Daniel Gale, PhD, MB BChir, is the director of the UK-based RaDaR Registry and the St Peter's Chair of Nephrology at University College London.

A new analysis from the phase 3 VALIANT trial reinforces the potential of pegcetacoplan (Empaveli) as a disease-modifying therapy for 

 and idiopathic immune-complex membranoproliferative glomerulonephritis (IC-MPGN).

Results of the study, which were presented at the 

62nd European Renal Association (ERA 2025) Congress

, suggest use of pegcetacoplan was associated with improvements in complement biomarkers, sustained reductions in proteinuria, and early signs of kidney protection.

“It’s an exciting trial to see those data and the 3 things that they showed was the striking 60% reduction in proteinuria, the really clear evidence of stabilization of GFR compared with a placebo arm that lost 7.5 mLs per minute in just 6 months, and, perhaps most strikingly, was the biopsy appearances, where 70% of the patients there was no C3 deposited on the biopsy after 6 months when it was present,” explained Daniel Gale, MBChB, PhD, director of the UK-based RaDaR Registry and the St Peter's Chair of Nephrology at University College London, in an interview.

In the 124-patient trial, participants received subcutaneous pegcetacoplan or placebo twice weekly for 26 weeks in addition to background therapy. The original results were presented at the American Society of Nephrology’s Kidney Week 2024 and demonstrated pegcetacoplan was associated with a statistically significant and clinically meaningful 68% (

 <.0001) reduction in proteinuria compared to placebo at week 26.

In the ERA 2025 study presented by Gale, the pegcetacoplan group showed robust complement rebalancing by week 4, with serum C3 rising by 308.7 mg/dL (SD, 94.7) and soluble C5b-9 decreasing by 612.3 ng/mL (SD, 614.7). Of note, no biomarker improvements were observed in the placebo group.

At week 26, 71% of pegcetacoplan-treated patients had complete clearance of glomerular C3c on biopsy. In terms of proteinuria, pegcetacoplan showed rapid and sustained effect: by week 4, reductions were apparent, and by week 26, 50.8% of patients (32/63) had UPCR less than 1 g/g, including 31.7% below 0.5 g/g. In contrast, the placebo arm showed no meaningful shift across proteinuria strata, with patients remaining in higher UPCR ranges or worsening.

In the study presented by Gale, investigators noted previous registry data show patients who achieve UPCR less than 0.88 g/g within the first year of diagnosis have an 87% reduction in long-term risk of kidney failure. In VALIANT, half of pegcetacoplan-treated patients reached this threshold by week 26.

To learn more about how pegcetacoplan could shift the treatment paradigm in C3G and IC-MPGN, watch our full interview with Dr Gale from ERA 2025.

Pegcetacoplan Could Halt Disease Progression in C3 Glomerulopathy, IC-MPGN, with Daniel Gale, PhD, MB BChir

 include Novartis, Alexion, Calliditas, Britannia, Vifor, Judo Bio, Adnovate, Sanofi, Anlylam, Boehringer Ingelheim, and Bayer.

Gale DP, Bomback AS, Licht C, et al. Pegcetacoplan Treatment Appears to Halt Disease Progression in C3G and Primary (Idiopathic) IC-MPGN Patients: Results from the Phase 3 VALIANT Study. Presented at: 62nd European Renal Association Congress. June 04 – 07, 2025. Vienna, Austria.

Campbell P. VALIANT: Pegcetacoplan Offers Benefit for UPCR, eGFR, C3 Staining in C3G, IC-MPGN. HCP Live. Published October 26, 2024. Accessed June 8, 2025. 

https://www.hcplive.com/view/valiant-pegcetacoplan-offers-benefit-for-upcr-egfr-c3-staining-in-c3g-ic-mpgn

An analysis of the VALIANT trial provides insight into the benefits of pegcetacoplan in patients with C3G and IC-MPGN. 

 Daniel Gale, PhD, MB BChir

Flexibility and convenience are staples in most aspects of our lives due to new technology. Healthcare is no exception with the availability of instant access to medical records, online appointments and efforts to decrease wait times through better scheduling technology. With these advances, people expect greater flexibility and an experience centered around patient convenience.

