for their hesitancy or getting into a political argument likely won’t work.

When talking to her own skeptical relatives, Dr. Garcia avoided politics: “I just explained any questions that they had.”

“Vaccines are a good part of our life,” she said. “It’s something that we’ve done since we were babies. So, it’s just something we’re going to do again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Insert clove A into nostril B

Just when you start wondering what crazy and potentially dangerous thing people can do to themselves next, comes a crazy and potentially dangerous new trend. The good folks at TikTok have provided patients a new treatment for stuffed up sinuses.

Dangerous? Well, that’s what doctors say, anyway.

“We typically do not recommend putting anything into the nostril for the obvious fact that it could get dislodged or lodged up into the nasal cavity,” Anthony Del Signore, MD, of Mount Sinai Union Square, New York, told TODAY.

“Not only does it have the potential to rot or cause a nasal obstruction, it can induce an episode of sinusitis,” Omid Mehdizadeh, MD, of Providence Saint John’s Health Center, Santa Monica, Calif., explained to Shape.

But who doesn't want to breathe easier and keep blood-sucking vampires at bay?

Max Pixel

Seeing faces in random places?

Ever look up at the clouds, at a fast-moving train, or into your morning bowl of cereal and see two eyes, a nose, and a mouth looking back at you? You may shake it off and think you’re imagining something, but it's actually your brain doing what it’s built to do and researchers know why.

The phenomenon is called face pareidolia, and it’s technically an error function of the human brain. Evolution has molded our brains to rapidly identify faces, according to David Alais, PhD, of the University of Sydney, Australia, lead author of the study.

“But the system plays ‘fast and loose’ by applying a crude template of two eyes over a nose and mouth. Lots of things can satisfy that template and thus trigger a face detection response,” he said in a separate statement. But not only are we seeing faces, our brains go one step further and seemingly give those faces feelings.

University of Sydney

Corporate dream manipulation

Advertisements are quite literally everywhere. On billboards, in commercials, in videos, in movies; the list goes on and on. Still, at least you can shut your eyes and be mercifully free of corporate interference inside your own head, right? Right?

Early in 2021, Coors launched an ad campaign that seemed to be a b bit of a gimmick, if not a joke. Coors claimed that if people watched an ad before bed, and played an 8-hour soundscape while sleeping, their dreams would be filled with crisp mountains and cold, thirst-quenching beverages. While, the Coors campaign didn’t go viral, someone was paying attention. A group of 35 leading researchers published an open letter on the subject of corporate dream manipulation, in the journal Dream Engineering.

"Multiple marketing studies are openly testing new ways to alter and motivate purchasing behavior through dream and sleep hacking. The commercial, for-profit use of dream incubation is rapidly becoming a reality," wrote the investigators. "As sleep and dream researchers, we are deeply concerned about marketing plans aimed at generating profits at the cost of interfering with our natural nocturnal memory processing."

People have tried to manipulate their dreams for countless years, but only in recent years have scientists attempted to target or manipulate behavior through dreams. In a 2014 study, smokers exposed to tobacco smoke and rotten egg smell while sleeping reduced their cigarette consumption by 30%.

Free-Photos/Pixabay

Got breast milk?

As we know, breast milk has endless benefits for newbords and babies, but many things can stand in the way of a mother’s ability to breastfeed. Baby formula has served as a good enough substitute. But now, there might be something that’s even better.

A start-up company called BIOMILQ created a product that could be groundbreaking. Using “breakthrough mammary biotechnology,” BIOMILQ created cell-cultured breast milk.

Focus_on_Nature/Getty Images

Insert clove A into nostril B

Just when you start wondering what crazy and potentially dangerous thing people can do to themselves next, comes a crazy and potentially dangerous new trend. The good folks at TikTok have provided patients a new treatment for stuffed up sinuses.

Dangerous? Well, that’s what doctors say, anyway.

“We typically do not recommend putting anything into the nostril for the obvious fact that it could get dislodged or lodged up into the nasal cavity,” Anthony Del Signore, MD, of Mount Sinai Union Square, New York, told TODAY.

