The American Cough Conference was held June 11-12. Coverage from the meeting, which brought together health care professionals involved in the research and management of patients with cough, is now available.

Coverage of the American Cough Conference

The SLEEP Meeting was held June 10-13. Coverage includes session summaries and interviews with key opinion leaders in sleep and circadian science.

Coverage of the SLEEP Meeting

Coverage from the EHA2021 Virtual Congress, including session summaries, poster write-ups, and interviews with key opinion leaders is now available

Coverage of EHA 2021

If 2020 was dominated by the news of how COVID-19 spread across the globe, then 2021 has so far been focused on ending the pandemic through vaccine distribution.

A Timeline of COVID-19 Vaccine Developments in 2021

We interview experts on investigational treatments such as liso-cel, and ask how to bring them to community practice.

Spotlight on CAR T-Cell Therapy

The American Journal of Accountable Care® features research and commentary on new payment models.

New Members for AJAC Board

Earlier this month, drugmakers unveiled positive new phase 2 data for a pair of therapies targeting 2 types of non-Hodgkin lymphomas.

The chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) had an overall response rate (ORR) of nearly 90% among patients with relapsed or refractory follicular lymphoma, and the humanized Fc-modified cytolytic CD19-targeting monoclonal antibody tafasitamab (Monjuvi) had an ORR of more than 50% when administered in combination with lenalidomide (Revlimid) to patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Both sets of data were unveiled at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which was held earlier this month in a virtual format.

Novartis AG released the pivotal phase 2 data from its ELARA trial, showing tisagenlecleucel led to an ORR of 86% (95% CI, 78-92) in patients with follicular lymphoma, and a 66% complete response (CR) rate (95% CI, 56-75).

 None of the 97 patients evaluated for safety experienced grade 3 or 4 cytokine release syndrome (CNS), the most common adverse event associated with CAR T-cell therapies, though nearly half (49%) had grade 1 or 2 CNS.

“Our goal as researchers is to continue to explore the potential of CAR-T therapy, and the robust ELARA safety and efficacy findings suggest Kymriah may play an important role in the third-line treatment of relapsed or refractory follicular lymphoma,” said Stephen J. Schuster, MD, of the University of Pennsylvania’s Perelman School of Medicine, in a press release.

The ELARA trial had a median follow-up of 11 months, by which time the duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached. Schuster and colleagues estimated DOR for patients with CR at six months to be 94% (95% CI, 82-98) and 76% for patients with PFS at six months (95% CI, 65-84). The median number of prior therapies in the cohort was 4, though the range went from 2-13 prior therapies.

Nine percent of patients reported grade 1 or 2 neurological events, and 1 patient had a grade 4 neurological event, though all recovered. The most common grade 3 or higher adverse events in the first 8 weeks following infusion were neutropenia (28%) and anemia (13%). No treatment-related deaths were reported.

Novartis said it is committed to expanding the availability of CAR T-cell therapies, and will push forward with regulatory submissions for the indication as soon as possible.

 Meanwhile, Incyte Corp. and MorphoSys US Inc. said its phase 2 L-MIND trial showed tafasitamab had an ORR of 57.5% (46 out of 80 patients; 95% CI, 45.9-68.5) when given to patients with relapsed or refractory DLBCL in combination with lenalidomide.

 Forty percent of patients achieved CR, and the median duration of response was 43.9 months (95% CI, 26.1 - not reached) The median OS was 33.5 months (95% CI, 18.3 - not reached) and the median PFS was 11.6 months (95% CI, 6.3-45.7).

“The three-year follow-up data not only show a durable response and consistent safety profile in patients with relapsed or refractory DLBCL treated with tafasitamab plus lenalidomide, it also suggests the combination could potentially lead to durable remission,” said MorphoSys senior vice president Nuwan Kurukulasuriya, 

 “We are looking forward to sharing these long-term follow-up findings with the scientific community.”

Tafasitamab in combination with lenalidomide was approved by the Food and Drug Administration via its accelerated approval pathway last July for the treatment in adult patients with relapsed or refractory DLBCL not otherwise specified, including those arising from low-grade lymphoma, who are not eligible for autologous stem cell transplantation.

Schuster SJ, Dickinson MJ, Dreyling MH, et al. Efficacy and safety of tisagenlecleucel (Tisa-cel) in adult patients (Pts) with relapsed/refractory follicular lymphoma (r/r FL): Primary analysis of the phase 2 Elara trial. 

. 2021;39(Suppl 15): abstr 7508. doi:10.1200/JCO.2021.39.15_suppl.7508

Novartis’ Kymriah pivotal trial demonstrates strong response rates and remarkable safety profile in relapsed or refractory follicular lymphoma. News release. Novartis; June 2, 2021. Accessed June 19, 2021. 

https://www.novartis.com/news/media-releases/novartis-kymriah-pivotal-trial-demonstrates-strong-response-rates-and-remarkable-safety-profile-relapsed-or-refractory-follicular-lymphoma

Düll J, Maddocks KL, Gonzalez-Barca E, et al. Long-term analyses from L-MIND, a phase II study of tafasitamab (MOR208) combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). J Clin Oncol. 2021;39(Suppl 15): abstr 7513. doi:10.1200/JCO.2021.39.15_suppl.7513

Incyte and MorphoSys announce three-year results from phase 2 L-MIND study of tafasitamab in combination with lenalidomide for the treatment of relapsed or refractory DLBCL. News release. BusinessWire; June 4, 2021. Accessed June 19, 2021. 

https://www.businesswire.com/news/home/20210604005569/en/Incyte-and-MorphoSys-Announce-Three-Year-Results-from-Phase-2-L-MIND-Study-of-Tafasitamab-in-Combination-with-Lenalidomide-for-the-Treatment-of-Relapsed-or-Refractory-DLBCL

Articles

Phase 2 Data for Tisagenlecleucel, Tafasitamab Show Objective Responses in More Than Half of Patients

Racial disparities in health outcomes, including in cancer, are well documented. However, it’s not always clear how biological or socioeconomic factors affect these disparities, or whether advances in genomics and precision medicine have an impact.

Now, new research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting is painting a clearer picture of what drives differences in mortality and outcomes for patients with prostate cancer, which has higher incidence and mortality among Black men.

The lifetime probability of developing prostate cancer is 18.2% among Black men compared with 13.3% among White men. Black men are also significantly more likely to die of prostate cancer than White men (4.4% vs 2.4%).1

Although the advances in genomics and precision medicine promise to improve risk prediction and outcomes for many cancers, they may actually exacerbate these disparities. In a study presented as an abstract by Foundation Medicine and collaborators, Brandon Mahal, MD, assistant professor of Radiation Oncology and Assistant Director of Community Outreach and Engagement at the Sylvester Comprehensive Cancer Center, and researchers looked at how patterns of comprehensive genomic profiling and treatment varied by race.2

The data, coming from the largest known cohort of its kind, revealed that despite having similar frequency of actionable gene alterations, men of African descent were less likely than men of European ancestry to receive early comprehensive genomic profiling and be enrolled in clinical trials.

The researchers collected data on over 11,000 patients with advanced prostate cancer with comprehensive genomic profiling, including 1400 men of African descent and 9200 patients of European descent. They also analyzed real-world data from nearly 900 patients from Foundation Medicine and Flatiron Health’s clinic-genomic database.

, DNA damage response pathway genes, and actionable genes were similar across the 2 ancestry types. And while both groups were just as likely to receive immunotherapy and PARP inhibitor treatment, men of African descent were nearly 3 times less likely to receive an investigational treatment in a clinical trial compared with men of European descent (11% vs 30%). This remained true even among men with actionable alterations (1% vs 6%).

“Men of African ancestry experience the greatest burden of disease in prostate cancer, and this research indicates that differences in cancer care are not solely based on biological factors, but rather points to socioeconomic factors such as access to comprehensive genomic profiling and clinical trial enrollment,” Mahal said in a statement.3 “To ensure equitable opportunities for precision medicine, we need to expand access to and awareness of advances that impact patient care and outcomes, including timely use of genomic testing to help make informed treatment decisions.”

During a separate presentation, Mahal explained that most genomic studies are based on Eurocentric cohorts, with approximately 80% of patients included in the genome-wise association study (GWAS) being of European descent despite accounting for 16% of the population, leaving the door open to worsening disparities due to a lack of representative studies.4

Mahal outlined several approaches that could be taken to both study and address disparities in prostate cancer, including:

Transdisciplinary research that bridges basic, clinical, and epidemiological research

Precision medicine used as a means to identify mechanisms of disparity

Outreach program to bring care delivery and cutting-edge science to diverse communities.

