New Insight with Dr. Veeral Sheth

Diabetes Dialogue

Don’t Miss a Beat

Crisis Point

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

A discussion of a website used to assess digital applications for patients struggling with mental health issues.

Patrick Hemming, MD: Which Mental Health App is Best for Internal Medicine Patients?

In this interview discussion, Patrick Hemming, MD, discussed some of the additional takeaways from his 

American College of Physicians (ACP) Internal Medicine Meeting

 presentation ‘Depression and Anxiety Treatment by the Internal Medicine Physician,’ touching on a useful website for internists.

Hemming works as an associate professor and as director of resident education for the Duke Outpatient Clinic at Duke University’s department of medicine. In his prior interview segments, Hemming had detailed utilizing the 

 for internal medicine patients with depression.

In this segment, Hemming was specifically asked about the website 

 and its use for internists looking to help direct patients to mental health-related smartphone applications.

“People are always interested in new technology in every part of medicine,” he explained. “I got some help from the Beth Israel Deaconess Medical Center here in Boston, as they have a division of digital psychiatry and Dr. John Torous met with me to go over some of these things. They study this and have developed a really nice online resource…It's a non-industry supported clearinghouse and a search mechanism for people who are looking for app-based health particularly in the mental health sphere.”

Hemming explained that this website may help patients to determine which app could work best for them, given the wide variety of potential apps designed for mental health needs.

“There are over 10,000 apps that do mental health stuff, so there's no shortage of things that are marketing themselves,” Hemming said. “But this website actually evaluates them for things like the cost, the interface, how usable it is, and the privacy settings. So if you're sharing sensitive stuff about yourself with a company, how is that being used? Things like that.”

Hemming noted that most individuals do not continue to use apps longterm, with many downloading them, using them a couple of times, and often forgetting about them.

“As patients ask us about this, my approach is, essentially, that there are some things that we don't have the time to teach patients or coach them through,” he said. “Things like deep breathing exercises, things like mindfulness or meditation, things like setting up new habits. The vast majority of these mental health apps do that and at least 40 or 50% of them are free.”

To learn more about the contents of Hemming’s interview, view the full segment posted above. The website referenced by Hemming is https://mindapps.org/Apps.

The quotes contained in this summary were edited for the purposes of clarity. Hemming has no relationships with entities whose primary business is marketing, selling, producing, re-selling, or distributing healthcare products used by or on patients.

Videos

This segment of Hemming’s ACP interview featured a discussion of a website used to assess digital applications for patients struggling with mental health issues.


Internal Medicine

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Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

In recent years, few topics have attracted the same level of attention in cardiovascular medicine, particularly among lipidogists, as the evolving recognition of lipoprotein(a) [Lp(a)] as a marker of elevated risk. This evolving recognition of risk is happening in tandem with a growing knowledge base and burgeoning therapeutic pipeline. 

In 2019, the National Lipid Association released a scientific statement on using Lp(a) in clinical practice. Fast-forward a half-decade to April 01, 2024, and the NLA has released an update to this statement further clarifying recommendations surrounding the use of Lp(a) in clinical practice. A 12-page document citing more than 80 references, the recommendations and insights are the subject of a 3-part clinical quiz series from HCPLive Cardiology. 

The first of the series, this quiz focuses on the basics surrounding the testing of Lp(a) in clinical practice. 

Immunochemical assay calibrated against WHO/IFCCLM reference material

Koschinsky ML, Bajaj A, Boffa MB, et al. A focused update to the 2019 NLA scientific statement on use of lipoprotein(a) in clinical practice. 

. Published online March 29, 2024. doi:10.1016/j.jacl.2024.03.001

Editor's note: This quiz was composed with the assistance of artificial intelligence tools. 

Articles

The first in our 3-part quiz series based on the NLA's 2024 update to their 2019 scientific statement on use of lipoprotein(a) in clinical practice focuses on basic considerations surrounding Lp(a) measurement.