“Not only does it have the potential to rot or cause a nasal obstruction, it can induce an episode of sinusitis,” Omid Mehdizadeh, MD, of Providence Saint John’s Health Center, Santa Monica, Calif., explained to Shape.

But who doesn't want to breathe easier and keep blood-sucking vampires at bay?

Max Pixel

Seeing faces in random places?

Ever look up at the clouds, at a fast-moving train, or into your morning bowl of cereal and see two eyes, a nose, and a mouth looking back at you? You may shake it off and think you’re imagining something, but it's actually your brain doing what it’s built to do and researchers know why.

The phenomenon is called face pareidolia, and it’s technically an error function of the human brain. Evolution has molded our brains to rapidly identify faces, according to David Alais, PhD, of the University of Sydney, Australia, lead author of the study.

“But the system plays ‘fast and loose’ by applying a crude template of two eyes over a nose and mouth. Lots of things can satisfy that template and thus trigger a face detection response,” he said in a separate statement. But not only are we seeing faces, our brains go one step further and seemingly give those faces feelings.

University of Sydney

Corporate dream manipulation

Advertisements are quite literally everywhere. On billboards, in commercials, in videos, in movies; the list goes on and on. Still, at least you can shut your eyes and be mercifully free of corporate interference inside your own head, right? Right?

Early in 2021, Coors launched an ad campaign that seemed to be a b bit of a gimmick, if not a joke. Coors claimed that if people watched an ad before bed, and played an 8-hour soundscape while sleeping, their dreams would be filled with crisp mountains and cold, thirst-quenching beverages. While, the Coors campaign didn’t go viral, someone was paying attention. A group of 35 leading researchers published an open letter on the subject of corporate dream manipulation, in the journal Dream Engineering.

"Multiple marketing studies are openly testing new ways to alter and motivate purchasing behavior through dream and sleep hacking. The commercial, for-profit use of dream incubation is rapidly becoming a reality," wrote the investigators. "As sleep and dream researchers, we are deeply concerned about marketing plans aimed at generating profits at the cost of interfering with our natural nocturnal memory processing."

People have tried to manipulate their dreams for countless years, but only in recent years have scientists attempted to target or manipulate behavior through dreams. In a 2014 study, smokers exposed to tobacco smoke and rotten egg smell while sleeping reduced their cigarette consumption by 30%.

Free-Photos/Pixabay

Got breast milk?

As we know, breast milk has endless benefits for newbords and babies, but many things can stand in the way of a mother’s ability to breastfeed. Baby formula has served as a good enough substitute. But now, there might be something that’s even better.

A start-up company called BIOMILQ created a product that could be groundbreaking. Using “breakthrough mammary biotechnology,” BIOMILQ created cell-cultured breast milk.

Focus_on_Nature/Getty Images

Insert clove A into nostril B

Just when you start wondering what crazy and potentially dangerous thing people can do to themselves next, comes a crazy and potentially dangerous new trend. The good folks at TikTok have provided patients a new treatment for stuffed up sinuses.

Dangerous? Well, that’s what doctors say, anyway.

“We typically do not recommend putting anything into the nostril for the obvious fact that it could get dislodged or lodged up into the nasal cavity,” Anthony Del Signore, MD, of Mount Sinai Union Square, New York, told TODAY.

“Not only does it have the potential to rot or cause a nasal obstruction, it can induce an episode of sinusitis,” Omid Mehdizadeh, MD, of Providence Saint John’s Health Center, Santa Monica, Calif., explained to Shape.

But who doesn't want to breathe easier and keep blood-sucking vampires at bay?

Max Pixel

Seeing faces in random places?

Ever look up at the clouds, at a fast-moving train, or into your morning bowl of cereal and see two eyes, a nose, and a mouth looking back at you? You may shake it off and think you’re imagining something, but it's actually your brain doing what it’s built to do and researchers know why.

