Aleena Banerji, MD, professor at Harvard Medical School and director of clinical care at the Center for Drug and Vaccine Allergy at Massachusetts General Hospital.

HAE in 2026: New Therapies, Updated Guidelines, the Case for Early Treatment

The treatment landscape for hereditary angioedema is undergoing one of its most significant evolutions in years. Updated international guidelines, pivotal phase 3 data, and promising early-phase results are collectively reshaping how clinicians approach both prophylaxis and acute management of this rare, potentially life-threatening condition.

 about where the field stands and where it is headed.

Guidelines Put Early Treatment Front and Center

have placed renewed emphasis on early, on-demand intervention, formally recommending sebetralstat (Ekterly) as a first-line option for acute treatment of attacks in patients aged ≥ 12 years.

 The oral plasma kallikrein inhibitor was approved by the US Food and Drug Administration (FDA) in July 2025.

Mauro Cancian, MD, PhD, head of the allergy division at the University of Padua and a KONFIDENT trial investigator, said the shift toward an oral agent has meaningfully changed how quickly patients are able to treat attacks.

"What we are emphasizing with our patients, and obviously as a result of the guideline, is that to make treatment more effective, you have to treat the attacks as early as possible," Cancian said. "That means treating at the onset of the attack, because we know that if there is a delay between attack onset and treatment, the drug will be less effective in reducing both the severity and the duration of the attacks."

Data from the phase 3 KONFIDENT study support this urgency. As of January 31, 2025, the median time from attack onset to treatment was just 4 minutes, with a median time to the beginning of symptom relief of 1.79 hours. In the open-label extension, treatment delays shortened further, to under 10 minutes, a figure Cancian attributed to the portability and ease of oral administration.

Cancian cautioned that even patients on long-term prophylaxis require reliable on-demand treatment, as no prophylactic therapy fully eliminates breakthrough attacks. That reality makes the availability of an effective, easy-to-administer acute option all the more critical.

BW-20805: A Long-Acting RNA Interference Approach

Among the investigational therapies attracting attention is 

, a small interfering RNA conjugated with N-acetylgalactosamine that targets hepatocytes via the asialoglycoprotein receptor. Once inside liver cells, it inhibits messenger RNA responsible for producing prekallikrein: the inactive precursor of plasma kallikrein and a central driver of the bradykinin cascade underlying HAE attacks.

Late-breaking phase 2 data presented at the 2026 American Academy of Allergy, Asthma & Immunology annual meeting in Philadelphia showed that BW-20805 achieved high rates of attack-free outcomes at dosing intervals of up to 6 months. Among 10 patients with post-dose efficacy data beyond day 29, 80% remained completely attack-free during the observation period. The highest dose cohort (600 mg every 24 weeks) achieved a 100% reduction in time-normalized HAE attack rate.

Within the first month after administration, prekallikrein levels declined by approximately 90% to 97% depending on the dosing regimen, with reductions remaining stable throughout follow-up.

"The drug BW-20805 is doing what we expect it to do, educing plasma kallikrein activity by more than 90% in a very stable way," said investigator Markus Magerl, MD, of Charité-Universitätsmedizin Berlin.

The therapy's safety profile has been favorable in early analyses, with most adverse events mild and transient, primarily injection-site reactions , and no treatment-related serious adverse events reported. Magerl noted the current findings come from a relatively small phase 2 cohort, and additional data from the completed phase 2 study and an eventual phase 3 trial will be needed to confirm durability and characterize long-term safety.

Lonvoguran Ziclumeran: One-Time CRISPR Therapy Shows 87% Attack Reduction

Perhaps the most headline-generating data came from the 

phase 3 HAELO trial of lonvoguran ziclumeran (lonvo-z)

, an in vivo CRISPR/Cas9 gene editing therapy that targets and inactivates the KLKB1 gene in hepatocytes, reducing kallikrein production and downstream bradykinin generation. Intellia Therapeutics reported top-line results in April 2026.

Patients receiving lonvo-z achieved a mean monthly attack rate of 0.26 compared with 2.10 in the placebo arm — an 87% reduction. More than half (62%) of patients in the treatment arm became both attack-free and free from long-term prophylaxis, compared with 11% on placebo.

Lead investigator Aleena Banerji, MD, professor at Harvard Medical School and director of clinical care at the Center for Drug and Vaccine Allergy at Massachusetts General Hospital, highlighted the significance of those findings, particularly the one-time dosing.

"The biggest benefit that we're seeing here is a one-time treatment that is leading to a significant reduction in attacks similar to the other long-term prophylactic treatments, except that this one does not require any ongoing long-term treatment," Banerji said.

Safety findings to date have been consistent with earlier studies, with no serious adverse events reported during the primary observation period. Common adverse events, all mild to moderate, included infusion-related reactions, headache, and fatigue. Banerji noted that continued follow-up will be essential to monitor for any delayed risks associated with in vivo gene editing.

Intellia has begun a rolling biologics license application submission, expected to be completed in the second half of 2026, with a potential US launch in 2027 pending approval.

These developments reflect a field moving with unusual speed. Patients with HAE now have access to 11 approved treatments in the United States — 6 of them for long-term prophylaxis — with potentially more on the horizon.

"This certainly adds another novel treatment option for prevention of attacks," Banerji said of lonvo-z. "It moves the needle quite a bit for our patients with hereditary angioedema as a one-time treatment with a significantly high rate of efficacy and very good safety data."

For clinicians, the evolving landscape underscores the importance of individualized decision-making, weighing treatment burden, patient preference, and the persistent need for effective on-demand options alongside any prophylactic strategy. As Cancian put it, the goal has not changed, even as the tools to achieve it multiply.

"The main goal [remains] to reduce the number of attacks and to improve the quality of life of patients,” Cancian said.

Check out other allergy news this year here: 

Farkas H, Martinez-Saguer I, Bork K, et al. International Guideline on the Diagnosis and Management of Pediatric Patients With Hereditary Angioedema. 

Zhi Y, Zhao X, Zhu R, et al. Significant HAE Attack Reduction with BW-20805, a Long-Acting Prophylactic Injection- An Ongoing Phase 2 Study in Adult with Hereditary Angioedema. Journal of Allergy and Clinical Immunology. 2026;157(2):AB426. 

doi:https://doi.org/10.1016/j.jaci.2025.12.948

Derman C. Single-Dose Lonvoguran Ziclumeran Cuts HAE Attacks by 87% in Phase 3 Trial. HCPLive. Published April 27, 2026. Accessed April 27, 2026. 

https://www.hcplive.com/view/single-dose-lonvoguran-ziclumeran-cuts-hae-attacks-87-phase-3-trial

Experts weigh in on a rapidly evolving treatment landscape, from a first-line oral option to a one-time CRISPR therapy showing 87% attack reduction.

Aleena Banerji, MD

On March 16, Eli Lilly and Company released 

 from the phase 3 ADorable-1 study regarding lebrikizumab (Ebglyss) and its success in treating those with moderate to severe atopic dermatitis, including infants and children as young as 6 months.

These data suggest both of the ADorable-1 study’s co-primary endpoints were met while using this interleukin (IL)-13–targeting monoclonal antibody, currently 

-approved for moderate to severe atopic dermatitis in adults and adolescents.

 Lilly has also indicated its intention to submit the data to US and international regulators for a label expansion in younger pediatric patients.

Amy Paller, MD, chair of the department of dermatology at Northwestern University and an investigator in the study, spoke with 

 following the release of these findings. The following is a Q&A discussion with Paller about the biggest highlights:

What would you say stood out most among these findings from ADorable-1 as an investigator on this trial?