Dyslipidemia

Clinical Quiz: Lp(a) Testing Basics from 2024 NLA Update on Use of Lipoprotein(a)

A new study found patients have a lower mortality when treated by female physicians, but female patients have a greater benefit from being treated by females.

“It is important to note that female physicians provide high-quality care, and therefore, having more female physicians benefits patients from a societal point-of-view,” said investigator Yusuke Tsugawa, MD, PhD, MPH, associate professor-in-residence of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at UCLA, in a press release.

Sex disparities often exist in health care, with research showing female patients are less likely to receive intensive care and procedures, more likely to face delayed diagnoses, and have more negative patient experiences including being dismissed by symptoms, compared with male patients.

 Studies have shown female physicians lead to better communication and rapport, and female patients are more likely to agree with the provided advice. However, the positive outcomes of being treated by a female physician are unknown for male patients.

Investigators, led by Atsushi Miyawaki, MD, PhD, from the department of health services research at The University of Tokyo, conducted a retrospective observational study to assess whether the association between physician sex and hospital outcomes varied between hospitalized female and male patients. They collected a 20% random sample of Medicare fee-for-service beneficiaries hospitalized with medical conditions during 2016 – 2019 and leveraged data from the Medicare Data on Provider Practice and Specialty. The primary outcomes were patients’ 30-day mortality and readmission rates. They adjusted the rates for patient and physician characteristics.

The sample included 458,108 females and 318,819 males aged ≥ 65 years. Female physicians treated 31.1% of female patients and 30.6% of male patients. The exposure variables were 4 patient-physician dyads: female patient–female physician, female patient–male physician, male patient–female physician, and male patient–male physician.

Although both female and male patients had lower mortality when treated by female physicians, females experienced a greater benefit (difference-in-differences, -0.16 percentage points [pp] (95% confidence interval [CI], -0.42 to 0.10 pp). The team observed a large and clinically meaningful difference between female patients being treated by female vs male physicians.

Female patients had a lower mortality rate (8.15%) when treated by female physicians compared to when treated by male physicians (8.38%) (average marginal effect [AME], -0.24 pp (95% CI, - 0.41 to -0.07 pp). As for male patients, males only had a slightly lower mortality rate when being treated by female physicians (10.15%) over male physicians (10.23%) (AME, -0.08 pp (95% CI, -0.29 to 0.14). Investigators noted a similar pattern for patients’ readmission rates.

A limitation the team pointed out was the findings may not be generalizable to younger populations with the sample being older adults.

Investigators hypothesized the factors driving the differences, such as male doctors underestimating the severity of their female patients’ illness, female doctors being better at communicating with their female patients, and female patients being more comfortable with receiving sensitive examinations and having detailed conversations with female physicians.

“What our findings indicate is that female and male physicians practice medicine differently, and these differences have a meaningful impact on patients' health outcomes,” Tsugawa said. “Further research on the underlying mechanisms linking physician gender with patient outcomes, and why the benefit of receiving the treatment from female physicians is larger for female patients, has the potential to improve patient outcomes across the board.”

Miyawaki A, Jena AB, Rotenstein LS, Tsugawa Y. Comparison of Hospital Mortality and Readmission Rates by Physician and Patient Sex. 

. Published online April 23, 2024. doi:10.7326/M23-3163

Treatment From Female Doctors Leads to Lower Mortality And Hospital Readmission Rates. EurekAlert! April 22, 2024. 

https://www.eurekalert.org/news-releases/1041811

A new study found female patients (8.15%) had a lower mortality rate when treated by female physicians than male physicians (8.38%).

Patients Have Lower Mortality When Treated by Female Physicians

 Monday night, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Abeona Therapeutics for the company’s biologic license application (BLA) for prademagene zamikeracel (pz-cel).

 The novel cell-based therapy is under development for the treatment of 

recessive dystrophic epidermolysis bullosa (RDEB)

, a rare, inherited, debilitating skin disease associated with severe outcomes including increased risk of skin cancer and death.

