Safety Profile, Accessibility of Tapinarof Cream for Atopic Dermatitis, with Adelaide Hebert, MD

December 2024 US Food and Drug Administration (FDA) approval

 announced by Organon for tapinarof (Vtama) cream 1% expanded the drug’s indicated age range, with patients diagnosed with atopic dermatitis aged 2 years and older now approved to receive the medication.

, the FDA approval of this aryl hydrocarbon receptor agonist and the ADORING phase 3 clinical trial program leading to the approval were discussed between the 

 editorial team and ADORING investigator Adelaide A. Hebert, MD, a professor of dermatology and pediatrics at UTHealth Houston. In the above segment of her interview, Hebert was asked about the drug’s safety profile in her team’s findings.

“We had excellent results with long term safety,” Hebert explained. “We did not see new emergent adverse events in the long term safety study that would have suggested application over that duration, up to a full 52 weeks in a full year of treatment…[would] lead to any undue sequelae. It didn't raise any concerns and we didn't see anything we call a signal, which is something we would want to identify, and it remains one of the purposes of these long term safety evaluations.”

Overall, Hebert highlighted that in the ADORING trial, tapinarof cream 1% was well-tolerated among study subjects.

“One thing we learned in addition was many of the patients can develop time off medication because of the remitive effect of this drug,” Hebert said. “And the duration of that time off drug with disease control was as much as 80 days. That is really a remarkable interval of treatment-free time when you have a condition that's chronic, relapsing, and prone to flares. So this, again, was a very important learning arena for us, as we did this clinical trial out to the 52 week time point.”

Hebert highlighted that the ADORING investigators were pleased that the patients could go without medication during this brief period. Then, she was asked about any potential barriers to accessibility to this medication for patients aged 2 years and older with atopic dermatitis.

“I think 1 of the things for those of us, particularly in the pediatric realm, is to begin to generate awareness in our colleagues within pediatrics and family practice,” Hebert said. “Because they may or may not have heard of this drug, as it was only approved previously for those patients 18 above with psoriasis, so they will have had little opportunity to see patients who are on the drug, or to have prescribed it potentially themselves. We need to educate these colleagues, because it is once-a-day, it is steroid-free, and it can be used as a single drug over all body parts. I don't think many of our pediatric colleagues are aware of what we call this remitive effect.”

To find out more information about tapinarof 1% and its safety profile among patients aged 2 years and older with atopic dermatitis, view the full video posted above.

The quotes used in this summary were edited for the purposes of clarity.

Hebert's disclosures are as follows: Research grants paid to the medical school (Dermavant, Arcutis, Pfizer, Leo Pharma, Incyte), Honoraria (Dermavant, Arcutis, Pfizer, Leo Pharma, Incyte, Sun Pharma, Ortho Dermatology, Apogee), DSMB (Sanofi Regeneron, OrthoDermatologics, GSK, Apogee).

FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organon. December 16, 2024. https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/. Date accessed: December 16, 2024.

Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organon. November 5, 2024. https://www.organon.com/news/update-on-fda-review-of-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/. Date accessed: December 16, 2024.

This segment of Hebert’s interview features a discussion regarding the safety profile of tapinarof 1% for patients aged 2 years and older with atopic dermatitis.

Safety Profile, Accessibility of Tapinarof Cream 1% for Atopic Dermatitis, with Adelaide Hebert, MD

Adelaide A. Hebert, MD

Craig Lammert, MD, is an associate professor of medicine at Indiana University School of Medicine and executive director for the Autoimmune Hepatitis Association. 

Advancing Autoimmune Hepatitis Treatment and Research, with Craig Lammert, MD

 treatment landscape has remained stagnant, relying on the same standard therapies with little innovation.

AIH is a rare chronic disease, with little known about its etiology and pathophysiology. Additionally, epidemiological data on AIH is scarce and likely unreported and underrecognized.

