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 appears to better-protect elderly patients in nursing homes from influenza outbreaks when compared to non-adjuvanted vaccines, according to a new study.

Corresponding author Stefan Gravenstein, MD, PhD, of the Warren Alpert Medical School of Brown University, and colleagues, wanted to learn more about how best to prevent deadly outbreaks of influenza in nursing homes. Specifically, the investigators sought to understand whether adjuvanted trivalent influenza vaccine (aTIV) would provide a meaningful benefit versus non-adjuvanted trivalent vaccine (TIV).

An adjuvant is a substance added to a vaccine to boost its efficacy. In the current study, the investigators used the Fluad vaccine, which contains the adjuvant 

 pandemic has been the dominant public health concern for the past 13 months, Gravenstein and colleagues noted that influenza is a perennial threat, particularly to elderly patients living in close quarters, such as in nursing homes and long-term care facilities.

“Influenza outbreaks in nursing homes pose a threat to frail residents and occur even in vaccinated populations,” Gravenstein and colleagues noted.

US Centers for Disease Control and Prevention (CDC) estimates

 for the 2019-2020 influenza season showed that while only about 5% of influenza cases in the US occurred in a patient over the age of 65, that age cohort made up nearly half of the 404,646 hospitalizations for influenza. Those aged 65 and older comprised nearly two-thirds of the 21,909 estimated flu deaths in the US occurred in elderly patients (13,673 deaths).

The push to boost flu vaccinations in nursing homes is not only related to the high risk of death; it also is an 

 because a high number of hospitalizations related to influenza could exacerbate the already stretched capacity of healthcare providers in the United States due to the pandemic.

The new study is based on data from the 2016-2017 flu season. Graventstein and colleagues selected 823 nursing homes for their study, 777 of which reported information related to influenza outbreaks. Those nursing homes were randomized into aTIV and TIV groups, with 387 using adjuvanted vaccines, and the remaining 390 using non-adjuvanted vaccines.

The investigators used CDC definitions for suspected outbreaks and outbreaks with laboratory-confirmed cases to evaluate the nursing homes’ flu seasons, and then adjusted the data for facility-level vaccination rates and the characteristics of the facilities’ residents.

A total of 133 outbreaks were reported at the nursing homes distributing aTIV, versus 162 outbreaks at the nursing homes in the TIV cohort. Most of the outbreaks (115 and 140, respectively) were laboratory confirmed. Using those data, the investigators calculated that the aTIV group had a 17% reduction in suspected and laboratory-confirmed influenza outbreaks. A covariate adjustment further boosted the estimated reduction in outbreaks to 21% for suspected outbreaks and 22% for laboratory-confirmed outbreaks.

Trivalent Fluad is approved by the US Food and Drug Administration (FDA) for patients 65 years and older. A 

 was approved last year, making it the only adjuvanted quadrivalent flu vaccine available in the US.

Adjuvanted influenza vaccine and influenza outbreaks in U.S. nursing homes: Results from a pragmatic cluster-randomized clinical trial

Articles

New data suggests a clear benefit to adjuvanted flu vaccines in elderly populations.

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Influenza

Infectious Disease

Geriatrics

Adjuvanted Flu Vaccine Outperforms Non-Adjuvanted Vaccines in Nursing Home Residents

Findings from a new study indicated that potent or high cumulative amounts of topical corticosteroids was associated with increased risk of 

Given the widespread use of topical corticosteroids in patients with psoriasis, 

, and other inflammatory diseases, assessing the risk of prolonged use of such medications may prove valuable from a public health perspective.

Therefore, a team led by Alexander Egeberg, MD, PhD, Herlev and Gentofte Hospital, University of Copenhagen, Denmark, conducted a nationwide retrospective cohort study to evaluate associations between topical corticosteroids and risks related to osteoporosis.

“Because some patients may consume very large quantities of topical corticosteroids per year, the effect of high cumulative use of potent or very potent topical corticosteroids on the risk for osteoporosis and major osteoporotic fractures needs to be quantified to better support treatment decisions in patients requiring long-term treatment,” Egeberg and colleagues wrote.

