While glecaprevir/pibrentasvir (GLE/PIB) treatment is proven safe and effective in adults and adolescents with chronic 

 (HCV) infections, the data is fairly limited in children.

A team, led by Maureen M. Jonas, Division of Gastroenterology, Hepatology, and Nutrition, Boston Children’s Hospital, Department of Pediatrics, Harvard Medical School, evaluated the pharmacokinetics, efficacy, and safety of a pediatric formulation of glecaprevir and pibrentasvir in children 3-12 years old.

In the DORA part 2 phase 2/3 nonrandomized, open-label study, the researchers examined children with chronic HCV infection, genotype (GT) 1‐6, with or without compensated cirrhosis. The patients were divided into 3 cohorts by age, cohort 2 (9–12 years), cohort 3 (6–9 years), and cohort 4 (3–6 years) and given weight-based doses of the treatment for 8,12, or 16 weeks.

The researchers sought primary endpoints of SVR12 and steady-state exposure and secondary endpoints of the rates of persistent viremia, relapse, and reinfection.

The team also assessed safety and laboratory abnormalities.

“Final pediatric dosages determined to be efficacious were 250 mg GLE + 100 mg PIB (in children weighing ≥ 30 kg to < 45 kg), 200 mg GLE + 80 mg PIB (≥ 20 kg to < 30 kg), and 150 mg GLE + 60 mg PIB (12 kg to < 20 kg),” the authors wrote.

A total of 80 patients participated in the trial and 96% (n = 77) achieved SVR12. However, 1 participant relapsed by post-treatment week 4 on the initial dose ratio.

In addition, no participants had virologic failures on the final dose ratio of GLE 50 mg/ PIB 20 mg and 2 non-responding participants prematurely discontinued the study.

The majority of adverse events were mild with treatment-related serious adverse events occurred. In addition, pharmacokinetic exposures were ultimately comparable to adults.

“A pediatric formulation of GLE/PIB was highly efficacious and well‐tolerated in chronic HCV‐infected children 3 ‐ < 12 years old,” the authors wrote.

Last year, researchers found glecaprevir/pibrentasvir after failure of sofosbuvir with an NS5A inhibitor for patients with 

A team of investigators, led by Anna S. Lok, MD, Division of Gastroenterology and Hepatology, University of Michigan, performed a randomized, phase 3B, open-label, pragmatic trial of the safety and efficacy of 12 and 16 weeks of G/P, with or without ribavirin (RBV), in 177 patients with HCV genotype 1 (GT1) infection with treatment failure after sofosbuvir and an NS5A inhibitor.

The treatment failed in 13 (7.3%) patients with HCV genotype 1a infection, 6 (7.9%) in the first group, 3 (6.1%) in second group, 3 (6.1%) in the third group (6.1%), and 1 (3.4%) in the fourth group.

The majority of patients had baseline resistance-associated substitutions in NS5A.

Treatment-emergent resistance-associated substitutions in NS3 and NS5A were observed in 9 and 10 patients with treatment failure. While G/P was well-tolerated, ribavirin increased adverse events and did not increase efficacy.

Pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir in children with chronic hepatitis C virus: part 2 of the DORA study,” was published online in 

Articles

There were no drug-related serious adverse events found in the study.

Glecaprevir, Pibrentasvir Efficacious for Children with HCV

 pandemic there has been a fear of long-term neurological and psychiatric sequalae. However, this theory previously has lacked the data needed to properly assess how COVID-19 impacts brain health.

A team, led by Maxime Taquet, PhD, Department of Psychiatry, University of Oxford, gave estimates on incidence rates and relative risks of neurological and psychiatric diagnoses in patients in the 6 months following a COVID-19 diagnosis.

In the retrospective cohort study and time-to-event analysis, the researchers used data obtained from the TriNetX electronic health records involving over 81 million patients.

The primary cohort involved 236,379 COVID-19 patients and the matched control cohort included patients diagnosed with influenza. The other matched control cohort included patients diagnosed with any respiratory tract infection including influenza in the same period. All 3 cohorts included patients older than 10 who had an index event on or after Jan. 20, 2020 and were still alive as of Dec. 13, 2020.

