Anne Dixon, MD, joins Lungcast to discuss obesity's effect on asthma, and the newest recommendations for managed care.

New Asthma Management Guidelines: A Podcast Primer

Expert David W. Goodman, MD, explains why adults with ADHD may face unknown challenges during the pandemic.

Adult ADHD Challenges During COVID-19

What you need to know about vaccinator and patient education, counseling, billing, and reimbursement.

ACP Policy Statement on COVID-19 Vaccine Distribution and Administration

New ADA guidelines list more than 40 recommendations related to blood pressure targets, screening and diagnosis, and overall management strategies.

Cardiovascular Disease in Diabetes: How to Manage Risks

An American Red Cross discusses the importance of National Blood Donor Month and the challenges faced during the COVID-19 pandemic.

The National Blood Shortage: An Unprecedented Challenge

Students share their experience in the virtual classroom, navigating new requirements, and the lessons learned from their position in a global pandemic.

How COVID-19 Transformed Medical Education

Findings from a new study support the safety and tolerability of bi-level positive airway pressure ventilation (BiPAP) as supportive care for hospitalized children with 

“While incentive spirometry has been shown to be effective at preventing acute chest syndrome (ACS) in hospitalized children with acute SCD pain, this intervention can only be used during waking hours,” noted the study investigators. “An additional strategy is needed to prevent oxygen desaturation and hypoventilation for these patients during sleep.”

BiPAP was first used as supportive care in the Boston Medical Center pediatric inpatient unit in February of 2017. To help with breathing, the device offers non-invasive ventilation through a mask and provides positive airway pressure during exhalation in addition to higher pressure breaths during inhalation.

A team, led by Cara Guenther, MD, Boston Medical center, conducted a retrospective chart review where BiPAP was recommended as supportive care for patients with sickle cell disease and ≤22 years of age.

All patients were admitted in the unit between February 1, 2017-March 1, 2020.

Guenther and colleagues primarily evaluated the proportion of hospitalizations in which BiPAP was used successfully for ≥1 night. Secondary outcomes included tolerability, adverse events attributable to BiPAP, and development of ACS or worsening respiratory distress requiring care in the intensive care unit.

Overall, they evaluated 23 patients representing 53 hospitalizations. Median age at time of admission was 16 years old.

All had hemoglobin SS, 20 were on hydroxyurea, and 20 had a history of acute chest syndrome — ACS was diagnosed at admission in 15 hospitalizations.

Furthermore, 11 patients had 1 or more ICU admission for respiratory issues.

“Indications for BiPAP included prior ACS (n = 50, 94%), chest/back pain (n = 42, 79%), oxygen desaturation (n = 35, 66%), his- tory of an abnormal sleep study (n = 15, 28%), and/or mild to moderate ACS diagnosed at or after admission but not requiring PICU-level care (n = 20, 38%),” the investigators reported.

Of the 53 hospitalizations, BiPAP was used in 40 hospitalizations for a median of 2 nights. For some patients, BiPAP was not initially tolerated but tolerated in subsequent attempts.

The mask proved to be a common reason for inability to tolerate the BiPAP. Also, some patients found it difficult to breath with the positive pressure.

Over the course of the study period, BiPAP utilization increased from use in 12 hospitalizations in 2017 to 24 hospitalizations in 2019. Further, there were no adverse events associated with BiPAP use.

ACS was diagnosed in 17 hospitalizations in the emergency department. A patient developed suspected ACS one day following BiPAP use.

ICU transfer for respiratory support occurred in 3 hospitalizations, 2 of which occurred in the same patient (who had a history of severe sickle cell disease and recurrent ACS).

And finally, among 26 hospitalizations in which high-risk patients had no history of ACS, 23 did not progress to ACS after BiPAP use.

“We have demonstrated that using BiPAP on a general pediatric inpatient unit is safe, feasible, and well tolerated as supportive care for hospitalized children with SCD at risk for adverse respiratory outcomes,” Guenther and team wrote.

However, they indicated more data is needed to ascertain the efficacy of BiPAP for treatment and prevention of ACS in a pediatric ICU setting.

