Alex Hacopian, MD is a cataract and refractive surgeon at Mann Eye Institute.

Interim Data Support TECNIS Odyssey IOL Performance, With Alex Hacopian, MD

Interim results from a single-center study show promising outcomes for Johnson & Johnson’s TECNIS Odyssey intraocular lens (IOL) for 

, with patients reporting excellent vision across distances and minimal bothersomeness of dysphotopsias.

American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

, most patients reported little or no reliance on glasses, and 90% rated their vision as “Excellent” or “Very good.” Although some experienced glare, halos, or rings at night, few found them significantly bothersome.

“I used to say three weeks to three months, you’d be over the halos. Now, to cover myself, I say six weeks to six months,” Alex Hacopian, MD, a cataract and refractive surgeon at Mann Eye Institute, told 

. “If we set those reasonable expectations, the ability for patients, even in low light situations, to read up close and see things in the distance, gives this lens the premier spot in my list when I’m choosing a presbyopia-correcting IOL.”

In the single-center, ambispective study investigating visual outcomes after bilateral cataract surgery and TECNIS Odyssey implantation, a total of 80 eyes from 40 subjects were targeted for analysis. Participants were evaluated for ≥3 months postoperatively at a single visit, with clinical evaluations including visual acuities at distance, intermediate, and near.

Hacopian and colleagues also pursued the administration of the assessment of intraocular lens implant symptoms (AIOLIS) and ocular surface disease index (OSDI) questionnaires for this population. At the time of reporting at ASCRS 2025, investigators indicated that 19 patients completed the study.

Upon analysis, binocular mean uncorrected visual acuities at 6 m, 66 cm, 40 cm, and 33 cm were -0.05 ± 0.06, 0.02 ± 0.12, 0.04 ± 0.10, and -0.02 ± 0.07 logMAR, respectively. Dysphotopsias most commonly reported included glare at night, halos, and rings, with 26%, 21%, and 16% of participants, respectively, experiencing them “Always.”

Notably, only 11%, 0%, and 5% of participants were “Extremely” bothered by glare at night, halos, and rings, respectively. Approximately 85% of participants reported needing glasses “Not at all” or “A little of the time,” while 90% rated overall vision as “Excellent.”

Hacopian emphasized the importance of preoperative ocular surface optimization, noting that addressing issues like dry eye and blepharitis before surgery can lead to better measurements, data, and ultimately outcomes from the formulas predicting the refractive power of the implant.

“If we can optimize the ocular surface on the front end, we're going to give the patients a better outcome and we’ll have a better reputation within the community,” Hacopian told 

. “They'll be more satisfied, and we'll feel better for it.”

Hacopian reports disclosures with Allergan and others.

Hacopian A, Brunson PB. Patient Reported Outcomes and Visual Acuity after Bilateral Implantation of a Next Generation Presbyopia Correcting Intraocular Lens. Poster presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. April 25-28, 2025. Los Angeles, CA.

A study reveals Johnson & Johnson’s TECNIS Odyssey IOL offers excellent vision for presbyopia, with minimal dysphotopsia bothersomeness reported by patients.

Alex Hacopian, MD

Ally Brassette

Brian Lee, MD, is a hepatologist and liver transplant specialist with Keck School of Medicine of USC.

Improving Fibrosis Risk Stratification in MetALD, with Brian Lee, MD

In 2023, A modified Delphi process led by the American Association for the Study of Liver Disease, the European Association for the Study of the Liver, and the Latin American Association for the Study of the Liver yielded new liver disease nomenclature to address concerns regarding the terminology “nonalcoholic fatty liver disease” and “metabolic-associated fatty liver disease.”

The revised nomenclature introduced the term 

“metabolic dysfunction-associated steatotic liver disease” (MASLD)

 to describe patients who have hepatic steatosis and ≥ 1 of 5 cardiometabolic risk factors (CRMF). Additionally, the updated nomenclature added a new classification, MetALD, to represent a separate group of patients with MASLD who consume alcohol at a rate of 140–350 g/wk for females and 210–420 g/wk for males.

“There have been several questions that have come up because of the nomenclature, but one of the controversies was whether MetALD should be defined by just 1 metabolic risk factor, Brian Lee, MD, a hepatologist and liver transplant specialist with Keck Medicine of USC, explained to 

. “We know that alcohol can actually cause metabolic risk factors. So if you have just 1 and increased alcohol intake, is it truly a distinct disease?”

Lee noted this was one of several questions he and a group of colleagues sought to answer in their recent analysis of NHANES data assessing FIB-4 scores in adults ≥ 20 years of age with complete alcohol and CMRF status.