1. Cancer Facts & Figures for African Americans 2016-2018. American Cancer Society website. Accessed June 18, 2021. 

https://www.cancer.org/research/cancer-facts-statistics/cancer-facts-figures-for-african-americans.html

2.Sivakumar S, Lee J, Moore J, et al. Ancestral characterization of the genomic landscape, comprehensive genomic prostate cancer: A large-scale analysis. 

. 2021;39(Suppl 15): abstr 5003. doi:10.1200/JCO.2021.39.15_suppl.5003

3. New study results presented by Foundation Medicine and collaborators at ASCO21 on cancer care underscore importance of equitable access to precision medicine advances. News release. Foundation Medicine; June 4, 2021. Accessed June 6, 2021. 

https://www.foundationmedicine.com/press-releases/aa904bd1-4854-44e9-8d03-24b5af5ff392

4. Martin AR, Kanai M, Kamatani Y, et al. Clinical use of current polygenic risk scores may exacerbate health disparities. 

New research presented at the 2021 American Society of Clinical Oncology Annual Meeting is painting a clearer picture of what drives differences in mortality and outcomes for patients with prostate cancer. Black men with prostate cancer have higher incidence of both.










Study Finds Genomics, Precision Medicine May Exacerbate Racial Disparities in Prostate Cancer

A new analysis elucidates the links between 

 (AD) and major depressive disorder (MDD), suggesting the former promotes the pathological development of MDD.

The study, which was published in the journal 

 could help better explain the pathogenesis of MDD and potentially lead to new targets for preventative therapies.

Corresponding author Xuehua Huang, PhD, of Sichuan University, and colleagues, explained that AD has a number of consequences that can intersect with quality-of-life diminishment, including irritation, itching, and sleep disturbances. However, patients with AD also have a higher prevalence of MDD, which is defined as experiencing at least 2 weeks of pervasive “low” mood. One study found as many as 1 in 3 patients with AD met the criteria of MDD.

Yet, it is not yet clear what mechanistic link, if any, exists between AD and MDD. In hopes of finding out, Huang and colleagues conducted a literature review in search of proteins, cells, functional classes, and small molecules linking AD and MDD. They then analyzed gene expression variance of MDD-regulating genes and then examined the functionality of AD-driven MDD-genetic regulators.

The analysis found 22 entities driven by AD that were upstream MDD regulators, 11 of which were genes. Four of those genes had significant expression changes in AD, and those changes were found to align with the development of MDD.

Of the 11 MDD-regulating genes driven by AD, the investigators said 8 are MDD promoters and the remaining 3 are MDD inhibitors. Four of those genes had significant expression changes in patients with AD, including one MDD promoter (

“These results support the relationship between these four genes, AD, and MDD, suggesting that AD might regulate the expression levels of these four genes to influence the pathological development of MDD,” they said.

The authors cautioned, however, that the expression data come from skin and blood samples. They said a more direct experiment should be conducted, using data from peripheral blood only.

Huang and colleagues also noted that the expression changes of 2 additional genes (

) “might not favor the development of MDD.” Thus, they said, the issue warrants additional study.

Most of the genes regulating MDD “were enriched with cytokine/chemokine regulation and neuroinflammatory response-related pathways,” which aligns with earlier findings that cytokine/chemokine overexpression, which has been linked with the pathogenesis of MDD, is present in AD.

“Our results showed that AD could influence multiple MDD regulators at different levels and drive cytokine/chemokine regulation and inflammatory response-related pathways that play important roles in the development of MDD,” Huang and colleagues wrote.

The authors said their findings also support the idea that cerebral inflammation plays an important role in the development of depression and other neuropsychiatric diseases.

“Elevated microglia activation and neuroinflammatory response have been observed in the brains of AD by using a mice model,” Huang and colleagues said, “which may add to the explanation of the AD-promoting effect on the development of MDD. Moreover, three out of the 11 AD-driven MDD regulating genes presented physical linkage to common targets, supporting their functional connection.”

Yang T, Huang X, Xu J, et al. Explore the underlying mechanism between atopic dermatitis and major depressive disorder. 