Osteoporotic Risks of Topical Corticosteroids

The investigators defined topical corticosteroid exposure as filled prescriptions of cumulative amounts corresponding to the equivalent of at least 500 g of mometasone.

Patients considered exposed were compared with patients using filled prescriptions of 200-499 g — the study reference group. 

The primary endpoints for the study were hospital inpatient or outpatient diagnosis of osteoporosis or major osteoporotic fractures, which was determined in accordance with the World Health Organization’s definition of a fracture of the hip, distal antebrachium, vertebrae, or humerus.

As such, Egeberg and his team evaluated a total of 723,251 adults treated with at least 200 g of mometasone. A majority (52.8%) were women, and the mean age was 52.8 years.

Furthermore, 25.8% of participants were considered exposed to 500-999 g of mometasone. A smaller percentage (13.0%) were exposed to 1000-1999 g, followed by 1.9% who were exposed to at least 10,000 g of mometasone.

The investigators thus reported that hazard ratios of osteoporosis and major osteoporotic factures increased with increasing use of topical corticosteroids.

As such, in terms of risk of osteoporosis, the hazard ratio was 1.06 (95% CI, 1.02-1.09) for exposure to 500-999 g, 1.09 (95% CI, 1.05-1.13) for 1000-1999 g, 1.10 (95% CI, 1.06-1.14) for 2000-9999 g, and 1.24 (95% CI, 1.13-1.36) for exposure to ≥10, 000 g.

In terms of major osteoporotic fractures, the hazard ratio for 500-999 g was 1.01 (95% CI, 0.99-1.03), followed by 1.05 (95% CI, 1.02-1.08) for 1000-1999 g, 1.10 (95% CI, 1.07-1.13) for 2000-9999 g, and 1.27 (95% CI, 1.19-1.35) for exposure to ≥10,000 g.

The team also noted that a doubling of the cumulative topical corticosteroid dose was associated with a 3% relative risk increase of both osteoporosis and major osteoporotic fractures (HR, 1.03 [95% CI, 1.02-1.04] for both).

The overall population-attributable risk was 4.3% (95% CI, 2.7%-5.8%) for osteoporosis and 2.7% (95% CI, 1.7%-3.8%) for major osteoporotic fractures.

And, finally, analysis showed that exposures to ≥10,000 g of mometasone was the lowest exposure for 1 additional patient to be harmed from major osteoporotic fractures.

These findings underscore the importance of careful consideration when prescribing corticosteroids, systemic or topical, in patients with dermatological or inflammatory conditions.

“Although dosage consideration is crucial when prescribing all types of medication, topical corticosteroids are normally prescribed with little thought regarding the applied quantity per skin surface area,” the investigators wrote.

They noted that alternative topical and systemic therapies may offer themselves as better options for inflammatory skin conditions, considering such conditions may require large quantities or prolonged treatment. Nevertheless, they acknowledged, efficacy of such interventions do require further research.

“Alternatively, earlier evaluation of and prophylaxis for osteoporosis and prophylactic therapy may be considered in patients with extensive use of potent and very potent topical corticosteroids,” Egeberg and colleagues suggested.

Association of Potent and Very Potent Topical Corticosteroids and the Risk of Osteoporosis and Major Osteoporotic Fractures

Increasing dosage of mometasone is associated with elevated risk of osteoporosis and major osteoporotic fractures.

Atopic Dermatitis

Dermatology

Osteoarthritis

Rheumatology

Internal Medicine

Prolonged, Potent Topical Corticosteroid Use Linked to Osteoporotic Events

There is not much proven evidence showing the link between smoking status and adverse outcomes from 

In addition, the evidence that does exist does not encompass the cumulative impact of smoking over time.

A team, led by Katherine E. Lowe, MSc, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University School of Medicine, assessed the cumulative effect of smoking over time measured by pack-years through a single study of coronavirus disease 2019 (COVID-19).

In the cohort, the investigators examined patients with lung cancer who tested positive for COVID-19 between March 8 and August 25, 2020 and had full smoking information recorded.

The investigators identified 7102 patients, 6020 of which were never smokers, 172 were current smokers, and 910 were former smokers.

The researchers used a COVID-19 registry that began at the Cleveland Clinic last March and included all patients tested for COVID-19 within the Cleveland Clinic Health system in Ohio and Florida.

