Response rates with litifilimab, a monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2), continued to rise through week 52 in patients with 

 refractory or intolerant to antimalarials, according to Victoria P. Werth, MD, professor of dermatology and medicine at the University of Pennsylvania, and François Chasset, MD, PhD, professor of dermatology at Sorbonne Université and Hôpital Tenon in Paris. The 2 discussed the phase 2 AMETHYST Part A data in an HCPLive special report from the 

European Academy of Dermatology and Venereology (EADV) Congress 2026

 in Vienna, Austria (September 30–October 3). The findings come from a Biogen-sponsored congress abstract that has not been peer-reviewed, and both speakers are authors on it.

52-Week Litifilimab Data in Cutaneous Lupus Erythematosus

AMETHYST Part A (NCT05531565) randomized 93 adults to subcutaneous litifilimab (

 = 34) every 4 weeks through week 24, after which all participants received litifilimab through week 52.

 Chasset noted the cohort was 74% women and 33% non-white. At week 16, 14.7% of litifilimab participants achieved clear or almost clear skin on the Cutaneous Lupus Activity Investigators’ Global Assessment Revised (CLA-IGA-R) erythema score versus 2.9% with placebo (difference, 11.8%; 95% CI, 1.39–22.27).

 “There’s been no approved therapies for over 80 years in cutaneous lupus, and we’re really on a cusp of changing the way that we practice,” Werth said.

Among participants who started litifilimab at baseline, response rates rose from week 24 to week 52 for CLA-IGA-R erythema 0–1 (19.0% to 27.2%), Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 (21.7% to 28.8%), and CLASI-50 (40.8% to 46.0%), while CLASI–Activity 0–3 held at 16.3% to 16.7%.

 Participants who switched from placebo at week 24 began responding within about 4 weeks, reaching week-52 rates of 33.7%, 35.4%, 48.5%, and 22.2%, respectively.

 Werth cautioned that after week 24 the comparisons are largely within group rather than placebo-controlled, so the extension speaks to durability rather than relative efficacy. Adverse events in the extended period occurred in 76.8% and 78.1% of early and late starters, respectively, nearly all mild or moderate; serious adverse events occurred in 3.6% and 3.1%, and no serious viral infections were observed.

Chasset said litifilimab reduces type I interferon and other proinflammatory cytokines by binding BDCA2 on plasmacytoid dendritic cells. He also highlighted a companion analysis from AMETHYST Part A defining meaningful within-patient change in CLASI–Activity as a 7.0- to 8.0-point decrease or a 35% to 50% reduction, with percentage change tracking clinician and patient perceptions more closely and supporting CLASI-50 and CLASI-70 as trial endpoints.

 Chasset added that a separate EADV analysis of RNA sequencing data from the earlier LILAC trial showed interferon-pathway signatures declining over time, which he said could eventually help identify likely responders.

The phase 3 portion of AMETHYST remains blinded and ongoing, and litifilimab received FDA Breakthrough Therapy designation for CLE in January 2026.

 Chasset said a phase 3 readout in systemic lupus erythematosus is expected later in 2026.

Relevant disclosures for Chasset include AstraZeneca, Biogen, BMS, GSK, Celgene, Merck, Horizon Therapeutics, Novartis, Kyowa Kirin and Principabio. Relevant disclosures for Werth include

Xoma, RPS, Janssen/Centocor, Biogen-Idec, Sanofi-Aventis, UVC, Novartis, Idera, Pfizer, Lupus Foundation of America, Medimmune, Rigel, Merck, Genentech, GSK Stiefel and Celgene.

Merola JF, Werth V, Chong B, et al. Efficacy and safety of litifilimab in cutaneous lupus erythematosus (CLE): 52-week results of the phase 2 study, AMETHYST Part A. Abstract 1846. Presented at: European Academy of Dermatology and Venereology (EADV) Congress 2026; September 30-October 3, 2026; Vienna, Austria.

Biogen. Biogen announces second positive phase 2 litifilimab trial in cutaneous lupus erythematosus at 2026 American Academy of Dermatology Annual Meeting, showing a significant reduction in skin disease activity. News release. March 28, 2026.

Chasset F, Werth V, Fernandez A, et al. Defining clinically meaningful change in Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI-A) scores: data from AMETHYST Part A, a phase 2 study of litifilimab in cutaneous lupus erythematosus. Abstract 2364. Presented at: EADV Congress 2026; September 30-October 3, 2026; Vienna, Austria.

Biogen Inc. Quarterly report (Form 10-Q) for the period ended June 30, 2026. US Securities and Exchange Commission.