Abeona stated on Monday the CRL entailed an FDA request for additional information regarding Chemistry Manufacturing and Control (CMC) requirements being “satisfactorily resolved” prior to a potential approval for pz-cel. The company stated they submitted plans to the FDA with the commitment to provide the relevant CMC data prior to a potential BLA approval.

“The information needed to satisfy the CMC requests in the CRL pertains to validation requirements for certain manufacturing and release testing methods, including some that were captured in the observations during the FDA’s pre-license inspection,” they wrote. “The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel.”

Abeona chief executive officer Vish Seshardri expressed surprise and disappointment with the CRL, but said the company is working to remediate the issue all the same.

“We are already hard at work generating the additional CMC information, and we expect that all of FDA’s requests will be addressable in a reasonable timeframe,” Seshandri said in a statement. “We anticipate completing the BLA resubmission in the third quarter of 2024 with necessary updates to fully satisfy all the deficiencies outlined in the CRL.”

spoke with a trio of experts regarding pz-cel, its supporting phase 3 data from the VIITAL trial, and the novel therapy’s potential role in the treatment of RDEB.

Joyce Teng, MD, PhD, professor of dermatology at Stanford University, explained how the use of genetically corrected cells derived from patients could create for the opportunity to provide a “true, personalized approach” to managing RDEB. “The genetically corrected keratinocytes will be growing into a sheet of skin without the genetic defect, then grafted back onto the individual where the initial cells were derived from, to correct the area where the disease is affected,” Teng said.

That said, skin graft procedures with pz-cel will have to be performed in skilled tertiary centers, she explained.

“But the advantage of that kind of approach to some of these data are already in the public domain—that the durability of these skin grafts are quite good compared to other products,” Teng said. “It can probably tailor to patients that have, for instance, a chronic wound in a particular location of their body that's really, really difficult to heal.”

The potential application of pz-cel to treat patients with RDEB comes at a time when gene therapy beremagene geperpavec (B-VEC; VYJUVEK) was recently approved to treat DEB; Amy Paller, MD, chair of dermatology at Northwestern Medicine, discussed with 

“Aging, older individuals and those maybe a little bit slower in general to heal, those who have more of these larger (wound) areas, maybe are really who we would more readily designate for these (pz-cel) transplants,” Paller said. “And obviously, there may be those who can't be putting on (the topical) every week, because it's complicated, right?”

Paller explained that patients will experience more inflammation and a slower healing process as they age; the properties of pz-cel’s clinical benefit may be especially pronounced in the older RDEB patient population.

“The deficiency in type VII collagen affects both the adhesive properties of skin—because it is a major component of the anchoring fibrils...but also collagen VII can be involved as an extracellular matrix component that cells can migrate on,” Paller said. “There's so many reasons why it's problematic.”

In the event the BLA is eventually approved by the FDA, there will likely be a rollout phase to ensure the grafting procedure is handled optimally, explained investigator Peter Marinkovich, MD, director of the Stanford Bullous Disease and Psoriasis Clinics.

“You want to have very good EB surgeons and anesthesiologists who understand EB patients, who know how to manage their fragile airways effectively to try to minimize the risk,” he explained. “And then you also want the patients to be hospitalized and treated during their medical care by people who are familiar with EB, who will handle the skin gently and not incur blistering and try to give the patient as good a hospital experience as possible. “

Stansfield N. FDA Issues CRL for Abeona's Epidermolysis Bullosa Gene Therapy Pz-Cel. 

. Published April 22, 2024. https://www.cgtlive.com/view/fda-issues-crl-abeona-epidermolysis-bullosa-gene-therapy-pz-cel

Abeona. Abeona Therapeutics Provides Regulatory Update on Pz-cel. Press release. Published April 22, 2024. https://investors.abeonatherapeutics.com/press-releases/detail/276/abeona-therapeutics-provides-regulatory-update-on-pz-cel

Kunzmann K. Comparing New Therapies for Dystrophic Epidermolysis Bullosa. 

