Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Credit: European Crohn’s and Colitis Organisation

Guselkumab (Tremfya) demonstrated significantly increased rates of combined fistula remission compared with placebo at week 24 in the phase 3 FUZION trial, marking what investigators describe as the first randomized controlled trial of an approved 

therapy to show efficacy in perianal fistulizing Crohn's disease in 2 decades. Johnson & Johnson announced the results on May 5, 2026, with the data presented as late-breaking findings at 

"The pain, swelling and persistent drainage associated with perianal fistulizing Crohn's disease can be profoundly disruptive to patients' daily lives," said Laurent Peyrin-Biroulet, MD, PhD, a study investigator and paid consultant for Johnson & Johnson. "Achieving durable fistula closure without repeated surgical interventions remains a significant unmet need."

The FUZION study (NCT05347095) is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial evaluating guselkumab in adults with active perianal fistulizing Crohn's disease. 2 Eligible patients had one or more active draining perianal fistulas confirmed by blinded central MRI review, a Crohn's Disease Activity Index (CDAI) < 350, and inadequate response to conventional therapies or up to 2 advanced therapy classes. Patients were randomized in a 2:2:1 ratio to receive guselkumab 200 mg intravenously at weeks 0, 4, and 8 followed by either 100 mg subcutaneously every 8 weeks (q8w), 200 mg subcutaneously every 4 weeks (q4w), or placebo.

The primary endpoint, combined fistula remission at week 24, was defined as complete closure of all external fistula openings with no drainage, no development of new fistulas, and no evidence of underlying fluid collections on magnetic resonance imaging (MRI). This composite endpoint represents a stringent radiographic-clinical measure, requiring not only clinical closure but also confirmation of deep tissue healing on imaging.

Investigators observed combined fistula remission in 28.3% of patients in the 100 mg q8w group and 27.0% in the 200 mg q4w group, compared with 10.3% receiving placebo. Treatment differences were statistically significant for both dosing regimens (

 = .013, respectively). Adverse events through 24 weeks were reported to be consistent with the known safety profile of guselkumab in Crohn's disease, though detailed safety data beyond this characterization were not disclosed in the announcement.

Disease Burden and Unmet Need in Perianal Fistulizing Crohn's Disease

Perianal fistulizing disease affects nearly 25% of patients with Crohn's disease and represents one of its most disabling manifestations.

 In this disease, fistulas form when chronic inflammation drives ulceration through the full thickness of the bowel wall, creating abnormal channels between the intestine and the perianal skin or surrounding structures. Symptoms include persistent pain, swelling, drainage, recurrent abscess formation, and frequent need for surgical intervention, all of which carry significant quality-of-life consequences.

The last major randomized trial of an approved biologic in this specific population was conducted approximately 20 years ago, underscoring the longstanding evidence gap in this area. Remission rates remain low with existing approaches, and the stringent combined endpoint used in FUZION, requiring both clinical closure and MRI-confirmed absence of fluid collection, reflects the complexity of achieving meaningful disease control.

Guselkumab Mechanism and Regulatory History

Guselkumab is a fully human monoclonal antibody that inhibits interleukin-23 (IL-23) and is described as having dual-acting properties through additional binding to CD64, a receptor on IL-23-producing cells, although the clinical significance of this binding remains unknown and is based on in vitro data only.

The drug is currently approved in the United States for adults with moderately to severely active Crohn's disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis, with pediatric indications in psoriasis and psoriatic arthritis for patients ≥ 6 years of age weighing ≥ 40 kg.

Limitations and Next Steps for Guselkumab in Fistulizing Crohn's Disease

The FUZION data as reported represent week-24 results; longer-term durability of fistula closure and maintenance of remission remain to be established. The press release did not include granular safety data, patient-reported outcome measures, or subgroup analyses. It is also worth noting that Peyrin-Biroulet, the quoted study investigator, is a paid consultant for Johnson & Johnson, which should be considered when interpreting his commentary. Johnson & Johnson has also announced the CHARGE study, described as the first head-to-head trial of IL-23 inhibitors in IBD, comparing guselkumab with risankizumab in Crohn's disease, with enrollment now open. 1

Drug: guselkumab (Tremfya), IL-23 inhibitor

Indication: perianal fistulizing Crohn's disease

Combined fistula remission: 28.3% (q8w) and 27.0% (q4w) vs 10.3% placebo

Johnson & Johnson. Johnson & Johnson study shows TREMFYA (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn's disease. Press release. May 5, 2026. 

https://www.prnewswire.com/news-releases/johnson--johnson-study-shows-tremfya-guselkumab-is-the-first-and-only-il-23-inhibitor-to-demonstrate-efficacy-in-perianal-fistulizing-crohns-disease-302760610.html

ClinicalTrials.gov. A study of guselkumab in participants with fistulizing, perianal Crohn's disease (FUZION CD). NCT05347095. 

https://clinicaltrials.gov/study/NCT05347095?tab=researcher

Sulak A, et al. Where are we and where to next?—the future of perianal Crohn's disease management. 

. 2023;12(19):6379. doi:10.3390/jcm12196379

Spinelli A, Yanai H, Girardi P, et al. The impact of Crohn's perianal fistula on quality of life: results of an international patient survey. 

. 2023;5(3):otad036. doi:10.1093/crocol/otad036

Articles

Phase 3 FUZION randomized adults with active draining perianal fistulizing Crohn’s disease to guselkumab induction followed by 100 mg SC q8w, 200 mg SC q4w, or placebo. At week 24, stringent combined fistula remission—clinical closure without drainage or new fistulas plus MRI-confirmed absence of fluid collections—occurred in 28.3% (q8w) and 27.0% (q4w) versus 10.3% with placebo (P=.007; P=.013). Safety was described as consistent with known Crohn’s experience. This narrows a two-decade evidence gap for approved therapies in this phenotype.

The phase 3 FUZION trial found guselkumab achieved increased fistula remission rates than placebo in perianal fistulizing Crohn's disease.

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Guselkumab Shows Efficacy in Perianal Fistulizing Crohn's Disease in Phase 3 FUZION Trial

New 13-year follow-up data from the NordICC randomized controlled trial confirm that a single screening colonoscopy significantly reduces 

 incidence, though the observed reduction in CRC-specific mortality did not reach statistical significance in intention-to-screen analyses.

The updated results, drawn from more than 84,000 participants across Norway, Poland, and Sweden, were presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, by Michael Bretthauer, MD, PhD, a professor of medicine at the University of Oslo, and extend findings previously reported at 10 years, representing the most mature evidence available from a randomized trial evaluating once-only colonoscopy as a primary screening modality.

The NordICC trial enrolled 84,583 men and women between the ages of 55 and 64 years at baseline and randomly assigned them in a 1:2 ratio to either an invitation for colonoscopy screening or no screening. All analyses were conducted at 13 years of follow-up and reported both intention-to-screen (ITS) and per-protocol (PP) effect estimates.

CRC incidence at 13 years was 1.46% in the screening group (375 cancers among 28,217 participants) compared with 1.80% in the no-screening group (912 cancers among 56,366 participants), yielding an intention-to-screen risk ratio (RR) of 0.81 (95% CI, 0.71–0.90). In per-protocol analyses accounting for the subset of participants who actually underwent colonoscopy, the incidence reduction was larger, with an RR of 0.55 (95% CI, 0.33–0.81).

The differential effect by tumor location was statistically significant. For distal CRC, the screening group showed a risk of 0.87% versus 1.11% in the no-screening group (RR, 0.79; 95% CI, 0.65–0.89), while for proximal CRC, the difference was: 0.51% versus 0.56% (RR, 0.91; 95% CI, 0.71–1.09; 

Sex-stratified analyses showed an incidence reduction in both men (RR, 0.77; 95% CI, 0.64–0.88) and women (RR, 0.87; 95% CI, 0.70–1.02; 

CRC mortality at 13 years was 0.41% in the screening group and 0.47% in the no-screening group, producing an intention-to-screen RR of 0.88 (95% CI, 0.68–1.08). The per-protocol RR for mortality was 0.70 (95% CI, 0.26–1.25).

Investigators noted the observed CRC mortality in the no-screening group (0.47%) was substantially lower than the 0.82% projected when the trial was designed. This discrepancy directly affects the trial's statistical power to detect a mortality benefit, since the anticipated event rate underpinned the original sample size calculations. The NordICC trial was designed based on an assumed 50% CRC mortality-reducing efficacy of the intervention, with 50% compliance predicted to yield a 25% mortality reduction among those invited to screening.

The NordICC trial enrolled participants between 2009 and 2014 across multiple Nordic and Central European countries. Participants were identified through population registries and followed via national cancer and cause-of-death registries. Randomization used a 1:2 ratio, with 28,217 assigned to the colonoscopy invitation arm and 56,366 to the control arm.

The per-protocol analyses presented at DDW are particularly important for interpreting true colonoscopy efficacy, since roughly 42% of those invited for colonoscopy in the original 10-year publication actually underwent the procedure.

“In this randomised trial, one colonoscopy significantly reduced CRC incidence but not mortality over 13 years. CRC mortality is lower in both study groups than when the trial was designed,” Bretthauer and colleagues concluded.

Kaminski MF, Kalager M, Løberg M, et al. LONG-TERM EFFECTS OF COLONOSCOPY SCREENING ON COLORECTAL CANCER INCIDENCE AND MORTALITY: UPDATE FROM THE NORDICC RANDOMISED TRIAL. Presented at Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

Bretthauer M, Kaminski MF, Løberg M, et al. Population-based colonoscopy screening for colorectal cancer: a randomized clinical trial. JAMA Intern Med. 2016;176(7):894–902.

Bretthauer M, Løberg M, Wieszczy P, et al. