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The FDA has approved Dyanavel XR, an amphetamine extended-release (ER), once- daily tablet for the treatment of individuals aged 6 years and older with attention- deficit/hyperactivity disorder (ADHD). In a clinical study of healthy individuals aged 6 years and older, the tablets were deemed to be bioequivalent to amphetamine ER oral suspension. The oral suspension appeared to improve ADHD symptoms as soon as 30 minutes after dosing.

Repository Corticotropin Injection (Purified Cortrophin Gel)

The repository corticotropin injection is for the treatment of chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis. It can also help decrease excess urinary protein, due to nephrotic syndrome. The injection is an adrenocorticotropic hormone known as purified corticotropin.

Pilocarpine HCI Ophthalmic Solution (Vuity)

The FDA has approved pilocarpine HCI ophthalmic solution 1.25% for the treatment of presbyopia, or age- related blurry near vision, in adults. It is the first and only FDA-approved eye drop for this condition, according to AbbVie. Improvements to near vision in low light conditions without loss of distance vision were seen as early as 15 minutes and lasted through 6 hours. There were no serious adverse events recorded in the clinical trial.

Asciminib was approved for the treatment of individuals with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) in chronic phase who were administered 2 or more tyrosine kinase inhibitors. It was also approved for use in individuals with Ph-positive CML in chronic phase with a T315I mutation. The clinical trials showed that asciminib had a molecular response rate of 25% at the 24-week mark.

Articles

This month features asciminib (Scemblix), pilocarpine HCI ophthalmic solution (Vuity), and amphetamine (Dyanavel XR).

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Rx Product News: January 2022

 has published 2 papers that highlight 1-year results from 4 pivotal phase 3 studies of faricimab, an investigational bispecific antibody, in neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME), Roche said in a statement.

All 4 studies, which enrolled more than 3000 individuals in total, met their primary endpoints, showing that individuals treated with faricimab up to every 4 months achieved non-inferior vision gains compared with aflibercept, given every 2 months.

Additionally, approximately half of eligible individuals on faricimab were able to go 4 months between treatments within the first year, and approximately three-quarters could go 3 months or longer in the TENAYA and LUCERNE nAMD studies and the YOSEMITE and RHINE DME studies.

The current standard of care for these potentially blinding conditions requires eye injections as often as once every month.

“We remain deeply committed to developing new medicines such as faricimab that may help preserve sight in many people living with serious retinal conditions,” Levi Garraway, MD, PhD, chief medical officer and head of global product development, said in the statement.

If approved, faricimab would be the first bispecific antibody for the eye, targeting and inhibiting 2 distinct pathways linked to vision-threatening retinal conditions by neutralizing angiopoietin-2 and vascular endothelial growth factor-A (VEGF-A).

The inhibition of both pathways has been shown to have potentially complementary benefits, stabilizing vessels, thereby reducing vessel leakage and inflammation more than inhibition of the VEGF-A pathway alone.

In the TENAYA and LUCERNE studies that examined the effect of faricimab for individuals with nAMD, the average vision gains from baseline at 1 year in the faricimab arms were +5.8 and +6.6 letters, respectively, compared with +5.1 and +6.6 letters in the aflibercept arms.

The studies also measured the proportion of individuals in the faricimab arm who were treated on dosing schedules of every 3 or 4 months during the first year.

Investigators found that 46% of individuals in TENAYA and 45% in LUCERNE were able to be treated every 4 months in the first year.

Additionally, 34% of individuals in TENAYA and 33% in LUCERNE were able to be treated every 3 months.

Combined, nearly 80% of individuals treated with faricimab were able to go 3 months or longer between treatments during the first year. Consistent with vision outcomes, faricimab treatment resulted in a meaningful and comparable reduction in central subfield thickness (CST) and comparable decreases in choroidal neovascularization lesion area and size.

Faricimab was generally well-tolerated in both studies. Adverse events (AEs) were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with nAMD.