. Published March 6, 2024. https://www.hcplive.com/view/comparing-therapies-dystrophic-epidermolysis-bullosa

Kunzmann K. Amy Paller, MD: What Pz-cel, B-VEC Each Bring to Recessive DEB. 

. Published March 6, 2024. https://www.hcplive.com/view/amy-paller-pz-cel-b-vec-recessive-deb

Kunzmann K. The Prospect of Pz-cel in RDEB Treatment, with Peter Marinkovich, MD. 

. Published March 6, 2024. https://www.hcplive.com/view/pz-cel-rdeb-treatment-peter-marinkovich-md

Abeona's pz-cel is up for indicated use to treat patients with recessive dystrophic epidermolysis bullosa.

FDA News

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.

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.

FDA Issues CRL to Abeona for Potential RDEB Cell Therapy

Connor Iapoce is an associate 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 

New, positive data from the pivotal phase 3 LUNA 3 study show rilzabrutinib achieved the primary endpoint of durable platelet response in adult patients with 

persistent or chronic immune thrombocytopenia (ITP)

Announced by Sanofi on April 23, 2024, the oral, reversible, covalent BTK inhibitor, taken at 400 mg twice daily, led to a significantly higher proportion of patients with ITP achieving durable platelet response versus a placebo-treated cohort.

“The results of this study reinforce rilzabrutinib’s potential to be a first-in-class oral, reversible BTK inhibitor that can provide clinically meaningful improvements for people living with severe immune-mediate diseases like ITP,” Houman Ashrafian, executive vice president and head of research and development at Sanofi, said in a statement.

ITP is characterized by autoantibody-mediated platelet distribution and impairment in platelet production, leading to thrombocytopenia and an elevated risk of life-threatening bleeding episodes.

 Patients with the acquired autoimmune blood disorder can experience significant impairments to quality of life, including fatigue and cognitive dysfunction.

LUNA 3 is a multi-center, phase 3 study investigating the efficacy and safety of rilzabrutinib versus placebo in adults and adolescents with persistent or chronic ITP.

 Participants received either oral rilzabrutinib 400 mg twice daily or placebo during a 12- to 24-week double-blind treatment period, followed by a 28-week open-label treatment period and a 4-week safety follow-up or long-term extension period

The study’s primary endpoint was durable platelet response, categorized as the proportion of participants able to achieve platelet counts ≥50,000/µL for at least 8 of the last 12 weeks of the 24-week blinded treatment period, in the absence of rescue therapy.

Achieving the primary endpoint, Sanofi reported a significantly higher proportion of patients in the rilzabrutinib cohort achieved a durable platelet response. The clinically and statistically significant endpoint was achieved in patients with primary ITP who had been refractory to prior therapy.

Specifically, participants in LUNA 3 experienced a median of four prior therapies for ITP and had a median baseline platelet count of 15,000/µL—normal platelet counts range from 150,000 to 450,000/µL.

Secondary endpoints in LUNA 3 consisted of the weeks with and time to platelet responses, rescue therapy use, physical fatigue, and bleeding scores. Sanofi indicated the positive results on these key secondary endpoints emphasize rilzabrutinib’s ability to provide clinically meaningful benefits for patients with ITP. The safety profile of rilzabrutinib in LUNA 3 remained consistent with findings from previous studies.

As of November 2020, rilzabrutinib has been granted Fast Track Designation by the US Food and Drug Administration (FDA) for treating ITP.

 The drug was previously granted Orphan Drug Designation. Sanofi announced the full results of the LUNA 3 study will be presented at a medical congress and regulatory submissions in the US and European Union are expected by Q4 2024.

“These pivotal results are a testament to our commitment and expertise in rare blood diseases and ability to build a portfolio of next-generation small-molecule inhibitors that are both more selective and optimized to deliver robust efficacy and safety outcomes as compared to existing therapies,” Ashrafian added.