 The biggest takeaway is that we've been living with one advanced systemic only, for such a long time now, yet we have such a large part of our population, the pediatric population under 12, who have moderate to severe atopic dermatitis. They are just not responding well enough to topicals, or parents are putting on so much steroid that I'm sure that it's having some adverse effects over time. Not to mention the burden of disease and spending so much time.

The fact that we now have a second one that, hopefully, will move forward for FDA clearance is really thrilling to us as pediatric dermatologists. We've been waiting for this for a long time. We don't have any options other than what we've had for decades: methotrexate and cyclosporine. These are the options for kids who don't respond well to dupilumab or have an issue with it.

ADorable-1 enrolled patients as young as 6 months, a population where we have very few approved targeted options. How meaningful are these topline results to you as an investigator, and what does a 63% EASI-75 response rate tell us about the potential role of selective IL-13 inhibition in this age group?

 What it tells us is probably going to be on par with the type of changes that we've seen with dupilumab, and that's great. You know, we've all now had some experience with those who are 12 and above. We know that they're very different, these approaches, and we can't take a response to one and just apply it to the other. They're quite different, and again, it gives us an option. But it tells us that it's an option that looks to be pretty promising, and the majority, that is two-thirds of children within as short a period of 16 weeks, will have a tremendously meaningful improvement in their disease.

The trial used weight-based dosing alongside background topical corticosteroids. Can you walk us through the rationale for that design, and how confident are you that the efficacy signal here reflects lebrikizumab's contribution specifically, rather than the combination with topical therapy?

This has also been done with these other pediatric trials, including with dupilumab. It's just really not considered ethical in children to not provide some modicum of relief. Of course, these are children in whom the topicals weren't enough anyway, so putting them on a topical steroid on both arms is really an ethical move to try to assuage some of the pain, itch, and terrible aspects of this disease. That's where that comes from. The weight-based dosing, of course, reflects the fact that this is pediatrics.

We can't just give them adult doses, but it is tiered. So, the smallest children in the study would be getting something like the two loading doses, and then going to 125 every 4 weeks. Whereas the older children in the study would be, depending on where they were, if they were 40 kilograms and above, on the standard 250 milligram for 0, 2 weeks, and then every 2 weeks after that. If they were in the next tiered group, that is under 40, but I think it was over 15 milligrams, they would be getting the 250 after that, 2 weeks on an every-4-week basis.

Atopic dermatitis in infants and toddlers carries a significant burden not just for the patient but for the whole family. Beyond the clinical endpoints, what did you observe in terms of the real-world impact on patients and caregivers throughout the trial?

I don't know that that data is out there in the public domain yet, but I will just say, from my own experience, when you get something that works great, you get a lot of smiles on everybody's face. This is a disease that has a terrible burden, not just for the young children, but for the entire family. The parents don't sleep. When the kids don't sleep, the parents spend more time at the doctors and out of work. Kids are homesick, and it's a tremendous burden for, not just the parents but, of course, the entire family. Being able, in a relatively short period of time in this study, to turn around the burden of this disease really helps the physical and emotional burden for the entire family.

With Lilly planning regulatory submissions based on these data, what would a label expansion down to 6 months mean for how pediatric dermatologists approach treatment sequencing?

As I mentioned, it gives us options. I think we're very used to using dupilumab. I don't think that's going to go away, but I think that we now have an option for one or the other. There is going to potentially be a difference. We'll see what the FDA does. I really don't know, but the cutoff for going every 2-week-dosing with dupilumab was set at 30 milligrams. You get that 200-milligram every 2 weeks. Here, it's set at 40. So that means under 40, they'd be every 4 weeks based on the FDA. I don't know if that'll make a difference, but it gives a certain group of kids more of an on-label every 4 weeks.

For dupilumab, I often use it every 4 weeks for the kids in that group. That's 30 and above. This is just because that's the on-label for Europe, and it works just fine. The answer to your question is that we have options now for these kids of this age. We can have first-line dupilumab, we can have first line lebrikizumab. We certainly have options if they don't do well with whatever our first choice is.