SNAP: Supportive noninvasive ventilation for acute chest syndrome prevention in children with sickle cell disease

Articles

More studies are needed to determine whether bi-level positive airway pressure ventilation can help prevent acute chest syndrome.

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Supportive Noninvasive Ventilation Safe, Tolerated in Sickle Cell Children

A new cross-sectional study detailed the prevalence of 

 in the United States, providing insight into its epidemiology and incidences.

Few large-scale population-based studies have explored the prevalence and incidences of the rare disease, and the burden of it has not been well-established.

As such, a team led by John Barbieri, MD, MBA, of the University of Pennsylvania Perelman School of Medicine, utilized ICD-10 codes to assess patient data from the Optum Clinformatics Database between January 1, 2017-December 31, 2018.

“The Optum Clinformatics Data Mart includes deidentified commercial claims data for approximately 18 million to 20 million covered individuals in the United States annually,” they noted.

The team thus gathered demographic and clinical data from 11,608 patients with incident granuloma annulare as well as 17,862 patients with prevalent granuloma annulare. Among those with incident disease, 74.8% were female, and the mean age was 56.5 years.

Of those with prevalent granuloma annulare, 75.8% were female, and mean age was 56.6 years.

Thus, the overall annualized incidence was 0.04%, or 37.9 per 100,000 (95% CI, 36.9-38.9) person-years. The overall annualized prevalence was 0.06%, or 58.3 per 100,000 (95% CI, 57.1-59.5) person-years.

Barbieri and colleagued noted that the overall incidence of granuloma annulare was higher among women (female to male ratio, 2.8:1; 

<.001) and in those in the 5th decade of life.

The incidence for those between 50-59 years old was 58.6 per 100,000 (95% CI, 55.2-62.0) person-years—compared to 34.6 per 100,000 (95% CI, 31.9-37.2) person-years among those 40 -49 years of age and 23.1 per 100,000 person-years (95% CI, 21.0-25.3) for those 30-39 years of age (

Furthermore, incidence was higher among White patients (48.2 [95% CI, 46.8- 49.7]) than Black patients (21.3 [95% CI, 18.8-23.9]; P < .001).

The investigators also reported that prevalent granuloma annulare was higher among women as well (female to male ratio, 3.0:1; 

Similar to incident disease, prevalence was higher among those in the fifth decade of life (91.5 per 100,000 [95% CI, 87.3-95.8] person-years) and White individuals (72.7 [95% CI, 70.9-74.4]).

“Within 6 months of their first diagnosis, 4822 patients (41.5%) filled a prescription for a topical corticosteroid, and 1087 patients (9.4%) received an intralesional injection,” they wrote. “Within 6 months of their first diagnosis, oral tetracycline-class antibiotic prescriptions were filled by 820 patients (7.1%), and hydroxychloroquine prescriptions were filled by 268 patients (2.3%).” 

Frequencies of treatment use were similar at month 12, the investigators noted. Phototherapy, dapsone, systemic retinoids, and TNF inhibitors were rarely used as therapies.

Patients also rarely presented to the clinician with other inflammatory skin disorders—such as acne (2.4%) psoriasis (1.2%), and atopic dermatitis (1.7%)—within 3 months prior to or following first diagnosis of granuloma annulare.

“These findings provide important background regarding the basic epidemiology and over- all burden of granuloma annulare in the United States,” Barbiere and colleagues wrote. “Future studies are needed to better understand the association of granuloma annulare with quality of life and the most optimal treatment approaches for this condition.”

Incidence and Prevalence of Granuloma Annulare in the United States

Data from the large-scale, population-based study corroborate previous single-center study findings.

Dermatology

Inflammation

Study Reports on US Incidence, Prevalence of Granuloma Annulare

This article was originally published in ContagionLive.

New data shows Novavax Inc’s NVX-CoV2373 

 vaccine produced a 90.4% overall prevention of symptomatic disease.