Videos

Victoria P. Werth, MD, and François Chasset, MD, PhD, discuss 52-week AMETHYST Part A data showing litifilimab responses continued to rise.

Released on July 23, 2026, the most recent update to the American College of Cardiology (ACC) Expert Consensus Decision Pathway (EDCP) aims to redefine, recategorize, and reestablish treatment criteria for 

heart failure with preserved ejection fraction (HFpEF)

ACC Expert Consensus Decision Pathway Updates HFpEF Definition, Diagnosis & Treatment

Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026

, James Januzzi, MD, chief scientific officer and C. Michael Gibson Chair in Medicine at the Baim Institute for Clinical Research and Adolph Hutter Professor of Medicine at Harvard Medical School and co-author of the new guidelines, discusses their implications for HFpEF care moving forward.

“In the document, we acknowledge that heart failure with preserved ejection fraction is unique compared to other forms of heart failure, such as reduced ejection fraction,” Januzzi told 

. “We argued that clinicians need to take a very careful look at each patient on an individual level before deciding on specific therapeutic interventions.”

The original EDCP was published in 2023 – the present update shifts the definition of HFpEF from an individual cardiac condition to a multisystem syndrome driven by inflammatory pathways, visceral adiposity, and metabolic dysfunction. Additionally, the document highlights the distinct patient phenotypes prevalent in HFpEF and the individualized care required for these groups.

Among the key components of the new guideline is the critical importance of accurate diagnoses. Januzzi and colleagues provide a structured approach to evaluating patients, composed of 3 main steps: identifying patients with possible HFpEF based on characteristic signs and symptoms, assessing for HFpEF noncardiac and cardiac mimics, and implementing an HFpEF management plan incorporating comorbidities and nonpharmacologic management in addition to optimal medical therapy.

Additionally, the document provides an extensive list of potential cardiac and noncardiac mimics, recommending a diagnostic evaluation for each potential confounder to eliminate the possibility of HFpEF. These mimics can range from kidney disease, obesity, and pulmonary disease on the noncardiac side to aortic stenosis, ischemic heart disease, and cardiac amyloidosis.

Following diagnosis, the document offers a variety of guidelines regarding treatment and medication. Part of the impetus for the update was additional research conducted in the years following the 2023 release – this includes positive trial data supporting the use of SGLT2 inhibitors, nonsteroidal mineralocorticoid receptor agonists, and incretin-based therapies like GLP-1 receptor agonists. The new guidelines recommend dosing and titration strategies for a wide range of medications in each of these classes.

However, Januzzi places a significant amount of importance on the diagnostic process itself. Given the long list of potential causes of HFpEF, he stresses that underdiagnosis is a prevalent threat as components of HFpEF are addressed individually rather than seeing the bigger picture.

“I would argue that underdiagnosis is probably more of a concern than overdiagnosis, given the fact that a person who has dyspnea, atrial fibrillation, and obesity, even before we start off with diagnostic testing, most likely has heart failure with preserved ejection fraction,” Januzzi said. “Clinicians therefore really need to have a high index of suspicion for the presence of heart failure because treatment in that situation can improve quality of life and functional capacity and can potentially reduce mortality and hospitalization risk.”

Editors’ Note: Januzzi reports disclosures with Abbott Laboratories, AbbVie, Inc., Eli Lilly, AstraZeneca Pharmaceuticals, Jana Care, Siemens, and others.

Kittleson MM, Panjrath GS, Bates K, et al. Management of heart failure with preserved ejection fraction: 2026 ACC expert consensus decision pathway. JACC. 2026;88(15):1817-1846. 

American College of Cardiology. Updated ACC Expert Consensus Decision Pathway Addresses Management of HFpEF. 

. July 23, 2026. Accessed October 14, 2026. 

https://www.acc.org/latest-in-cardiology/journal-scans/2026/07/22/17/25/updated-acc-ecdp-addresses-management-of-hfpef

James Januzzi, MD, discusses the recently released guideline update and how it should change clinicians’ priorities in addressing and preempting HFpEF.

Adults with irritable bowel syndrome with constipation (IBS-C) used fewer gastrointestinal (GI) health care resources in the year after starting tenapanor (Ibsrela). The data were presented at the 

American College of Gastroenterology (ACG)

The retrospective analysis included 470 patients from a national 

 practice. Median GI-related health care resource utilization (HCRU) fell from 4.5 visits in the year before tenapanor initiation to 3.0 visits in the year after 

 <.001).² Significant reductions were also seen among patients who had previously tried ≥1 IBS-C medication.