Results showed the prevalence of FIB-4 >2.67 among individuals with and without increased alcohol use was higher at each quantity of CMRFs and with each incremental CMRF:

0 CRMFs: (2.3%; 95% CI, 1.0-5.0% vs 0.7%; 95% CI, 0.5-0.9%)

1 CRMF: (3.0%; 95% CI, 1.6-5.6% vs 1.7%; 95% CI, 1.4-2.1%)

2 CRMFs: (3.3%; 95% CI, 2.1-5.1% vs 2.1%; 95% CI, 1.8-2.4%)

3 CRMFs: (5.9%; 95% CI, 3.5-9.6% vs 2.5%; 95% CI, 2.1-2.9%)

4 or 5 CRMFs (6.1%; 95% CI, 3.3-9.7% vs 4.0%; 95% CI, 3.5-4.5%)

Among individuals with increased alcohol, in multivariable logistic regression analysis, 3 (adjusted odds ratio [aOR], 2.57; 95% CI, 0.93-7.08) and 4 or 5 (aOR, 2.64; 95% CI, 1.05-6.67) CMRFs were associated with 2-fold greater odds of high FIB-4 versus 0 CRMFs, but not 1 (aOR, 1.24; 95% CI, 0.41-3.69) or 2 (aOR, 1.39; 95% CI, 0.56-3.50) CMRFs.

“The cutoff where you have a different risk of liver fibrosis is not with 1 cardiometabolic risk factor, but it's really with 3 or more,” Lee said. “So, the take-home message here is that we should be classifying MetALD with not just 1, but really 3 or more cardiometabolic risk factors, and maybe having this higher threshold for cut-off would better differentiate the patient populations in steatotic liver disease.”

Editors’ note: Lee has no relevant disclosures.

Brooks A. From NAFLD to MASLD: 2023 Brings New Liver Disease Nomenclature. 

. December 13, 2023. Accessed February 13, 2025. https://www.hcplive.com/view/from-nafld-to-masld-2023-new-liver-disease-nomenclature

Lee BP, Molina J, Kim S, et al. Association of Alcohol and Incremental Cardiometabolic Risk Factors with Liver Disease: A National Cross-Sectional Study. 

Lee explains study findings suggesting MetALD classification should be based on ≥ 3 cardiometabolic risk factors rather than just alcohol intake.

Brian Lee, MD

Daniel P. Judge, MD, is the Edwin W. and Teresa H. Rogers Endowed Chair for Cardiovascular Research at the Medical University of South Carolina.

Data from an analysis of the pivotal ATTRibute-CM trial offer further insight into the effects of acoramidis (Attruby) on outcomes in patients with 

transthyretin amyloid cardiomyopathy (ATTR-CM)

 for ATTR-CM in November 2024, the latest info presented at the 

American College of Cardiology (ACC) 2025 Annual Scientific Sessions

 demonstrate the benefits of acoramidis on the trial’s efficacy endpoint were consistent regardless of concomitant tafamidis (Vyndamax) use.

“One of the questions that came up about the clinical trial is: did tafamidis play a role in in our endpoints? One of the things I was glad to show was that when we analyzed by 2 different methods to exclude patients with tafamidis… In both of those statistical analyzes that were prespecified, we showed that the effect of acoramidis was completely independent of tafamidis,” explained lead investigator Daniel Judge, MD, the Edwin W. and Teresa H. Rogers Endowed Chair for Cardiovascular Research at the Medical University of South Carolina, in an interview with 

In the ATTRibute-CM trial, the investigational transthyretin stabilizer acoramidis met its 4-part primary efficacy endpoint, which included all-cause mortality, cardiovascular-related hospitalization, change in NT-proBNP, and 6-minute walk distance compared to placebo (

<.0001). As the trial permitted concomitant use of tafamidis (TAF), a pre-specified analysis was conducted to evaluate its potential impact on the primary efficacy endpoint.

The ACC.25 analysis included 611 participants assessed at Month 30 using the Finkelstein-Schoenfeld (F-S) test. Investigators performed a pair of sensitivity analyses: the first excluded patients who received tafamidis and another disregarding observations after tafamidis initiation.

Initial analysis indicated a lower proportion of patients in the acoramidis group (14.9%) received concurrent tafamidis compared to the placebo group (22.8%) and median tafamidis exposure was similar between groups, (11.6 and 10.5 months for acoramidis and placebo, respectively). Further analysis suggested the primary efficacy endpoint remained highly statistically significant in both sensitivity analyses (

<.0001 for both). Safety data detailed a consistent safety profile regardless of concurrent tafamidis use.

For more on this study and the evolving landscape of ATTR-CM management, check out our interview with Judge from ACC.25:

Acoramidis, ATTR-CM, & Tafamidis: ATTRibute-CM Insights, with Daniel Judge, MD

Relevant disclosures for Judge include ADRx, Alleviant Medical, Astra Zeneca, BridgeBio, Capricor, Cytokinetics, Pfizer, Novo Nordisk, Tenaya Therapeutics, and others.

