Dr. Castro and Dr. Rizzo discuss the evolving world of monoclonal antibodies for severe asthma. Plus, the ALA team discusses September's annual Asthma Peak Week, and what it means for reopening schools.

ALA Discusses Severe Asthma Biologics with Mario Castro, MD, MPH

Listen to an expert discuss the heterogenous, and potentially fatal, lysosomal storage disorder.

The Rare Disease Report Podcast: Niemann-Pick Disease

The vitiligo expert discusses new tactics and therapeutic options in treating inflammatory skin disorders like vitiligo, alopecia areata, and atopic dermatitis.

John E. Harris, MD, PhD: The Current State of Vitiligo and Alopecia Areata Research

Manesh Patel, MD, kicks off his first podcast by discussing HFpEF findings in EMPEROR-Preserved, the GUIDE-HF trial and more with his Duke colleague.

New Heart Failure Data from ESC 2021 with Marat Fudim, MD

On this episode of Coping After COVID, Dr. Yamalis Diaz explained just how challenging this year has been for patients with ADHD.

Coping After COVID: Challenging Circumstances for ADHD Patients

The first iteration of Crisis Point addresses the obesity crisis in the United States and beyond, with expert interviews and discussion.  

Crisis Point - Obesity Crisis

, Edward Ivy, MD, MPH, Vice Chief Medical Officer, Sickle Cell Disease Association of America (SCDAA), addressed the important elements currently at work in the field of 

 from the blood shortage the nation's facing, to future treatments for the disease. 

Ivy has a comprehensive perspective on the topic. In addition to being an MD and obtaining a Master of Public Health, Ivy is an individual living with sickle cell disease. 

He has first hand knowledge of how difficult it can be to get quality care as a patient. 

"We can do better, we can treat diseases better in the United States," Ivy said. "But I think it's going to take a concerted effort of groups like the Sickle Cell Disease Association, working with the researchers, working with the federal government, and working with states and other entities to figure out--what are those strategies that allow us to more effectively get the therapies that are sitting there and available to the patients that need them?"

Prior to 2019, hydroxyurea was one of the only drugs approved for treating sickle cell disease. Since then Novartis has released crizanlizumab (Adakveo) to treat pain, and Global Blood Therapeutics (GBT) introduced voxelotor (Oxbryta), which can reduce the sickling that occurs as a result of the disease. 

Ivy spoke about new therapies that are in the pipeline. Specifically, he focused on several different strategies that are being examined in gene therapy. 

"Now, as I've mentioned previously though, bone marrow transplant has been a therapy that has been used since the 1990s, but it has those limitations around on finding matching donors," Ivy explained. "With gene therapy, the idea is to use the individual's own bone marrow, make some modifications to the bone marrow, and then give that back to the patient so that they can be cured of sickle cell disease."

It's not a lack of treatment options that poses a threat to the quality of care for these patients, but accessibility. Ivy mentioned the importance of training medical professionals and students on how to treat sickle cell disease and implement the treatment approaches that are known to be successful.

In addition to the myriad of obstacles patients with sickle cell disease already struggle with when seeking treatment, the current blood shortage--deemed a "blood crisis" this month by the American Red Cross--could have negative implications for the population. 

"With the blood shortage that's happening nationally, unfortunately, that will impact sickle cell patients because it will reduce their ability, of course, to get access to the blood they need for their therapies," Ivy said. 

However, he also emphasized the great progress that's been made with models of care, which can begin promoting better access to care.

"How do we create the entire spectrum of care for individual patients so that they can be managed whether they have a chronic disease, whether they had their primary health that needs to be managed," Ivy asked, "we're right now in a situation of COVID, so managing that."

"So, we need to look at a map of the medical neighborhood model that helps us to look at treating the whole patient," he explained. "And I'm happy to say that there has been a lot of progress made at the national level, in sickle cell in particular, to develop models that allow hematologists to more effectively connect to primary care providers and get that information."

Videos

As the year begins, Edward Ivy addresses what's currently happening in the field of sickle cell disease from the impact of the blood shortage to exciting new therapies.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Sickle Cell

Sickle Cell condition center page, resources on the topics of medical news and expert insight into sickle cell disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sickle cell research, treatment, and drug development.

Rare Disease Report®

The Rare Disease Report page is a resource for medical news and expert insights on rare diseases. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for sickle cell disease, multiple myeloma, and more.

Pediatrics

Pediatrics page, resources on the topics of medical news and expert insight into childhood health care can be found. Content includes articles, interviews, videos, podcasts, and breaking news on pediatric disease research, treatment, and drug development.