But what about the clinical side? Niraj C. Patel, MD, Associate Professor, Pediatric Allergy and Immunology, Emory University, Children’s Healthcare of Atlanta, Atlanta, GA, who specializes in treating patients with Primary Immunodeficiency (PI), a genetic condition that impairs the immune system, participated in a Q&A with CSL Behring to discuss a recent survey centered around treatment preferences for people living with PI, and how he considers both convenience and flexibility in his practice. He emphasizes the importance of physicians and patients working together to determine the right treatment option.

How are considerations around patients’ lifestyles becoming more integrated into treatment decisions?

Today, more and more patients prefer and prioritize flexibility and convenience when it comes to their medical treatments.

People living with a rare disease like PI, or any chronic disease, require lifelong medical care and often lifelong treatments. For these persons especially, creating a patient experience that equally prioritizes flexibility, convenience and outcomes is critical.

How do you ensure you treat each patient with an individualized approach?

The physician/patient relationship is all about finding a balance between the science and the unique human needs of the patient. Both sides need to be heard and work in harmony to achieve optimal outcomes.

A physician’s day can be unpredictable as well as emotionally and physically taxing. Physicians often feel they don’t have enough time for thorough conversations with each patient, and appointments can feel rushed at times.

Before I enter an appointment with a patient, I take a few seconds to clear my mind and focus all my attention on them. I try to create an environment where my patients feel comfortable sharing what’s working well and what can be improved with their treatment plan.

What are the key factors you consider when developing a treatment plan for your PI patients?

For people living with life-long conditions like PI, finding a treatment that offers both efficacy and convenience is paramount in ensuring a favorable treatment experience and overall quality of life. People living with PI often receive regular infusions of immune globulin (Ig) replacement therapy to maintain their health, and this can interfere with their daily routine if they need to go to treatment centers to receive their medicine. A recent Harris poll survey of 104 PI patients sponsored by CSL Behring found that 94% of PI patients surveyed agree that flexibility and options are important in personalizing Ig treatment.

So, taking the time to understand a patient’s lifestyle can be an important factor when determining treatment. If a patient prioritizes flexibility and convenience, we may need to discuss whether they are candidates for subcutaneous immune globulin (SCIg), like 

 (Immune Globulin Subcutaneous [Human] 20% Liquid), which allow PI patients to self-infuse in the comfort of their home and on a schedule that is convenient for them.

During my initial conversations, I try to get a feel for how involved the patient wants to be in their treatment administration. Some patients prefer intravenous immune globulin (IVIg) – having someone else infuse their treatment – because they are nervous or unsure if they can handle sticking themselves with needles. For many patients, unfamiliarity with a treatment process can make them apprehensive. In these instances, I aim to arm my patients with information and resources, such as training videos and the reassurance that a nurse will be available for training patients to self-infuse. I believe we need to give patients the time and tools to make an informed decision and allow them to explore their options.

How often do you approach discussions about treatment options with patients?

I recommend asking patients at each appointment about their treatment experience and if there are concerns that arise, schedule a separate appointment to have a robust dialogue around all options, as well as background on their lifestyle, to inform the decision. I firmly believe that physicians must work in tandem with patients to align on a treatment plan. PI patients have a number of choices when it comes to treatment, but the thing I like to point out is whether we are talking about IVIg or SCIg, all Ig products approved by the FDA for treatment of PI meet certain standards in terms of efficacy. From there, it’s our responsibility to check in with our patients about their treatment experience to determine if there are any adjustments that need to be made. I’ve found that some issues with SCIg can be mitigated by making adjustments like changing the needle length or infusion site. We also need to ask about the impact of their treatment schedule on their quality of life – are they missing time with family or friends because of side effects or time spent infusing – and adjust treatment as needed.

According to the aforementioned survey sponsored by CSL Behring, at least 97% of surveyed PI patients using SCIg prefilled syringe reported being satisfied with the ease of administration and overall convenience. I find that patients who are busy with work, school, and family and are looking for the next thing in terms of convenience, are willing to give it a try.

At the end of the day, if a patient isn’t happy with their treatment, they are unlikely to adhere to it. Many physicians engage in some shared decision-making, but not to the extent that it should be, and it goes back to the obstacle of time.

What advice do you have for your fellow physicians to ensure their patients are on a treatment that best fits their needs?

