 approval of ruxolitinib cream was announced for pediatric patients 2 years of age and older with 

, providing a new therapeutic option in the treatment armamentarium for those with the disease.

To address the significance of this decision by the FDA, the 

 editorial team spoke with Amy S. Paller, MD, chair of the department of dermatology, director of Skin Biology and Diseases Resource-Based Center, and a Walter J. Hamlin Professor of Dermatology at Northwestern University’s Feinberg School of Medicine. Paller was asked about her hopes for the approval’s impact on pediatric patients.

Reacting to FDA Approval of Ruxolitinib for Pediatric Atopic Dermatitis, with Amy Paller, MD

“We've been really fortunate to see 3 new topicals coming out within the last few years, including getting it down to 2 years of age,” Paller explained. “So I'm delighted to see ruxolitinib joining the recent availability of tapinarof down to 2 years of age, and soon to be roflumilast down to 2 years of age. We'll really have some choices now for our families, particularly in more sensitive areas where we may not want to be using a topical corticosteroid. I think the next question is going to be, when are we going to get more under the age of 2, where we have many very young children who have atopic dermatitis, including in sensitive areas.”

Paller highlighted that for such patients, there has yet to be an FDA approval for a drug outside of crisaborole, which she stated can result in stinging and burning among many such patients.

Paller later connected the approval to the conclusions of her team's 

 from the PEDISTAD registry, in which the burdens of atopic dermatitis were highlighted among children and their families.

 Paller noted that a high disease burden was seen among children younger than 12 years with inadequately controlled disease at baseline, adding that long-term disease control and newer, safer drugs are needed in this pediatric population.

“Altogether, about 41% of patients were on a systemic medication at the time of enrollment, when these data were collected, so many of them were already being treated,” Paller said. “...When you look at how that was distributed, what was somewhat surprising to me was the large proportion that were on systemic corticosteroids in their history of treatment for atopic dermatitis. That was about 20%, including 18% of those kids who are under 2 years of age, who had received systemic corticosteroids.”

Paller noted that dupilumab had previously been used in only 21% of those under 6 years of age at the time of enrollment, and only in 4% from 0 to 2 years of age.

“But it was primarily the corticosteroids that these kids were being treated with, and I think that's an important point to make,” Paller explained. “I hope that really changes with time.”

For additional information on the significance of the FDA’s approval of ruxolitinib cream for atopic dermatitis in pediatric patients, view Paller’s full video response posted above.

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

Incytye. Incyte Announces Additional FDA Approval of Opzelura® (Ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis. September 18, 2025. Accessed September 18, 2025. 

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-additional-fda-approval-opzelurar-ruxolitinib

Paller A. Atopic Dermatitis Burden Among Families of Children Under 6 Years, with Amy S. Paller, MD. HCPLive. June 11, 2025. 

https://www.hcplive.com/view/atopic-dermatitis-burden-among-families-children-under-6-years-amy-s-paller-md

This interview with Amy Paller, MD, highlights the significance of the approval of ruxolitinib for the treatment of pediatric atopic dermatitis.

Amy S. Paller, MD

Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP: 

I'm not finding this, but I'm wondering if any of you are. Given that many of these medications are now generic, not all of them. But are there challenges in getting these medications covered by payers at this point? We heard earlier that, for instance, the Orexin Antagonists for sleep, we must often have a prior authorization done. But what about the medicines, Milnacipran? Are you seeing any issues? Duloxetine? Pregabalin? Gabapentin? Getting these drugs approved?

One reason why I select Gabapentin first is that I know I don't have to get it approved. It's so widely available and affordable. But if you want to transition to Pregabalin you must show–a prior authorization is required and you do have to demonstrate failure at least with a therapeutic dose of Gabapentin.

What do you think the biggest challenges are in terms of unmet needs for our patients with fibromyalgia?

Treatment and I guess my colleagues see patients on the severely ill end of that skewed spectrum and I'd like not to have to use an opioid so if there was anything that I could put in after I ramp up. I have this ramp up schedule, so if I didn't have to go to opioids, I'd love to have that tool.

The problem as I see it is we need to train a new group of providers to take care of people with chronic pain. The people that hang out a shingle in the United States as pain management have usually got a one-year fellowship to put needles into people. We really need people, providers to embrace the fact that in the right settings where they can provide integrative care, where they're not out on an island taking care of individuals on their own. Where they have more of a village. They can put someone in. In those systems, these patients get better. They're a lot easier to care for. But if you're a single, individual provider, who's trying to do this on your own, good luck.