Edward Ivy, MD, MPH: A Comprehensive Perspective on Sickle Cell Disease

. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with 

. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

An investigational live microbiome therapeutic continues to show positive results in treating patients with recurrent 

A team, led by Paul Feuerstadt, MD, Yale University School of Medicine, New Haven, recently released phase 3 data showing SER-109 resulted in a significant reduction in CDI recurrence in comparison to placebo.

SER-109 is an investigational microbiome therapeutic designed to address the disrupted microbiome that supports C difficile spore germination into toxic producing bacteria. The treatment is composed of purified Firmicutes spores.

“Clinical outcomes in recurrent C. difficile infection may be improved by using a two-pronged treatment approach: antibiotics to kill toxin-producing bacteria followed by a microbiome therapeutic to inhibit C. difficile spore germination and bacterial replication through microbiome repair,” the authors wrote.

In the phase 3, double-blind, randomized, placebo-controlled study, the investigators examined 182 patients with 3 or more episodes of CDI. Each participant received either SER-109 or placebo, 4 capsules daily of each for 3 days, following standard-of-care antibiotic treatment. The mean age of the study population was 65.5 years.

The investigators sought primary efficacy outcomes of superiority of SER-109 to placebo in reducing the risk of C difficile infection recurrence up to 8 weeks after treatment.

The team performed toxin testing for diagnostic reasonings at baseline and then stratified participants according to age and antibiotic agent received. They also performed analysis of safety, microbiome engraftment, and metabolites.

The results show the primary efficacy objective was met and SER-109 was deemed superior to placebo.

Overall, only 12% of the SER-109 group had a recurrence of CDI, compared to 40% of the placebo group (RR, 0.32; 95% CI, 0.18-0.58; 

The majority of recurrence events occurred as early as day 4 after randomization, with 75% (n = 36) occurring within 2 weeks and 85% (n = 41) occurring within 4 weeks of administration of SER-109 or placebo.

Looking at the stratified groups, the investigators found the study drug led to less frequent recurrence (RR, 0.24; 95% CI, 0.07-0.78 for patients <65 years of age and RR, 0.36; 95% CI, 0.18-0.72] for those ≥65 years). This was also true for antibiotics (RR, 0.41; 95% CI, 0.22-0.79 with vancomycin and RR, 0.09; 95% CI, 0.01-0.63 with fidaxomicin).

For safety, the majority of adverse events reported were mild to moderate in nature, mainly gastrointestinal issues, with similar prevalence between the SER-109 and placebo cohorts. In addition, SER-109 dose species were detected by week 1 and were associated with bile-acid profiles known to inhibit C difficile spore germination. However, there were no serious adverse events reported.

Three deaths did occur in the SER-109 group, but the investigators discovered the deaths were not related to the drug treatment.

“In patients with symptom resolution of C. difficile infection after treatment with standard-of-care antibiotics, oral administration of SER-109 was superior to placebo in reducing the risk of recurrent infection,” the authors wrote. “The observed safety profile of SER-109 was similar to that of placebo.”

The study, “SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection,” was published online in the 

Articles

Only 12% of SER-109 treated patients had a recurrence, compared to 40% of the placebo group. 

C Difficile Infection

C. difficile condition center page, resources on the topics of medical news and expert insight into Clostridium difficile can be found. Content includes articles, interviews, videos, podcasts, and breaking news on C. diff research, treatment, and drug development.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Infectious Disease

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on viruses, infections, and bacteria. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for COVID-19, influenza, vaccine-preventable diseases, and more.

SER-109 Reduces Risk of Recurrence of C Difficile Infections

The US Food and Drug Administration (FDA) has cleared the endomina system for 

 of sutures and approximation of soft tissue in the gastrointestinal tract for adult patients.

The approval allows Endo Tools Therapeutics to move forward with the system comprised of a universal triangulation platform and an instrument for tissue piercing and approximation (TAPES).

The platform can be affixed to various testing standard endoscopes to provide a bendable therapeutic channel that moves independently and enables the clinician to perform endoscopic suturing similar to laparoscopy interventions while using only the mouth to provide an incisionless procedure.

"This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing," said Ivo Boškoski, MD, PhD, Policlinico Gemelli, in a 

. "The endomina system represents a significant advancement in interventional gastroenterology which could expand treatment options for patients."

The system is currently available outside of the US and being considered for a wide range of procedures in the digestive tract, including bariatric interventions, gastroesophageal reflux disease (GERD), and endoscopic full thickness resection (EFTR).

Endo Tools Therapeutics has indicated plans for a limited market release in the US in the first half of 2022, followed by a larger market release later in the year.

"We are delighted to bring this innovative and disruptive technology to the U.S. market," said Alexandre Chau, chief executive office, Endo Tools Therapeutics, in a statement. "Developed with physician needs in mind, the endomina system was designed to enable physicians to perform endoscopic suturing similar to laparoscopic procedures, but without an incision."