. 2021;12:640951. Published online May 28, 2021. doi:10.3389/fgene.2021.640951

The analysis identified 4 genes that were driven by atopic dermatitis (AD) and which had significant expression changes in favor of MDD development.

Analysis Supports Link Between AD, MDD Pathogenesis

 (MS) globally, and epilepsy occurs in 3% of patients, according to a new review article.

The report provides a more comprehensive and international picture of the co-incidence of MS with seizure/epilepsy, an issue that has been studied extensively on a smaller scale, but which remains shrouded in considerable mystery. The findings were 

International Journal of Preventive Medicine

Seizure and epilepsy are known to be more prevalent in persons with MS than in the general population, although reports from different regions and countries have reached different prevalence conclusions, according to corresponding author Mahsa Ghajarzadeh, MD, MPH, PhD, of Tehran University of Medical Science, in Iran, and colleagues.

The investigators searched several scholarly databases in search of studies and abstracts looking at seizure and epilepsy in MS that were published up until October 2019. Nearly 5000 studies were identified. After eliminating duplicates, non–cross-sectional studies, and those not published in English, the authors had 39 studies and abstracts to include in their final analysis. The studies were published between 1972 and 2019, and the majority (29) were published in Europe.

Ghajarzadeh and colleagues found a pooled prevalence of seizure in MS cases of 2% (95% CI, 1%-3%), and a pooled prevalence of epilepsy of 3% (95% CI, 2%-4%). Rates varied significantly by continent.

Studies from Asia showed an epilepsy prevalence of 6%, while the prevalence was 3% in both Europe and America. The investigators said they did not believe that location was the cause of the heterogeneity, noting that “the level of heterogeneity decreased after subgroup analysis in Asian and American subgroups.”

The investigators said their findings align with previous research estimating the prevalence of epilepsy in MS being between 3.2% and 4%, which is roughly 4 times the rate of epilepsy in the general population. They said epilepsy could have a significant impact on disease progression, increasing the likelihood that relapsing-remitting MS becomes secondary-progressive MS. Epilepsy in MS has also been linked with more intensive cortical inflammation.

“Seizure/epilepsy can be the first symptom of MS, the incidence rate of which increases with the longer duration of the disease or the higher number of lesions,” they wrote. “However, no relationship has been found between the severity of MS and epilepsy.”

Turning to seizures, the authors said it is not yet known how they affect MS prognosis, and the issue remains highly controversial.

“The cause of seizure in MS is not clear; however, cortical and juxtacortical inflammation, demyelination, and atrophy are considered to play a role in the development of seizures/epilepsies in MS,” Ghajarzadeh and colleagues wrote.

More broadly, the authors said much remains unknown about the issue of seizures/epilepsy in MS. Seizures can occur at any time during MS, and all types of seizures have been reported. Some researchers have pointed to focal seizure followed by secondary progression as the most prevalent type of seizure in patients with MS, but others have found primary generalized tonic-clonic seizures to be the most common.

The investigators said patients with seizures are generally advised to take antiepileptic medications to prevent new seizures and status epilepticus.

Mirmosayyeb O, Shaygannejad V, Nehzat N, Mohammadi A, Ghajarzadeh M. Prevalence of seizure/epilepsy in patients with multiple sclerosis: a systematic review and meta-analysis. 

. 2021;12:14. Published 2021 Feb 24. doi:10.4103/ijpvm.IJPVM_75_20

The report gives a more holistic picture of a highly studied by little understood issue in multiple sclerosis.

Review Finds 3% of Patients With MS Have Epilepsy, 2% Experience Seizures

Hidradenitis suppurativa (HS), also known as acne inversa, impairs quality of life (QOL) more than 

Approximately 60% of HS patients reported very or extremely large QoL impairment, according to the study published in 

. The degree of disturbance correlated with the severity of changes to the skin, blood leucocyte count, and particularly with presence in the anogenital region as well as the presence of nodules and fistulas.

HS is a chronically relapsing inflammatory disease with characteristic alterations in skinfolds. It is estimated to affect about 1% of the population, generally occurring in the second and third decade of life. It can also affect the inner thighs, perineal area, and the lower boundary where the breast and chest meet. It causes painful bumps under the skin in the hair roots near the sweat glands that can become infected. Inflammation can be destructive to the skin and lead to scarring.

HS is frequently associated with both spondyloarthritis and metabolic alterations, which increase the risk of cardiovascular disease and reduces life expectancy, the authors said.