Physicians need to take a holistic treatment approach and evaluate individual patient needs to customize treatment based on efficacy, as well as flexibility and convenience, to fit into the everyday life of those living with a life-long disease. We need to keep patients informed of any updates and new products to ensure they are on the best possible treatment for their unique needs.

WARNING: Thrombosis may occur with immune globulin products, including Hizentra. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

For patients at risk of thrombosis, administer Hizentra at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin (Ig) or components of Hizentra (eg, polysorbate 80), as well as in patients with immunoglobulin A deficiency with antibodies against IgA and a history of hypersensitivity. Because Hizentra contains L-proline as stabilizer, use in patients with hyperprolinemia is contraindicated.

IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with Ig products, including Hizentra.

Monitor patients for aseptic meningitis syndrome (AMS), which may occur following treatment with Ig products, including Hizentra. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. In addition, monitor patients for clinical signs of hemolysis or pulmonary adverse reactions (eg, transfusion-related acute lung injury [TRALI]).

Hizentra is derived from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

The most common adverse reactions (observed in ≥5% of study subjects) were local infusion-site reactions, as well as headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, upper respiratory tract infection, rash, pruritus, vomiting, upper abdominal pain, migraine, arthralgia, pain, fall, and nasopharyngitis.

The passive transfer of antibodies can interfere with response to live virus vaccines and lead to misinterpretation of serologic test results.

Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is indicated for:

Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older.

Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.

Limitation of Use: Maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Continued maintenance beyond these periods should be individualized based on patient response and need for continued therapy.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 

Striking the Right Balance: Shared Decision-Making in Primary Immunodeficiency Care

CSL Behring 

This has been a great program. I’ve learned a lot. We covered lots of ground about antithrombotic therapy, coronary artery disease [CAD], and peripheral artery disease [PAD] in general. Let me turn to our distinguished panel for some closing thoughts. I’ll start with you, Manesh. Any final points [that] you want to make for the audience?

Deepak, it’s been fun and exciting. It’s fun to talk to people about evidence for the things we see. We’ve learned over the last decade is that vascular disease unfortunately is still the leading cause of cardiovascular mobility issues and mortality. As we have more options, which is a good thing, we have to get the right dose for the right patient at the right time. Some of that is understanding the risk and the risk benefits that we’ve talked about. Concerning patients with polyvascular disease, patients with broad thrombotic risk, it’s important to understand how you can make them have better outcomes. We’ve talked about that today. Hopefully it’s something that people will take home.

 I agree. It’s been a wonderful panel. I’m thrilled to be part of this. My take-home message would be to focus on identifying these polyvascular patients. Because they’re such high-risk patients, it’s important not to be focused on the coronary artery disease. But if patients have coronary artery disease and vascular disease in another territory, then that’s the pinnacle of our risk. Diabetes on top of that is going to be at that highest cardiovascular risk, so we need to talk with our patients about the fact that they’re at a higher risk and how that guides our recommendations for changing medications. Oftentimes patients can be resistant, understandably, to wanting to add another medication. But part of patient-centered decision-making is educating them that this is why that goes a long way.

We need to educate the medical community about those risks that identify polyvascular disease, diabetes is a real risk amplifier. Great points. Eric, any closing thoughts?

 This was a fantastic discussion. For everyone watching this, it’s important for us to not be fearful of making a change in our practice. We’ve been set in our ways for a long time, but we’ve had these accumulating data. It’s time for us to be open-minded about making changes that benefit our patients. We’ve heard today that there are many agents that can optimize long-term cardiovascular and limb-related risk outcomes and improve the care for our patients, so it was a great discussion.

Absolutely agree and Sahil, any final thoughts?

 That’s really important. What Eric just said is that we’ve been in this mode of using dual-antiplatelet therapy for extended amounts of time with very little evidence, particularly in the PAD population, which is the predominant part of my practice. It’s great that we have strong evidence to support the use of dual-pathway inhibition. We need to get the message out to our referring doctors and our patients that this is the way forward to optimize the risk.

Terrific. Marc, you’ll get the final word.

 It’s been an honor to be part of this panel. We’ve learned that we have a gap in terms of the evidence and how we treat our patients. Part of that is that we have a lot of patients to see. We’re all very busy clinicians. Everyone wants to do their best. But understanding who the highest-risk patient is and what the best evidence is needs to be at the top of your mind as you see your clinic patients, and polyvascular disease resonates. I learned that term from you, Deepak, many years ago. It has been shown in every study to be such a potent marker of risk and beneficial for some of these strategies and other things like diabetes. We need to take that into the clinic and start treating our patients better.