The phenomenon is called face pareidolia, and it’s technically an error function of the human brain. Evolution has molded our brains to rapidly identify faces, according to David Alais, PhD, of the University of Sydney, Australia, lead author of the study.

“But the system plays ‘fast and loose’ by applying a crude template of two eyes over a nose and mouth. Lots of things can satisfy that template and thus trigger a face detection response,” he said in a separate statement. But not only are we seeing faces, our brains go one step further and seemingly give those faces feelings.

University of Sydney

Corporate dream manipulation

Advertisements are quite literally everywhere. On billboards, in commercials, in videos, in movies; the list goes on and on. Still, at least you can shut your eyes and be mercifully free of corporate interference inside your own head, right? Right?

Early in 2021, Coors launched an ad campaign that seemed to be a b bit of a gimmick, if not a joke. Coors claimed that if people watched an ad before bed, and played an 8-hour soundscape while sleeping, their dreams would be filled with crisp mountains and cold, thirst-quenching beverages. While, the Coors campaign didn’t go viral, someone was paying attention. A group of 35 leading researchers published an open letter on the subject of corporate dream manipulation, in the journal Dream Engineering.

"Multiple marketing studies are openly testing new ways to alter and motivate purchasing behavior through dream and sleep hacking. The commercial, for-profit use of dream incubation is rapidly becoming a reality," wrote the investigators. "As sleep and dream researchers, we are deeply concerned about marketing plans aimed at generating profits at the cost of interfering with our natural nocturnal memory processing."

People have tried to manipulate their dreams for countless years, but only in recent years have scientists attempted to target or manipulate behavior through dreams. In a 2014 study, smokers exposed to tobacco smoke and rotten egg smell while sleeping reduced their cigarette consumption by 30%.

Free-Photos/Pixabay

Got breast milk?

As we know, breast milk has endless benefits for newbords and babies, but many things can stand in the way of a mother’s ability to breastfeed. Baby formula has served as a good enough substitute. But now, there might be something that’s even better.

A start-up company called BIOMILQ created a product that could be groundbreaking. Using “breakthrough mammary biotechnology,” BIOMILQ created cell-cultured breast milk.

Focus_on_Nature/Getty Images

Children conceived with assisted reproductive techniques (ART) do not appear to be more likely to have attention-deficit/hyperactivity disorder or poor school performance, compared with children conceived spontaneously, according to a study published in Pediatrics.

The findings, based on an analysis of data from more than 1.5 million children in Sweden, provide “additional reassurance concerning offspring neurodevelopment after use of ART,” study author Chen Wang, MPH, and colleagues said. The results show the importance of accounting for underlying infertility when studying ART safety, they added. Mr. Wang is a researcher in the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

Prior research has not shown major differences during early childhood between children conceived with ART and those conceived spontaneously. To examine long-term neurodevelopmental outcomes, including ADHD and school performance, the investigators analyzed data in Swedish population registers from children born between 1986 and 2012.

Infertility and the use of ART became increasingly common during the study period, the researchers noted. Between 1986 and 2001, 7% of births were to couples with known infertility, and 13% of these births were achieved with ART. Between 1996 and 2012, 11% of births were to couples with infertility, and 26% of these births were achieved with ART.

“Couples with infertility were more likely older and married or cohabiting, compared with couples with no known infertility,” Mr. Wang and colleagues reported. “Among infertile couples, those that conceived with ART had, on average, higher age and education, and the women were less likely to smoke.”

The investigators estimated that the cumulative incidence of ADHD by age 15 years was 6.2% in children conceived with ART, 7.3% among children of couples with infertility who did not use ART, and 7.1% in children born to couples with no known infertility.

Overall, children conceived with ART were at lower risk of ADHD (hazard ratio, 0.83). But after adjusting for parental characteristics and health factors, the researchers found a “slightly elevated risk of ADHD with ART,” with adjusted HRs of 1.05-1.07.