The to-be-published data from the phase 3 PREVENT-19 trial, shared by the company Monday morning, would likely power Novavax’s bid to become the fourth COVID-19 vaccine regulated by the US Food and Drug Administration (FDA)—albeit at a time when vaccine supply has already met national demand.

NVX-CoV2373 is a protein-based recombinant nanoparticle vaccine designed from the genetic sequence of the first SARS-CoV-2 strain, to generate S protein-derived antigen.

Preclinical assessment of the vaccine showed its capability to induce S protein bind-blocking antibodies, while remaining well tolerated by patients.

NVX-CoV2373 is stored at 2-8 degrees Celsius and is packaged in an immediate-use liquid formulation as 10-dose vials. It is designed as a two-dose administration, like mRNA vaccines BNT162b2 from Pfizer-BioNTech, and mRNA-1273 from Moderna.

The PREVENT-19 trial is a randomized, placebo-controlled, observer-blinded assessment of NVX-CoV2373 for the prevention of COVID-19.

Investigators administered the vaccine and placebo 2:1 to 29,960 participants aged ≥18 years old from 119 different locations across the US and Mexico.

The PREVENT-19 primary endpoint was first occurrence of PCR-confirmed symptomatic COVID-19—defined as either mild, moderate, or severe in status—with onset ≥7 days after the second vaccine dose among previously uninfected adult participants.

An additional placebo-controlled, adolescent-based assessment of NVX-CoV2373, among 2248 participants aged 12-17 years old, is ongoing.

The investigators accrued efficacy endpoints from January 25 – April 30, 2021. As they noted, the B.1.1.7 variant originally observed in southeast England was the predominant SARS-CoV-2 strain at that time in the US.

What’s more, other Variants of Interest and Variants of Concern—per the US Centers for Disease Control and Prevention (CDC)—were on the rise during the trial’s endpoint accrual window.

In Monday’s preliminary findings for PREVENT-19, investigators reported an overall vaccine efficacy of 90.4% (95% CI, 82.9 – 94.6) for NVX-CoV2373 after 7 days post-second dose among participants previously not infected with SARS-CoV-2.

Among the 77 cases observed at the trial endpoint, 63 were among placebo participants and just 14 were among the vaccine participants. All cases were defined as mild per trial protocol. The observed 10 moderate cases and 4 severe cases all occurred within the placebo group, indicating a 100% efficacy (95% CI, 87 – 100) against moderate or severe disease with NVX-CoV2373.

In assessment of the 54 cases with available sequence data, investigators reported that 35 (65%) were Variants of Concern, 9 (17%) were Variants of Interest, and 10 (19%) were other variants, per CDC standards.

Investigators observed a 100% efficacy (95% CI, 80.8 – 100) against variants not deemed “concerning” nor “of interest.” NVX-CoV2373’s efficacy was 93.2% (95% CI, 83.9 – 97.1) versus Variants of Concern and Variants of Interest.

In an assessment of high-risk populations—defined as persons >65 years old, ≤65 years old with high-risk comorbidities, or those at frequent COVID-19 exposure risk due to life circumstances—investigators reported a 91.0% vaccine efficacy (95% CI, 83.6 – 95.0) among the 75 relevant COVID-19 cases.

Preliminary data indicated generally good tolerance of NVX-CoV2373, with few adverse events. In fact, no single adverse event term was reported by more than 1% of trial participants.

Injection site pain after either dose, lasting ≤3 days, were the most commonly reported local symptoms. Commonly reported systemic symptoms included fatigue, headache, and muscle pain, each lasting <2 days in vaccinated participants.

Novavax has expressed intent to file for regulatory authorizations in Q3 2021, once completing final process qualification and assay validation phases. Once regulated by authorities, the company is capable of manufacturing 100 million NVX-CoV2373 doses monthly by October 2021, and 150 million doses monthly by the end of the year.

The company is working with a “sense of urgency,” Novavax President and Chief Executive Officer Stanley C. Erck said in a 

, to complete regulatory submission and deliver the vaccine to a world in need of greater COVID-19 prophylaxes.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines,” Erck said. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection.”