The researchers estimated the incidence of 14 neurological and psychiatric outcomes in the 6 months following a COVID-19 diagnosis, including intracranial hemorrhage; ischemic stroke; parkinsonism; Guillain-Barré syndrome; nerve, nerve root, and plexus disorders; myoneural junction and muscle disease; encephalitis; dementia; psychotic, mood, and anxiety disorders (grouped and separately); substance use disorder; and insomnia.

They then used a Cox model to compare incidences with those in propensity score-matched cohorts of patients with influenza or other respiratory tract infections.

They also investigated how these estimates were impacted by COVID-19 severity, as proxied by hospitalization, intensive therapy unit (ITU) admission, and encephalopathy (delirium and related disorders and assessed the robustness of the differences in outcomes between cohorts by repeating the analysis in different scenarios.

“To provide benchmarking for the incidence and risk of neurological and psychiatric sequelae, we compared our primary cohort with four cohorts of patients diagnosed in the same period with additional index events: skin infection, urolithiasis, fracture of a large bone, and pulmonary embolism,” the authors wrote.

The estimated incidence of a neurological or psychiatric diagnosis in the following 6 months was 33.6% (95% CI, 33.17-34.07) of the COVID-19 patients, with 12.84% (95% CI, 12.36-13.33) receiving their first such diagnosis.

For the patients who were admitted to the ITU,. The estimated incidence of a diagnosis was 46.42% (95% CI, 44.78-48.09). The estimated incidence for a first diagnosis was 25.7% (95% CI, 23.50-28.25).

For the individual diagnoses of the study outcomes, the entire COVID-19 cohort had estimated incidences of 0.56% (95% CI, 0.50–0.63) for intracranial hemorrhage, 2.10% (95% CI, 1.97–2.23) for ischemic stroke, 0.11% (95% CI, 0.08–0.14) for parkinsonism, 0.67% (95% CI, 0.59–0.75) for dementia, 17.39% (95% CI, 17.04–17.74) for anxiety disorder, and 1.40% (95% CI, 1.30–1.51) for psychotic disorder, among others.

For the patients in the group with ITU admissions, estimated incidences were 2.66% (95% CI, 2.24–3.16) for intracranial hemorrhage, 6.92% (95% CI, 6.17–7.76) for ischemic stroke, 0.26% (95% CI, 0.15–0.45) for parkinsonism, 1.74% (95% CI, 1.31–2.30) for dementia, 19.15% (95% CI, 17.90–20.48) for anxiety disorder, and 2.77% (95% CI, 2.31–3.33) for psychotic disorder.

The majority of diagnostic categories were common in COVID-19 patients than it was in patients with influenza (HR, 1.44; 95% CI, 1.40–1.47, for any diagnosis; HR, 1.78; 95% CI, 1.68–1.89, for any first diagnosis) and those who had other respiratory tract infections (HR, 1.16; 95% CI, 1.14–1.17, for any diagnosis; HR, 1.32; 95% CI, 1.27–1.36, for any first diagnosis).

The hazard ratios were higher in patients who had more severe COVID-19 cases and the results were robust to various sensitivity analyses and benchmarking against the 4 additional index health events.

“Our study provides evidence for substantial neurological and psychiatric morbidity in the 6 months after COVID-19 infection,” the authors wrote. “Risks were greatest in, but not limited to, patients who had severe COVID-19. This information could help in service planning and identification of research priorities. Complementary study designs, including prospective cohorts, are needed to corroborate and explain these findings.”

6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records

The majority of diagnostic categories were common in COVID-19 patients than it was in patients with influenza.

Neurologic and Psychiatric Morbidity Linked to Severe COVID-19 Infections

Findings from a new study conducted in Denmark affirmed that an adalimumab biosimilar has similar efficacy to brand-name adalimumab (Humira) in patients with 

The study also found that switching from the originator to a biosimilar had no apparent effect on medication retention.

Although previous studies have shown comparable efficacy and safety between an adalimumab originator and biosimilar, there have been little real-world data to determine whether switching from the former to the latter has any effect on treatment course and experience.

A team, led by Nikolai Loft, MD, Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, used patient data from the Patients in the Biological Treatment in Danish Dermatology (DERMBIO) registry to study 1-year drug retention in patients who switched from an originator to a biosimilar.

Retention rates for this cohort was compared with those who remained with the brand-name.

All included patients who had switched (n = 348) had doctor visits between November 1, 2018 – May 1, 2019. Of this population, a majority (72.1%) were male, and the mean age was 52.2 years.

Further, 186 patients switched to GP2017, and 162 switched to SB5.

Patients who remained with the originator (n = 378) had visits from May 1, 2017 – November 1, 2017. In this group, 72.0% were male, and the mean age was 51.1 years.

The investigators used Kaplan-Meier estimates and the log-rank test to assess treatment retention. Cox proportional hazards regression was used to compare drug retention between the cohorts.

As many as 92.0% (95% CI, 89.0-94.9) of patients in the biosimilar cohort continued their treatment regimen following 1 -year —compared to 91.2% in the originator group cohort (95% CI, 89.4-94.8).

Of those who switched and discontinued treatment, 42.3% stopped because of insufficient effect, 32.1% because of adverse events, and 25.0% because of other reasons. Notably, 32.1% switched back to adalimumab originator because of adverse events or insufficient effects.

“The crude hazard ratios for drug discontinuation for the adalimumab biosimilar cohort compared with the adalimumab originator cohort were 1.02 (95% CI, 0.61-1.70; 

 = .94) for all causes of drug discontinuation, 0.82 (95% CI, 0.39-1.73; 

 = .60) for insufficient effect, and 1.41 (95% CI, 0.52-3.77; 

 = .50) for AEs,” the investigators wrote.

And finally, there were no observed changes in disease activity or Dermatology Life Quality Index after 1 year between the cohorts.

A separate historical analysis of biologic-naïve patients was performed for those initiating adalimumab biosimilars (n = 321) and originator (n = 389).

There was a similar retention rate between the cohorts; although, more patients in the biologic-naïve biosimilar cohort experienced dermatological adverse events when compared with the biologic-naïve originator cohort (7 [3.6%] vs 0, 

 < .001). Nonetheless, there were no differences between the groups for any adverse events.

“This study found that 1-year drug retention for biologic-naive patients initiating treatment with adalimumab biosimilars was similar to that for biologic-naive patients initiating treatment with adalimumab originator in a historical cohort,” Loft and colleagues concluded.

“Taken together with the switch data, the results of this study support the interchangeability of adalimumab originator with adalimumab biosimilars,” they said.

Outcomes Following a Mandatory Nonmedical Switch From Adalimumab Originator to Adalimumab Biosimilars in Patients With Psoriasis

Patients with psoriasis who either remained on Humira or switched to a biosimilar showed similar retention rates and efficacy/safety data.

Brand-Name Adalimumab for Psoriasis May Be Interchangeable with Biosimilars 

The transitional use from in-person to remote ambulatory 

 led to a significant increase in remote visits during the 

Investigators conducted a cross-section study of 176,781 ambulatory cardiology visits, finding that remote-use patients during the COVID-19 era were more likely to be Asian, Black or Hispanic individuals, traditionally underserved patient groups, as well as those with private insurance.

However, clinicians had significantly lower rates of ordering medication and tests during video and telephone visits compared to pre-pandemic in-person visits.

The study, headed by Neal Yuan, MD, of the Smidt Heart Institute at Cedars-Sinai Medical Center, stated it is the first to investigate how the “dramatic increase in the use of telehealth is associated with changes in cardiovascular patient care in a real-world setting.”

The data did not measure differences in care access, but they were able to characterize overall differences in care usage.

“The promise of telemedicine has always been tempered by concerns about disparities in access driven by the digital divide,” investigators wrote.

These disparities in access are generally thought to affect those who are older, have lower income and less education, as well as underrepresented minority groups, patients in rural areas and patients with chronic conditions. These communities are known to have less access to the internet and thus telemedicine services, making technology literacy and use a concern for telemedicine access

Trends in the data were consistent with certain expectations. Patients with private insurance and higher socioeconomic status made up a large percentage of remote visits compared to low-income individuals without access to technology.

However, disparities not expected included those in underrepresented racial communities using video and telephone care more than White individuals. Data also showed patients using remote visits were more likely to have documented cardiovascular comorbidities.