The study involved 462 patients suffering from HS who visited University Hospital Charité in Berlin from 2012 to 2017. It showed that QOL important was also associated with specific comorbidities, including obesity and back pain, but not with family history of HS. QOL analysis was based on the Dermatology Life Quality Index, with scores ranging from 0 (no impairment) to 30 (maximum impairment), with 10 indicating being severely affected.

The average score of all HS patients was 13.18 (standard deviation, 0.37). A very large impairment (between 10 and 20) was reported by 40.3% of patients, and 20.1% reported an extremely large impairment (above 20). Questions focusing on symptoms like pain, soreness, stinging, itching, embarrassment, or restrictions in self-consciousness produced the highest values of impairment.

The level of impairment was significantly worse compared to patients with other chronic skin diseases including alopecia areata, acne vulgaris, vitiligo, atopic eczema, psoriasis vulgaris, and nonmelanoma cancer, the authors said. The presence of soreness and pain, as well as embarrassment, seem to be crucial contributors to lower QOL. Being affected in the anal and genital regions also showed a substantial negative impact on QOL, likely due to psychological effects in addition to pain, malodorous secretion, and limited mobility.

There were no differences between patients with small to moderate vs. large QOL impairment regarding having undergone resection surgery or antibiotic treatment, suggesting these classical treatment options do not lead to long-lasting QOL improvement. 

The study found a significant association between QOL and body mass index (

 = .000), as well as between QOL and waist circumference (

= .002). But no correlation was found in relation to patients’ age, disease duration, family history, or gender.

The authors said the findings support the necessity of prescribing anti–tumor necrosis factors. Adalimumab (Humira) and its biosimilars are approved for moderate to severe HS and have been demonstrated to improve QOL in trials and clinical practice.

Schneider-Burrus, Tsaousi A, Barbus S, et al. Features associated with quality of life impairment in hidradenitis suppurativa patients. 

 (2021);8: 538. doi:10.3389/fmed.2021.676241

Hidradenitis suppurativa impairs quality of life (QOL) more than many other dermatological conditions, a new study shows.

Study Details Effects of Hidradenitis Suppurativa on QOL

Two Clinical Trials Assessing Novel Gene Therapies in PD Underway

, Bayer announced updates on their phase 1 and phase 1b clinical trials of gene therapies for the treatment of PD. In the 

, BlueRock Therapeutics, a subsidiary of Bayer, began administering doses of its DA01 candidate, a gene therapy consisting of 

Designed to innervate the putamen, the investigational therapy seeks to reverse the degenerative process and potentially restore motor function in people with PD, a benefit that has yet to be achieved.

 assessing glial cell line–derived neurotrophic factor (GDNF) gene therapy, manufacturer Asklepios BioPharmaceutical, another subsidiary of Bayer, has begun enrolling patients to examine the preliminary efficacy and safety of the 1-time treatment. Providing a continuous production of GDNF, the therapy is designed to promote the survival and functioning of brain cells associated with degeneration in PD.

Novel DBS System Gains FDA Approval in Treatment for Movement Disorders

 Medtronic’s SenSight Directional Lead System for deep brain stimulation (DBS) therapy, the first directional, sensing-enabled lead designed to enhance the detection of local field potentials (LFPs) in the treatment of symptoms associated with PD and other movement disorders.

, LFP brain signals correlate with the severity of PD symptoms and are 1 million times smaller than DBS stimulation pulses. When pairing it with the Percept PC device, the system will expand on Medtronic’s BrainSense technology, enabling clinicians to capture and record enhanced, directional LFP information from the implanted lead.


Furthermore, in detecting LFPs, clinicians can then correlate these brain signals with stimulation and events capturing medication, symptoms, and adverse effects, which will provide patients with a personalized, data-driven therapy that would be adjusted as treatment needs evolve.


Integrating Advanced Practice Clinicians in Care of Neurologic Conditions

, Calli L. Cook, NP, DNP, nurse practitioner, Woodruff School of Nursing at Emory University, spoke on the reluctance among neurologists in integrating advanced practice clinicians, also known as advanced practice providers (APPs), in the neurology field.