They collected basic demographic information during testing, including age, height, weight, self-reported gender, self-reported race, and selective comorbidities. They also extracted additional data on comorbidities, medications, and outcomes from patient electronic medical records.

The investigators classified patients based on their cumulative recorded smoking exposure, including those who were never smokers compared to patients reporting 0-10 pack-years, 10-30 pack-years, and more than 30 pack-years. Demographic differences between the different groups and previous literature on the risk factors of adverse COVID-19 outcomes informed the overall study modeling.

The investigators also used multivariable logistic regression models to determine the odds ratio (OR) for hospitalization following a positive test, admission to the intensive care unit given hospitalization, and death following a positive test for each pack-year cohort compared to never smokers.

The team also used regression models run unadjusted, adjusted for identified confounders such as age, race, and gender, and adjusted for mediators adding coronary artery disease, hypertension, chronic obstructive pulmonary disease, diabetes, use of angiotensin receptor blockers, and use of oral or inhaled corticosteroids.

Finally, the researchers used likelihood ratio tests to determine whether a given covariate would remain in the model.

The investigators found a dose-response association between pack-years and adverse COVID-19 outcomes.

The patients who smoked more than 30 pack-years had a 2.25 times higher odds of hospitalization (95% CI, 1.76-2.88). This patient population was 1.89 times more likely to die following a COVID-19 diagnosis (95% CI, 1.29-1.76) when compared with never smokers. The link between cumulative smoking and adverse outcomes is likely mediated in part by the individual’s comorbidities.

The odds ratios for all adverse outcomes were attenuated in the mediation models.

The researchers also did not find evidence of effect modification by smoking status.

“We have demonstrated in this single central registry of patients who tested positive for COVID-19 that increased cumulative smoking was associated with a higher risk of hospitalization and mortality from COVID-19 in a dose-dependent manner,” the authors wrote.

Association of Smoking and Cumulative Pack-Year Exposure With COVID-19 Outcomes in the Cleveland Clinic COVID-19 Registry

Increased cumulative smoking was associated with increased risk of hospitalization and death. 

Coronavirus

Pulmonology

Hospital Medicine

Family Medicine

Researchers Explore Link Between Smoking Status and COVID-19 Outcomes

The US Food and Drug Administration (FDA) has approved carglumic acid (CARBAGLU) tablets 200 mg for the treatment of 

 associated with propionic acidemia and methylmalonic acidemia.

The approval allows Recordati Rare Diseases to move forward with the treatment as an adjunctive therapy to standard of care for both pediatric and adult patients.

Carglumic acid represents the first and only approved medication for acute hyperammonemia because of propionic acidemia and methylmalonic acidemia.

The drug was initially approved for N-acetylglutamate synthase (NAGS) deficiency, another rare metabolic disorder, as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency, and maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.

PA and MMA are both rare inherited metabolic disorders that cause dysfunction of a specific step of amino acid catabolism or breaking down of certain fatty acids because of deficient enzyme activity. This results in toxic metabolites to accumulate, causing hyperammonemia.

The treatment acts a replacement for N-acetylglutamate (NAG) in NAGS deficiency, PA, and MMA patients by activating carbamoyl phosphate synthetase (CPS 1), improves or restores the function of the urea cycle, and facilitates ammonia detoxification and urea production.

The approval is based on the results of a randomized, double-blind, placebo-controlled, multicenter trial comparing the study drug to placebo in PA or MMA patients with hyperammonemic episodes.

The efficacy profile was based on 90 hyperammonemic episodes for 24 patients, showing that patients who received carglumic acid demonstrated a quicker reduction of ammonia compared to the placebo group.

The researchers sought primary endpoints of the time from the first dose to the earlier of blood ammonia level below 50 micromol/L or hospital discharge. Throughout the first 3 days of treatment there was a higher proportion of carglumic acid patients that reached the primary endpoint.

There was also at least 1 adverse reaction reported by 42.2% of the 90 hyperammonemic episodes that occurred, with the most common events being neutropenia, anemia, vomiting, electrolyte imbalance, decreased appetite, hypoglycemia, lethargy/stupor, encephalopathy, and pancreatitis/lipase increased.