The endomina system can be affixed to various testing standard endoscopies for a bendable therapeutic channel. 

Ulcerative Colitis

Ulcerative Colitis condition center page, resources on the topics of medical news and expert insight into colitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on UC research, treatment, and drug development.

Surgery

The HCPLive surgery page is a resource for medical news and expert insights on invasive medicine. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for surgery, and more.

Gastroesophageal Reflux Disease (GERD)

The HCPLive gastroesophageal reflux disease page is a comprehensive resource for clinical news and insights on GERD. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for reflux disease, and more.

FDA Clears New Endoscopy Technology Tool

Lloyd Clark, MD, and Roger A. Goldberg, MD, MBA, share the process for giving injections in the eye for patients who have wet AMD.

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

Using Intravitreal Injections for the Treatment of Wet AMD

A panel of eye care specialists review the 4 currently available anti-VEGF agents available for the treatment of wet AMD.

Anti-VEGF Agents for Wet AMD Treatment

Armand Butera is the assistant editor for 

. He attended Fairleigh Dickinson University and graduated with a degree in communications with a concentration in journalism. Prior to graduating, Armand worked as the editor-in-chief of his college newspaper and a radio host for WFDU. He went on to work as a copywriter, freelancer, and human resources assistant before joining 

. In his spare time, he enjoys reading, writing, traveling with his companion and spinning vinyl records. Email him at 

Investigators note that validation of these biomarkers would require multi-center and independent validation of the current findings.

Atopic Dermatitis

Atopic Dermatitis condition center page, resources on the topics of medical news and expert insight into eczema can be found. Content includes articles, interviews, videos, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Investigation Identifies 48 Biomarkers for Hidradenitis Suppurativa

Connor Iapoce is an assistant editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Data show the change in CHD prevalence from 2011 - 2018 (6.2% to 6.0%) was statistically insignificant. 

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Arterial Disease

Arterial Disease condition center page, resources on the topics of medical news and expert insight into PAD / CAD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on peripheral artery and coronary artery disease research, treatment, and drug development.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

National Change in Coronary Heart Disease Prevalence Not Significant in US 

Alloimmunization is more prevalent among patients with sickle cell disease than previous literature states. Baez-Sosa discusses her study and treatment practices. 

Valentina Baez-Sosa, MD: Treating Alloimmunization Alongside Sickle Cell Disease

Julia Haas, PhD, discusses her team's recent findings that one-third of patients in COVID-19 vaccine trials reported side effects after receiving a placebo dose.

COVID-19

COVID-19 page, resources on the topics of medical news and expert insight into coronavirus can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COVID-19 research, treatment, and drug development.

How the Nocebo Effect Influences COVID-19 Vaccine Safety Data

Despite attempts climbing since 2008, investigators have observed no significant change in suicidal adults seeking care.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Internal Medicine

Internal Medicine condition center page, resources on the topics of medical news and expert insight into internal medicine can be found. Content includes articles, interviews, videos, podcasts, and breaking news on internal medicine research, treatment, and drug development.

Hospital Medicine

The HCPLive hospital medicine page is a comprehensive resource for clinical news and insights on the emergency medicine specialty. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for emergent care, and more.

Suicide Attempts Increased 17% Among US Adults Since 2008

There are currently no approved systemic treatments for prurigo nodularis, but patients treated with dupilumab experienced significantly greater improvements in measures of overall health-related quality of life, skin pain, and symptoms of anxiety and depression.

Phase 3 Data Details Efficacy of Dupilumab in Patients with Prurigo Nodularis

Investigators observed that many patients with psoriasis are not actively seeing a primary care physician and would welcome management of their cardiovascular risk factors.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Dermatologists and Psoriatic Patients Show Interest in Specialist-Led CVD Prevention

Matthew Brunner, MHS, PA-C, DFAAPA, highlights the most anticipated developments in the field of treating patients with plaque psoriasis. 

Anticipated Developments in the Field of Plaque Psoriasis

Stratification of patients for the treatment of plaque psoriasis based on comorbidities and prior biologic experience.

Stratifying Patients With Plaque Psoriasis for Treatment With Biologics

There are several barriers that prevent better HCV care, including availability and access to diagnostic and monitoring tests and the requirement for frequent medical visits during treatment.

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Latest News

Edward Ivy, MD, MPH: A Comprehensive Perspective on Sickle Cell Disease

SER-109 Reduces Risk of Recurrence of C Difficile Infections

FDA Clears New Endoscopy Technology Tool

Using Intravitreal Injections for the Treatment of Wet AMD

Anti-VEGF Agents for Wet AMD Treatment