I couldn’t agree more. Hopefully the audience found this exchange of ideas informative, interesting, and educational. Hopefully these are things you can take this into your practices. As I mentioned, I learned a lot. A final point I’ll make is that when you’re thinking about coronary artery disease, think about the whole patient. For that patient you’re seeing for 1 specific condition, that might be the issue in the office for that day. But they may have other risk factors. They may have plaque in other arterial territories. We talked a lot in this session about polyvascular disease, but keep in mind that CAD, PAD, and cerebrovascular disease can coexist. Even though the patient might be seeing you for angina in that office visit or hospital encounter, think about all those associated risks. If you identify those associated risks, you realize that it’s a very high-risk patient, the sort of patient for whom we want to do everything possible to reduce their risk, including intense lifestyle modification. Beyond that, in many cases pharmacotherapy, polypharmacy with wisdom and caution, and in some cases procedural care are all complementary approaches, not competitive approaches.

Thanks to all of you on our panel and to our audience for this rich and informative discussion. If you enjoyed the content, please subscribe to our e-newsletters to receive upcoming 

 and other great content right in your in-box.

A panel of expert cardiologists share their concluding thoughts on management of polyvascular disease in clinical practice.  

Concluding Thoughts

Eric Secemsky, MD

Top Clinical Insights from SDPA 2025: Eczema, Alopecia, Burnout, Vitiligo, JAK Inhibitors

In late June, physician assistants convened at the 

SDPA Annual Summer Dermatology Conference

 in Washington, DC, from June 25 – June 29th, to attend talks from other physician assistants and clinicians.

in people of color. This edition of HCPLive Five spotlights interviews on tips for treating chronic hand eczema, using trichoscopy to differentiate alopecia subtypes, preventing career burnout, breaking down vitiligo misconceptions, and the workup before initiating JAK inhibitors for alopecia.

Tips to Optimize Diagnosis, Management of Chronic Hand Eczema with Adam Friedman, MD

Adam Friedman, MD, professor, chair of dermatology, and director of the Supportive Oncodermatology Program at The George Washington University School of Medicine & Health Sciences, shared clinical insights on diagnosing and managing chronic hand eczema (CHE), emphasizing its diagnostic complexity. CHE has symptoms that overlap with conditions, such as psoriasis, lichen planus, and secondary syphilis. In his interview, Friedman underscored the importance of patient history, especially recurrence, duration, and occupational exposure, and highlighted visual cues to differentiate CHE from other dermatoses.

He also noted that CHE often lacks sharp demarcation, unlike palmoplantar psoriasis, which favors pressure-prone areas. Recognizing patterns like lichenification and confluence helps inform diagnosis.

Trichoscopy Provides Clearer Differentiation of Alopecia Subtypes, With Amy Spizuoco, DO, FAOCD

Amy Spizuoco, DO, FAOCD, a board-certified dermatologist at True Dermatology and a clinical instructor at Mount Sinai, highlighted how trichoscopy enhances diagnostic accuracy in alopecia by revealing key patterns such as black dots, yellow dots, exclamation hairs, and follicular loss. She explained that recognizing these visual cues, like exclamation hairs in alopecia areata or follicular plugging in telogen effluvium, can distinguish scarring from non-scarring forms and guide proper treatment.

Discussing Ways to Help Clinicians Facing Career Burnout, with Hope Cook, PA-C

Hope Cook, PA-C, a physician associate from Georgia Skin Cancer & Aesthetic Dermatology, shared strategies for addressing clinician burnout, emphasizing that burnout is not the end—it can mark a new beginning.

In her session and interview, she introduced her CPR framework: Cocooning (inner reflection and awareness), Planning (evaluating what needs to change), and Revamping or Resigning (deciding whether to reshape or leave one’s role). Using a controlled burn metaphor, Cook illustrated how burnout can clear space for growth and career renewal. Drawing from her book (“Healing Clinician Burnout: How to Revive Your Life and Career”) and podcast, she offered practical, realistic steps clinicians can take to move from feeling stuck to rediscovering purpose in their professional lives.