Judge DP, Obi L, Mitter SS, et al. PRIMARY ENDPOINT EFFICACY RESULTS IN THE ATTRIBUTE-CM STUDY: PRE-SPECIFIED SENSITIVITY ANALYSES ADDRESSED TAFAMIDIS USE. Presented at: American College of Cardiology (ACC.25) Annual Scientific Session. March 29 – 31, 2025. Chicago, Il.

 (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related Hospitalization in ATTR-CM Patients - BridgeBio. BridgeBio. Published November 23, 2024. Accessed April 1, 2025. 

https://bridgebio.com/news/attruby-acoramidis-a-near-complete-ttr-stabilizer-%E2%89%A590-approved-by-fda-to-reduce-cardiovascular-death-and-cardiovascular-related-hospitalization-in-attr-cm-patients/

Daniel Judge, MD, discusses data from a prespecified analysis of ATTRibute-CM examining the effects of acoramidis with and without concomitant tafamidis use.

Daniel Judge, MD

Daniel Leffler, MD, MS, is Executive Medical Director and Celiac Disease Global Clinical Development Lead at Takeda Pharmaceuticals, a gastroenterologist and a founding member of the Celiac Center at Beth Israel Deaconess Medical Center, and an associate professor of medicine at Harvard Medical School.

Improving Celiac Disease Diagnosis and Management, with Daniel Leffler, MD, MS

Recent years have seen considerable advances in the understanding of 

 biology, pathogenesis, and clinical implications. Despite this progress, it remains underdiagnosed and frequently mismanaged.

Research presented at Digestive Disease Week (DDW) 2025 by Daniel Leffler, MD, MS, Executive Medical Director and Celiac Disease Global Clinical Development Lead at Takeda Pharmaceuticals, a gastroenterologist and a founding member of the Celiac Center at Beth Israel Deaconess Medical Center, and an associate professor of medicine at Harvard Medical School, sheds light on celiac disease practice patterns and educational needs among US healthcare providers.

“We've really evolved a great deal in many ways over the last few decades,” Leffler told 

, citing a better understanding of the biology of celiac disease, what triggers it, and how it leads to intestinal damage, malabsorption, and GI symptoms. “I think it's become abundantly clear how prevalent this disorder is, how undiagnosed it is, and how poorly diagnosed and poorly managed celiac disease is today.”

An estimated 1 in 133 people in the US, or about 1% of the population, has celiac disease, but recent screening studies suggest this prevalence may actually exceed 1%. Additionally, an estimated 83% of people in the US who have celiac disease are undiagnosed or misdiagnosed with other conditions.

Leffler points to the disease’s heterogeneity as one of the key barriers to diagnosis, describing how although celiac disease can manifest with classic gastrointestinal symptoms, many patients present with non-GI symptoms such as anemia, rashes, joint pain, and headaches, making it difficult for primary care providers and other frontline clinicians to know when to consider celiac disease as part of the differential diagnosis. Although the use of tissue transglutaminase IgA testing is relatively cheap and effective, it is often underutilized in appropriate clinical scenarios.

“When any patient is having ongoing issues that you don't really have a handle on or seem a little out of place for what they are, it just should be one of those reflexes to ask ‘Why don't we just test that?” Leffler said. “The same way people do a lot with thyroid disease… we need celiac disease testing to get to that level of awareness by frontline practitioners.”

He goes on to describe related diagnostic challenges with the premature initiation of a gluten-free diet before formal testing, which can complicate the process of making a formal diagnosis. Leffler says this was one of many challenges that emerged in his research at DDW, with others being awareness of diagnostic guidelines, when to refer for a biopsy, and what to do when a patient has been diagnosed with celiac disease.

Looking ahead, Leffler expresses interest in research on why only some patients have ongoing intestinal damage and a wide range of sensitivities to gluten, ways to facilitate more childhood diagnoses, and potential interventions to delay or prevent celiac disease onset.

“There's a bias in medicine that things that can be treated with diet aren't that serious, and I think celiac disease unfortunately falls into that category sometimes,” Leffler explained. “We need to get people to understand that this is actually a serious condition that can have life-threatening complications, so it really is something that they should be diagnosing and taking seriously, like any other immune-mediated condition.”

Editors’ note: Leffler has relevant disclosures with Takeda Pharmaceuticals.

Cazzetta S, Salinas G, Renfroe A, et al. CHALLENGES AND OPPORTUNITIES IN THE MULTIDISCIPLINARY MANAGEMENT OF CELIAC DISEASE IN THE UNITED STATES: RESULTS OF A CASE-BASED SURVEY. Abstract presented at Digestive Disease Week 2025 in San Diego, CA, from May 3 - May 6, 2025.