What remaining questions would you most like answered in the next phase of research for lebrikizumab in this younger patient population?

I think it's always important to see a larger group beyond what's in the study. We want to see what the real-world experience is with first-line lebrikizumab, with changing from dupilumab to lebrikizumab. We certainly didn't see much in terms of any kind of adverse events during this trial, no new signals, and nothing of concern. But we'll keep an eye on whether there seems to be any difference with instance of ocular surface disease, although it's so low with dupilumab as well in this young population.

I think we're also going to be looking at the long term. One of the big questions: We talk now about the potential that dupilumab, which we know is on-label for asthma, and we know it is helpful for a variety of allergic and new mediated disorders. [The question is] whether there is going to be a role in reducing the development of other atopic diseases, in addition to reducing the severity of those diseases while on the drug; we just don't know how much of that is.

Specifically, the fact that the IL-4 receptor inhibitor of dopamine also inhibits IL-4 signaling directly…We may not get that with the IL-13-specific targeting. I think that will be an interesting question to look at further, looking at the development or the occurrence of these other allergic disorders with IL-13. That's going to be something. Then obviously, other questions that we have as well, are why vaccines? Is there any concern with giving a live vaccine? Theoretically, there would not be, but obviously that remains to be answered with real data. I think those are the 2 big questions that are out there.

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

Disclosures for Paller include the following: AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi – investigator; AbbVie, Amgen, Asana, Dermavant, Dermira, Eli Lilly, Forte, Galderma, LEO Pharma, Matrisys Bioscience, Menlo Therapeutics, MorphoSys/Galapagos, Novartis, Pfizer, Regeneron Pharmaceuticals. Inc., Sanofi – consultant.

Campbell P. Phase 3 Trial Supports Lebrikizumab in Pediatric Atopic Dermatitis. HCPLive. March 16, 2026. Accessed March 17, 2026. 

https://www.hcplive.com/view/phase-3-trial-supports-lebrikizumab-in-pediatric-atopic-dermatitis

Eli Lilly and Company. Lilly’s EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis | Eli Lilly and Company. Eli Lilly and Company. Published March 16, 2026. Accessed March 17, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-first-and-only-selective-il-13

Phase 3 ADorable-1 topline data support lebrikizumab, a selective IL‑13 monoclonal antibody, in moderate-to-severe atopic dermatitis for patients aged 6 months to 18 years, meeting both co-primary endpoints and achieving ~63% EASI‑75 at 16 weeks with background topical corticosteroids. Weight-tiered dosing aligned with pediatric pharmacology and mirrored ethical trial norms for symptom control. A potential label expansion would add a second advanced systemic option for younger children, enabling alternative first-line sequencing and switch strategies beyond dupilumab and legacy immunosuppressants.

Following the release of new results from the phase 3 ADorable-1 trial on lebrikizumab in pediatric patients, Amy Paller, MD, speaks in a new Q&A interview.

Significance of ADorable-1 Data on Lebrikizumab in Children with Atopic Dermatitis, With Amy Paller, MD

Amy S. Paller, MD

Benjamin Natelson, 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

Oksana Hamidi, DO, is an associate professor in the division of endocrinology and metabolism at the University of Texas Southwestern Medical Center.

Crinecerfont and Classic CAH: 2-Year CAHtalyst Results, With Oksana Hamidi, DO

Classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency requires lifelong glucocorticoid replacement to suppress adrenocorticotropic hormone (ACTH) and control adrenal androgen excess. The fundamental clinical challenge is that achieving androgen control typically demands supraphysiologic glucocorticoid doses, which carry substantial toxicity. Patients are at risk for exogenous Cushing syndrome, cardiometabolic complications, and reduced quality of life from high-dose, multi-daily regimens.