Breaking Down Vitiligo Misconceptions at SDPA 2025, With Gina Mangin, PA-C

Gina Mangin, MPAS, PA-C, from Sand Lake Dermatology Center, addressed common vitiligo misconceptions, underlining that treatment is possible, even after years of the disease. In an interview, she highlighted the importance of using a Wood’s lamp to confirm diagnosis, especially in patients with skin of color.

Mangin discussed when to escalate to systemic therapy, using markers like rapid progression, confetti depigmentation, and inflammatory borders to assess disease activity. She also said harder-to-treat areas like hands and feet may require both topicals and phototherapy. With new therapies emerging alongside narrowband UVB, Mangin shared her optimism about re-pigmentation and maintaining results through an aggressive, tailored approach.

The Workup Before Initiating a JAK Inhibitor for Alopecia, With David Cotter, MD, PhD

David Cotter, MD, PhD, an assistant clinical professor at the University of Nevada, outlined key steps in evaluating patients with alopecia areata before starting a JAK inhibitor. His recommended workup includes a CMP, fasting lipids, TB and hepatitis B screening, QuantiFERON gold, and often varicella zoster titers—even beyond guideline recommendations—to assess shingles risk. He also considers pregnancy and HIV testing when appropriate.

Cotter stressed that clinicians should feel confident prescribing JAK inhibitors, as long as baseline labs are clear. Follow-up labs are crucial at 12 weeks, with frequency adjusted by patient risk. While many patients see significant regrowth, safety monitoring remains essential throughout treatment.

Check out insights from SDPA 2025 on eczema, alopecia, vitiligo, burnout, and JAK inhibitor workups—key tips to improve dermatology care.

HCPLive Five at SDPA 2025

Gina Mangin, PA-C

Juan Pablo Arab, MD, is a transplant hepatologist and an associate professor of Medicine at the Division of Gastroenterology at Western University.

Reflecting on Resmetirom’s Historic FDA Approval for MASH

On March 14, 2024, the US Food and Drug Administration (FDA) made history when it granted accelerated approval to Madrigal Pharmaceuticals’ resmetirom (Rezdiffra), making it the first and only treatment for noncirrhotic nonalcoholic steatohepatitis (NASH), now known as 

metabolic dysfunction-associated steatohepatitis (MASH)

One year later, resmetirom’s impact on clinical practice and patient care continues to evolve. In recognition of the anniversary of the landmark decision, the latest 

 spotlights a conversation between a trio of subject matter experts reflecting on the past year of having resmetirom as a treatment option for patients, remaining unmet needs in MASH management, and the evolving therapeutic pipeline poised to further transform care.

Estimated to affect more than 30% of the global population, MASLD is the most common chronic liver disease around the world. MASH represents an advanced stage of MASLD and has historically lacked treatment options beyond lifestyle changes with diet and exercise. In the absence of pharmacologic therapies, weight loss served as the cornerstone of disease management.

This changed in March 2024, when resmetirom became the first and only FDA-approved MASH therapeutic, earning accelerated approval for the treatment of noncirrhotic MASH with moderate to advanced fibrosis. Although lifestyle interventions continue to play a pivotal role in MASH care, as the thyroid hormone receptor-beta selective agonist is indicated in conjunction with diet and exercise, they are no longer the only tools available for disease management.

 on the 1-year anniversary of resmetirom’s FDA approval and the evolving landscape of MASH management, moderator Jeff McIntyre asks Mazen Noureddin, MD, MHSc, and Juan Pablo Arab, MD, about the clinical impact resmetirom has had since being approved and whether it lived up to the expectations set for it as the first-ever MASH therapeutic.

Noureddin begins by highlighting resmetirom’s “game-changing” impact, citing strong clinical results, guideline updates, and the shift toward noninvasive testing. He notes that patients are seeing benefits and that long-term data continues to support the drug’s efficacy.

Arab expresses agreement, emphasizing that resmetirom has not only improved patient outcomes but also changed how clinicians approach MASH. Previously, primary care providers and endocrinologists were reluctant to screen for at-risk MASH due to a lack of treatment options. Now, with an FDA-approved therapy, he says there is greater urgency in identifying and managing these patients.

Discussing challenges, Arab points to the need for broader screening, improved access to noninvasive tests, and overcoming reimbursement hurdles, additionally stressing that implementing a new treatment requires systemic change across healthcare.