In the YOSEMITE and RHINE studies to evaluate faricimab for individuals with DME, the average vision gains from baseline at 1-year were +11.6 and +10.8 eye chart letters in the faricimab treat-and-extend arms, +10.7 and +11.8 letters in the 2-month arms, and +10.9 and +10.3 letters in the aflibercept arms, respectively.

A secondary endpoint in both studies measured the proportion of individuals in the faricimab treat-and-extend arms that achieved dosing schedules of every 3 or 4 months at the end of the first year.

Approximately 53% of faricimab treat-and-extend patients in YOSEMITE and 51% in RHINE achieved 4-month dosing at 1 year.

Additionally, 21% of faricimab treat-and-extend patients in YOSEMITE and 20% in RHINE achieved 3-month dosing. Combined, more than 70% of faricimab treat-and-extend patients were able to go 3 months or longer between treatments at the end of the first year.

Reductions in CST and resolution of intraretinal fluid through the first year consistently favored faricimab over aflibercept. Faricimab was generally well-tolerated in both studies, with a favorable benefit-risk profile.

AEs were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with DME.

Faricimab is under review by the FDA for the treatment of DME and nAMD. The European Medicines Agency is also evaluating the faricimab marketing authorization application for the treatment of DME and nAMD.

Additionally, the BALATON and COMINO trials are under way, evaluating the efficacy and safety of faricimab in individuals with macular edema following retinal vein occlusion.

 publishes studies showing Roche’s faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months. Roche. News release. January 24, 2022. Accessed January 25, 2022. Email.

Data from 4 analyses show that individuals treated with the drug achieved non-inferior vision gains compared with aflibercept.

Eye Care

Roche Announces Results from Multiple Studies on Faricimab for nAMD and DME

Pfizer and BioNTech SE have announced the publication of new results from 2 laboratory studies showing that 3 doses of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) elicited antibodies that neutralize the omicron variant, Pfizer said in a statement.

Data, which was published in the peer-reviewed journal 

, include readouts of sera data from 51 individuals who were vaccinated and received either 2 or 3 doses of the Pfizer vaccine, as well as a second study that evaluated the neutralization potential of serum antibodies from a subset of vaccinated individuals against the live virus.

Both data sets confirm previously announced 

 showing that serum antibodies induced by the Pfizer vaccine neutralized the SARS-CoV-2 omicron variant after immunization with 3 doses.

By comparison, sera from individuals who received 2 doses of the COVID-19 vaccine showed limited neutralization titers against the omicron variant in both data sets, indicating that 2 doses of the vaccine may not be sufficient to protect against infection with the new variant.

However, based on observations that approximately 85% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the omicron variant, the 2 companies think that 2 doses may induce protection against severe disease.

Investigators analyzed a panel of 51 human immune sera obtained from the blood of individuals who received 2 or 3 30-µg doses of the COVID-19 Vaccine, using a pseudo virus neutralization test.

Additionally, data from a live virus laboratory study conducted with the University of Texas Medical Branch supports and extends these findings and was posted on the preprint server 

Investigators analyzed 4 panels that included human immune sera from the blood of individuals who had received 2 or 3 30-µg doses of the vaccine.

The first panel included sera from 20 individuals, collected 2 or 4 weeks after the second dose, while the second panel included sera from 22 individuals collected on the day of administration of a booster dose.

The third and fourth panels were collected 1 and 4 months after the third dose, respectively.

This study did not measure other immune indicators, including T cells and non-neutralizing antibodies.

Sera taken 1-month following a third dose showed a 22-fold increase in neutralization titers against omicron compared with titers just prior to the third dose when given, on average, 7.9 to 8.8 months after second dose, suggesting more robust protection against the new variant may be achieved with the current COVID-19 vaccine series, plus a booster dose.

The neutralizing titer levels against the omicron variant after immunization with 3 doses were like antibody titer levels after 2 doses against wild-type and other variants that emerged before the omicron.

Furthermore, from 1 to 4 months after a third dose, neutralization titers against wild-type and the omicron decreased by 1.6 and 2 times, respectively, suggesting similar waning for both variants.

All sera effectively neutralized the omicron variant at 4 months following a third dose.