“We know that the vast majority of patients with IBS don’t necessarily present to a gastroenterologist, but among those that do, they really have a high degree of healthcare resource utilization, and I think we wonder: is that really a surrogate for dissatisfaction? That perhaps these patients are utilizing resources because they’re not happy with the current plan of care,” Kyle Staller, MD, MPH, director of the Gastrointestinal Motility Laboratory at Massachusetts General Hospital and first author of the analysis, said in an interview with 

Tenapanor Linked to Lower IBS-C Care Use, With Kyle Staller, MD, MPH

How Tenapanor’s Mechanism Differs From IBS-C Secretagogues

Most existing IBS-C therapies are secretagogues. They actively secrete ions into the intestinal lumen, and water follows to produce bowel movements.

Tenapanor is a locally acting inhibitor of sodium/hydrogen exchanger 3 (NHE3). It reduces sodium absorption in the small intestine and colon, which keeps water in the lumen and softens stool.² Staller described the drug as a retainagogue rather than a secretagogue.

The different mechanism and the drug’s newness on the market prompted the investigators’ question: would patients starting tenapanor de novo show a change in HCRU?

Median GI Visits Fell From 4.5 to 3.0 After Tenapanor Initiation

Eligible patients had ≥1 year of data before and after starting tenapanor and ≥1 outpatient visit, according to Staller. The analysis drew on electronic health records rather than billing codes alone.

The interquartile range for GI-related HCRU narrowed from 2 to 9 before initiation to 1 to 6 after.² The reductions held in subgroups regardless of body mass index or comorbidity burden.

Staller said the decline was most notable in office visits. He said this could reflect patients who feel more satisfied and no longer return to report ongoing symptoms.

Before and After Design Limits Causal Conclusions on Tenapanor

“I’m very confident that that reduction is real. I’m not sure that we can definitively say that that reduction is because they started tenapanor, but I think you do have to wonder, right? The patient starts tenapanor, and that reduction is very clear,” Staller said.

The analysis compared each patient’s use before and after initiation without a separate comparison group. Staller noted that factors other than tenapanor could contribute to the decline.

He also pointed to the data source as a strength. Patients came from large community GI practices across the country rather than the academic centers that typically supply this type of research.

Editor's note: Staller reports disclosures with AbbVie, Ardelyx, Gemelli, Salix, and Takeda.

Staller K, Fossa A, O’Byrne M, Scott LL. Health care resource utilization decreases among patients with constipation predominant irritable bowel syndrome following initiation of tenapanor: a real-world analysis. Poster P3082. Presented at: ACG 2026 Annual Scientific Meeting; October 12, 2026.

Ardelyx presents real-world data at ACG 2026 showing reduced healthcare resource utilization following IBSRELA initiation in adults with IBS-C. News release. Ardelyx. October 12, 2026.

A real world analysis of 470 patients presented at ACG 2026 found median GI visits fell from 4.5 to 3.0 in the year after initiation

A combination of measurements of transthyretin stabilization (sTTR) with a later myocardial stress marker like NT-proBNP creates a biomarker ratio that may predict clinical outcomes in patients with 

transthyretin amyloid cardiomyopathy (ATTR-CM)

Ratio of sTTR and NT-proBNP Change May Predict Treatment Results in ATTR-CM

These data, from an analysis of the ATTRibute-CM trial, were presented at the 

 in Phoenix, Arizona, by James Januzzi, MD, chief scientific officer and C. Michael Gibson Chair in Medicine at the Baim Institute for Clinical Research and Adolph Hutter Professor of Medicine at Harvard Medical School.

“Acoramidis is an oral therapy used to stabilize transthyretin, and it’s known that treatment with acoramidis leads to an early increase in transthyretin, and it’s known that treatment leads to an early increase in transthyretin concentrations that are actually favorable,” Januzzi told 

 in an exclusive interview. “We hypothesized that the increase in transthyretin might predict changes in NT-proBNP later after treatment.”

ATTRibute-CM was a phase 3, randomized, double-blind, placebo-controlled study comparing acoramidis to placebo in ATTR-CM. Patients were eligible for inclusion if they had either wild-type or variant ATTR-CM and a history of 

, among other criteria. Patients with acute myocardial infarction, hemodynamic instability, or primary light chain amyloidosis, among other criteria, were excluded.

A total of 632 patients were enrolled in the study and randomly assigned in a 2:1 ratio to either acoramidis hydrochloride at 800 mg twice daily or matching placebo. Over 30 months, investigators evaluated a 4-step hierarchical analysis of death from any cause, cardiovascular-related hospitalization, change in NT-proBNP from baseline, and change in 6-minute walk distance from baseline.

This primary analysis ultimately favored acoramidis, with a corresponding win ratio of 1.8 (95% CI, 1.4 to 2.2) and 63.7% of pairwise comparisons favoring acoramidis. All-cause mortality and cardiovascular hospitalization contributed >50% of the wins and losses to the win ratio, while NT-proBNP pairwise comparisons yielded the highest ratio of wins to losses.

For the present post-hoc evaluation, Januzzi and colleagues used observed biomarker data from the intention-to-treat population to conduct time-to-event analyses. Samples were collected from this population at baseline, day (D)28, and every 3 months (M) from then on; sTTR and NT-proBNP were measured centrally. The team constructed an integrated biomarker ratio of log2-transformed D28 sTTR/log2-transformed M12 NT-proBNP from these data.

Of the 632 intention-to-treat patients, 587 had baseline and M30 biomarker values. The mean age among these patients was 77 +/- standard deviation (SD) 7 years. 90% of patients had wild-type ATTR-CM, 72% were New York Heart Association functional class 2, and 59% were National Amyloidosis Centre stage 1. Median sTTR and NT-proBNP were 23 mg/dL and 2324 ng/L, respectively.

Early changes in sTTR preceded later changes in NT-proBNP, with the former increasing rapidly by D28 and remaining elevated with acoramidis compared to little change with placebo. NT-proBNP increased to a lesser extent with acoramidis versus placebo. These changes correlated weakly when measured at the same time point, but correlations between D28 sTTR change and later NT-proBNP change were stronger.

This ratio was also strongly associated with all-cause mortality and cardiovascular hospitalization risks in M12 landmark analyses. Januzzi and colleagues found that each 0.1-unit increase in the ratio was associated with a 63% lower adjusted risk of these endpoints (HR, 0.37; 95% CI, 0.24 to 0.58; 

 <.001). The team observed a continuous biomarker-risk gradient, and mediation analyses revealed that the effect of acoramidis treatment on all-cause mortality and cardiovascular hospitalization was associated with an HR of 0.66.

Ultimately, Januzzi and colleagues concluded that, while these data may reflect an effective and accurate predictor of cardiovascular risk in ATTR-CM, several potential study limitations may hamper the ratio’s accuracy in real-world practice. To this end, they determined that further research is necessary to fully validate the biological pathway linking these targets with long-term clinical benefit with acoramidis.

“I think the most important thing that we can say is that biomarker testing really can be extremely informative, not just about the presence and severity of ATTR-CM, but also with respect to its response to treatment,” Januzzi said. “We need more data about the role of biomarkers to help people manage transthyretin cardiomyopathy, but I would argue that the future is very bright in this regard.”

Myhre P, Murtagh G, Gaggin H, et al. Implications of Serum Transthyretin to NT-proBNP Ratio in Transthyretin Amyloid Cardiomyopathy: Insights From ATTRibute-CM. 

https://doi.org/10.1016/j.jchf.2026.103493

Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of ACORAMIDIS in transthyretin amyloid cardiomyopathy. New England Journal of Medicine. 2024;390(2):132-142. 

Eidos Therapeutics. Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM). ClinicalTrials.gov Identifier: NCT03860935. Updated June 27, 2026. Accessed October 14, 2026. 

https://clinicaltrials.gov/study/NCT03860935

James Januzzi, MD, discusses his post-hoc analysis of the ATTRibute-CM study, revealing a potential predictive ratio between these 2 measurements.

An updated version of the SimpleScreen CRC blood test detected advanced precancerous lesions (APLs) with 18.2% sensitivity, up from 13.7% with the previous version, while maintaining 80.4% sensitivity for 

. The late-breaking results come from a clinical validation study presented at the 

American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting

SimpleScreen CRC, developed by Freenome, received US Food and Drug Administration (FDA) approval based on the PREEMPT CRC study. In that study, the original test achieved 79.2% CRC sensitivity, but its 12.5% APL sensitivity missed the prespecified acceptance criterion.

Aasma Shaukat, MD, MPH, of NYU Grossman School of Medicine, told 

 APL detection is central to CRC prevention, and current blood tests fall short of stool-based tests on this measure.

Can Blood Tests Catch Precancerous Lesions? Updated CRC Screening Test

“It’s really important that we see an improvement in that advanced precursor lesion because in their current form they don’t confer the same amount of protection or prevention as tests that have higher detection of advanced precursor lesions,” she explained.