Noureddin adds that while hepatology clinics were well-prepared for resmetirom’s arrival, uptake in gastroenterology practices has been mixed. He sees a need for more education on noninvasive tests and fibrosis staging but says that overall, awareness and access are improving. He remains optimistic about the drug’s future and the potential for combination therapies to further transform MASH treatment.



Jeff McIntyre is the vice president of Liver Health Programs at the Global Liver Institute.

Mazen Noureddin, MD, MHSc, is a professor of medicine and a transplant hepatologist at Houston Methodist and director of the Houston Research Institute.

Juan Pablo Arab, MD, is an associate professor of medicine in the division of gastroenterology, hepatology, and nutrition at Virginia Commonwealth University School of Medicine.

Noureddin has relevant disclosures with Altimmune, Madrigal Pharmaceuticals, Merck, Takeda, Terns, and others. Arab and McIntyre have no relevant disclosures.

US Food and Drug Administration. FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease. March 14, 2024. Accessed March 13, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease

Brooks, A. Stephen Harrison, MD: Promising Phase 3 Data for Resmetirom in NASH, Fibrosis. HCPLive. February 7, 2024. Accessed March 13, 2025. 

https://www.hcplive.com/view/stephen-harrison-md-promising-phase-3-data-resmetirom-nash-fibrosis

In the opening segment of this 6-part HCPLive RX Review, experts reflect on resmetirom’s FDA approval for MASH and clinical challenges to implementing it.

Juan Pablo Arab, MD

Clinical Perspectives on DORAs for Insomnia Management

The dual orexin receptor antagonist (DORA) class of medications is often considered a first-line treatment for chronic insomnia, particularly when patients experience sleep maintenance issues, insufficient total sleep time, or challenges with sleep latency and wakefulness after sleep onset. While DORAs are FDA-approved for treating chronic insomnia, other medications like selective serotonin reuptake inhibitors, trazodone, and off-label options such as doxepin or mirtazapine are sometimes used in clinical practice. However, DORAs are preferred for their superior tolerability, lack of withdrawal symptoms, and favorable adverse effect profiles. This makes them a more suitable option for long-term management of chronic insomnia, especially for patients who need consistent and safe sleep support.

Patients seeking treatment for insomnia commonly report difficulties with daytime functioning, including excessive sleepiness and fatigue. Addressing these concerns is crucial in treatment planning, and evidence from clinical trials shows that DORAs, particularly daridorexant, can significantly improve next-day sleepiness. It’s essential for health care providers to communicate these benefits to patients, as the impact on daytime functioning is a major concern for many individuals with insomnia. With DORAs, patients can experience relief from daytime fatigue, ultimately enhancing their ability to function normally during the day.

To assess the effectiveness of treatments like DORAs, questionnaires such as the Insomnia Daytime Symptoms and Impacts Questionnaire are valuable tools for evaluating next-day functioning. These tools provide a clear measure of improvements in sleepiness, cognition, and mood. Educating patients about the clinical trial results and the potential for better daytime functioning can help set realistic expectations and build trust in the treatment approach. By addressing these concerns upfront, clinicians can help patients feel more confident in their treatment plan.

A panelist discusses how dual orexin receptor antagonists (DORAs) are considered a first-line treatment for chronic insomnia, particularly for sleep maintenance issues, due to their superior tolerability, lack of withdrawal symptoms, and positive impact on daytime functioning.

Laura B. Herpel, MD

 One of the things I’m curious about is does it make a difference if a patient is biologic naïve and comes to you with moderate to severe psoriasis, vs a patient who has been on several biologic agents? Does that change how you approach which agent you’re going to put them on?

 It does, actually. For the patient’s biologic experience, I want to know what biologic they took and what their experience was. What adverse effects did that patient experience? Did they have a good experience? Did it work well for them? Was there some reason, such as loss of insurance, that they had to interrupt that? And if there wasn’t a reason not to restart that therapy. I will usually restart the patient on that therapy. If a patient had a loss of efficacy, they were unsatisfied, they had some adverse effect or lab abnormality, I will absolutely switch them to a different class. For the biologically naïve, approach them based on their comorbidities, their presentation, and what’s important to the patient. I approach them differently, but those are some of the nuances in terms of selecting an agent for them.