The investigators identified visits from 31 different cardiology clinics in the Los Angeles area between the COVID-19 period of April 1 – December 31, 2020, when remote visits increased. This data was compared to a pre-COVID cohort from April 1 – December 31, 2019 to minimize fluctuations in patient composition and ordering.

Data analysis of the study included the following:

Information available from the electronic health record (EHR) was used to determine visit type (in-person, video, or telephone) and ordering frequency of the most common cardiology-specific diagnosis test (ECGs. TTEs, etc.) Ordering frequencies of tests and medications by visit type were categorized by month and compared against daily COVID-19 case rates as reported by the Los Angeles County Department of Public Health.

Investigators stratified the visit data by time period, pre-COVID and COVID era. All 2019 visits were held in person, creating 4 visit types pre-Covid in-person, COVID-era in-person, COVID-era video, and COVID-era telephone. In the data, the differences in discrete variables between groups were evaluated by the χ2 test and continuous variables evaluated using the t test.

Multivariable linear regression studied the association between visit type and the number of diagnostic tests ordered per visit. Multivariable logistic regression studied the association between visit type and the odds of ordering at least 1 medical test or medication.

All analyses adjusted for these patient demographics and visit characteristics that may affect ordering patterns, including age, sex, race and insurance status, as well as adjusting for 155 individual clinicians practice patterns.

A minority of patients (45%) were female, while 71.9% were non-Hispanic White, and the mean age was 68.1 years.

Patients accessing remote visits in the COVID-era were more likely to be Asian, Black or Hispanic individuals. These minority communities Pre-COVID in-person visits were 24,934 (28.6%) versus 19,742 (26.5%) for COVID-era in-person visits. COVID-era video visits were 3,633 (30.4%) versus 1,435 (35%) for COVID-era telephone visits.

Investigators believe the gradual increase of telehealth in previous decades and the now-widespread use during the pandemic will result in a permanent and significant future for remote cardiovascular care.

“The rapid and large-scale transition from in-person to remote cardiovascular care during the COVID-19 pandemic has important implications for patient access to care as well as clinician practice patterns,” they concluded.

The study, “Patient Use and Clinical Practice Patterns of Remote Cardiology Clinic Visits in the Era of COVID-19,” was published online in 

A new study finds ambulatory telemedicine visits were exceptionally greater among minority communities through the pandemic.

Remote Cardiovascular Care Reached Underserved Populations During COVID-19

 are on the horizon, clinicians can still look to complementary treatments to help mitigate disease or medication-related symptoms.

, Peter Lio, MD, Clinical Assistant Professor of Dermatology & Pediatrics, Northwestern University Feinberg School of Medicine, touted the utility of such integrative therapeutic options.

“I do think in atopic dermatitis there are a number of places where we can leverage an integrative approach,” he said. “And I stress that it’s integrative because I’m not trying to say don’t use any conventional medicine.”

In fact, he stressed, unconvetional therapies can be brought into a treatment regimen in order to fully optimize the patient treatment experience. Certain therapies can work to address side effects or augment the effects of a primary treatment course.

Some examples he mentioned were topical coconut oil as a potential antimicrobial agent, topical sunflower seed oil as an addition to moisturizers, and oral hempseed oil as a potential antiinflammation and skin barrier treatment.

“Another thing I do like as well is L-histadine,” Lio said. “There’s some data to show that, [when administered] in vitro and in vivo in patients, [...] their filaggrin production goes up. And we know that many patients with atopic dermatitis are filaggrin deficient, and so this may be able to bolster it.”

Videos

A dermatologist discusses alternative and complementary options for the treatment of atopic dermatitis.


Peter Lio, MD: Atopic Dermatitis and Integrative Therapies

The use of Bcr-Abl tyrosine kinase inhibitors (TKIs) for 

 virus could lead to a reactivation of hepatitis B flares.

A team, led by Ling-Yi Wang, PhD, Epidemiology and Biostatistics Consulting Center, Department of Medical Research, Buddhist Tzu Chi General Hospital, examined the link between hepatitis B flare and exposure to Bcr-Abl TKIs compared to non-Bcr-Abl TKIs.