Discussing her viewpoint editorial on the issue, Cook said that neurologists have concerns on integrating APPs due to issues such as return on investment implications, the potential financial and mental stress of replacing an APP, and the time it takes to have them fully comfortable with the system of care. Moreover, APPs have voiced their own concerns that align mostly with those of neurologists, including monetary issues and fear of having their voices marginalized.


Able to assist with seeing urgent new and returning patients in the office, expediting admissions and discharges, and patient education, Cook said that a multilevel effort is warranted to incorporate APPs into common multidisciplinary neurology care.

An overview of the latest news in Parkinson disease reported across MJH Life Sciences™.

Latest News in Parkinson Disease: Gene Therapy Clinical Trials, FDA Approves Novel DBS System, and More

 since 2019 and has a BA in philosophy and journalism & professional writing from The College of New Jersey. 

Throughout the COVID-19 pandemic, more Finnish children with 

 (T1D) had severe diabetic ketoacidosis (DKA) at the time of diagnosis, according to study 

However, this was most likely due to diagnostic delays resulting from changes in parental behavior and health care accessibility, the authors wrote.

Although reports suggested an increase in the number of children with newly diagnosed T1D throughout the pandemic, due to the lack of epidemiological studies on the matter, “it is unclear whether there is a true increase in the T1D incidence or rather an exacerbation of the disease presentation,” they explained.

Finland currently has the highest incidence of T1D in the world, and during COVID-19, the researchers noticed more children were admitted to the pediatric intensive care unit (PICU) at Helsinki University Hospital (HUH) for newly diagnosed T1D, beginning in May of 2020.

To determine whether T1D occurrence had increased or disease presentation at diagnosis worsened, the authors conducted a retrospective cohort study using datasets of children who received their T1D diagnosis between April and October 2020. Findings were then compared to rates seen between April and October of 2016 through 2019.

One dataset included all children admitted to the PICU at HUH for new-onset T1D with severe DKA while the second data set consisted of all children prospectively enrolled in the Finnish Pediatric Diabetes Registry (FPDR) from the HUH district.

Information on patient characteristics, duration of symptoms, length of stay, and biochemical findings upon presentation was included in the final analysis.

The number of children admitted to the PICU due to new-onset T1D increased from an average of 6.25 admissions in 2016-2019 to 20 admissions in 2020 (incidence rate ratio [IRR], 3.24; 95% CI, 1.80-5.83; 

On average, 57.75 children were registered to the FPDR in 2016-2019 compared with 84 in 2020 (IRR, 1.45; 95% CI, 1.13-1.86; 

Thierty-three of the children who got their diagnosis in 2020 were analyzed for SARS-CoV-2 (the virus that causes COVID-19) antibodies, and all were negative

During the pandemic period, 84 children with newly diagnosed T1D from the HUH district were registered to the FPDR compared with 53 to 62 (mean, 57.75) children each year in the prepandemic periods from 2016 to 2019

Because none of the children had SARS-CoV-2 antibodies, the researchers concluded COVID-19 was not the primary trigger for more severe presentation of T1D or for the increase in children with a T1D diagnosis, they explained.

Findings are also in line with increased incidence of DKA in children with new-onset T1D in Italy, Germany, the United Kingdom, and Australia during the COVID-19 pandemic.

“A longer follow-up is needed to confirm the change in the T1D incidence. Furthermore, we cannot exclude the possibility that the pandemic could have influenced the participation or recruitment to the FPDR,” the authors wrote.

In addition, the potential association of COVID-19 with either increasing incidence of T1D or more severe disease presentation needs to be addressed as T1D may be triggered by viral infections in susceptible individuals, they added.

Many patients admitted to the PICU were symptomatic for longer periods of time compared with patients admitted in previous years. Furthermore, regardless of high or low infection rates in certain geographic areas, data showed COVID-19 infection control measures led to severe delays in the diagnosis and treatment of critically ill children.

The researchers noted that during the start of the pandemic, their hospital’s pediatric emergency department visits dropped by 45%. “Social distancing measures, prioritization of COVID-19 infection control in health care, and, possibly, unfounded parental fears of their child contracting COVID-19 seem to have needlessly impaired the functioning of the health care system,” they explained.

Should future waves of the pandemic occur, the authors stressed the importance of balancing social distancing promotion to the public against risks of this advice to families with children. “Health care providers must learn to prioritize their functions so that patients at risk for critical illness are not missed. Otherwise, children continue to be at risk of becoming collateral damage of infection control measures designed to protect adults,” the researchers concluded.