 One of the things about being a nurse practitioner [NP] and a physician assistant in dermatology is that we often manage the chronic diseases in dermatology, such as psoriasis and atopic dermatitis. Some of the roles that we play in the management of plaque psoriasis is that we can take the time to develop a relationship with these patients, spend some time educating them about their disease, reviewing all the treatment options that are available, and then really working with the patient to come up with a decision that’s going to be helpful for the patient and that the patient can live with and be successful with.

Nurse practitioners and PAs [physician assistants] can impact the quality of life of these patients with psoriasis and psoriatic arthritis. The most rewarding days I have are when I see those patients come in who were covered head to toe or who were just miserable in pain, who were socially isolating, but they happen to be on a good agent for their psoriasis and feel like they have a new lease on life. They’re engaging in their family activities. They’re holding down jobs and successful. They’re traveling and going on vacations. They’re going to the gym and working out, and subsequently, their diabetes is getting better under control. They’re losing weight. You can really see the transformation in these patients, and that’s something that’s really, as an NP, I really value. As a PA, Matt, you’ve seen these patients and transformed their lives, and it can be remarkable. When you counsel patients about psoriasis, what are some of the challenges you face in helping patients come to terms with their psoriasis and then helping them move past them and be successful in their treatments?

The first challenge that I would like to pinpoint is helping patients accept the chronicity of their disease. Many patients come in with the expectation that there’s something we can give them, something we can do for them that’s going to make this problem go away. It’s important to have that discussion, as we’ve mentioned, over the chronicity of the disease. You pinpointed that those patients sometimes have trouble with compliance with their therapies.

Sometimes that’s because we’ve taught them that with topical therapies, they should use them intermittently. We have to make sure we educate our patients when we put them on a systemic agent, whether it’s an oral agent or an injectable agent, to understand that these are not intended to be intermittent therapies. These are therapies that patients are meant to initiate and stay on, unless there’s a reason the provider stops them from their therapy, or they’re having some health concern that they need to stop it. Because patients have become accustomed to using topical agents intermittently, they sometimes transfer that into systemic agents. We have to do a better job as practitioners of educating our patients on that.

The other part is helping patients know when it’s appropriate to hold their objections if they’re on a biologic agent to recognize those concerns, but it can be challenging sometimes to coordinate with the rheumatologist or their primary care provider. Being able to communicate effectively as a part of the care team, with the other individuals who are responsible for the patient, is another crucial part of the puzzle.For the biologic naïve, it’s ]approaching the patient understanding their comorbidities, understanding their concerns. Will they feel comfortable? Was the patient more comfortable with us giving the injection in clinic? Is this something that would not at all fit for their lifestyle? That’s the proper approach to helping the patient and having that discussion about the appropriate education for them.

®. If you enjoyed the content, please subscribe to our e-newsletters to receive upcoming 

® and other great content right in your in-box.

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

Stratifying Patients With Plaque Psoriasis for Treatment With Biologics

Matthew Brunner, MHS, PA-C, DFAAPA  

Importance of Multispecialty Communication in Hypercortisolism Management and Referrals

Video content above is prompted by the following:

What is the role of primary care clinicians in identifying and screening patients for hypercortisolism?

How does hypercortisolism affect mental health? How can primary care clinicians help identify patients with mental health conditions who might be at risk for hypercortisolism?

How does hypercortisolism contribute to osteoporosis and an increased risk of fractures?

Experts discuss the role of primary care clinicians in identifying and screening patients for hypercortisolism, how hypercortisolism affects mental health and how primary care clinicians can identify at-risk patients, and how hypercortisolism contributes to osteoporosis and an increased risk of fractures.

Pamela Kushner, MD, FAAFP 

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

 in San Diego, Scott Sicherer, MD, from Mt. Sinai School of Medicine, presented the 

, “Randomized Trial of High Dose, Home Measured Peanut Oral Immunotherapy in Children with High Threshold 

His team’s phase 2 trial compared the tolerance levels of peanut oral immunotherapy vs avoiding peanuts altogether in 73 children aged 4 – 11 years with a high threshold peanut allergy (> 143 mg) The study assessed whether patients on oral immunotherapy could tolerate 3400 mg of store-bought peanuts and then 9043 mg during the oral challenge.