The physiologic replacement range for hydrocortisone is approximately 15 to 20 mg/day, yet many adults with classic CAH are managed on doses nearly double that threshold.

Crinecerfont, a first-in-class corticotropin-releasing factor type 1 (CRF1) receptor antagonist, offers a mechanistically distinct approach. By blocking CRF from activating the CRF1 receptor, crinecerfont reduces ACTH drive and adrenal androgen production, potentially enabling GC dose reduction without sacrificing androgen control. In December 2024, the agent received US Food and Drug Administration approval as an adjunct to physiologic glucocorticoid replacement in classic CAH.

2-year data from the CAHtalyst Adult Study presented at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026 by Oksana Hamidi, DO, an associate professor in the division of endocrinology and metabolism at the University of Texas Southwestern Medical Center, extend previously reported findings supporting the FDA approval. The trial enrolled 182 adults taking supraphysiologic glucocorticoid doses at baseline, with a mean daily dose of approximately 32 mg/day. By week 24, crinecerfont-treated participants achieved a least-squares mean glucocorticoid reduction of 27% versus 10% with placebo (LSMD, -17%; 95% CI, -24% to -10%; 

Results showed that reduction was sustained through month 24, with mean glucocorticoid doses stabilizing at approximately 19.4 mg/day (10.6 mg/m²/day). Of note, the proportion of participants achieving a glucocorticoid dose within the physiologic range held at approximately 70% from month 12 through month 24.

Reductions in treatment burden were also documented. Among patients on hydrocortisone with > 2 doses per day, 62% reduced their dosing frequency by ≥ 1 dose per day. Of those on dexamethasone-containing regimens, 75% became dexamethasone-free. Cumulatively, actual glucocorticoid exposure over 2 years was 8010 mg/m² versus a projected 12,152 mg/m² had patients remained on their baseline dose.

“Patients who have classic CAH oftentimes require multiple medications per day, multiple doses per day, so it is a big challenge for them to live on a clock and constantly have reminders on their watches and calendars to keep taking their glucocorticoids, otherwise they lose control of their androgens,” Hamidi explained. “By reducing the doses, say, from 3 times a day dosing to 2 times a day dosing, I strongly believe that that improves patients' overall quality of life, but also their sense about their disease control and allows them to be more consistent with their medication.”

Safety data across the full 2-year period showed no new signals, with most adverse events rated mild or moderate and few discontinuations. Hamidi noted that as glucocorticoid doses are lowered, clinicians should ensure patients are equipped with sick-day guidance and injectable glucocorticoids for adrenal crisis prevention.

The trial's retention rate of > 80% over 2 years reflects sustained patient engagement that Hamidi described as exceeding her expectations and as evidence that patients were seeing the outcomes they had hoped for.

Editors’ note: Hamidi reports relevant disclosures with Corcept Therapeutics, Neurocrine Biosciences, Adaptyx, Camurus, Crinetics Pharmaceuticals, and Recordati Rare Diseases, Inc.

Iapoce C. FDA Approves Crinecerfont for Congenital Adrenal Hyperplasia. HCPLive. December 13, 2024. Accessed April 24, 2026. 

https://www.hcplive.com/view/fda-approves-crinecerfont-for-congenital-adrenal-hyperplasia

Bancos I, Hamidi O, Kiefer FW, et al. Adults With Classic Congenital Adrenal Hyperplasia Taking Crinecerfont Demonstrated Sustained Decreases in Glucocorticoid Doses: 2-Year Results from the CAHtalyst Adult Study. Presented at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026 in Las Vegas, Nevada, April 22-24, 2026.

Hamidi reviews 2-year CAHtalyst data showing crinecerfont enabled sustained glucocorticoid reductions to physiologic range in adults with classic congenital adrenal hyperplasia.

CAHtalyst Adult: Sustained GC Reduction With Crinecerfont in CAH, With Oksana Hamidi, DO

Oksana Hamidi, DO

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. 

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