Salmi H, Heinonen S, Hästbacka J, et al. New-onset type 1 diabetes in Finnish children during the COVID-19 pandemic. 

Published online May 27, 2021. doi:10.1136/archdischild-2020-321220

Study results indicate COVID-19 transmission mitigation efforts may have led to delayed diagnoses of type 1 diabetes (T1D) in Finnish children, resulting in more cases of diabetic ketoacidosis at presentation. 

Pandemic Mitigation Efforts May Have Aggravated Pediatric T1D Presentation 

® since 2019 after receiving his Bachelor's degree at Rutgers University–New Brunswick in journalism and economics.

With the Affordable Care Act (ACA) upheld by the Supreme Court yesterday in a 

 indicating that plaintiffs seeking to declare the law unconstitutional 

, HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure discussed in a press call today next steps to continue to build the landmark law.

On the eve of the newly inaugurated federal holiday 

, Becerra opened the discussion by highlighting notable populations, including 133 million Americans with pre-existing conditions, who will continue to be insured under the ACA.

“At stake, women's health, the need for access to birth control, life-saving maternal care, preventative care for women would have been gone had the ACA disappeared. At stake, millions of Americans who can only afford their prescription drug medications because of the ACA—we can all rest a little easier,” said Becerra.

 by COVID-19, there remains a significant proportion of the US population who continue to be affected by disparities in access to health care. Although progress has been made from 2010 to 2019 as the uninsured rates of Americans in the Latino community dropped by 10% and in the Black community by 8%, certain geographical locations still demonstrate markedly higher uninsured rates.

For example, in Colorado, where Becerra conducted the call from and is set to meet with a number of community leaders, the state’s uninsured rates are 8.5% for Black Americans and nearly 16% for Latino Americans.

So, what are the next steps to improve health care access following the ACA decision?

Becerra noted some of the ongoing efforts by HHS to address barriers to health coverage nationwide, which will leverage funding from the 

 to support prevention services and COVID-19 response for 1400 HHS community-funded health clinics.

“The patients that we've been reaching through these dollars, about 91% of them live at or below 200% of the federal poverty guidelines, and nearly 63% of them, almost two-thirds, are racial or ethnic minorities.”

Additionally, Becerra detailed plans to tackle US maternal mortality rates, which have been 

 to be 3 to 4 times higher for Black women compared with White women.

“The president's budget also dedicates about $138 million to improve maternal health, and specifically to reduce maternal mortality and morbidity. And it provides an additional $92 billion above what was provided last year,” said Becerra. “Those funds will support the maternal mortality review committee, which advances the administration's goals of reducing maternal death rates nationwide, and we're working with communities to reach those women who do need those services upfront.”

Working in a partnership with the state of Illinois, he said that they are implementing a full 360 days of coverage under Medicaid for a woman postpartum, compared with the 60 days of postpartum care currently provided.

This could have a significant impact on maternal mortality rates, as CMS Administrator Chiquita Brooks-LaSure discussed in the call that many of the health outcomes that we see in maternal deaths and other adverse events actually come in the several months after a baby is born, “which is why we really need to make sure that we have continuity of coverage.”

Speaking further on the importance of the Supreme Court decision, she said that the ACA has reduced or eliminated barriers limiting health coverage, including the 

, as well as expanded access to Medicaid.

“The Medicaid expansion has been found to significantly lower maternal mortality, and that impact is felt most acutely among black mothers, meaning that expanding the coverage can be a great key tool to decreasing racial disparities in maternal mortality and morbidity,” said LaSure.

Prioritizing health equity, LaSure said that CMS will continue to partner with states and trusted groups during the special enrollment period, and invest in navigators as they look ahead to open enrollment in the fall.

“We know that 4 million more Americans stand to gain access to quality health coverage in the remaining Medicaid nonexpansion phase,” said LaSure. “When it comes to guaranteeing that Americans in every community have access to comprehensive affordable health care, we will continue to work to ensure that no one is left behind.”

Asked about any particular next steps to expand health care coverage during the press call with reporters, Becerra said that HHS will work with Congress on expanding access to health care through the Medicaid program, which would reach working adults who are often overlooked and live close to the poverty line.