Assay and Algorithm Updates to the SimpleScreen CRC Blood Test

Shaukat said the updated version incorporates two changes: assay modifications to improve the signal-to-noise ratio, and algorithm refinements trained on prior results to detect circulating tumor DNA at the base-pair level. Validation drew on PREEMPT CRC, which enrolled 48,995 average-risk adults aged 45 to 85 years undergoing screening colonoscopy.

The validation cohort included all previously untested CRC (n = 26) and APL (n = 1142) samples. As prespecified and aligned with the FDA, investigators added previously tested samples with sufficient volume: 70 CRCs, 517 randomly selected APLs, and 70 additional APLs with high-grade dysplasia (HGD).

The evaluable cohort comprised 9001 participants, including 89 with CRC, 1570 with APLs, and 7342 without advanced neoplasia, with a mean age of 60.0 years. The positivity threshold targeted 90% specificity among participants with no colonoscopic findings, and sensitivity estimates were adjusted to the US Census age-sex distribution.

Updated Blood Test Sensitivity for CRC and Advanced Precancerous Lesions

The updated test achieved CRC sensitivity of 80.4% (95% CI, 70.2%-87.7%).¹ Sensitivity was 52.0% for stage I cancers (T1, 39.9%; T2, 81.2%), 100% for stage II, 97.3% for stage III, and 100% for stage IV. The stage I estimate was numerically lower than with the previous version, with overlapping confidence intervals.

APL sensitivity was significantly higher with the updated test (18.2%; 95% CI, 16.3%-20.4%) than with the previous version (13.7%; 95% CI, 12.4%-15.0%), with improvements across APL subtypes.¹ Sensitivity for APLs with HGD was 41.9% (95% CI, 34.0%-50.3%) among 157 evaluable cases.

Specificity was 90.0% (95% CI, 89.0%-91.0%) among participants with no colonoscopic findings and 89.7% (95% CI, 89.0%-90.4%) among those without advanced neoplasia.

Modeled Impact and Role of Blood-Based CRC Screening

In a validated microsimulation model of screening every 3 years from ages 45 to 75, the updated test was projected to prevent 426 more CRC cases (9.5%) and 143 more CRC deaths (9.5%) per 100,000 adults, and to add 1582 life-years (7.7%), compared with the previous version.

Shaukat said blood tests are better than no screening but currently inferior to colonoscopy and stool-based testing, and she still prefers patients complete one of those options. She expects blood test sensitivity for APLs to reach parity with stool tests over time. She added the goal is to reach patients who decline or cannot complete colonoscopy, with follow-up colonoscopy after any abnormal result.

“So we’re looking for that addition and not substitution, which is obviously a big concern,” said Shaukat.

Editors’ note: Shaukat reports relevant disclosures with Freenome, Geneoscopy, and UniversalDx.

Shaukat A, Burke CA, Gupta S, et al. Improved sensitivity for advanced precancerous lesions demonstrated in clinical validation of an updated colorectal cancer screening blood test in an average-risk population. Presented at: American College of Gastroenterology 2026 Annual Scientific Meeting; October 9-14, 2026; Nashville, TN.

Shaukat A, Burke CA, Chan AT, et al. Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer. JAMA. 2025;334(1):56-63. doi:10.1001/jama.2025.7515

Aasma Shaukat, MD, MPH, discusses an updated SimpleScreen CRC blood test with 18.2% sensitivity for advanced precancerous lesions, up from 13.7%.

Updated SimpleScreen CRC Blood Test Improves Precancerous Lesion Detection

, Manish Ramesh, MD, PhD, chief of the division of allergy & immunology at Albert Einstein College of Medicine, cited early allergen introduction, oral immunotherapy (OIT), and omalizumab (Xolair) as key advances in 

Ramesh described food allergy as the first chronic immune illness clinicians can prevent, not only treat. He linked the 

first population-level reduction in peanut allergy incidence to the early introduction strategy

“You can’t prevent lupus, you can’t prevent asthma, but you can prevent food allergies,” Ramesh said. “Early introduction of foods in very young children can help prevent the development of food allergies in the future.”

Food Allergy Prevention and Treatment Advances, With Manish Ramesh, MD, PhD

Early Allergen Introduction and Declining Peanut Allergy Incidence

Peanut Allergy Rates Plummet 10 Years After AAP Early Introduction Guideline


Investigators and allergists discuss real-world declines in peanut and food allergy following the 2015 and 2017 early introduction guidelines.