In addition, having our primary care providers feel more comfortable and realize this doesn't have to be a specialist. This is something they see more often. They have the same tools that we have and it's something that can be easily treated rather than cycling through a variety of specialists and ultimately a delayed diagnosis, because as we mentioned, sometimes the diagnosis itself can be therapeutic for the patient.

Experts highlight current challenges in their practice treating patients with fibromyalgia (FM).

Challenges and Unmet Needs in FM

Benjamin Natelson, MD

Aggressive fluid resuscitation has long been the cornerstone of treatment for 

While initial observational studies suggesting hypovolemia is associated with pancreatic necrosis fueled this practice, subsequent work has signaled that increased volume resuscitation may not improve outcomes. 

Randomized controlled trials comparing different volumes of fluid resuscitation, though, have had heterogeneous results and were limited by their small sample sizes and inclusion criteria.

E. de-Madaria et al. conducted an open-label, parallel-group, multicenter randomized controlled trial comparing moderate versus aggressive fluid resuscitation in patients with acute pancreatitis of multiple disease severities.

Adult patients with a diagnosis of acute pancreatitis according to the Revised Atlanta Classification who presented to the emergency department within 24 hours of pain onset were recruited from 18 centers. 

Patients meeting criteria for moderately severe or severe disease at baseline were excluded. Enrolled patients were randomly assigned to either receive aggressive or moderate fluid resuscitation per the trial protocol (Figure 1). 

Randomization was stratified according to trial center, systemic inflammatory response syndrome (SIRS), and hypovolemia. 

Enrolled patients underwent an initial physical assessment at 3 hours and then both biochemical and physical assessments at periodic intervals up to 72 hours, with adjustment of volume resuscitation based on the protocol and presence of hypovolemia, normovolemia, or hypervolemia. 

Oral feeding was initiated at 12 hours if abdominal pain was significantly improved. The sample size included all patients who underwent randomization and the data were analyzed according to an intention-to-treat principle.

A total of 249 patients were enrolled in the study and randomly assigned to the aggressive resuscitation group (n = 122) or the moderate resuscitation group (n = 127). Patients in the aggressive resuscitation group received a median of 7.8 L (interquartile range [IQR], 6.5 - 9.8) of fluid while patients in the moderate fluid resuscitation group received a median of 5.5 liters (IQR, 4.0 - 6.8). 

There was no significant difference between the aggressive and moderate fluid resuscitation groups in the primary outcome of rates of development of moderately severe (22.1%) or severe acute pancreatitis (17.3%; adjusted relative risk [aRR], 1.30; 95% confidence interval [CI], 0.78 - 2.18; 

However, aggressive fluid resuscitation was associated with a significantly higher incidence of fluid overload (20.5% vs 6.3%; aRR, 2.85; 95% CI, 1.36 - 5.94) with 1 patient in the aggressive fluid group requiring orotracheal intubation, and 6 patients classified as having moderate-to-severe fluid overload.

While not statistically significant, there was also a notable trend toward worse symptom intensity, longer hospital stay duration, and increased incidence of necrotizing pancreatitis among patients in the aggressive fluid resuscitation group. 

These safety results were reviewed by the data and safety monitoring board who halted the trial early due to the worse safety outcomes in the aggressive resuscitation group that were not balanced by improved outcomes. Subgroup analysis to assess the effect of baseline hypovolemia and SIRs did not find any major differences compared to the main analysis. 

While patients with acute pancreatitis have traditionally been treated with early aggressive fluid resuscitation, E. de-Madaria et al. demonstrated that this practice does not significantly improve the prevention of moderately severe or severe acute pancreatitis. Furthermore, when accounting for the risk of volume overload, these data lend support towards a more conservative fluid resuscitation approach.

This study is limited by its early termination and is thus underpowered to definitively evaluated efficacy.

While the study’s fluid resuscitation protocol is one method for managing patients with acute pancreatitis, there remains debate over the best practice for managing these patients during the first 24 hours. Still, this trial is the best evidence to date supporting the practice for less aggressive fluid resuscitation in patients with acute pancreatitis.

1. de-Madaria E, Buxbaum JL, Maisonneuve P, et al. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022;387(11):989-1000. doi:10.1056/NEJMoa2202884

A recent randomized controlled trial showed the limitations of either option, despite being a cornerstone of care.