“The standard of care that we've been using for almost 70 years really has not evolved,” Craig Lammert, MD, an associate professor of medicine at Indiana University School of Medicine and executive director for the Autoimmune Hepatitis Association, explained to 

. “We have very much used azathioprine, or Imuran, as a hammer and the patients as a nail.”

He notes that recent studies have sought to widen the standard of care, specifically referencing the CAMARO trial comparing azathioprine and mycophenolate mofetil, both in combination with prednisolone, for the induction of biochemical remission in treatment-naive patients with AIH. Results showed mycophenolate mofetil with prednisolone led to a significantly higher rate of biochemical remission at 24 weeks with fewer adverse events compared to azathioprine combined with prednisolone.

Still, Lammert points out a significant proportion of patients fail to achieve biochemical response with currently available therapies and face long-term corticosteroid dependence.

“Anything we can do to herald in a new wave of clinical trials, and how we design those trials to not suffer from what we've seen in the PBC space, but also to identify agents and test them in a way to get full approval, would be tremendously impactful for autoimmune hepatitis patient populations,” he said.

In the meantime, Lammert describes efforts to optimize current standard of care and assess tools for long-term disease monitoring, including FibroScan.

“More to come on this area, and again, an exciting area, but we need so much more collaboration and patient-level data,” he said. “I think this will help guide us into the future, and hopefully, autoimmune hepatitis will catch up with all the other autoimmune diseases in terms of treatment and more individualized level of care.”

Editors’ note: Lammert has relevant disclosures with Eli Lilly, Kezar Life Sciences, and the Autoimmune Hepatitis Association.

Linzay CD, Sharma B, Pandit S. Autoimmune Hepatitis. StatPearls. August 14, 2023. Accessed March 25, 2025. 

https://www.ncbi.nlm.nih.gov/books/NBK459186/

Snijders RJALM, Stoelinga AEC, Gevers TJG, et al. An open-label randomised-controlled trial of azathioprine vs. mycophenolate mofetil for the induction of remission in treatment-naive autoimmune hepatitis. 

Lammert describes the lack of developments in autoimmune hepatitis care over the past several decades and points to what might be next in disease management.

Craig Lammert, MD

Implementation of Blood Eosinophil Testing Into Clinical Practice

Blood eosinophil counts have become an important tool in managing COPD, as reflected in clinical guidelines. However, there can be a gap between the recommendations in these guidelines and real-world practice, partly because guidelines are updated annually and sometimes lag behind recent therapeutic approvals. Additionally, eosinophil levels naturally fluctuate, making a single measurement less reliable. For this reason, multiple checks over time are recommended to better understand a patient’s eosinophilic phenotype. While guidelines provide a broad framework, clinical resources often offer more practical advice to help clinicians apply eosinophil data effectively in patient care.

One of the main challenges in integrating blood eosinophil counts into routine clinical practice lies not in obtaining the measurements themselves but in accurately capturing patients’ symptoms and exacerbation histories. This information is critical for appropriate patient classification and treatment decisions but is frequently not systematically recorded in electronic health records (EHRs). Some academic centers have developed customized tools within their EHR systems to track exacerbations and symptom severity scores, but these solutions require substantial resources and are not widely available in most clinical settings. Without reliable data on symptoms and exacerbations, it becomes difficult to apply eosinophil-guided treatment recommendations consistently.

Fragmented health care delivery further complicates the use of blood eosinophils in COPD management. Patients often receive care across multiple health systems, limiting clinicians’ access to complete medical histories and prior laboratory results. This lack of continuity can lead to misunderstandings, such as mistaking frequent COPD exacerbations for recurrent pneumonias, which can cloud clinical decision-making. Despite these challenges, continued efforts to improve data collection, increase clinician education, and promote guideline dissemination are essential steps toward more widespread and effective use of blood eosinophil counts in COPD management.

