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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

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

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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

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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

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

The Impact of Biosimilars in Retinal Diseases

In this segment, the discussion shifts to the use of biosimilars in the treatment of neovascular age-related macular edema (nAMD) and diabetic macular edema (DME). David Eichenbaum, MD asks the panelists about their thoughts on biosimilar use, particularly with the current commercially available ranibizumab biosimilar. Seenu Hariprasad, MD shares his experience with biosimilars in his practice. He expresses that biosimilars have been helpful in his practice, especially in situations involving step edits and insurance issues. He notes that biosimilars, while cost-effective, belong to an older generation of drugs and are not interchangeable with the newer extended-durability agents. He emphasizes the importance of recognizing the limitations and differences in efficacy and durability. Kenneth Fan, MD, MBA discusses the practical aspects of using biosimilars, mentioning that step mandates often play a role in their utilization. Fan points out that if patients do well on a biosimilar without adverse events and remain dry, he tends to continue with it. However, if there are issues or a need for a more effective treatment, he considers switching to a newer agent. The conversation touches on the role of biosimilars in the context of step edits, patient adherence, and the anticipation of aflibercept biosimilars in the future. The panelists express a range of viewpoints, emphasizing the need to balance cost considerations with ensuring effective and safe treatment for patients.

This summary was AI-generated and edited for clarity.

Videos

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

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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.

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

American College of Physicians (ACP) Internal Medicine Meeting

 in Boston this past weekend, Kelley Branch, MD, MSc, professor in the division of cardiology at the University of Washington Heart Institute, reviewed approaches to the use of antithrombotics for the primary and secondary prevention of cardiovascular disease.

In his introduction at the beginning of the session, Branch described the current landscape as a “very confusing time,” noting his goal was to dissect what the latest data suggests.

Branch reviewed key points highlighted in the session and described guideline recommendations for primary and secondary prevention of cardiovascular disease. In this segment, he began by explaining circumstances in which dual antiplatelet therapy should be used as well as when it should be discontinued or interrupted.

“There have been lots of strides, not only in the antiplatelet and antithrombotic realms, but also in stents and our therapies and how we approach patients, making sure the stents are deployed, et cetera, so there have been lots of those improvements,” Branch said.

Specifically, in patients at high risk of bleeding, he noted dual antiplatelet therapy should be used for a short period of time and patients should be pulled off relatively early, citing data presented at the American College of Cardiology meeting earlier this year showing this can be as little as 1 month of dual antiplatelet therapy before patients can be transitioned to monotherapy.

Branch also discussed strategies for stroke prevention in valvular versus nonvalvular atrial fibrillation using anticoagulants, describing the importance of distinguishing between the two.

“We really want to be calling this just atrial fibrillation, but there really is a stratification to valvular or nonvalvular,” he said, going on to explain different circumstances in which various anticoagulants may or may not be appropriate for patients.

Branch has relevant disclosures with Bayer, Amgen, Hanmi, Janssen Pharmaceuticals, and Kestra.

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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

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 

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


Internal Medicine

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

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.

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.

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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.

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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. 

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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. 

Early Adherence to Glaucoma Medication Predicts Future Treatment Patterns

Eblasakimab shows promising itch relief in dupilumab-experienced atopic dermatitis patients, with significant reductions in symptoms observed.

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Eblasakimab Shows Benefit in Atopic Dermatitis Among Dupilumab-Treated Patients

Announced on April 18, the approval is based on the VISIBLE 2 trial and comes less than 7 months after the approval of SC vedolizumab in ulcerative colitis.

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Latest News

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

The Impact of Biosimilars in Retinal Diseases

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