Viaskin Peanut Patch FAQ: Where It Fits Beside Omalizumab and OIT


A clinician FAQ on DBV Technologies’ BLA for the patch in children aged 4 to 7 years, and where it would sit beside omalizumab and office-based OIT.

Anaphylm Is Back at the FDA: A Clinician FAQ on Needle-Free Epinephrine


What changed in Aquestive’s resubmission of its sublingual epinephrine film after an FDA Complete Response Letter focused on usability, not efficacy.

Primary care data from a multistate pediatric network support the population-level shift Ramesh described. Stanislaw J. Gabryszewski and colleagues compared health records of children aged 0 to 3 years before and after the 2015 early peanut introduction guidelines and 2017 addendum guidelines.¹

The cumulative incidence of peanut IgE-mediated food allergy fell from 0.79% to 0.53% after the initial guidelines (hazard ratio [HR], 0.65; 95% CI, 0.55-0.77; 

 <.0001).¹ Following the addendum guidelines, incidence fell further to 0.45% (HR, 0.55; 95% CI, 0.46-0.66; 

 <.0001).¹ Rates of any IgE-mediated food allergy also declined, from 1.46% to 1.02% (HR, 0.69; 95% CI, 0.61-0.78).¹

Ramesh said the timing of exposure matters beyond foods alone. Early childhood exposures, including environmental exposures, appear central to whether allergic disease develops, he noted.

Oral Immunotherapy and Omalizumab for Food Allergy

Oral immunotherapy (OIT) remains the most common treatment option, according to Ramesh.

Ramesh also highlighted omalizumab as the first biologic approved for food allergy in both children and adults.

 He said the anti-IgE antibody reduces reaction severity and raises the amount of food needed to trigger a reaction.

Among 177 children and adolescents aged 1 to 17 years in a randomized, placebo-controlled trial, 67% receiving omalizumab tolerated a single dose of ≥ 600 mg of peanut protein without dose-limiting symptoms.

 This compared with 7% of participants receiving placebo (

 <.001). Results for cashew (41% vs 3%), milk (66% vs 10%), and egg (67% vs 0%) were consistent with the primary end point, and safety end points did not differ between groups aside from more injection-site reactions with omalizumab.

 Ramesh said both are expected to become available for clinical use soon.

How Genetics Is Reshaping Allergic Disease Phenotyping

Asked how understanding of allergic disease has changed in the past decade, Ramesh pointed first to immune mechanisms. Recognition of distinct phenotypes in asthma, chronic urticaria, and atopic dermatitis has shifted management toward immune mechanism-based phenotyping, he said.

Ramesh also cited hereditary alpha-tryptasemia, defined by extra copies of the tryptase gene, as a readily screened genetic trait associated with increased anaphylaxis risk.

Epigenetic changes, which are heritable but arise far faster than mutations, account for much of the generation-to-generation rise in atopy, according to Ramesh.

Monogenic disorders have offered further insight, as genetic testing has revealed single-gene mutations in some patients presenting with severe allergic disease and immune dysfunction. Unlike classic immunodeficiencies, where a mutation confers susceptibility to infection, these mutations alter immune behavior itself.

“In this case, the alterations in the genes change how your immune system behaves and, in some ways increases allergic disease, similar to what we would see with autoimmune disease,” said Ramesh.

Ramesh said these insights into immune mechanisms are now driving development of new biologics and small molecules for chronic allergic disease. He noted these agents already support management of properly phenotyped patients with asthma, atopic dermatitis, and chronic urticaria.

Gabryszewski SJ, Dudley J, Faerber JA, et al. Guidelines for early food introduction and patterns of food allergy. 

Gabryszewski S, Gupta R, Hernandez-Trujillo V, et al. Peanut Allergy Rates Plummet 10 Years After AAP Early Introduction Guidelines. HCPLive. Published October 30, 2025. Accessed October 14, 2026. 

https://www.hcplive.com/view/peanut-allergy-rates-plummet-10-years-aap-early-introduction-guidelines

Smith T. FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults. HCPLive. Published February 16, 2024. Accessed October 14, 2026. 

https://www.hcplive.com/view/fda-approves-omalozumab-first-treatment-of-1-or-more-food-allergies-for-children-adults

Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the treatment of multiple food allergies. 