Beyond Celiac. Celiac Disease: Fast Facts. Accessed May 12, 2025. 

https://www.beyondceliac.org/celiac-disease/facts-and-figures/

Leffler describes progress made in the understanding of celiac disease but points to continued challenges in diagnosis and management.

Daniel Leffler, MD, MS

What I want to do is go around to each of you and let you speak directly to the audience for 30 seconds to a minute and leave them with some pithy thought that you’ve had over the past hour and a half from the past decade or 2. I want to leave time for that before we go. Let’s start with you, Henry.

My closing remarks are as follows: I wish that we, in psychiatry, adopt evidence-based practices for the sake of the patient. We have to stop doing the traditional same old, same old, which is often done in patients with schizophrenia, and start thinking of it as an acute emergency—a brain disorder that needs to be treated just as seriously as a stroke or a heart attack—and the only way to stabilize patients with schizophrenia on an ongoing basis, at least the majority. It’s a heterogeneous disorder, I admit to you. We estimate there are at least 800 types of schizophrenia, genetic and nongenetic. Fortunately, 70% of them respond to dopamine antagonist, which is what the long-acting injectables [LAIs] available are. 

We can manage the patient, keep them well. We need to change the habit of giving them pills when they’re discharged from the hospital only to see them come back again and again, and to think this is the way it is with schizophrenia and accept that disability as a fact of life. This is the worst thing you can do for a patient, to expect negative outcomes. I tell my colleagues in psychiatry, how would you treat your own son or daughter if they develop an acute psychotic episode with schizophrenia? How would you treat them based on the best evidence we know these days? Would you treat them differently from the patients? 

Shouldn’t you treat everybody the same, which is to protect them from the hazards of relapse as early as possible, not dillydally and wait for the patient to have multiple relapses and then use long-acting? By then they are disabled, they’re homeless, they’re incarcerated, they may have committed several suicide attempts, and they’re treatment resistant. All those negative things that can happen, most important the disability. They are written off. They have no life anymore. Wouldn’t you want to treat your son or daughter in a different way from how you’re treating your patient? I would ask them that question, knowing what they know about LAIs.

First of all, great panel. Thank you to the moderator and both of my copanelists. I’ll end with some pithy statement that I started with. This stigma has raised its head throughout my career, and that in many regards is at the foundation of today’s discussion. Stigma very often refers to fear; it’s unrealistic. It’s not based on fact, but it’s perpetuated in an ongoing fashion, and that’s a reasonable consideration for today’s discussion of why it’s so difficult to make the argument, to clinicians, patients, and families, why we should use an empirically based approach and do what’s best for the patient clinically short term and long term.

There’s more. There’s also this idea that, as physicians, there’s stigma within our own profession. This last comment that Henry makes is timely. Much of my career…. You go away and stop all your medications as if the other clinicians and physicians in health care think our medicines don’t matter or that they’re doing something to actually prevent mortality in human beings whose lives are as important to me as they should be to them if that patient has heart disease, diabetes, asthma, cancer, or something that’s a component there as well. It’s likely that other individuals, including other physicians and clinicians, are also sending the same message that one shouldn’t take the medication—you shouldn’t take the injections; you shouldn’t need medication. They’re noncompliant; you don’t really need this. Nothing is wrong with you. We’ve got to make that argument much more effectively.

I’ll end with my comment of my mother. To be a doctor you have a good therapeutic alliance. The bedside manner was always what she talked to me about. I have a daughter who’s a doctor, but I always say the smartest doctor in our family was the one who was a schoolteacher: my mother. It made so much sense. At this time in my career, I’ve appreciated that if patients believe in me in many regards and what I represent, if they trust and believe in the doctor, then they’ll trust and believe in our message. Then they’d arguably be more likely to be compliant. Compliance can also occur with LAIs, and they just happen to be with oral treatment. Today’s discussion was remarkably timely for my patient population and 1 that we all should take to heart. We had a very good session. Thank you for having me.

Joe, this is either very good or very bad. You’ve got the last word. Did they take all the good stuff, or do you have something pithy to say?

Actually, I’m going to begin with LAIs and close with LAIs. This surge of people experiencing psychiatric problems has the potential to impact the health care system for years to come. What I’m talking about is the pandemic has not only interrupted the treatment of people managing mental or substance abuse disorders but has also placed broader segments of the population at risk for developing conditions, such as depression, anxiety, alcohol use disorder, and as Henry alluded to earlier, post-traumatic stress disorder, PTSD. After 25 years in the military, the challenges with PTSD are still forthcoming.

But let me close with this, because we started with LAIs: As our distinguished panelists Rahn and Henry alluded to and you facilitated, Peter, LAI is our hope for the future. We take it for granted, and it’s underutilized. Better education of LAIs for our psychiatric population is certainly a sign of hope.