Panelists highlight that while blood eosinophil counts are valuable for guiding chronic obstructive pulmonary disease (COPD) treatment, real-world challenges like fluctuating levels, incomplete symptom tracking, and fragmented care hinder their consistent use, underscoring the need for better data integration and clinician education.

Diego J. Maselli Caceres, MD 

Associate professor in the Hubert Department of Global Health, and the School of Public Health at Emory University

VA MOVE! Reinforces Why Veteran-Specific Diabetes Prevention Research Matters, with Piaopiao Li and Hui Shao, MD, PhD

The VA MOVE! Program generally reduced the incidence of type 2 diabetes (T2D) over 15 years, although efficacy significantly varied by subgroups and declined over time.

These long term data were presented at the 

2025 American Diabetes Association (ADA) Scientific Sessions

, held June 20-23, in Chicago, Illinois, by Piaopiao Li, MS, a PhD candidate at University of South Florida.

 spoke with Li and the primary investigator of the study, Hui Shao, MD, PhD, associate professor in the Hubert Department of Global Health, and the School of Public Health at Emory University, to learn more about VA MOVE!, the efficacy it has shown previously, and its real-world findings out to 15 years.

Li emphasized the specific disease burden of T2D in the veteran population and to the health care system. She overviewed the VA MOVE! study and its origins from NIH diabetes prevention program (DPP) trials.

Prior to the long-term follow-up, investigators had found that participating in VA MOVE! was associated with a 33% risk reduction for T2D. Shao outlined how VA MOVE fits into the larger scheme of CDC-funded DPP-like intervention studies in different populations.

“The disease burden [in veterans] is different and we're kind of moving to a precision diabetes era. So, diabetes has many different subtypes and in veterans, not only is the disease burden different, the composition of different subtypes are very different from the general population. And so, the targeted type of diabetes prevention strategies specifically for veterans is very important as compared to the one deployed in the general population,” Shao told 

Li and Shao have no disclosures to report.

Li P, Shao H, Xue Q, et al. Assessing the Real-World Effectiveness of the VA MOVE! Lifestyle Program in Preventing Type 2 Diabetes—A 15-Year Follow-up Study [Board No. 160]. Presented at: ADA 2025; June 20-23; Chicago, Illinois. Presentation #160-OR

Li and Shao discussed the heavy disease burden of type 2 diabetes in the VA population and outlined the VA MOVE! study.

Hui Shao, MD, PhD

Jack March

COVID-19 has disrupted healthcare practices and challenged Primary Care Providers (PCPs) to rapidly innovate to deliver care. It has also upended patients’ lives and forced many to skip preventive care checkups and screenings, as well as highlighted gaps in chronic diseases and disparities in outcomes. In the last two years, cancer screening rates have plummeted in nearly all age groups

despite a rising incidence of colorectal cancer (CRC) in younger adults.

 Colorectal cancer is the second leading cause of cancer deaths in the United States;

 however, when caught in early stages, it is treatable in ~90% of people.

Regular screening can help catch cancer early.

 So, as we consider patient care in light of the ongoing pandemic, how can we encourage eligible adults to get screened when they’re due? We have an opportunity to redesign our approach – action is needed across the healthcare spectrum to ensure health systems, community centers, and PCPs partner to prioritize health literacy and ensure patients have the necessary support and resources to make informed decisions.

Increasing health literacy is critical to combatting colorectal cancer. With the recommended colorectal cancer screening age starting at 45 for average-risk Americans

, there should be a sense of urgency in finding new ways to engage with patients around preventive care measures.

New data from The Harris Poll** highlighted a lack of awareness about the risk*** of colorectal cancer. Many of those surveyed perceived themselves to be at minimal risk. In fact, 73% of respondents aged 45-49 believed they are at low risk for colorectal cancer. This demonstrates a critical and concerning gap in health literacy. We have a responsibility to ensure screening-eligible Americans, particularly adults aged 45-49 and those in vulnerable communities, have the resources and information they need to understand why screening should be a priority.