Pfizer and BioNTech have put into place a booster research program to help ensure that the vaccine continues to offer a high degree of protection.

The companies intend to evaluate the efficacy and immunogenicity of the additional dose of both the current formulation and an omicron-based vaccine in a clinical setting.

The companies previously announced that they expect to produce about 4 billion doses of the Pfizer COVID-19 vaccine in 2022, and this number is not expected to change if another adapted vaccine is required.

Pfizer and BioNTech publish data from two laboratory studies on COVID-19 vaccine-induced antibodies ability to neutralize SARS-CoV-2 omicron variant

News release. Pfizer. January 24, 2022. Accessed January 24, 2022.

Both data sets confirm previously announced results showing that the boost protects against the variant.

Coronavirus

Immunization

Studies: Antibodies From 3 Doses of Pfizer-BioNTech COVID-19 Vaccine Neutralize Omicron

Several factors in autoantibodies can be measured at the initial point of COVID-19 diagnosis that anticipate if an individual is likely to develop long COVID-19, the results of a new study show.

The PASC factors are Epstein-Barr virus (EBV) DNA levels in the blood, pre-existing types 2 diabetes, the presence of certain antibodies, and SARS-CoV-2 RNA levels in the blood.

A significant number of individuals who contract SARS-CoV-2 suffer chronic effects known as post-acute sequalae of COVID-19 (PASC), also known as long COVID. Symptoms include brain fog, fatigue, loss of smell and taste, and shortness of breath.

“Identifying these PASC factors is a major step forward for not only understanding long COVID and potentially treating it but also which patients are at highest risk for the development of chronic conditions,” Jim Heath, PhD, president of the Institute for Systems Biology (ISB), said in a statement. “These findings are also helping us frame our thinking around other chronic conditions, such as post-acute Lyme syndrome, for example.”

Additionally, investigators found that mild cases of COVID-19, not just severe cases, are also associated with long COVID. They also suggest that administering antivirals very early in the disease course could potentially prevent some PASC.

“Our study pairs clinical data and patient-reported outcomes with deep multi-omic analyses to unravel important biological associations that occur in patients with PASC. Certain findings, such as the low cortisol state in patients with long COVID, have potential to translate rapidly to the clinic. Our results form an important foundation for the development of therapeutics to treat long COVID,” Jason Goldman, MD, co-corresponding author of the paper and an infectious disease expert, said in the statement.

Investigators collected blood and swab samples from 309 individuals with COVID-19 at different points to perform comprehensive phenotyping, which was integrated with clinical data and patient-reported symptoms to carry out the investigation.

A key finding of the study is that early blood viral measurements are associated with long covid symptoms that individuals will develop months later, another author of the paper, Yapeng Su, PhD, said in the statement.

Additionally, the EBV, a virus that infects 90% of the human population and is normally inactive in the body after infection, is reactivated early on after a SARS-CoV-2 infection, which is significantly associated with future long COVID symptoms.

Investigators also found that PASC is anticipated by autoantibodies, which associate with autoimmune diseases, such as lupus, at diagnosis, and that as autoantibodies increase, protective SARS-CoV-2 antibodies decrease.

This suggests a relationship among autoantibodies, individuals at elevated risk of re-infection, and long COVID.

“Many patients with high autoantibodies simultaneously have low, protective, antibodies that neutralize SARS-CoV-2, and that’s going to make them more susceptible to breakthrough infections,” Daniel Chen, a lab assistant in Health lab at ISB, a co-first author of the paper, said in the statement.

The findings of the research were published in the journal, 

Predicting long COVID at initial point of COVID-19 diagnosis. EurekAlert. News release. January 20, 2022. Accessed January 21, 2022. https://www.eurekalert.org/news-releases/940806

Investigators say that the post-acute sequalae markers are Epstein-Barr virus (EBV) DNA levels in the blood, pre-existing types 2 diabetes, the presence of certain antibodies, and SARS-CoV-2 RNA levels in the blood.