 I want to thank all of you. This has been a tremendous discussion. Because I’m not a psychiatrist, there was a lot of new information, all of which was hopeful. I didn’t expect it to be. This was great stuff. I want to thank all of you at home, of course, or wherever you’re watching this HCPLive® Peer Exchange broadcast. If you enjoyed the content, we invite you to subscribe for our e-newsletters to receive upcoming Peer Exchanges and other great content right in your inbox. I’m Dr Peter Salgo. Thank you, and I’ll see you next time.

A panel of experts in schizophrenic psychiatric care share their thoughts on the practice, patients, and treatment based on their years of experience.  

Schizophrenia: Practice, Patients, and Treatment 

Joe Avelino, RN, BSN, MHSA, CPHQ, College Medical Center

1:20 Obesity-associated metabolic disturbances

5:37 When to start medication for obesity

8:28 Metabolic pathways leading to weight gain

13:19 Long-term impact of weight fluctuations

20:26 Insurance coverage for anti-obesity medications (AOMs)

24:50 Combining lifestyle changes with AOMs

26:27 ‘Super-responders’ to GLP-1 agonist therapies

30:51 Non-responders to GLP-1 agonist therapies

37:28 Comprehensive approach to weight management

In this episode of MEDcast, Diana Isaacs and Natalie Bellini interview Dr. Ken Fujioka, an endocrine specialist, to discuss practice guidelines on obesity treatment and the evolution of anti-obesity medications over the last decade.

Emerging Evidence on the Treatment of Obesity

Ken Fujioka, MD

Topicals are the mainstay of treatment for patients with plaque psoriasis (PsO) of any disease severity.

 Since 1997, corticosteroids, retinoids, and vitamin D analogues have been the only active ingredients used in topical therapies for PsO; new formulations introduced since then have featured changes in the vehicle components or in combinations of active ingredients. Many of these formulations have limitations on duration of use and body areas on which they can be applied due to the potential for certain adverse effects (AEs). Patients may need to use multiple different topical agents at a time, which increases the likelihood of medication misuse and nonadherence. The 2022 approvals of the tapinarof cream, 1% (VTAMA®; Dermavant Sciences) (an aryl hydrocarbon receptor agonist) and roflumilast cream, 0.3% (Zoryve®; Arcutis Biotherapeutics), (a phosphodiesterase-4 [PDE4] inhibitor) for treatment of plaque PsO has provided 2 new options for safe, effective, and well-tolerated steroid-free topical therapies with the potential to simplify management for patients.

As an aryl hydrocarbon receptor agonist, tapinarof uses a novel mechanism of action to downregulate expression of T helper type 17 cytokines that drive inflammation in PsO, normalize skin barrier function, and increase antioxidant activity.

 In the pivotal phase 3 PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) trials, researchers found that a Physician’s Global Assessment (PGA) score of 0 or 1 with a 2-grade reduction was achieved by a considerably greater proportion of groups given once-daily tapinarof compared with the respective vehicle groups at 12 weeks (PSOARING 1: 35.4% vs 6.0%; adjusted difference, 29.4 percentage points; relative rate, 5.8; 95% CI, 2.9-11.6; 

 < .001; PSOARING 2: 40.2% vs 6.3%; adjusted difference, 33.9 percentage points; relative rate, 6.1; 95% CI, 3.3-11.4; 

 Among 312 patients who achieved PGA 0 at least once during the vehicle-controlled and/or the open label extension period, the median time to relapse (defined as PGA 2 or greater) was an unprecedented 4 months. Additionally, patients treated with tapinarof, 1%, cream who had a Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 4 points at baseline experienced at least a 4-point reduction as early as 2 weeks, which continued to increase to 60.7% and 56.9% by 12 weeks, compared to just 43.2% and 29.6% of patients in the vehicle groups, demonstrating rapid and robust itch reduction.

In the 40-week, open-label safety study (PSOARING 3), participants continued the tapinarof cream until they had complete skin clearance, after which the patients held application of the cream. The duration to symptom recurrence was measured, and a durable remittive effect was observed. On average, the median remittive duration was approximately 4 months, and some remained symptom-free for up to 8 to 9 months. In addition, the trial results showed a durable response out to 52 weeks without evidence of tachyphylaxis.

Overall, tapinarof demonstrated good local tolerability. In the PSOARING 1 and PSOARING 2 trials, respectively, contact dermatitis was experienced by 5% and 5.8% of the patients who received tapinarof vs 0.6% and no patients who received the vehicle; one of these cases in PSOARING 2 was a severe adverse event. Folliculitis was reported in 23.5% and 17.8% in the tapinarof-treated groups vs 1.2% and 0.6% in the vehicle groups. Most cases of folliculitis were mild to moderate with only 1 grade 3 event that was reported during the PSOARING 1 trial; therapy was discontinued due to folliculitis in 1.8% and 0.9% of patients.