Larenas-Linnemann D. Sublingual Immunotherapy for Allergy in 2026, With Désirée Larenas-Linnemann, MD. HCPLive. Published March 9, 2026. Accessed October 14, 2026. 

https://www.hcplive.com/view/sublingual-immunotherapy-allergy-2026-d-sir-e-larenas-linnemann-md

Derman C. Viaskin Peanut Patch FAQ: Where It Fits Beside Omalizumab and OIT. HCPLive. Published October 8, 2026. Accessed October 14, 2026. 

https://www.hcplive.com/view/viaskin-peanut-patch-faq-omalizumab-oit

Korošec P, Lyons JJ, Svetina M, et al. Hereditary α-tryptasemia is Associated With Anaphylaxis to Antibiotics and Monoclonal Antibodies. 

Ramesh outlines early food introduction, oral immunotherapy, omalizumab, and genetic insights shaping how allergists treat allergic disease.

2026 Fall Clinical Dermatology Conference

 in Las Vegas brought a notable focus on hidradenitis suppurativa (HS), alongside long-term acne data, an update on the atopic dermatitis pipeline, and expert guidance on advanced skin cancer care. The 

 editorial team was on-site covering the meeting, which ran from October 8 - 11, 2026.

In the following recap, highlights of several major stories from the second half of 

’s coverage of Fall Clinical are included:

Is Hidradenitis Suppurativa Underdiagnosed in Male Patients?

A retrospective US claims analysis led by Hadar Lev-Tov, MD, of the University of Miami Miller School of Medicine, challenged the long-held female predominance in HS. Formally diagnosed HS remained more common in females through 2024, at 253 vs 97 per 100,000. However, symptom-defined disease without an HS diagnosis was slightly more common in males, at 67 vs 54 per 100,000, suggesting possible underdiagnosis in men.

Q&A: Comorbidity Screening and Biologic Timing in HS, With Jennifer Hsiao, MD

Jennifer L. Hsiao, MD, of the University of Southern California, emphasized starting treatment early in moderate disease and reassessing response at 3 to 4 months. She encouraged clinicians to frame success as less drainage, pain, and flaring rather than complete clearance. Hsiao also discussed povorcitinib, an oral Janus kinase 1 inhibitor now under FDA review for HS, and prioritized screening for inflammatory bowel disease and spondyloarthritis.

HS Care Beyond Medications: Expectations, Comorbidities, and Wound Care

Iltefat Hamzavi, MD, of Henry Ford Health, outlined practical strategies for managing HS beyond drug selection. He recommended waiting-room questionnaires on drainage, pain, and missed work, along with written flare plans and a comorbidity handout for primary care physicians. Hamzavi also highlighted wound care as a training gap and described procedures such as deroofing as tools for persistent draining tunnels.

What New Data Emerged in Acne, Atopic Dermatitis, and Urticaria?

Denifanstat Sustains Acne Improvement Through 52 Weeks in Phase 3 Extension

Julie Harper, MD, of the Dermatology and Skin Care Center of Birmingham, presented open-label extension data for denifanstat, an oral, once-daily fatty acid synthase inhibitor, in moderate-to-severe acne. Through 52 weeks, 57% of patients achieved Investigator’s Global Assessment success, with 72% and 77% reductions in total and inflammatory lesion counts, respectively. A US phase 3 trial including adolescents has begun screening.

Atopic Dermatitis Pipeline and Remibrutinib’s Approval in Dermographism

Raj Chovatiya, MD, PhD, of Rosalind Franklin University Chicago Medical School, highlighted oral small molecules, bispecific and trispecific antibodies, and novel targets as key atopic dermatitis pipeline trends. He also discussed the October 7 FDA approval of remibrutinib for symptomatic dermographism, which gives dermatologists an on-label option for a condition often treated off-label.

What Role Should Dermatologists Play in Advanced Skin Cancer?

Why Dermatologists Should Stay Involved in Advanced Cutaneous SCC

Shannon C. Trotter, DO, of Dermatologists of the Central States, urged dermatologists to remain involved in caring for patients with locally advanced or metastatic cutaneous squamous cell carcinoma after oncology referral. She reviewed the 3 approved immune checkpoint inhibitors for the disease and noted research on intralesional cemiplimab may create an in-office role for dermatologists.

’s full coverage of the 2026 Fall Clinical Dermatology Conference for more interviews and data from the meeting.

Articles

Catch up on HCPLive’s second-half Fall Clinical 2026 coverage, from HS underdiagnosis in men and long-term acne data to advanced cutaneous SCC care.