Study: Factors in Autoantibodies Can Help Predict Likelihood of Long COVID-19

Despite some safety concerns and delays, officials with the FDA have approved the Janus kinase (JAK) inhibitors upadacitinib (Rinvoq; AbbVie) and abrocitinib (Cibinqo; Pfizer) for the treatment of refractory atopic dermatitis.

The 2 drugs are the first small molecule JAK-1 inhibitors to be approved in the United States as treatment options for patients who are not responding to other therapies. The approval could signify increased competition within the medication class, according to a press release from GlobalData.

“Although it is an exciting breakthrough for the atopic dermatitis space, these agents will not be used in the first line, as the labels say they should be used once all other therapy options are exhausted, including biologics, or when the use of certain therapies is inadvisable,” said Ramla Salad, a health care analyst at GlobalData, in the press release.

All of the doses were approved, including 15 mg and 30 mg doses for upadacitinib and 50 mg, 100 mg, and 200 mg doses of abrocitinib, despite initial concerns that only the lower doses would gain FDA approval. Patients receiving the therapies will need close monitoring due to specific FDA guidelines for each dose, including titration as needed.

Although abrocitinib’s recommended starting dosage is 100 mg, the 50 mg dosage was approved for patients with moderate renal impairment, patients receiving cytochrome P450 inhibitors or patients who are known or suspected to be poor metabolizers of CYP2C19. Patients with these considerations may increase their dosage up to 100 mg if they do not respond adequately to 50 mg, according to the press release.

“Pfizer may have a unique advantage due to the specific populations Cibinqo is targeting, and they will likely face little competition in these patients since competitors have not targeted these niche populations,” Salad said in the press release. “Rinvoq has a different advantage to Cibinqo as it is approved for use in both adults and adolescents (patients ages 12 years and older), whilst Cibinqo is just approved for adult use.”

Regardless, the FDA approvals will help solidify the JAK inhibitor class of therapies for atopic dermatitis, according to the press release. The approvals could also offer new options to patients who do not respond to already available therapies.

 as a once-daily oral treatment for adults with moderate to severe atopic dermatitis.

Rinvoq and Cibinqo Janus kinase (JAK) inhibitors approved by FDA with boxed warnings and restrictive labeling, says GlobalData. News release. GlobalData; January 25, 2022. Accessed January 25, 2022. 

https://www.globaldata.com/rinvoq-cibinqo-janus-kinase-jak-inhibitors-approved-fda-boxed-warnings-restrictive-labelling-says-globaldata/

The 2 drugs are the first small molecule JAK-1 inhibitors to be approved in the United States as treatment options for patients who are not responding to other therapies.

Dermatology

FDA Approvals of Upadacitinib, Abrocitinib for Refractory Atopic Dermatitis Come With Boxed Warnings, Restrictive Labelling 

Individuals with inflammatory bowel disease (IBD) with incomplete COVID-19 vaccinations are at greater risk of hospitalization from severe COVID-19, according to the results of a study presented at the Crohn’s & Colitis Congress, which took place virtually January 20 through 22, 2022.

Investigators analyzed data from the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease database to describe outcomes and identify risk factors for severe disease from COVID-19 infection in this population.

The study results, which were presented by Emily Spiera of the Icahn School of Medicine at Mount Sinai, show that in patients with IBD, incomplete vaccination, non-mRNA vaccines, and combination therapy are associated with an increased risk of adverse events during breakthrough COVID-19 infections.

Meanwhile, the results of another study presented by Hyeong Sik Ahn of Korea University’s Department of Preventive Medicine, Medical School at the meeting show that there is a higher risk of autoimmune disease, growth failure, and IBD in the children of women with IBD.

This is the largest study to assess the long-term influence of maternal IBD on the disease’s effect on the development and growth of their offspring. Using a database of 3 million women who gave birth during the study period, the investigators identified that children born to mothers with IBD were at higher risk of developing autoimmune disease and IBD. These children were also at higher risk for growth failure up to aged 6 years, defined as less than the 3 percentiles in height and weight. There was no increased risk for other diseases tracked, including autism spectrum disorder, bronchial asthma, juvenile rheumatoid arthritis, metabolic diseases, and neurodevelopmental disorders.