, Erck expects to first receive authorization for distribution outside the US; Novavax is applying for use with authorities for the UK, the European Union, India, and South Korea.

that Novavax may best serve the US at the mark when supplemental booster doses are advised for persons with waning immunity against emerging variants—either later this year or even further down the road.

Approximately 144 million, or 43.8% of the population, were fully vaccinated against COVID-19 in the US as of this weekend.

Results from the PREVENT-19 trial show the vaccine yields a 90% efficacy rate against symptomatic disease. 

COVID-19

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Novavax Moving Forward with COVID-19 Vaccine FDA Submission

 What effect does uncontrolled severe asthma have on patients’ lung function and, more importantly, functional status and quality of life? Geoff, what do you think? Why don’t you start off?

 The evidence is pretty clear that individuals who are uncontrolled both by chronic symptoms and poor ACT [Asthma Control Test] scores and asthma control scores, and people who flare frequently, have a steeper decline in lung function. The individuals that we see who are middle-aged, who’ve had asthma for 20, 30 years and have never been adequately controlled, really have some of the most impressively low lung function that I’ve seen. I saw a gentleman the other day who has an FEV1 [forced expiratory volume in 1 second] of 22% of predicted. He has never had controlled asthma, has never smoked, and doesn’t have alpha-1 antitrypsin deficiency or anything like that. We’ve checked the patient. You can have really horrible decline in lung function and poor quality of life. That links to functional status very well. You need pulmonary reserve, especially as you get older, to exercise and be active. These things really become limiting for people. I talked to a patient yesterday who’s about 70 years old, and she’s had asthma for about 20 years. She said that she had just been looking at her breathing and how it was going to be bad—and continue to get worse—because she had uncontrolled asthma and was on steroids 3 or 4 times a year. Then she received a biologic drug, and she felt like she got her life back. Instead of looking at the next 10 or 20 years of her life as something that was just going to be in decline, she feels as if the whole world is open to her.

That’s a really good point. You raised a very interesting angle, and we all need to keep this in mind when we question the patient. The patient will say, “I’m fine,” but that’s because they reacclimate to the severity of their disease and then acceptance. What we can’t lose sight of, maybe by using objective measures, is really to define: What’s your quality of life? People will acclimate to what their life is like the last month or 2 months and assume a new baseline. We shouldn’t accept that. We should try to strive for the best. Nic, do you have comments on this question?

No. The scenario that Geoff mentioned is very familiar to me. There’s definitely an “aha” effect in many patients when we start treating them right. Unfortunately, most uncontrolled asthmatics don’t have severe asthma, but it affects their quality of life and lung function. Actually, most of the uncontrolled disease is mainly due to an adherence problem with taking the medication or even taking it correctly. But whatever the cause of uncontrolled asthma is, whether it’s severe disease or poor compliance or comorbidities, it affects every aspect. When patients come to me, they want to get their life back. They don’t want to keep missing work. They want to participate in gym again. Asthma should not be a disabling disease, but unfortunately in some of these uncontrolled patients, it can be. That’s what we all strive to improve: To get them back to their life. We can’t cure them, but we can get them better controlled.

It’s a great question. We’re going to finish this segment with the last question. Sid, 1 of the hardest things to understand is an exacerbation of asthma. Is this an exacerbation of a comorbidity that then triggers the asthma attack? How do you define that?

 Sometimes it’s tough. You need to go over the potential reversible factors. Do they start smoking again? Are they really taking their medications? Did the young man just get a new girlfriend and he’s visiting her home, and she has a cat but he’s allergic to cats? What’s happening in the environment? These are some of the things that will let us know. However, as we’ve discussed, there are other comorbidities that may have the same symptoms: chest tightness, wheezing, shortness of breath, and cough. These are all the symptoms that you’ve mentioned—about asthma and other conditions—that the lungs would be related to. At a minimum, I would do a chest radiograph. I would like to see, especially because you’re getting older, if there may be concomitant cardiac disease. Wouldn’t it be something if you saw cardiomegaly [megacardia] on the x-ray or evidence of congestive heart failure, pleural effusion [excess fluid in the pleural cavity], and other things? Certainly, in asthmatics who may develop severe mucus plugging, atelectasis [collapsed lung] of a lobe may suddenly cause worsening. You think it’s asthma. It’s not asthma. It may just be mucus plugging that can be treated in different ways. These are some of the things that I would certainly consider doing the chest x-ray for.