Does Aggressive or Moderate Fluid Resuscitation Better Treat Acute Pancreatitis?

Hassieb Din, MD

But maybe we could finish up this discussion. And Dr Seminerio, you could start us off. Maybe a piece of advice or one take home message from the discussion today and we could go around.

: The take home is that there is a lot that's coming and that it is going to be very, very important for us to have discussions with our patients, come up with a plan together, and just be very cognizant that that plan may need some adjustments. If we put that out there that it's not a failure if we have to make an adjustment or one treatment doesn't work but that we're on top of it as quickly as possible. That is the best thing we can do for our patients is to show that we're never going to give up on them.

I'd say a couple of things, one listen to your patient. Obviously, the shared decision, set the goals with the patient. And then number 2, like we've talked about is if you know that Crohn's disease, 80% of Crohn's disease, from the start will require an advanced therapy. Starting that earlier, Jen said that several times, but also then, even within that group, what are the ones with the highest risk factors? Fistula and deep ulcers, multiple segments involved versus which are the ones that are moderate to severe single segments. I know we have great options for both.

: Not much more to add other than we are not exactly at precision medicine and practice of precision medicine in IBD but we are certainly getting there. And again, identifying- initiate early appropriate therapy and recognize that we could still practice individualized care.

: I would echo everyone's comments here. But the key takeaway I would say is start our patients early. Don't delay their care. We can limit all the complications and poor outcomes if you start that patient early. Then personalize it based on all their risk, their severity, comorbidities. Choose appropriately. And then once you have done that, follow them closely over time. This is not a disease that ends after one year. This is a chronic lifetime disease. You cannot go wrong by starting early, choosing a therapy that you think may be the best for that patient. It may or may not work but if it doesn't then you know that you're following them closely and then follow them throughout their time. And of course, you can adjust how frequently you follow them once you get them into complete remission.

I agree. And just one last thing to add is personalizing the target. We've been hearing about treat to target so much. But the target for each patient is different. And as we started the discussion, it's different for each patient. Starting early and personalizing that target. But I want to thank everyone for this rich and informative discussion and thank you for watching this 

® Peer Exchange. If you enjoy the content, please subscribe to our e-newsletters to receive upcoming Peer Exchanges and other great content right in your inbox.

Experts in gastroenterology share advice for the treatment of patients of Crohn’s disease.

Take-Home Messages for the Management of Crohn’s Disease

Jennifer Seminerio, MD

Experts discuss the recent use of biosimilars like inolimomab as treatment for ulcerative colitis (UC).

Biosimilar Treatment Options for Patients With UC

Maia Kayal, MD

Pulmonary critical care physician, Cone Health

Monoclonal Antibodies and the Future of Lung Preservation in COPD

, Joseph Khabbaza, MD, moderates an expert discussion with Nikita Desai, MD, and Eric Costanzo, MD, on the impact of and recent developments with monoclonal antibodies in chronic obstructive pulmonary disease (COPD).

In this clip, Desai and Costanzo reflected on the future direction of monoclonal antibody use in COPD, including sequencing, combination therapy, and long-term impact on disease progression. Desai highlighted that, while current use is largely shaped by payer approvals and clinical trial inclusion criteria, she typically assesses efficacy after 6 to 12 months before switching agents, acknowledging the need for head-to-head trials to inform sequencing decisions. Simultaneous biologic therapy, while mechanistically plausible, remains unlikely in the near future due to cost and logistical barriers.

Turning to disease modification, Costanzo emphasized the importance of early, upstream intervention to limit inflammatory cascades that drive irreversible lung remodeling. He underscored the clinical value of preserving lung function, noting that while COPD cannot be cured, biologics may arrest progression and mitigate long-term damage. Both clinicians agreed that unchecked type 2 or neutrophilic inflammation leads to structural changes and that the evolving use of targeted therapies offers an opportunity to protect lung health over time. As the field advances, they anticipate growing physiologic and imaging data will reinforce biologics’ role in modifying COPD's natural history.

is a pulmonary and critical care physician at the Cleveland Clinic and a director of the non-cystic fibrosis bronchiectasis program., who serves as the moderator for this panel discussion.

is a pulmonary critical care physician at Cone Health in Greensboro, North Carolina. She is triple board certified in critical care medicine, internal medicine, and pulmonary medicine.

is a pulmonary critical care and neurocritical care physician and program director of the Pulmonary and Critical Care fellowship at Jersey Shore University Medical Center with Hackensack Meridian Health System and Shore Pulmonary Associates

Relevant disclosures for Khabbaza include Insmed, Regeneron, Sanofi, and Baxter Healthcare Corporation. Desai and Costanzo have no relevant disclosures to report.

Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD). News release. GSK. May 22, 2025. https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-by-us-fda/

In this video, the last in a 6-part series, panelists discuss the potential future impact of biologics in the COPD field.

Nikita S. Desai, MD

Biliary complications remain a common source of morbidity following liver transplantation. The most common post-transplant biliary complications are strictures and leaks. Endoscopic retrograde cholangiopancreatography (ERCP) has become the first line of therapy for post-transplant biliary complications. However, outcomes of ERCP in early as compared to late liver transplant period are not known. We aimed to study the safety and outcomes of late (> 30 days) versus early (≤ 30 days) ERCP in liver transplant recipients with biliary complications.  

After IRB approval, we conducted a retrospective analysis of patients who underwent ERCP after liver transplant at Cleveland Clinic. Variables including transplant indication; MELD score at the time of transplant; baseline labs prior to ERCP; and procedure factors such as antibiotic use, prior medication use, and post-procedure outcomes were collected. Patients were then divided into 2 groups: ERCP ≤ 30 and ERCP > 30 days after liver transplant. The outcomes were technical success, clinical success, and adverse events post-ERCP.  

A total of 174 patients were included in our analysis. Mean age, gender, race, BMI, etiology of liver disease, type of liver graft, and type of anastomosis were similar in both groups. Patients who had ERCP in ≤ 30 days after liver transplant had significantly lower hemoglobin, alkaline phosphatase, bilirubin, and albumin as well as higher white cell count compared to patients who underwent ERCP > 30 days post-transplant. More patients in the ERCP ≤ 30 days group were on anticoagulation (10.6% vs 3.2%; 

= .049) with no difference in antiplatelet drugs.

ERCP ≤ 30 days after transplant was performed more commonly for indication of bile leak (36.2% vs 4.7%), whereas ERCP > 30 days post-transplant was more often performed for biliary stricture (90.6% vs 57.4%; 

 <.001). Patients who underwent ERCP ≤ 30 days at significantly high rates of post-procedure bleeding (12.8% vs 3.9%; 

In terms of procedural details, there were no significant differences in patients with prior ERCP and sphincterotomy done, history of Roux-en-Y anatomy, antibiotic use during the procedure, or advanced cannulation technique. However, there were significantly high rates of balloon dilation in patients who underwent ERCP > 30 days post-liver transplant.

Technical success, late postprocedural bleeding, post-ERCP pancreatitis, stent deployment, dislodgment, and cardiopulmonary complications were similar in both groups. The need for future ERCP, interventional radiology, or surgical interventions was also similar in both groups.  In this study, we report high rates of early post-procedure bleeding in patients who underwent ERCP ≤ 30 days after liver transplant as compared to ERCP > 30 days with overall similar rates of technical and clinical success. These data will help risk stratify patients prior to ERCP and raise awareness of the higher risk of bleeding in the early liver transplant period. 

Patients who underwent ERCP ≤ 30 days post-transplant had greater rates of early post-procedure bleeding but similar rates of technical and clinical success compared to late ERCP.

Safety, Outcomes of Early Versus Late ERCP in Liver Transplant Recipients

Rajat Garg, MD

discuss the most asked questions and common concerns patients have on adalimumab biosimilars.

Common Questions From Patients About Adalimumab Biosimilars

This is a video synopsis/summary of a panel discussion involving Jamie T. Brogan, MSN, APRN, FNP-BC; Kostas Botsoglou, MD; Jordan Axelrad, MD, MPH; Sophia Humphreys, PharmD, MHA; and Peter Lio, MD.

The dialogue revolves around patient education regarding biosimilar medications, focusing on common questions and concerns raised by patients and healthcare providers. Cost emerges as a primary concern for patients, with inquiries centered on out-of-pocket expenses and affordability. Providers emphasize the importance of addressing cost-related anxieties to ensure patient access and adherence to treatment.

Furthermore, patients often express apprehension about the efficacy and safety of biosimilars compared to originator drugs. Providers aim to alleviate these concerns by providing comprehensive education on the data supporting biosimilar efficacy and safety, highlighting studies and addressing questions about immunogenicity and device changes.