Folliculitis presentation includes keratotic papules, pustules, and milia and varies among patients; it was generally limited to the site of application. In the authors’ experience, this appears to occur more frequently in hair-bearing areas. Treatments for folliculitis include temporary interruption of tapinarof, antibiotics, urea, retinoids, salicylic acid, or topical corticosteroids; however, many cases resolved even without any treatment. Educating patients about the potential for this AE and how it may be managed is important to ensure patient adherence.

Unlike other available PDE4 inhibitors, roflumilast has 3 major anchoring points that bind to the PDE4 enzyme, which drastically increases the potency (as assessed in vitro) compared with that of other PDE4 inhibitors. In the phase 3 DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) trials, considerably greater proportions of patients given roflumilast achieved the primary end point of Investigator’s Global Assessment (IGA) scale (clear or almost clear status and at least a 2-grade improvement from baseline) at 8 weeks compared to those given the vehicle (DERMIS-1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3-46.9]; DERMIS-2: 37.5% vs 6.9%; difference, 28.8% [95% CI, 20.8-36.9]).

 Additionally, significant improvements in IGA success with roflumilast were observed as early as 4 weeks after start of treatment (DERMIS-1: 20.6% vs 2.3%; difference, 19.3% [95% CI, 13.5-25.1]; 

 < .001; DERMIS-2: 19.1% vs 5.3%; difference, 13.5% [95% CI, 7.2-19.9]; 

Additional findings from the DERMIS-1 and -2 trials showed that roflumilast was also beneficial for patients with intertriginous psoriasis. Compared with use of the vehicle treatment, roflumilast treatment significantly improved intertriginous IGA scores at 6 weeks among patients having an intertriginous IGA score of 2 or more at baseline (DERMIS-1: 56.6% vs 22.2%; difference, 41.0% [95% CI, 20.1-61.8]; 

 = .005; DERMIS-2: 57.8% vs 13.8%; difference, 40.5% [95% CI, 18.7-62.2]; 

 = .004), leading to the inclusion of intertriginous psoriasis in the US prescribing label.

Regarding safety, nonsteroidal options have traditionally been associated with tolerability issues. Findings from the DERMIS-1 and -2 trials indicated that application site pain was infrequent, and nearly 99% of patients reported no signs of irritation at 4 and 8 weeks.

 Additionally, the rates of diarrhea and headache, which are commonly associated with oral PDE4 inhibitors, were low (diarrhea, 2.8%-3.5%; headache, 1.0%-3.8%) and mild or moderate in severity; no events involving diarrhea required interruption or discontinuation of treatment.

Given the difficult of treating intertriginous PsO, a topical nonsteroidal option that is effective, safe, and well tolerated when used in these areas is particularly valuable. The ability to use roflumilast, 0.3%, cream on multiple areas of the body, including difficult-to-treat areas like the elbows and sensitive areas like the skin folds, can simplify treatment options for appropriate patients.

Roflumilast has a trademarked drug delivery formulation (HydroARQ Technology™) that does not contain propylene glycol, a potential irritant and allergen, and includes a proprietary hydrophilic emulsifier (Crodafos™ CES) found in many other popular cosmeceuticals, resulting in an elegant cream that is well tolerated and compatible with most other skin care products.

 Educating patients about the formulation’s novel mechanism of action and the well-tolerated vehicle may provide reassurance in patients who have had a negative experience with previous PDE4 inhibitors or topical agents.

Use of roflumilast in a foam vehicle has also been studied for scalp and body PsO. In a phase 2b study (NCT04128007), use of this formulation yielded an achievement of scalp-IGA clear or almost clear and a 2-grade or more improvement from baseline to week 8 in 59.1% of patients vs 11.4% of those given vehicle, with significant effects observed as early as week 2.5 Roflumilast foam was also well tolerated; there was no evidence of irritation in 96% or more of patients based on investigator-rated tolerability and mild or no sensation in 94% or more on patient-rated tolerability.

 Due to the anionic nature of the Crodafos CES emulsifying wax, roflumilast foam is repulsed by the natural negative charge of the hair, allowing it to selectively target the scalp skin while avoiding the hair shaft. This is particularly advantageous for patients with tightly coiled hair who may be more susceptible to hair shaft breakage from harsh ingredients.

Incorporating Novel Topical Agents Into Clinical Practice

While topical corticosteroids will continue to be an important option in our topical armamentarium, novel nonsteroidal topicals such as tapinarof and roflumilast can address some of the limitations associated with topical corticosteroids. Furthermore, these agents could simplify the treatment regimen because of both their once-daily application versus the twice-daily frequency required by many other topical agents and their effectiveness, safety, and tolerability across a wide range of body areas. No direct comparative studies have been conducted between tapinarof or roflumilast, yet each of these agents has unique characteristics that should be considered when choosing treatment for a given patient.