Other abstracts presented at the meeting included cell-autonomous hedgehog signaling controls TH17 differentiation to drive intestinal inflammation and is a druggable target for the treatment of IBD; corticosteroids and 5ASA versus corticosteroids alone for acute severe ulcerative colitis: a randomized controlled trial; endoscopic stricturotomy, which is a novel therapeutic modality for IBD-related strictures: first European experience; and point-of-care intestinal ultrasound for the detection of postoperative Crohn disease endoscopic recurrence.

In total, there were 27 abstracts presented at the meeting, according to a statement.

All abstracts that were presented at the meeting were published in online supplements to 

Gastroenterology and Inflammatory Bowel Diseases.

During the IBD meeting, presenters reviewed the latest advancements in IBD patient care to improve the lives of the millions of Americans living with Crohn disease and ulcerative colitis.

Nearly 3 million Americans are affected by IBD, according to the American Gastroenterological Association, which co-hosted the meeting with the Crohn’s & Colitis Foundation.

1. IBD patients with incomplete COVID-19 vaccinations are at greater risk of hospitalization. News release. January 20, 2022. Accessed January 24, 2022. https://www.eurekalert.org/news-releases/940120

2. Inflammatory bowel disease (IBD). American Gastroenterological Association, Accessed January 24, 2022. https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/ibdfactbook.pdf

Investigators analyzed data to determine the outcomes and risk factors for severe cases and how individuals with inflammatory bowel disease are affected.

Gastrointestinal Health

Patients With IBD With Incomplete COVID-19 Vaccinations Have More Risk of Hospitalization

The 30-day incidence of myocarditis following a COVID-19 diagnosis was nearly 17 times higher than the incidence among patients receiving the COVID-19 vaccine, new data show.

That stands in contrast to recent reports indicating that adolescents and young adults, particularly males ages 12 to 29, who receive an mRNA COVID-19 vaccine have an increased risk of myocarditis, which is an inflammation of the heart muscle.

In October 2021, the FDA delayed the authorization of the Moderna COVID-19 vaccine for adolescents because of these concerns.

The results of previous studies by Epic Research show that the risk of myocarditis following the COVID-19 vaccine was not substantively different from the incidence before the COVID-19 pandemic.

In this study, Epic Research aimed to determine the risk of myocarditis among individuals aged 12 to 30 years across 3 age, sex, and vaccine type.

To determine the risk, investigators examined historical incidence, risk after vaccination, and risk after a COVID-19 diagnosis.

Historical incidence was determined by the annual incidence of individuals aged 12 to 30 who had an interaction with the health system in 2019. The historical incidence was used as a baseline to put the risk after vaccination and risk after COVID-19 diagnosis into perspective, but investigators said that it should not be directly compared with the other 30-day risks.

For risk after vaccination, investigators viewed the 30-day incidence of a new myocarditis diagnosis after the first or second vaccination against COVID-19 among individuals aged 12 to 30 years who received at least 1 vaccination dose between December 11, 2020, and December 20, 2021.

The risk after a COVID-19 infection was defined as the 30-day incidence of a new diagnosis of myocarditis following a diagnosis of COVID-19 among individuals aged 12 to 30 years who did not receive a COVID-19 vaccine between January 20, 2020, and November 21, 2021.

Investigators found that the risk of myocardia following a COVID-19 diagnosis is much higher than the risk of myocarditis following a COVID-19 vaccination for all ages and sex studied.

Overall, the 30-day incidence following a COVID-19 diagnosis was nearly 17 times higher than the incidence among individuals receiving the COVID-19 vaccine.

The historical incidence of myocarditis was 11.7 cases per 100,000 individuals.

Investigators also broke down the risk of myocarditis by sex and found that their data were consistent with other reports showing that adolescent and young adult males have a higher risk than females.

Additionally, the investigators also analyzed the risk based on vaccine manufacturer.

The Pfizer-BioNtech vaccine was the only one evaluated for the 12- to 17-years-old age group, as it was the only vaccine authorized for that age group during the study period.