So, what steps can we take to drive progress? While I would love to see sweeping public health changes on initiatives for self-management of preventive care, where colon cancer screenings could be as accessible and convenient as a home-delivered rapid COVID antigen test, taken after using a validated screening calculator to self-assess their risk level for colorectal cancer, I believe that there are a few simple actions that can make a large impact now. 

We could reframe how we engage in cancer screening conversations. It is easy to lead with, “Now you’re 45, it’s time for your colonoscopy.” But perhaps start with, “Do you ever think about getting cancer?” It might be a surprising question to hear, even alarming, but it could give you some insights on your patient’s fears or willingness to screen for the recommended cancers or only specific types and why. Primary care providers are a trusted resource and can start the conversation about personal risk and share the best screening options to meet patients where they are.

Another option is to offer a choice in colon cancer screening options to patients first, before waiting to hear if there is any hesitancy about colonoscopy. While a colonoscopy is considered the primary screening option for colorectal cancer, offering a choice in screening can encourage those who have hesitancy to get scoped.

 Many respondents to the Harris Poll noted that their discomfort – physical or stigma-related – with colorectal cancer screening has prevented them from staying up to date, indicating an opportunity for more screening options. In fact, among those who have ever skipped a colorectal cancer screening after a referral, 38% of those surveyed cite having done so due to discomfort with the idea of invasive procedure. Additionally, 74% of adults surveyed agreed that they would get screened for colorectal cancer if it were a non-invasive procedure, while 72% of respondents said that they would be more willing to get screened if they could use an at-home test instead of going to a doctor's office.

Despite these results, only 4 in 10 respondents (40%) were familiar with at-home DNA based stool tests. Each type of screening test has its strengths and shortcomings when comparing effectiveness, accessibility, and ease of use, but the best screening is the one that gets done. When considering health disparities in populations where paid sick time is not available, or patients are primary caregivers to children or elders and unable to take time away for the colonoscopy prep and procedure, providing resources that clearly delineate various screening options is critical.

At-home screening options such as Cologuard® can provide a non-invasive, effective, and convenient screening option for adults 45 and older, who are at average risk for colorectal cancer. In the effort to improve health literacy, it is important to discuss with patients what makes them eligible and ineligible for Cologuard. Small practices and solo PCPs with limited resources have found it helpful that Cologuard also has a built-in, 24/7 patient support team to follow-up on and encourage test completion in over 240 languages which can help make the process more convenient and contact free, particularly as screening rates have dropped amidst COVID-19.

As we navigate this complex healthcare landscape, action is needed to ensure health systems, community centers, and PCPs partner to prioritize health literacy and engage patients with the meaningful resources and necessary support to make informed decisions. To do so, we must reframe our approach as we face increasingly challenging areas of care. With colorectal cancer incidence rates on the rise in younger populations,

 screenings remain the most important tool to detect preventable fatalities. Meeting patients where they are with solutions that fit their specific needs is critical to catching up on missed screenings and encouraging future screenings.

Indication and Important Risk Information


Cologuard is intended to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use if you have had adenomas, have inflammatory bowel disease and certain hereditary syndromes, or a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high-risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative). Rx only.

** Data is according to a national survey of 5,021 U.S. adults aged 45-75 conducted by The Harris Poll on behalf of Exact Sciences between March 25 and April 15, 2021.

*** Average risk in this survey was defined as those who do not have a personal history of: colorectal cancer, Inflammatory Bowel Disease, adenomas, a positive result from a colorectal cancer screening within the last 6 months, a family history of: colorectal cancer, Familial adenomatous polyposis (FAP, Hereditary non-polyposis colorectal cancer syndrome (HNPCCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner’s Syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome, or Neurofibromatosis, and are not experiencing rectal bleeding.

Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of Cancer Screening Deficit in the United States With the COVID-19 Pandemic. JAMA Oncol. 2021;7(6):878–884. doi:10.1001/jamaoncol.2021.0884

Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average‐risk adults: 2018 guidelines update from the American Cancer Society. CA Cancer J Clin. 2018;68(4):250‐281. doi:10.3322/caac.21457.

Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654.

National Cancer Institute. Cancer stat facts: colorectal cancer. Accessed November 10, 2021. https://seer.cancer.gov/statfacts/html/colorect.html.

Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer - US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238

Redesigning our Approach to Combating the Rising Incidence of CRC in Young Adults

Jenny Chiang, MD, FAAFP, Medical Director, MetroWest Healthcare Alliance, Wellforce

Mark Warren, MD, FACE is an endocrinologist and clinical associate professor at Campbell University School of Osteopathic Medicine.

 is a rare endocrine disease with consequences across multiple organ systems, which makes it challenging to diagnose and manage. Conventional therapy for HypoPTH focuses on normalizing serum calcium levels and not treating the source, which is a lack of the parathyroid (PTH) hormone. HypoPTH results from insufficient levels of PTH and patients with this disease must be managed holistically, similar to how patients with other hormone deficiencies, such as diabetes, are treated. Just as people with diabetes are more than their HbA1c level, people living with chronic HypoPTH are more than their calcium levels.

HypoPTH is a rare endocrine disease that results from the absence or deficiency of PTH, which is crucial for regulating calcium and phosphate levels in the body. While HypoPTH is frequently underdiagnosed, it is estimated that approximately 77,000 people are living with the disease in the United States. HypoPTH may result from surgery that damages the parathyroid glands, autoimmune/genetic causes, or may not have a known origin, such as idiopathic HypoPTH.

Insufficient parathyroid hormone leads to low levels of calcium and high levels of phosphate, which have significant effects on multiple organ systems. These effects may manifest as clinical symptoms (tingling/numbness, muscle cramps, seizures, wheezing, and irregular heartbeat), adverse health outcomes (kidney stones, kidney damage resulting in chronic kidney disease, cataracts, and basal ganglia calcifications), and decreased quality of life (due to fatigue, cognitive dysfunction, “brain fog,” and the challenge of managing symptoms and disease-related health issues).

Patients with HypoPTH experience the feeling that their symptoms and quality-of-life concerns are not being seen or heard by their healthcare providers when they address only the results of their blood tests and not the broader, negative impacts their hormone deficiency has on many aspects of daily living. These patients’ feelings are validated by several disturbing statistics from 

, a recent patient survey conducted by the HypoPARAthyroidism Association.

Two-thirds of respondents reported having at least one disease-related hospitalization before being diagnosed with HypoPTH, and most patients lived with symptoms of their disease for at least 6 months and, in some cases, more than 20 years before an accurate diagnosis. Even once diagnosed, only 25% of respondents strongly agreed that their physician fully understood their condition, and only 10% were happy with their treatment option.

Additionally, 87% of respondents had developed HypoPTH following head or neck surgery (the most common cause of the disease), yet only 11% fully understood that this was a potential risk before they consented to surgery.

 This underscores the importance of hearing our patients and communicating with them more effectively, especially when a newly FDA-approved treatment option may help patients feel better and live more satisfying lives.

Conventional therapy for HypoPTH typically involves the use of calcium supplements and vitamin D to raise serum calcium levels into the normal reference range. Some patients may also be given magnesium supplements and phosphate binders based on laboratory assessments of serum phosphate and magnesium levels. While these supplements can help to normalize blood chemistry, they are not entirely benign. When administered at the high doses needed in patients with HypoPTH, calcium supplementation can cause gastrointestinal side effects. When used long-term, they can also lead to chronic kidney disease and the development of calcifications in the kidneys, brain, and other organs.

In 2024, the US Food and Drug Administration (FDA) approved a new PTH hormone analog for the treatment of HypoPTH called palopegteriparatide (

). It is administered daily by subcutaneous injection.