Moreover, he said they will leverage waivers in working with states to expand access at a more affordable price, begin work on increasing access to prescription drugs at better prices, and continue to build on the ACA.

“We will continue to work with states to encourage them to take advantage of the significant funding in the American Rescue Plan to expand the Medicaid program and encourage states to work with us on waivers, if that's the direction they want to go to continue to innovate,” added LaSure.

HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure discussed next steps following the Supreme Court’s decision to uphold the Affordable Care Act (ACA), including continued expansion of Medicaid benefit coverage and addressing disparities in maternal mortality rates nationwide.

Next Steps for HHS, CMS Following Supreme Court Decision to Uphold ACA

Medtronic Heeds FDA Warning, Stops Sales of HVAD System

, 14 of which were patient deaths and 13 involving necessary explantation, Medtronic has halted sales of its HeartWare Ventricular Assist Device (HVAD), reports 

™. The device was initially approved by the FDA in November 2012.

Medtronic has also issued an urgent call to clinicians to stop new implants and provided an Urgent Medical Device Communication Notification Letter to both clinicians and patients, which contains guidance on next steps.

The sale stoppage follows 2 previous moves Medtronic took, in December 2020 and 

, in which it recalled pump implant kits due to risk of potential patient harm. The recalled kits were shown to fail to start or restart or be delayed in restarting after stoppage.

PCOS Associated With Greater CVD Risk in Women

A 26% greater chance of adverse cardiovascular disease (CVD)–related outcomes was seen among women with polycystic ovary syndrome (PCOS) following a matched analysis with those without PCOS, 

Journal of Clinical Endocrinology and Metabolism, 

had a primary end point of time to major adverse cardiovascular event (MACE; heart attack, stroke, angina, revascularization, and CV mortality). Elevated risks were also seen among women with PCOS for heart attack (HR, 1.38; 95 CI, 1.11-1.72), angina (HR, 1.60; 95% CI, 1.32-1.94), and revascularization (HR, 1.50; 95% CI, 1.08-2.07).

In addition, history of type 2 diabetes (HR, 2.40; 95% CI, 1.76-3.30) and social deprivation (HR, 1.53; 95% CI, 1.11-2.11) were shown to significantly increase the risk of progressing to a MACE, suggesting these as potential targets to modify risk.

New Study Investigates QI Strategies in CVD

In a review that encompassed studies from 45 countries and 150,148 patients, an investigation to measure the impact of quality improvement (QI) strategies in CVD showed that most efforts evaluated outcomes among patients with heart failure (37.9%), followed by stoke (27.6%), post heart attack (14.0%), and stable coronary artery disease (10.1%), according to 

Patient support, information communication technology, community support, supervision, and high-intensity training were the QI strategies most often evaluated for their impact on patients. With the review results showing variations in effectiveness and implementation success, the authors of the study are calling for “a comprehensive map of CV QI strategies for future identification of improvements in CV outcomes.”

Future investigations need to gauge outcomes in the longer term to better understand how QI strategies affect CV health, they concluded.

The latest happenings in the heart failure space from across MJH Life Sciences™.


Heart Failure Beat: HVAD Sales Halted, PCOS and CVD Risk Linked in Women, and More 

Following a consensus meeting, health care professionals who work with patients with 

 (AD) published 7 vaccination recommendations for pediatric patients treated with dupilumab (Dupixent), according to an opinion piece 

“These recommendations serve to guide physicians’ decisions about vaccination in children with atopic dermatitis treated with dupilumab,” wrote the panelists.

The guide is the first consensus statement addressing whether vaccinations in children treated with dupilumab for AD are safe and effective. The recommendations also highlighted an unmet need for research on how dupilumab influences the effectiveness of cellular and humoral immune responses to different types of vaccines.

AD affects young children and most patients’ disease presents before they turn 5 years old. The CDC and the Public Health Agency of Canada encourage physicians to dole out vaccinations for immunocompromised patients on a case-by-case basis to avoid infections that could be prevented with vaccines.

In the United States and Europe, dupilumab is the only biologic therapy approved for use in children as young as 6 years of age with severe AD and is often prescribed off-label for younger children, which has raised concerns on how to immunize pediatric patients on dupilumab safely.

A panel of health care professionals reviewed published literature to develop a recommendation guide to advise providers on best practices when considering vaccinations for children with atopic dermatitis (AD) on dupilumab.