"There are few approved drugs that treat hyperammonemia, and none that are indicated for the treatment of acute hyperammonemia in PA and MMA patients," said Mendel Tuchman, MD, Medical Geneticist and Professor Emeritus of Pediatrics at The George Washington University School of Medicine and Health Science, in a 

. "Carbaglu has the potential to impact these patients by reducing high plasma ammonia levels during critical situations."

The treatment is the first approved medication for this patient population. 

Rare Disease Report®

FDA Approves Carglumic Acid for Acute Hyperammonemia Associated with PA or MMA

Researchers may have developed a new method in identifying patients at a high risk of developing 

A team, led by Meghan G. Lubner, MD, Department of Radiology, University of Wisconsin School of Medicine and Public Health, E3/311 Clinical Science Center, evaluated the utility of laboratory and CT metrics in identifying which patients are at a higher risk of developing NAFLD.

The study included 186 patients with biopsy-proven NAFLD who underwent CT within 1 year of a biopsy. The mean age of the patient population was 49 years old.

A total of 87 (47%) patients had nonalcoholic steatohepatitis (NASH) and 112 (60%) had moderate to severe steatosis. There were also a total of 51 patients classified as fibrosis stage F0, 42 individuals classified as F2, 37 patients as F3, and 33 participants as F4.

In addition, 70 (38%) individuals had advanced fibrosis—stage F3 or F4—considered to have high-risk for NAFLD.

The researchers performed a histopathologic review to determine steatosis, inflammation, and fibrosis and categorized the presence of any lobular inflammation and hepatocyte ballooning as NASH.

Patients with NAFLD and advanced fibrosis—classified as a stage F3 or higher—were categorized as having high-risk disease. The researchers also calculated aspartate transaminase to platelet ratio indexes and Fibrosis-4 laboratory scores.

The CT metrics in the study included hepatic attenuation, liver segmental volume ration, splenic volume, liver surface nodularity score, and selected texture features.

In addition, a pair of readers subjectively assessed the presence of NASH and fibrosis.

Overall, FIB-4 score correlated with fibrosis (ROC AUC of 0.75 for identifying high-risk NAFLD), while the individual CT parameters, LSVR and splenic volume performed best (AUC of 0.69 for both for detecting high-risk NAFLD).

Subjective reader assessment performed best among all parameters (AUCs pf 0.78 for reader 1 and 0.79 for reader 2 for detecting high-risk NAFLD.

FIB-4 and subjective scores were complementary (combined AUC of 0.82 for detecting high-risk NAFLD) and for NASH assessment, FIB-4 performed best (AUC of 0.68), while the AUCs were less than 0.60 for all individual CT features and subjective assessments.

“FIB-4 and multiple CT findings can identify patients with high-risk NAFLD (advanced fibrosis or cirrhosis),” the authors wrote. “However, the presence of NASH is elusive on CT.”


NAFLD is a condition where excess fat is stored in the liver. However, this condition does not usually cause symptoms and is most often found when blood tests indicate elevated liver enzymes.

When the fat builds up, it can cause inflammation and damage, causing NASH, which can lead to scarring of the liver and cirrhosis.

Non-alcoholic fatty liver disease is often linked to obesity, with the prevalence of both diseases becoming increasingly notable. Research indicates that NAFLD is found in 40-80% of individuals who have type 2 diabetes and 30-90% of people who are obese.

However, there is a lack of effective treatments currently available for NAFLD, leading to many researchers taking alternative approaches for new treatments. There are currently no medicines approved by the US Food and Drug Administration (FDA) to treat NAFLD.

Utility of Multiparametric CT for Identification of High-Risk NAFLD

Subjective reader assessments performed best among several different parameters.

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New Way to Identify High-Risk NAFLD Patients

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Diabetic Preventive Practices Are Variable Among Patient Populations

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Prolonged, Potent Topical Corticosteroid Use Linked to Osteoporotic Events

Researchers Explore Link Between Smoking Status and COVID-19 Outcomes

FDA Approves Carglumic Acid for Acute Hyperammonemia Associated with PA or MMA

New Way to Identify High-Risk NAFLD Patients