 In an 82-patient randomized, double-blind, placebo-controlled Phase 3 clinical study, 79% of patients in the palopegteriparatide group met a 5-part efficacy assessment endpoint compared with 5% of patients in the placebo group.

 The 5-point efficacy assessment required that patients meet all of the following criteria at Week 263:

• Normalization of albumin-corrected serum calcium

• Independence from conventional therapy since Week 22 (that is, no active vitamin D and 

• No increase in palopegteriparatide dose since Week 22

• No missing active vitamin D and calcium data since Week 22

• Palopegteriparatide dose of 30 mcg or less once daily during the 26-week treatment period

A collaborative approach to optimizing outcomes for patients with HypoPTH

Normalizing calcium is necessary but not sufficient to achieve optimal patient outcomes. Comprehensive and compassionate care of patients with HypoPTH must include consideration of physical, psychological, and quality-of-life factors in addition to calcium and phosphate levels. Achieving this holistic approach requires that HCPs work collaboratively with patients to understand the spectrum of symptoms they experience and how these symptoms impact their daily lives.

In my practice, I routinely ask specific questions to elucidate this rather than assuming that patients will recognize that what they are experiencing is related to their disease. In each interaction with one of my HypoPTH patients, I ask questions about:

• Physiologic aspects of the disease, including tingling/numbness, muscle cramps, seizures, wheezing, etc.

• Quality of life issues, including fatigue and brain fog.

• How they feel today compared with how they felt before disease onset.

• Anything they want to change about how their disease impacts their life.

Once I am fully informed about how each patient is experiencing HypoPTH, I can have a productive discussion about treatment options, including PTH hormone therapy, which allows the patient to make an informed decision about how they want to manage their disease.

One particular patient exemplifies how finding the right treatment can transform care. She is a 42-year-old woman who was very active and enjoyed surfing, running, and other activities as part of her daily routine. She developed HypoPTH after thyroid surgery, which significantly limited her ability to engage in these activities and other aspects of daily living. She required 4200 mg of calcium and 1 mcg of calcitriol daily to keep calcium between 8 and 8.5. Her calcium levels fluctuated with activity and illness, resulting in recurrent symptomatic hypocalcemia. She was no longer able to participate in any of her previous sports activities due to muscle cramping, fatigue and decreased sense of well-being.

She entered a clinical trial evaluating palopegteriparatide prior to its FDA approval and had a rapid and very positive response — so much so that she told me that she had “gotten her life back” and had been able to resume her previous activities.

Other patients have shared with me that they didn’t realize how poorly they had been feeling until they tried PTH replacement therapy. These patient stories are a compelling reminder that HCPs must remain up to date on the latest developments in HypoPTH diagnosis and treatment and empower patients to confidently advocate for the highest quality of care, fostering better health outcomes.

Now that we can address parathyroid deficiency rather than just calcium levels, treating our patients with HypoPTH will prove to be gratifying to both the provider and the patient. For me, being told that I helped someone “get their life back" never gets old.

YORVIPATH Prescribing Information. Available at: 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216490s000lbl.pdf

Khan AA, et al. Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. 

. 2023 Jan;38(1):14-25. doi:10.1002/jbmr.4726

Chronic hypoparathyroidism (HypoPTH) is a rare endocrine disorder characterized by insufficient parathyroid hormone (PTH), leading to low calcium and high phosphate levels, affecting multiple organ systems. Traditional treatments focus on normalizing calcium levels but do not address the underlying hormone deficiency. A new PTH analog, palopegteriparatide, has shown promising results in clinical trials, offering a more comprehensive treatment approach. Effective management requires a holistic, patient-centered approach, considering both physiological and quality-of-life factors, to improve patient outcomes and satisfaction.

Chronic hypoparathyroidism requires holistic management addressing more than just calcium normalization to achieve optimal patient outcomes.