100% of children on oral immunotherapy tolerated 9043 mg of peanuts, compared with 10% in the avoidant arm. 

 spoke with Sicherer at AAAAI 2025 about these promising findings.

: What prompted this research, and does it address a significant gap in peanut allergy management?

 All of the products that [the FDA has approved]—which are two omalizumab and also a commercial version of peanut oil immunotherapy—specifically brought people into the study if they reacted to half of a peanut or less. [This] makes sense because they're very sensitive to small amounts [and] more prone to have a reaction if there's a little bit of peanut in a cookie, a little mistake like that. But [these studies are] ignoring the half of the children who have a peanut allergy but could already eat half a peanut…who might be what we call “bite safe.”

[This group] could represent almost half of the peanut-allergic population. We figured that [they] would even be easier to treat, and maybe treatable with very simple measures, [such as] peanut butter. Something that you could just buy in the store…measure…[and] use as a medicine, except that obviously would have to be done under doctor supervision. That's what brought the study together.

: Your trial found that participants who underwent peanut oral immunotherapy had a significantly higher rate of desensitization compared to those who avoided peanuts. What are some of the key factors that contributed to this success, and what does this mean for the future of peanut allergy treatment?

 We randomized the group that was already identified as [having a] higher threshold, [meaning they could] eat more than half of the peanut before they would react. We randomized them to either go through this process of oral immunotherapy using home-measured amounts of peanut, but under allergy supervision versus [to] just avoid it.

The group that did not go through the…gradual increases under doctor supervision… had the same threshold at the end of the study. Some…actually showed a lower threshold than they started with. Some showed a higher threshold than they started with, but on average, they had no change. They were [often] still bite-safe, but they couldn't eat peanut butter.

For the ones who had the feeding test, all of [them] were able to eat a peanut butter and jelly sandwich worth of peanut butter—so they were basically able to eat it like regular food.

We wanted to also ask the question: is this a durable response? What would happen in real life if they stopped taking it as a daily dose? Because they were taking…a tablespoon a day as a daily dose as treatment? We had them spend 4 months eating it… so we encouraged them to have peanut butter and to hopefully have about two tablespoons a week, but we didn't give them a specific plan. We had them completely stop any peanut butter for 2 months so they wouldn't have any exposure. Then we brought them back to a feeding test, and for all the ones that came back for that feeding test, almost 90% were able to still ingest that whole peanut butter sandwich worth of peanut butter.

Typically, you would have said, “Oh, gee, you’re allergic to peanuts, don't eat it.” But with this information, you can make a very strong argument that if the family and child were interested in raising their threshold and eating the food more like regular food, although I would not call it a cure, it's still a treatment. They could go through a process that's relatively simple, not a lot of visits with the doctor, and could end up having them eat peanut butter like regular food.

Is there anything else you want to add about the findings?

 The starting point here is to determine [a] threshold. Is this person sensitive to tiny amounts or not? If you don't figure that out, you would never want to apply this particular protocol. Secondly, it's important to have allergist supervision. I do worry that people will look at this and say, ‘Oh, home measured, home purchase’ [and interpreting it could mean] you just do this all on your own, like you're a family. No, that could be risky and dangerous. You have the allergy. You have to work with an allergist if you're going to approach something like this.

Sicherer, S, Bunyavanich, S, Berin, C, et al. Randomized Trial of High Dose, Home Measured Peanut Oral Immunotherapy in Children with High Threshold Peanut Allergy Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB445

Derman, C. Peanut Oral Immunotherapy Boosts Tolerance in Children with High-Threshold Peanut Allergy. HCPLive. March 3, 2025. 

https://www.hcplive.com/view/peanut-oral-immunotherapy-boosts-tolerance-children-high-threshold-peanut-allergy

A phase 2 trial presented at the 2025 AAAAI meeting explored high-dose, home-measured peanut oral immunotherapy in children with high-threshold peanut allergies. The study demonstrated that 100% of children undergoing oral immunotherapy tolerated 9043 mg of peanuts, compared to 10% in the avoidance group. The research addresses a gap in peanut allergy management by focusing on children who can already tolerate small amounts of peanuts. The findings suggest that oral immunotherapy could enable these children to consume peanuts like regular food, though allergist supervision is crucial.

A phase 2 trial found that 100% of children on peanut oral immunotherapy tolerated 9043 mg of peanuts, vs 10% in the avoidant group.

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