“Drug-induced liver injury is an infrequent but challenging complication of drug therapy, and drug-induced hepatitis B virus (HBV) reactivation is particularly important in an HBV endemic area,” the authors wrote. “In patients who receive immunosuppressants, HBV reactivation is a well-recognized complication, especially among those who receive high-dose or long-term use of steroids, biologic drugs (rituximab), and chemotherapy.”

Small-molecule inhibitors that target Bcr-Abl tyrosine kinase, including Bcr-AbL TKIs such as imatinib, nilotinib, and dasatinib are considered the standard treatment of disorders like chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTSs), but are also believed to be associated with an increased risk of HBCV reactivation.

In addition, the US Food and Drug Administration (FDA) highlighted the potential risk of HBV reactivation associated with Bcr-Abl TKI treatment and required updated product labels.

In the nested case-control study, the researchers examined 698,342 patients who entered a hepatitis B carrier cohort in Taiwan after 2005, including patients who received their first antiviral agents for hepatitis B flare for more than 28 days after the cohort entry date.

Of the patient population, 66,702 patients had hepatitis B flares that required antiviral treatment, 47,492 of which were men. This subgroup had a mean age at index data of 50,2 years old.

For each case, the researchers formed a corresponding risk set that included all eligible patients in the cohort who had the same age within 1 year, same sex, and were at risk of developing hepatitis B flare at the case date.

The investigators then randomly selected as many as 10 control patients from the risk set for each case patient. They also evaluated TKIs before the hepatitis B flare for case patients and before the corresponding index date for control patients.

The researchers sought main outcomes of the rate ratio for the association between hepatitis B flare and exposure to Bcr-Abl TKIs compared with non-Bcr-Abl TKIs using conditional logistic regression.

Bcr-Abl TKI use during the previous 90 days was independently associated with a 56% higher risk of hepatitis B flare (aRR, 1.56; 95% CI, 1.11-2.20). The aRR increased to 1.66 (95% CI, 1.20-2.28) for Bcr-Abl TKI use during the previous 365 days.

The use of Bcr-AbL TKIs during the previous 60 days was linked to a significantly increased risk of flare among women (aRR, 3.20; 95% CI, 1.70-6.03), but not among men (aRR, 1.14; 95% CI, 0.72-1.81).

“These findings suggest that sex-specific strategies may be needed to monitor for hepatitis B reactivation among patients receiving Bcr-Abl TKIs,” the authors wrote.

Association of Bcr-Abl Tyrosine Kinase Inhibitors With Hepatitis B Virus Reactivation Requiring Antiviral Treatment in Taiwan

Treatment use was linked to an increase in hepatitis B flare among women, but not men. 

Hepatitis B Flare Trends Identified for Bcr-Abl TKI Treatment

Researchers are touting a new targeted opioid that could treat the diseased tissues of patients with 

 without yielding some of the harmful and painful side effects often seen with treatments.

A research team from New York University College of Dentistry and Queen's University, are hoping to begin clinical trials on a novel opioid called NFEPP involving both human tissue and human subjects to test the targeted opioid that spares health tissues from pain.

When treating chronic pain for IBD, opioids target opioid receptors, including the mu opioid receptor. However, when these treatments activate the mu opioid receptor in healthy tissues they can cause severe and potentially life-threatening side effects, including difficulty breathing, constipation, sedation, and addiction.

Senior study author Nigel Bunnett, PhD, professor and chair of the Department of Molecular Pathobiology at NYU College of Dentistry, explained in an interview with 

, that promising preclinical results will allow the research team to move forward with later phase studies on the targeted opioid.

Bunnett said the treatment should ultimately be effective in both Crohn’s disease and ulcerative colitis patients and could eventually offer pain relief without side effects for a number of other diseases and conditions, including cancer.

Researchers are preparing to study the treatment in IBD patients.

Nigel Bunnett, PhD: Targeted Opioid for Inflammatory Bowel Disease

 pandemic surged in 2020, according to a recent analysis of mortality in the United States.

The study, conducted at Virginia Commonwealth University, and led by Steven H. Woolf, MD, MPH, and Derek A. Chapman, PhD, showed the United States experienced 22.9% more deaths than expected, with a total mortality of 2,801,439, from March 2020 to January 2021.