Beyond Calcium: A Holistic Approach to Optimizing Outcomes for Patients with Hypoparathyroidism

Mark Warren, MD

Benralizumab Reduces Severe Asthma Exacerbations in Older Adults, with Muhammad Adrish, MD

ZEPHYR-5, a real-world evidence study, showed that older adults with severe 

 experienced meaningful reductions in the rate of asthma exacerbations on benralizumab.

“This particular study was aimed to actually see what happens with this drug when it's given to patients who are old,” lead investigator Muhammad Adrish, MD, from Baylor College of Medicine, told 

2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) 

Adrish and colleagues sought to assess the change in asthma exacerbations following the initiation of benralizumab among older adults. Older adults are often underrepresented in asthma clinical trials, with the focus on younger individuals.

“Asthma is relatively considered a disease of young patients,” Adrish explained. “As the overall median age in [the] US is increasing…we expect to see more and more older patients with asthma.”

ZEPHYR-5 included 5611 patients with a mean age of 69.3±10.9 years. Participants were included if they had a prescription for benralizumab and ≥ 1 refill within 90 days, 12 months of enrollment with Medicare Fee-for-Service or Medicare Advantage with benefits lasting before and after the index date, ≥ 1 inpatient or ≥ 2 outpatient claims with a diagnosis code for asthma, and ≥ 2 asthma exacerbations. Most participants were females (69.1%) and Medicare fee-for-free beneficiaries (91.4%).

Investigators evaluated for exacerbations during the baseline and follow-up periods, which were defined as either an asthma-related hospitalization, a mechanical ventilation claim, or an outpatient or emergency department visit with an asthma diagnosis and a claim for systemic corticosteroids within 7 days. The team also assessed the percent change in annual asthma exacerbation rate from baseline to follow-up.

Benralizumab led to a 43.5% reduction in the annual asthma exacerbation rate from baseline to follow-up in older adults (3.8±2.0 to 2.2±2.2 exacerbations per year; 

 < .001). Moreover, the proportion of patients with ≥ 4 exacerbations were reduced by 50.5%.

“It was very important for me to know that in this particular age group, this drug is also very effective,” Adrish said. “No matter how many exacerbations they had to begin with, whether they had 2 exacerbations, 3 exacerbations, or 4 exacerbations… the beneficial effect of [the] drug was seen across the spectrum.”

A relevant disclosure for Adrish includes Astrazeneca Pharmaceuticals.

Adrish, M. Reduction in Asthma Exacerbations Following Initiation of Benralizumab Among Medicare Beneficiaries: Results from the ZEPHYR-5 Study Adrish. Abstract 938. Presented at AAAAI 2025 on March 3 at 1:10 pm

A real-world study shows benralizumab significantly reduced severe asthma exacerbations in older adults, with a 43.5% decrease in annual rates.

Muhammad Adrish, MD

Assistant Professor of Medicine, Harvard Medical School, and Division of Hemostasis and Thrombosis, Beth Israel Deaconess Medical Center

Bendapudi gave an overview of 2 studies presented at ASH 2024 from his Harvard lab.

Pavan K. (Tem) Bendapudi, MD: Large-Scale Analyses Elucidate Genetic Risk of Thrombosis

New large-scale database analyses of hemostasis-related genes have elucidated relationships between genes such as protein S (PROS1) and factor 12 (FXII) and thrombosis.

Findings from the analyses were presented at the

 66th American Society of Hematology (ASH) Annual Meeting and Exposition

, held December 7-10, 2024, in San Diego, California, by members of the lab of Pavan K. (Tem) Bendapudi, MD, Assistant Professor of Medicine, Harvard Medical School, and Division of Hemostasis and Thrombosis, Beth Israel Deaconess Medical Center.