Both of the pivotal studies were conducted as monotherapy, yet the product label allows for tapinarof and roflumilast to be used together with other therapeutic agents. Prescribing a topical corticosteroid in addition to tapinarof or roflumilast may benefit patients who want a more rapid response. Patients on a systemic treatment with residual disease may also benefit from adding tapinarof or roflumilast. Educating patients on the mechanism of action and setting specific expectations on the timeline for a therapeutic response is particularly important to improve treatment adherence.

Faculty presenters: Eingun James Song, MD, FAAD; and Kimberly Gutowsy Baker, MSN, FNP-C

. This article was reviewed, edited, and approved by Dr Song, Ms Gutowsy Baker, and Dr Stein Gold.

Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. 

. 2021;385(24):2219-2229. doi:10.1056/NEJMoa2103629

FDA approves Dermavant’s VTAMA (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults: first topical novel chemical entity launched for psoriasis in the U.S. in 25 years. Press release. 

. Updated May 24, 2022. Accessed December 14, 2023. https://www.dermavant.com/u-s-fda-approves-our-novel-topical-treatment-for-adults-with-plaque-psoriasis/

FDA approves Arcutis’ ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in individuals age 12 and older. Press release. Arcutis Biotherapeutics. Updated July 29, 2022. Accessed December 14, 2023. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-3-for-the-treatment-of-plaque-psoriasis-in-individuals-age-12-and-older/

Lebwohl MG, Kircik LH, Moore AY, et al. Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials. 

. 2022;328(11):1073-1084. doi:10.1001/jama.2022.15632

Strober B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial. 

. 2022;87(4):800-806. doi:10.1016/j.jaad.2022.06.1171

Kircik LH, Alonso-Llamazares J, Bhatia N, et al. Once-daily roflumilast foam 0.3% for scalp and body psoriasis: a randomized, double-blind, vehicle-controlled phase IIb study. 

. 2023;189(4):392-399. doi:10.1093/bjd/ljad182

This publication was developed independently by MJH Life Sciences Global Medical Affairs. Support for the thought leaders meeting and the publication was provided by Arcutis Biotherapeutics, Inc; The Bristol Myers Squibb Company; Janssen Global Services, LLC; and UCB, Inc.

New Topical Agents for Treatment of Plaque Psoriasis

Kimberly Gutowsky Baker, FNP-C

 I know it’s a loaded question, but what are the biggest challenges you face when it comes to managing patients with atopic dermatitis?

 One is access and insurance frustrations, which can wear on you as a physician. All you’re trying to do is do the best for the patient, and you feel as if there are roadblocks in your way. Sometimes going through the prior off struggle, it’s like jumping over hurdles. But every time you jump over a hurdle, somebody says, “Wait, did you fail pimecrolimus [Elidel] first”? Can I jump this hurdle, please? Every hurdle is more than the hurdle. It’s questions and paperwork and all that stuff. Access is a big deal. The other thing is there’s a lot of misinformation out there. Programs like this with participants like this are excellent resources for patients with atopic dermatitis who are struggling. But there’s a lot of stuff out there on the internet that isn’t exactly the information I want my patients perusing and following. Sometimes I’m combating that during my clinic visits as well.

 You highlighted a couple of big challenges. I’ll take a forward-facing view. In my estimation, 1 of the big challenges when it comes to medications—let’s say in new treatments—is that atopic dermatitis sometimes feels like it’s a bunch of different conditions under this umbrella. Patients present so differently and have different constellations of signs and symptoms. Their comorbidities are totally different. It’s 1 reasons why having 1 or 2 treatments isn’t enough. We’re not at a point where we can say this is going to work for everybody without any exceptions. We’ll probably never get to that point because of the way that atopic dermatitis works. We definitely need to continue looking into new mechanisms of actions for new therapies.

As far as unmet needs go, evolution in the topical space has largely been limited until recently. We’ve had topical corticosteroids and topical calcineurin inhibitors, but at a certain point, everyone said, “That’s enough. We’re done. We don’t need any more.” Until essentially the approval of crisaborole a few years ago on topical ruxolitinib, there wasn’t much happening, but now there is a lot of stuff that’s far in the pipeline. A new topical PDE4 inhibitor roflumilast looks to be more potent than the previous predecessor crisaborole that also has good application site. Not much reactivity for patients. Topical tapinarof is another 1, a new class of medications with a new mechanism based on returning the skin to homeostasis. That’s just to highlight a couple.