Fall Clinical 2026 Second Half Recap: Acne, Skin Cancer, and More

metabolic dysfunction-associated steatohepatitis (MASH)

, semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, resolved steatohepatitis without worsening fibrosis at 72 weeks.¹ Resolution occurred in 62.9% of 534 patients receiving semaglutide vs 34.3% of 266 receiving placebo (P < .001).¹ A preclinical study from Chiba University, published in Cell Reports, examines how GLP-1 signaling reduces liver fat, with implications for metabolic dysfunction-associated steatotic liver disease (MASLD).²,³

The work centers on peroxisome proliferator-activated receptor α (PPARα), a nuclear receptor which switches on genes for fatty acid breakdown in the liver.² The investigators found the bile acid hyodeoxycholic acid (HDCA) reduced liver fat in mice by activating PPARα through 2 routes: invariant natural killer T (iNKT) cells, an immune population in the liver, and GLP-1.² “Both HDCA and the GLP-1 receptor agonist liraglutide exhibited potent anti-steatotic effects in mice in a PPARα-dependent manner,” Takashi Miki, MD, PhD, dean of the Graduate School of Medicine at Chiba University and the study’s lead investigator, said in a statement.³

To test whether GLP-1 needs the immune route, the team gave liraglutide to normal mice and to mice lacking iNKT cells, PPARα, or the GLP-1 receptor.³ Liraglutide still reduced liver fat in mice without iNKT cells but not in mice without PPARα, indicating GLP-1 acts on liver fat through PPARα independently of the immune route.³

In a written interview with HCPLive, Miki discussed what these findings could mean for how clinicians understand the hepatic effects of GLP-1 receptor agonists. He also outlined the questions to resolve before HDCA or PPARα-targeted strategies reach patients with MASLD and his team’s plans to extend the work to MASH.

Q&A: GLP-1 Receptor Agonists, PPARα, and MASLD

HCPLive: Liraglutide reduced liver fat through PPARα independently of iNKT cells. What could this mean for understanding the hepatic effects of GLP-1 receptor agonists?

Takashi Miki, MD, PhD: In recent years, numerous studies have reported beneficial effects of GLP-1 receptor agonists in patients with MASLD. However, the underlying mechanisms of their hepatic effects remain incompletely understood, particularly because GLP-1 receptors are generally considered to be expressed at very low levels, if at all, in hepatocytes.

Furthermore, previous studies have implicated innate immune cells, including iNKT cells, in the regulation of hepatic steatosis, raising the possibility that GLP-1 receptor agonists might suppress hepatic steatosis by activating iNKT cells. However, our findings argue against this hypothesis. Instead, our results suggest that GLP-1 receptor agonists can exert their anti-steatotic effects independently of iNKT cells, through a mechanism involving PPARα.

This provides a new perspective on the hepatic actions of GLP-1 receptor agonists and suggests that their benefits may involve metabolic pathways beyond their well-established effects on appetite and body weight.

HCPLive: These findings come from mouse models. What questions need answering before HDCA or PPARα-targeted strategies could be tested in patients with MASLD?

Takashi Miki, MD, PhD: Our present study demonstrated the protective effects of HDCA against high-fat diet-induced hepatic steatosis in mice and elucidated some of the underlying mechanisms. However, MASLD encompasses a broad spectrum of liver diseases, ranging from simple steatosis to more advanced conditions such as metabolic dysfunction-associated steatohepatitis (MASH). Therefore, an important next step will be to determine whether HDCA can also prevent or ameliorate MASH and its potential progression to hepatocellular carcinoma (HCC).

We also need to establish the safety, efficacy, and mechanisms of action of HDCA in more advanced disease models before considering its potential clinical application.

HCPLive: What are the next steps for your research, and what do you hope clinicians take away from this work?

Takashi Miki, MD, PhD: As mentioned in my response to the previous question, we would like to extend our research to MASH, a more advanced stage of MASLD. Another important finding of our study was that the anti-steatotic effect of liraglutide was abolished in PPARα-deficient mice. This suggests that PPARα signaling plays an important role in mediating the beneficial hepatic effects of GLP-1 receptor agonists.

Based on these findings, we believe that combining GLP-1 receptor agonists with PPARα activators could represent a promising therapeutic strategy for MASLD. We hope that our findings will encourage further research into the interaction between incretin signaling and hepatic lipid metabolism, and ultimately contribute to the development of more effective treatments for MASLD.

Editor’s Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Miki doesn’t report relevant disclosures. 

Sanyal AJ, Newsome PN, Kliers I, et al. Phase 3 trial of semaglutide in metabolic dysfunction–associated steatohepatitis. 

. 2025;392(21):2089-2099. doi:10.1056/NEJMoa2413258

In mice, liraglutide reduced steatosis through PPARα without needing iNKT cells, pointing to a possible GLP-1 RA plus PPARα combination.

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