When the researchers focused on children born to couples with infertility, ART was associated with a lower risk of ADHD (adjusted HR, 0.80), compared with spontaneous conception. Accounting for parental characteristics and health history, however, “attenuated the association toward the null,” the researchers reported.

The researchers also compared ART methods, including intracytoplasmic sperm injection versus standard in vitro fertilization (IVF), and fresh embryo transfer versus frozen embryo transfer. The various procedures were not associated with substantially different risks.

Patterns for school performance were generally similar to those for ADHD.

“In this large follow-up of nationwide birth cohorts, we observed lower risk of ADHD and slightly better overall school performance in children conceived with ART, compared with all other children. Differences in parental characteristics appeared to completely explain and even slightly reverse the associations,” the study authors said. “When the comparison was restricted to children of couples with known infertility, no differences were seen.”

The study was well designed and “spans more than 25 years of ART during which treatments have changed dramatically,” commented Barbara Luke, ScD, MPH, professor of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

Dr. Luke and colleagues have studied academic achievement in children conceived with IVF in Texas. The results of the Swedish study “are in line with U.S. studies, and are generally reassuring,” Dr. Luke said.

The U.S. studies also showed that parental factors may play a role in understanding academic performance.

“In our studies of third-grade and sixth-grade academic outcomes, we found differences by racial/Hispanic origin groups, gender, and maternal age,” she said.

The study by Mr. Wang and coauthors was funded by grants from a Swedish government agency and the National Institutes of Health. The researchers and Dr. Luke had no relevant financial disclosures.

[email protected]

Children conceived with assisted reproductive techniques (ART) do not appear to be more likely to have attention-deficit/hyperactivity disorder or poor school performance, compared with children conceived spontaneously, according to a study published in Pediatrics.

The findings, based on an analysis of data from more than 1.5 million children in Sweden, provide “additional reassurance concerning offspring neurodevelopment after use of ART,” study author Chen Wang, MPH, and colleagues said. The results show the importance of accounting for underlying infertility when studying ART safety, they added. Mr. Wang is a researcher in the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

Prior research has not shown major differences during early childhood between children conceived with ART and those conceived spontaneously. To examine long-term neurodevelopmental outcomes, including ADHD and school performance, the investigators analyzed data in Swedish population registers from children born between 1986 and 2012.

Infertility and the use of ART became increasingly common during the study period, the researchers noted. Between 1986 and 2001, 7% of births were to couples with known infertility, and 13% of these births were achieved with ART. Between 1996 and 2012, 11% of births were to couples with infertility, and 26% of these births were achieved with ART.

“Couples with infertility were more likely older and married or cohabiting, compared with couples with no known infertility,” Mr. Wang and colleagues reported. “Among infertile couples, those that conceived with ART had, on average, higher age and education, and the women were less likely to smoke.”

The investigators estimated that the cumulative incidence of ADHD by age 15 years was 6.2% in children conceived with ART, 7.3% among children of couples with infertility who did not use ART, and 7.1% in children born to couples with no known infertility.

Overall, children conceived with ART were at lower risk of ADHD (hazard ratio, 0.83). But after adjusting for parental characteristics and health factors, the researchers found a “slightly elevated risk of ADHD with ART,” with adjusted HRs of 1.05-1.07.

When the researchers focused on children born to couples with infertility, ART was associated with a lower risk of ADHD (adjusted HR, 0.80), compared with spontaneous conception. Accounting for parental characteristics and health history, however, “attenuated the association toward the null,” the researchers reported.

The researchers also compared ART methods, including intracytoplasmic sperm injection versus standard in vitro fertilization (IVF), and fresh embryo transfer versus frozen embryo transfer. The various procedures were not associated with substantially different risks.

Patterns for school performance were generally similar to those for ADHD.

“In this large follow-up of nationwide birth cohorts, we observed lower risk of ADHD and slightly better overall school performance in children conceived with ART, compared with all other children. Differences in parental characteristics appeared to completely explain and even slightly reverse the associations,” the study authors said. “When the comparison was restricted to children of couples with known infertility, no differences were seen.”