“[This work] really highlights the value of these extremely large population scale next generation sequencing data sets to answer long standing and kind of previously unapproachable questions in hemostasis and thrombosis. And I would just encourage people to stay tuned, because we have a lot of other ideas and a lot of other things we're interested in looking into, and I think we will have, finally, have the power to do that in a way we weren't able to before,” Bendapudi told 

Among the new findings were a stronger than previously though relationship between 

deficiency and thrombosis and a protective effect against venous thromboembolism (VTE) in people with inherited FXII deficiency. In this clip, Bendapudi discussed the research more in-depth and emphasized the potential of new technology, such as that employed in this research from the Broad Institute's Cardiovascular Disease Initiative, to enable these large-scale analyses.

Bendapudi's relevant disclosures include Takeda Pharmaceuticals, Verve Therapeutics, and Alexion Pharmaceutical.

Chaudhry SA, Haj AK, Ryu J, et al. Leveraging Population-Scale Multiomic Datasets to Elucidate the Risk of Thrombosis Associated with Protein S (PROS1) Deficiency. Presented at: ASH Annual meeting; December 7-10; San Diego, California. Abstract 17

Haj AK, Paul D, Chaudhry SA, et al. Coagulation Factor XII (F12) Haploinsufficiency Is Protective Against Venous Thromboembolism. Presented at: ASH Annual meeting; December 7-10; San Diego, California. Abstract 133.

Pavan K. (Tem) Bendapudi, MD

Smoking is the most preventable health hazard in the US, responsible for over 480,000 deaths annually. About 19% of US adults reported current use of a commercial tobacco product in 2020, of which cigarette smoking was the most prevalent.

 perspective, smoking is a risk factor for esophageal, pancreatic and colon cancer, and adversely affects peptic ulcer disease, pancreatitis and Crohn’s disease. Smoking cessation is strongly encouraged by the American College of Gastroenterology (ACG) guideline for Managing Crohn’s Disease in Adults. Despite key recommendations for the management of smoking in healthcare settings, the degree to which this is implemented in GI clinics is unknown.

In our study that was presented at the recent Digestive Disease Week (DDW) 2023 Annual Meeting’s GI Fellow-Directed Quality Improvement Projects session—and which won an American Gastroenterological Association (AGA) Fellow Abstract Award—we aimed to assess our providers’ practices regarding smoking cessation, identify perceived barriers for administering smoking cessation treatments, and address these barriers by implementing a novel Electronic Health Record (EHR)-assisted tobacco treatment model (ELEVATE) in our GI clinics.

ELEVATE is implemented by the medical assistant during the patient rooming process, and utilizes the “5 A’s” recommended by the US Public Health Service Clinical Practice Guideline Panel, as illustrated in 

A rate of 91% of GI physicians responded to our survey, and nearly half of them stated they always asked patients if they smoked. Although 75% of physicians stated they would assess their patients’ willingness to quit at the time of the visit, less than half consistently advised smokers to quit, and only 20% often assisted patients who smoke with counseling.

Lack of a systematic program to offer help to patients was reported by 80% of providers as an extremely/very important barrier limiting their smoking cessation practices. ELEVATE module training was implemented at the beginning of 2021 using Epic Systems EHR. The proportion of smokers receiving cessation treatment increased from pre-ELEVATE to post-ELEVATE (14.36% to 27.47%; RR, 1.90; 95% CI, 1.60 - 2.26, 

<.001). Post-ELEVATE, 14.4% (n = 38) of patients with treatment quit smoking, compared to 7.9% (n = 55) of patients without treatment (RR, 1.89; 95% CI 1.26 – 2.82, 

This study sheds light on an often under-recognized source of morbidity in our GI patients and identifies an efficient and scalable strategy to combat tobacco use and improve clinical outcomes in our patients. ELEVATE smoking module has been selected by Epic Systems for wide dissemination to other healthcare systems.

How an outpatient-based smoking cessation model may come to aid other health systems' gastroenterology patients.

Authors