This percentage greatly exceeds the average annual increase observed in recent years of ≤2.5%. More than 500,000 deaths (n = 522,368) were estimated to be excess.

The study used a Poisson regression model of US mortality data set from 2014 - 2019 to predict expected deaths in 2020, with sources including the National Center for Health Statistics and US Census Bureau. During the period of observation, data was taken from provisional, unweighted death counts for Washington, D.C. and 49 states, excluding North Carolina for insufficient data.

Mortality rates from non-COVID-19 causes were examined with data including all deaths where non-COVID-19 conditions were listed as the underlying cause of death.

Particular demographic groups were unequally impacted by the pandemic, reflecting racial disparities in COVID-19 mortality. The percentage of excess deaths among non-Hispanic black individuals was 16.9%, compared to their 12.5% share of the US population.

The data analysis also showed the non-Hispanic Black population experienced 208.4 deaths per 100,000. The non-Hispanic White population experienced 157.0 deaths per 100,000, and the Hispanic populations experienced 139.8 deaths per 100,000.

Geographic regions experienced surges in excess related to seasons throughout the year. The eastern US experienced a surge in April, whereas the southern and western states experienced extended summer and early winter surges. The regional surges were correlated with instances of COVID-19 outbreaks in the respective areas.

“Many of these states weakly embraced, or discouraged, pandemic control measures and lifted restrictions earlier than other states,” investigators wrote.

But by the end of 2020, deaths were exceeding against investigators’ model-based estimations in all regions of the country. States with the highest per capita excess death rate included New York and New Jersey in the northeast with a ratio of 1.38 and 1.37 observed versus expected deaths, respectively. Other areas including Arizona and New Mexico in the southwest had a 1.32 and 1.27 ratio of observed versus expected deaths.

Excess deaths could also result from immediate or delayed mortality from undocumented COVID-19 infection, as well as secondary non-COVID-19 deaths during surges. Prevalent drivers of death in the US, including heart disease and Alzheimer disease, increased during surges. Population aging could also contribute to an overestimation of excess deaths, which the study did not adjust for in their findings.

 accompanying the study, Alan M. Garber, MD, PhD, of Harvard University, championed the data found by Woolf and Chapman, comparing the pandemic to war and the failed response of the United States to combat its effects on mortality rates.

“Just as military leaders prepare their armies for fighting the last war, society will always be better prepared to fight the pandemics of the past than the unknown pandemics yet to come,” Garber said.

Garber believes despite the progress in creating vaccines and treating those with the disease, the increase in the risk of death and misclassifications and inconsistencies in reporting have caused death rates to go up, both directly and indirectly.

“The US and other countries are most likely to learn from the pandemic if they understand the consequences of failure,” Garber said. “The work of Woolf and colleagues illustrates what is at stake: despite the scientific, medical, and public health progress of recent decades, the loss of life attributable to the COVID-19 pandemic exceeds the mortality of major wars.”

Excess Deaths From COVID-19 and Other Causes in the US, March 1, 2020, to January 2, 2021

A new analysis suggests the country experienced 23% more deaths than anticipated during the first year of the pandemic.

COVID-19 Drives Surge of Excess Deaths in 2020

A new cross-sectional study has further elucidated the clinical, geographic, and temporal characteristics of cases related to 

multisystem inflammatory syndrome in children (MIS-C

), a newly identified condition arising from the ongoing coronavirus disease 2019 (COVID-19) pandemic.

“Although most children with SARS-CoV-2 infection have mild or no symptoms, some children, particularly those with underlying conditions, can have severe illness,” the study investigators noted. “Clinical manifestations of hospitalized patients with COVID-19 may have some overlap with that of MIS-C.”

A team, led by Ermias Belay, MD, US Centers for Disease Control and Prevention Response Team, used clinical and laboratory data of patients diagnosed with MIS-C, which included cases of illness onset from March 2020-January 2021.

The geographical and temporal distributions of MIS-C were then compared with cases of COVID-19 at the national level and by region.

The investigators identified a total of 1733 patients who met the clinical definition of MIS-C (and whose condition could not otherwise be explained).