For the 18-to-30-year-old age group, which had all 3 vaccines authorized for use, incidents of myocarditis were similar across vaccine manufacturers.

The results of the analysis show that the 30-day risk of myocarditis was less than the 1-year historical incidence across all 3 vaccine manufacturers when both age and sex were considered.

When evaluating the combinations of age, gender, and manufacturer, 73 cases of myocarditis was reported of 364,249 male individuals who received the Moderna vaccine, making it about 20 cases per 100,000 individuals.

This is significantly higher than other combinations age, sex, and manufacturer. However, the risk of myocarditis after vaccination remains significantly less than the risk after a COVID-19 infection.

Little D, MacGibbon A, Allen S, Posner X, and Keogh T. Myocarditis risk 17 times higher for unvaccinated patients ages 12-30 who get COVID-19 than COVID-vaccinated patients. Epic Research. January 24, 2022. Accessed January 24, 2022. https://epicresearch.org/articles/myocarditis-risk-17-times-higher-for-unvaccinated-patients-ages-12-30-who-get-covid-19-than-covid-vaccinated-patients

New study results show that there are more incidences of this inflammation of the heart muscle related to not being vaccinated than there are to the vaccine itself.

Cardiovascular Health

Myocarditis Risk Is 17 Times Higher for Unvaccinated Patients Who Get COVID-19

, Alfred L'Altrelli, PharmD, senior director of pharmacy at UPMC Presbyterian-Shadyside, discussed the health system's new program offering monoclonal antibodies as pre-exposure prophylaxis for patients who are immunocompromised or who did not respond adequately to COVID-19 vaccination.

In the interview, L'Altrelli said having such a program spearheaded by pharmacists has helped show the public the vital roles that pharmacists play. He added that pharmacists are perfectly positioned to lead the program, considering their expertise with vaccinations and managing limited supplies. Furthermore, L'Altrelli said they have had overwhelming support from patients, who are excited to regain a feeling of safety after nearly 2 years of isolation.

Patient George P. Spine, Jr, said he was hesitant when he first received a phone call offering the treatment, but after talking to his son he decided to get the 2-shot series. At 87 years old, Spine said he hopes to live to see 88.

All footage and images courtesy of UPMC Presbyterian-Shadyside.

Videos

Having such a program spearheaded by pharmacists has helped show the public the vital roles that pharmacists play.

Pharmacist-Led Program Brings Pre-Exposure Prophylaxis Monoclonal Antibodies to Patients At High Risk of Contracting COVID-19

A new survey found that nearly two-thirds of Americans with anxiety, depression, or post-traumatic stress disorder (PTSD) experienced residual negative feelings after receiving traditional pharmaceutical treatments. Furthermore, these patients believe that psychedelic medicines should be made available for treatment-resistant anxiety, depression, or PTSD.

The survey was conducted online in December 2021 among 953 adults who suffer from anxiety, depression, or PTSD. Among those participants, 63% said that although prescription medications helped manage their conditions, they still experienced feelings of anxiety, depression, or PTSD. Notably, 18% said that the medication they were prescribed did not improve their condition or made it worse.

“Our country’s mental health crisis not only impacts public health, but also the economy—each yer, untreated mental illness costs the US up to $300 billion in lost productivity,” said Matt Stang, co-founder and CEO of Delic, in a press release.

According to the results, 83% of respondents who suffer from anxiety, depression, or PTSD would be open to pursuing alternative treatments that are proven to be more effective than prescription medications with fewer adverse effects (AEs). Among those participants, many said they would specifically be interested in using ketamine, psilocybin, or methylenedioxy-methamphetamine (MDMA).

Among the survey respondents, 66% said they would be open to pursuing treatment using ketamine to treat anxiety, depression, or PTSD if it was proven to be more effective than prescription medication with fewer AEs. Similarly, 62% said they would be open to using psilocybin prescribed by a physician, and 56% said they would be open to using MDMA.

“We are witnessing a silent crisis impacting people across the globe exacerbated by an ongoing pandemic, and the results of this survey should compel more medical professionals and lawmakers to support in-depth studies on the therapeutic benefits of psychedelic medicine,” Stang said in the press release. “This promising family or new medicines has the potential to be more effective than traditional medicines with minimal side effects, giving people their best selves back.”