The study was well designed and “spans more than 25 years of ART during which treatments have changed dramatically,” commented Barbara Luke, ScD, MPH, professor of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

Dr. Luke and colleagues have studied academic achievement in children conceived with IVF in Texas. The results of the Swedish study “are in line with U.S. studies, and are generally reassuring,” Dr. Luke said.

The U.S. studies also showed that parental factors may play a role in understanding academic performance.

“In our studies of third-grade and sixth-grade academic outcomes, we found differences by racial/Hispanic origin groups, gender, and maternal age,” she said.

The study by Mr. Wang and coauthors was funded by grants from a Swedish government agency and the National Institutes of Health. The researchers and Dr. Luke had no relevant financial disclosures.

[email protected]

Children conceived with assisted reproductive techniques (ART) do not appear to be more likely to have attention-deficit/hyperactivity disorder or poor school performance, compared with children conceived spontaneously, according to a study published in Pediatrics.

The findings, based on an analysis of data from more than 1.5 million children in Sweden, provide “additional reassurance concerning offspring neurodevelopment after use of ART,” study author Chen Wang, MPH, and colleagues said. The results show the importance of accounting for underlying infertility when studying ART safety, they added. Mr. Wang is a researcher in the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

Prior research has not shown major differences during early childhood between children conceived with ART and those conceived spontaneously. To examine long-term neurodevelopmental outcomes, including ADHD and school performance, the investigators analyzed data in Swedish population registers from children born between 1986 and 2012.

Infertility and the use of ART became increasingly common during the study period, the researchers noted. Between 1986 and 2001, 7% of births were to couples with known infertility, and 13% of these births were achieved with ART. Between 1996 and 2012, 11% of births were to couples with infertility, and 26% of these births were achieved with ART.

“Couples with infertility were more likely older and married or cohabiting, compared with couples with no known infertility,” Mr. Wang and colleagues reported. “Among infertile couples, those that conceived with ART had, on average, higher age and education, and the women were less likely to smoke.”

The investigators estimated that the cumulative incidence of ADHD by age 15 years was 6.2% in children conceived with ART, 7.3% among children of couples with infertility who did not use ART, and 7.1% in children born to couples with no known infertility.

Overall, children conceived with ART were at lower risk of ADHD (hazard ratio, 0.83). But after adjusting for parental characteristics and health factors, the researchers found a “slightly elevated risk of ADHD with ART,” with adjusted HRs of 1.05-1.07.

When the researchers focused on children born to couples with infertility, ART was associated with a lower risk of ADHD (adjusted HR, 0.80), compared with spontaneous conception. Accounting for parental characteristics and health history, however, “attenuated the association toward the null,” the researchers reported.

The researchers also compared ART methods, including intracytoplasmic sperm injection versus standard in vitro fertilization (IVF), and fresh embryo transfer versus frozen embryo transfer. The various procedures were not associated with substantially different risks.

Patterns for school performance were generally similar to those for ADHD.

“In this large follow-up of nationwide birth cohorts, we observed lower risk of ADHD and slightly better overall school performance in children conceived with ART, compared with all other children. Differences in parental characteristics appeared to completely explain and even slightly reverse the associations,” the study authors said. “When the comparison was restricted to children of couples with known infertility, no differences were seen.”

The study was well designed and “spans more than 25 years of ART during which treatments have changed dramatically,” commented Barbara Luke, ScD, MPH, professor of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

Dr. Luke and colleagues have studied academic achievement in children conceived with IVF in Texas. The results of the Swedish study “are in line with U.S. studies, and are generally reassuring,” Dr. Luke said.

The U.S. studies also showed that parental factors may play a role in understanding academic performance.

“In our studies of third-grade and sixth-grade academic outcomes, we found differences by racial/Hispanic origin groups, gender, and maternal age,” she said.

The study by Mr. Wang and coauthors was funded by grants from a Swedish government agency and the National Institutes of Health. The researchers and Dr. Luke had no relevant financial disclosures.

[email protected]