Of this total, 57.6% were male, and 71.3% were Hispanic or non-Hispanic black.

The proportion of reported cases of gastrointestinal symptoms, rash, and conjunctival hyperemia ranged from 53% to 67% of patients. As many as 54% had hypotension or shock, and 58.2% of patients were admitted to the intensive care unit.

As for prevalence of cardiological complications, cardiac dysfunction was reported in 31.0% of patients, pericardial effusion in 23.4%, myocarditis in 17.3%, and coronary artery dilatation or aneurysms in 16.5%.

Children aged 0-4 years notably had the lowest proportion of severe manifestations. Nonetheless, of this cohort, 38.4% experienced hypotension or shock, and 44.3% were admitted for intensive care.

Patients 18-20 years old had the highest proportions of myocarditis (30.9%), pneumonia (36.4%), acute respiratory syndrome (18.2%), and polymerase chain reaction positivity (70.9%). This age group also had the greatest proportion of reported COVID-19-like illness (63%) prior to diagnosis of MIS-C.

Overall, the analysis found that a total of 24 (1.4%) patients had died from MIS-C.

Highlights: Geographic and Temporal Characteristics

The national MIS-C incidence per 100,000 persons younger than 21 years was 2.1, with a variance of 0.2-6.3 in states that reported cases.

“Patients with MIS-C from large central metro counties made up 57% of [all MIS-C ] patients up to June 30, which declined to 37% from July onwards,” the investigators noted. “The proportion of patients from small metro, micropolitan, or noncore areas increased from 6% to 18% over the 2 time periods.”

The burden of MIS-C for each state was generally highest in the Northeast, while the West and Midwest demonstrated high burdens of pediatric COVID-19.

Belay’s team also identified 3 peaks in MIS-C cases—which occurred in early May, early August, and December. The first 2 peaks followed the COVID-19 peaks by 2-5 weeks, while the third peak may seem to follow the same pattern.

Even more, the first MIS-C peak largely centered in the northeastern region, and the second peak in the south and west regions, findings that are consistent with the predominance of COVID-19 during those times.

Further, patients identified during the first peak were significantly more likely to experience cardiac dysfunction and myocarditis, an observation that has yet to be fully understood.

“As the COVID-19 pandemic spreads, causing a third peak and more sustained transmission across the United States, physicians should maintain a high index of suspicion for MIS-C to promptly diagnose and treat these patients,” the investigators wrote.

"Practitioners should report patients suspected with MIS-C to local and state health departments,” they concluded.

Trends in Geographic and Temporal Distribution of US Children With Multisystem Inflammatory Syndrome During the COVID-19 Pandemic

Older children seem to be at higher risk for myocarditis and pneumonia. 

Study Offers Insight into Epidemiology of MIS-C Cases

The US Food and Drug Administration (FDA) has given 510(k) clearance to Pulsehaler™, a device developed by Respinova Ltd. to help facilitate the opening of airways and provide clearance of secretions for patients with 

The device is the first to use patented Dynamic Multi-frequency Pressure Pulse™ technology, which utilizes an internal turbine and multi-frequency disc to send air pressure pulsations directly into the lung. As such, this provides benefit for those with airway restrictions.

"Despite the available pharma treatments, patients with COPD, asthma, CF and other respiratory diseases unfortunately still suffer from poor quality of life," noted Professor Raphael Breuer, MD, former Head of the Institute of Pulmonology at Hadassah University Medical Center, 

"Pulsehaler™ brings a novel approach that will help patients with these conditions open their airways, which should improve their symptoms significantly,” Breuer said.

A cross-over controlled, double-blind study showed that the non-invasive device significantly improved 6-minute walk distance, as well as FVC and IC lung function, in patients with COPD. These results were superior when compared with placebo (

Further, patients experienced a significant improvement in Dyspnea and Mastery quality of life questionnaire scores.

According to Cliff Ansel, CEO of Respinova Ltd., this FDA clearance represents a major milestone for the medical technology company. Prior to approval, the device had not been cleared or approved for sale and marketing by any regulatory agency.

The non-invasive device uses air pressure pulsations to help open airways and provide clearance of secretions in patients with disease such as COPD, asthma, and cystic fibrosis. 

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