Press release: Rilzabrutinib Luna 3 phase 3 study met primary endpoint in immune thrombocytopenia. Sanofi. April 23, 2024. Accessed April 23, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-04-23-05-00-00-2867327.

Justiz Vaillant AA, Gupta N. ITP-Immune Thrombocytopenic Purpura. [Updated 2023 May 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK537240/

RILZABRUTINIB granted FDA Fast Track designation for treatment of immune thrombocytopenia. Sanofi. November 18, 2020. Accessed April 23, 2024. https://www.sanofi.com/en/media-room/press-releases/2020/2020-11-18-06-15-00-2128828.

Rilzabrutinib led to a durable platelet response in adult patients with persistent or chronic immune thrombocytopenia in the LUNA 3 study. 

Hematology

Rilzabrutinib Achieves Phase 3 Primary Endpoint in Immune Thrombocytopenia

Experts discuss the use of biosimilars in treating neovascular age-related macular edema (nAMD) and diabetic macular edema (DME).

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.

The Impact of Biosimilars in Retinal Diseases

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Branch provides an overview of the use of dual antiplatelet therapy and anticoagulants based on his session at the ACP Internal Medicine meeting.

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...

Kelley Branch, MD: Considerations for Dual Antiplatelet Therapy, Anticoagulation

Experts discuss the safety of aflibercept 8 mg, emphasizing familiarity, efficacy, and durability, supported by reassuring data from the two-year PULSAR and PHOTON studies. 

Safety Considerations for New Therapies

Another segment of her ACP 2024 interview featured a discussion on weight loss drugs, healthy living, and discussions with patients.


Anne Thorndike, MD, MPH: Discussing Obesity, Physical Activity, Weight Loss Drugs

NBI-1065845 shows promise in alleviating symptoms of major depressive disorder in patients with inadequate response to current antidepressant treatments, according to phase 2 SAVITRI study data.

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.

Phase 2 SAVITRI Supports Use of NBI-1065845 in Major Depressive Disorder with Inadequate Response to Antidepressants

A new study found the perceived onset of old age rose nearly 3 years from 1911 to 1953.

Geriatrics

Geriatric medicine condition center page is a comprehensive resource for clinical news and insights on frequent geriatric-related diseases and conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for sleep disorder, dementia, Alzheimer's disease, and more.

Middle Age and Older Adults Perceive “Old Age” Begins Later Than a Decade Ago

Shah discusses the prevalence of psychiatric illness among hospitalized patients and highlights key considerations for their management from her session at ACP.

Managing General Medical Inpatients with Psychiatric Illness, with Sejal Shah, MD

The expert panel addresses the common assumption of medication non-adherence in patients with resistant diabetes, provides strategies to differentiate non-adherence from underlying comorbidities contributing to resistance, and discusses the challenges of patients who are post-metabolic surgery, yet experience weight gain and symptom recurrence. 

Peer Exchange

HCPLive® Peer Exchange panel discussions feature authoritative insights, opinions, and perspectives on important issues facing today's care professionals.

Video Series

Differentiating Medication Non-Adherence From Underlying Comorbidities 

Hanford Yau, MD, Ralph DeFronzo, MD, Pam Kushner, MD, Honey East, MD, and Christopher Lucci, MD, explore resistant diabetes, share their clinical experience regarding the frequency of this condition, and highlight the role of continuous glucose monitoring in identifying patients who may be resistant, as indicated by prolonged periods of blood glucose levels outside the target range. 

Defining Resistant Diabetes 

The national registry-based analysis in Denmark may inform the clinical value of medication adherence in the first years of glaucoma treatment. 

Latest News

Patrick Hemming, MD: Which Mental Health App is Best for Internal Medicine Patients?

Clinical Quiz: Lp(a) Testing Basics from 2024 NLA Update on Use of Lipoprotein(a)

Patients Have Lower Mortality When Treated by Female Physicians

FDA Issues CRL to Abeona for Potential RDEB Cell Therapy

Rilzabrutinib Achieves Phase 3 Primary Endpoint in Immune Thrombocytopenia