Even on the systemic side, we have new oral therapies. We talked about the JAK inhibitor class. There are new targets being looked at for biologic therapy, and there’s more specific targeting of interleukin 13, another pathway called OX40 ligand, and a variety of others that are probably going to be coming to a toolbox near us. The more choices we have, we can hopefully get to that point of saying, “This is what somebody’s signs, symptoms, comorbidities look like at baseline. This is the best treatment I’m going to match up with.” That’s the Holy Grail for what we want in the dermatology community. Hopefully we’re going to get to that point. We’re a lot closer than we were before, so the treatment landscape is going to continue evolving. As I mentioned before, it’s not an exaggeration to say that we’re beyond 100 in terms of everything across various phases of trials. If anyone ever to the registered database for clinical trials, you’ll see there’s a ton going on for atopic dermatitis.

One big area that I’ll leave on, where I want to see more work done, is that when there are differences in racial and ethnic background, geography, patients with skin of color vs not, how does all this figure into No. 1, appropriate diagnosis and estimation severity, and No. 2, the best and most effective and safe treatment. Even with certain conventional treatments, there’s an undue burden placed on patients with skin of color. I’ll highlight topical corticosteroids as 1 of those. Chronic use of topical corticosteroids is associated with dyspigmentation. It’s a problem that I’ve had with my patients with skin of color. I’m sure Lisa has seen it in hers as well. We need other options from that simplistic standpoint, but even when you break it down in terms of differences in biology and presentation, there probably are different aspects of the disease that are going to need to be researched.

That’s how I see a few of those challenges from a treatment and patient-identification perspective. This awesome panel highlighted issues when it comes to actual access of medication, advocacy, building that community, what it like to go on that journey: from the patient and caregiver side and from the medical side. From that point, I’m going to close. A big thank-you for everyone for watching this 

®. If you enjoyed the program, please subscribe to our e-newsletters to receive upcoming programs and other great content right in your in-box. With that, a big thank-you.

Elizabeth A. Swanson, MD, and Raj. J. Chovatiya, MD, PhD, examine challenges in managing atopic dermatitis and explore the evolving treatment landscape.

Unmet Needs in Managing Atopic Dermatitis

Korey Capozza, MPH

Salvatore Viscomi, MD, is the chief executive officer of Carna Health.

Crisis Point: Curbing the Chronic Kidney Disease Epidemic

Our mini-docuseries has returned, taking a comprehensive look at public health crises affecting the United States today, with global implications tomorrow. If the crisis point is the moment where a crisis will worsen or begin to get better, the question remains: where are we now?

CKD’s Emergence As A Public Health Crisis: Next Steps for Halting the Silent Spread

In recognition of National Kidney Month, this episode addresses the growing burden of 

 and its emergence as the biggest public health crisis of our time.

CKD is estimated to affect 35 million adults in the US alone, but despite its widespread impact, it often flies under the radar. In many patients, the disease progresses silently and goes undetected until it reaches advanced stages when symptoms appear but treatment options are limited. While there has been no single cause of the CKD crisis, the growing prevalence of risk factors like diabetes, hypertension, and obesity has intensified the threat posed by CKD, setting the stage for a surge in cases that could overwhelm healthcare systems and disrupt countless lives.

Current estimates suggest 9 out of 10 people with kidney disease are unaware they have it, and 1 in 3 of those with severely reduced kidney function but who are not yet on dialysis are unaware they have kidney disease.

In addition to the need for better public awareness to facilitate early detection and treatment of CKD, patient-focused multidisciplinary care is also essential for improving outcomes. The burden of CKD cannot fall on nephrologists alone. Addressing this crisis requires a collaborative effort across the entire health care system but must be tailored in a way that ensures complete, equitable care for the patient.

Be sure to check out part 1 of this episode, which delves into the complex challenges surrounding CKD, exploring the various factors contributing to its growth, the importance of early detection and intervention, and the need for heightened public awareness.

In part 2, the conversation shifts to the importance of collaborative, multidisciplinary care that maintains a focus on patients’ wants and needs as well as the future of CKD care.

Brief descriptions of the speakers featured in this project are provided below:

, chief medical officer of the American Kidney Fund

, associate clinical professor of medicine in the division of nephrology at Icahn School of Medicine at Mount Sinai and chief medical officer of the National Kidney Foundation

, chief executive officer of Carna Health

, a patient advocate who was diagnosed with CKD during pregnancy, eventually requiring dialysis and a kidney transplant

 to see other episodes on improving health equity in eye care, disparities in cardiovascular health, insulin access in the United States, physician burnout across healthcare, and the ongoing obesity crisis.

American Kidney Fund. Quick kidney disease facts and stats. Accessed March 5, 2025. 

https://www.kidneyfund.org/all-about-kidneys/quick-kidney-disease-facts-and-stats

In part 2 of this episode of Crisis Point, 3 nephrology experts and a patient advocate discuss strategies to address the CKD crisis.

Authors