Survey Finds Majority of Affected Americans Approve of Psychedelics as an Alternative Treatment to Address Anxiety, Depression, and PTSD. News release; Delic Corp. January 17, 2022. Accessed January 18, 2022. 

https://deliccorp.com/press-releases/delic-corp-harris-poll-results/

Nearly two-thirds of respondents had residual feelings of anxiety, depression, or PTSD after using prescription medications. 

Mental Health

Survey Finds Majority of Affected Americans Approve of Psychedelics to Treat Anxiety, Depression, PTSD

Researchers at Newcastle University have developed a novel test that reliably predicts the spread or return of melanoma, according to a press release.

The test, called AMBLor, could help reassure patients who are diagnosed with early stage melanoma and who are concerned about the risk of spread. By applying the test to the standard biopsy of the primary melanoma on its removal, clinicians could be able to identify patients who are at a low risk of the disease reoccurring or spreading, according to the study authors.

The rate of melanoma is increasing worldwide, with more than 96,000 diagnoses in the United States annually. In the new research, the authors explained that early-stage melanomas at risk of spreading secrete the TGFβ2 growth factor, which causes the downregulation of the AMBRA1 and Loricrin proteins. Both proteins are found in the skin overlaying the tumor, and TGFβ2 also causes the loss of claudin-1, which negatively impacts the integrity of the skin and facilitates ulceration, according to the study.

“Like mortar and bricks holding together a wall, AMBRA1, Loricrin, and Claudin 1 are all proteins key to maintaining the integrity of the upper layer of the skin,” said senior author Penny Lovat, a professor of cellular dermatology and oncology at Newcastle University, in the press release. “When these proteins are lost, gaps develop—like the mortar crumbling away in the wall. This allows the tumor to spread and ultimately ulcerate, which we know is a process associated with higher risk tumors.”

In a study evaluating the role of TGFβ2 in the epidermis, researchers used immunohistochemistry to analyze AMBRA1 and TGFβ2 in a cohort of 109 patients with all-stage melanoma. Furthermore, TGFβ2 was analyzed in a cohort of 30 stage 1 melanomas, and claudin-1 was analyzed in a cohort of 42 stage I melanomas.

Increased tumoral TGFβ2 was significantly associated with a loss of peritumoral AMBRA1, ulceration, AMLo high-risk status, and metastasis. TGFβ2 treatment of keratinocytes resulted in downregulation of AMBRA1, loricrin, and claudin-1, whereas knockdown of AMBRA1 was associated with decreased expression of claudin-1 and increased proliferation of keratinocytes.

Importantly, the researchers found that loss of AMBRA1 in the peritumoral epidermis was associated with decreased claudin-1 expression, parakeratosis, and cleft formation in the dermoepidermal junction. Collectively, these findings suggest that TGFβ2 causes loss of AMBRA1 overlying high-risk early-stage melanomas and reduced epidermal integrity, which causes skin erosion and tumor ulceration.

“Our test offers a personalized prognosis as it more accurately predicts if your skin cancer is unlikely to spread,” Lovat said in the press release. “This test will aid clinicians to identify genuinely low risk patients diagnosed with an early-stage melanoma and to reduce the number of follow-up appointments for those identified as low risk, saving the [National Health Service] time and money.”

1. First melanoma test to offer reassurance of low risk of cancer spread. News release. EurekAlert; January 13, 2022. Accessed January 17, 2022. 

https://www.eurekalert.org/news-releases/939808

2. Cosgarea I, McConnell AT, Ewen T, Tang D, et al. Melanoma secretion of transforming growth factor-β2 leads to loss of epidermal AMBRA1 threatening epidermal integrity and facilitating tumor ulceration. 

. November 13, 2021. doi:10.1111.bjd.20889. Accessed January 17, 2022.

Early-stage melanomas at risk of spreading secrete the TGFβ2 growth factor, which causes the downregulation of the AMBRA1 and Loricrin proteins.

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