Another key discussion point is the management of patients who report problems after switching to biosimilars. Providers stress the need for thorough evaluation to differentiate between true treatment failure and potential psychological factors influencing patient perception. Strategies include objective assessment of disease activity and consideration of alternative treatment options based on clinical evidence.

Overall, the dialogue underscores the importance of patient-centered communication, comprehensive education, and evidence-based decision-making to optimize the transition to biosimilar medications while ensuring patient satisfaction and therapeutic success.

Video synopsis is AI-generated and reviewed by HCPLive editorial staff.

Drs Lio, Botsoglou, and Alexrad discuss the most asked questions and common concerns patients have on adalimumab biosimilars.

Sophia Humphreys, PharmD, MHA

 I’d love for you to share with the viewers what strategies you have implemented based on your experiences to educate patients about their journey. Because that’s so important, as John has said, about making this a patient-centered diagnosis. What’s a day in the life of Dr Maron and Dr Ommen in how you approach these issues?

 I’ll go first. Like I’m sure Steve does, we spend a lot of time with patients when they come and do our own education with them, along with our health care team and nurse practitioners to educate patients about the disease. We spend a lot of time on education, reassurance, putting these issues that we’ve talked about in perspective, and doing a lot of shared decision-making, going through treatment options. At the end of the day, we try to deliver the message that hypertrophic cardiomyopathy [HCM] is a highly treatable disease. It’s going to probably be more so in the future, but even today it’s very treatable and a disease that’s compatible with normal life expectancy and good quality of life for the vast majority of patients. That’s the messaging that we give to patients the best that we can.

 I’d echo the same thing. Patients come to us after having done their own education attempts on the internet, freaked out with wide eyes because they’ve read all the dramatic stories that are available, and we have to remind them that people who have normal lives don’t usually blog about it.

I’d like to reiterate the same words about HCM in the modern era. We’ve gone from an era where it was 100% fatal in 1958 when Donald Teare described it to a 6% annual mortality in the 1980s to an annual mortality that’s the same as the general population. It’s a highly treatable disease for most patients. There are patients in whom there are issues. This discussion wasn’t about sudden cardiac arrest, which would be another 2 hours. Then there are quality-of-life issues that some patients have. But it’s a highly treatable disease and we’re getting more tools in our toolbox for the future, which is exciting.

 That’s super. Javed, any final thoughts you want to share?

 My final thought is that we have these therapies and we want to do anything and everything that we can for the patients to not unnecessarily suffer. The question is how do we educate the clinical community at large to refer the patients to the appropriate centers and to diagnose and screen these patients? While the specialists are very interested in and have a lot of these tools, more mass education about this disease would also be needed.

 From an administrator’s point of view, let me ask you to put that hat on for a second. When you’re looking at making recommendations for clinicians who are interested in getting involved in this, what things would you say are needed in terms of understanding things like catheter-based approaches, surgical approaches, and volume, which you talked a bit about? What do you think about setting certain expectations?

 You can modify behavior quite a lot by creating appropriate incentive structures in terms of education, screening, and quality metrics. You can also set up tools. We live in this digital age and everybody is on an electronic health record. A lot of the education and best practice advisories can be had for our patients in this era. Education and reminder systems are easier in the current day and age.

 Super. John, I’m going to turn to you last. You always keep the patient in the center. I’m curious to hear your final thoughts.

 First, I’m humbled by the expertise at this panel and not being an HCM expert. I feel a tremendous need to think about the infrastructure for elevating the quality of care throughout the nation. What does that entail? Does it entail thinking about algorithms, building shared decision-making tools, integrating routine assessments of health status with the KCCQ [Kansas City Cardiomyopathy Questionnaire], and coming up with very practical management strategies so that you don’t have to be in Boston or Rochester, Minnesota, to get high-quality care?

 Or Kansas City. That’s what I’m left with. It’s a complicated disease, but it’s an exciting disease. As more treatment options become available, there’s a greater call for thinking about the infrastructure of delivering high-quality patient-centered care. That’s what I’d like to see us move toward so that we can all benefit from the advances being made.

 Super. That’s a great way to conclude. I want to thank all of you for this rich and informative discussion. I want to thank you, our viewers, for watching this 

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

 and other great content right in your inbox. I’m Jim Januzzi from the Massachusetts General Hospital. Thanks very much for joining.

Expert cardiologists share strategies for educating patients on the treatment and management of hypertrophic cardiomyopathy. 

Authors