Next, there should be very careful questioning about their sleep. Are they having difficulty with sleep? There’s a particular association between sleep apnea with those who have been put on oral corticosteroids and have weight gain. Sleep apnea is another thing I would be getting to think about. Lastly, there’s GERD [gastroesophageal reflux disease]. You may want to think about this. Although there’s no good evidence that treatment of GERD will improve your asthma, it will certainly improve your heartburn and your nocturnal awakening from that. Lastly, obviously, chronic rhinosinusitis and investigation into sudden nasal polyps that are obstructing the breathing should be taken into consideration. The patient has a perception that this breathing problem is their asthma. 

That last aspect is 1 that resonates with me. I can see someone’s nasal polyposis getting worse, and I can see a gradual increase in the upper-airway symptoms. Geoff, you see that also. Predictably down the road, they will have worsening asthma that requires oral steroids. I find that to be 1 of the major comorbidities. Geoff, have you seen similar aspects?

Yes, absolutely. We know that with this concept of eosinophilic phenotype, there’s a significant percentage of these people who have nasal polyposis. The upper- and lower-airway diseases tend to track together. We used to think, “Well, if you treated their sinuses, then their asthma would get better and you would have some of that for a time.” But now we recognize that we’re probably treating 1 endotype of disease when we’re doing this with systemic steroids. If you put the patient on steroids for their nasal polyps, then you tend to control their asthma. But the moment you get them off, they deteriorate.

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Videos

The panel discusses the effects of uncontrolled severe asthma on patients’ lung function and quality of life and how to determine if worsening symptoms are due to underlying asthma or comorbidities. 

Asthma

Effects of Uncontrolled Severe Asthma 

While clinical care quality improvement (QI) strategies work to control 

, there is limited data on which components of QI strategies work to impact the effects of CVD.

Investigators, led by Kavita Singh, PhD, Public Health Foundation of India, found substantial variations in the type, effectiveness, and implementation of QI strategies for patients with CVD. 

They noted a need for a comprehensive map of cardiovascular QI strategies to identify potential areas of knowledge for improvement of cardiovascular outcomes.

In the study, the team aimed to identify and map evidence on effectiveness and implementation of cardiovascular QI strategies to improve outcomes.

The study population included adults ≥18 years old with established CVD, while intervention included studies that evaluated the effect of any QI intervention (health system-, clinician-, or patient-level) to improve outcomes for patients with CVD.

Further, the investigators considered standard CVD care as the control.

Outcomes included studies that evaluated primary outcomes of changes in cardiovascular risk factors (blood pressure, total cholesterol level) and major adverse cardiovascular events (MACEs).

Secondary outcomes included medication adherence, tobacco cessation, physical activity level, health-related quality of life, cost-effectiveness, hospital readmission, rates, all-cause deaths, and treatment satisfaction.

In addition, investigators included acceptability, fidelity, and feasibility in the outcomes. The study designs included randomized clinical trials (RCTs), cluster RCTs, quasi-randomized studies, and pre-intervention and post-intervention evaluations.

Thus, they performed a systemic scoping review that collected data from 8 electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, the Cochrane Library, ProQuest, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform).

Data was collected from studies published between January 2009 – October 2019, with eligible study designs of randomized trials and pre-intervention and post-intervention evaluations.

Investigators identified a total of 8066 publications, narrowing it down to 892 after screening abstracts.

Of this number, 456 studies met eligibility criteria, including 427 randomized trials, 21 quasi-randomized studies, and 8 pre-intervention and post-intervention.

They noted the studies included were from 45 countries involving 150,148 unique patients, with 61.9% men, mean age of 64.6 years, and 186 unique interventions.

Further, the most common CVD conditions were heart failure (37.9%), stroke (27.6%), post-myocardial infarction (14.0%), and stable coronary artery disease (10.1%).

Investigators found the most evaluated QI strategies were patient support (n = 311), information communication technology (ICT) for health (n = 78), community support (n = 18), supervision (n = 15), and high-intensity training (n = 14)

In addition, most strategies were found to use a combination of 6 elements of the chronic care model (n = 200), with decision support (n = 113), delivery system (n = 99), and self-management support (n = 68) following.

They found 422 studies investigated patient support, ICT for health, community support, and training measures, with 32 studies evaluating clinical outcomes of MACE and results ranging from positive to negative/neutral.

Investigators also noted in group problem-solving studies (n= 8), 3 studies demonstrated improvement in patient self-care and 1 study showed improvement in quality of life. 

Strengthening infrastructure was also associated with improved treatment satisfaction.

However, they observed printed information and financial incentives had no meaningful effect on the patient.

In conclusion, the investigators observed variations in the type. effectiveness, and implementation of QI strategies for patients with CVD.

As a result, the team noted the usefulness of a comprehensive map of cardiovascular QI strategies for future identification of improvements in cardiovascular outcomes.

“Considering substantial variations in types, effectiveness, and implementation, future research should focus on high-quality, outcome-driven, and longer-term studies to understand the potential effect of QI strategies on cardiovascular health,” investigators wrote.

Assessment of Studies of Quality Improvement Strategies to Enhance Outcomes in Patients with Cardiovascular Disease

Data show variations in the type, effectiveness, and implementation of QI strategies for patients with CVD. 

Cardiology

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Effectiveness of Quality Improvement Strategies Varied in Cardiovascular Outcomes

An expert in rheumatic diseases considers therapeutic options for the treatment of SARDS including subcutaneous and intramuscular formulations of Repository Corticotropin Injection as well as immunosuppressive agents. 

Repository Corticotropin and Immunotherapy for SARDS 

Recommendations for treating patients with coronary artery disease and type 2 diabetes with dual antiplatelet therapy based on data revealed by the THEMIS trial. 

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Dual Antiplatelet Therapy for CV Risk Reduction 

Nicola Hanania, MD, MS, explains the pathophysiology of type 2 inflammation in patients with severe asthma and the importance of differentiating TH1-high and TH2-low phenotypes. 

TH2-High and TH2-Low Phenotypes in Severe Asthma 

An expert in hematology/oncology discusses the emerging role of gene therapy to treat sickle cell disease. 

Investigating Strategies to Treat SCD Using Gene Therapy 

A key opinion leader in rheumatology discusses the goals of therapy for SARDs and provides an overview of current approaches to treatment including the use of NSAIDs, corticosteroids, and immunosuppressive agents. 

Goals of Therapy and Treatment Approaches for SARDs 

Carl Regillo, MD and Diana Do, MD react to newer therapies being explored for wet AMD and discuss their place in future therapeutic algorithms. 

Ophthalmology

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Innovative Therapies on the Horizon to Treat AMD 

Strategies used to help determine patients’ risk for cardiovascular disease and the role of lifestyle management in helping reduce the risk for events in patients with type 2 diabetes. 

CV Risk Reduction in Patients with Type 2 Diabetes 

Considerations for using HSCT (hematopoietic stem cell transplantation) in patients with sickle cell disease. 

Stem Cell Transplant: Management of Sickle Cell Disease 

Suspected suicide attempts have increased more among females.

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Suicide Attempts Up Among Adolescents During COVID-19

Investigators study loci and the hereditary nature of the disease, which was categorized as a global health priority by the WHO 3 years ago.

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Latest Clinical News

Supportive Noninvasive Ventilation Safe, Tolerated in Sickle Cell Children

Study Reports on US Incidence, Prevalence of Granuloma Annulare

Novavax Moving Forward with COVID-19 Vaccine FDA Submission

Effects of Uncontrolled Severe Asthma

Effectiveness of Quality Improvement Strategies Varied in Cardiovascular Outcomes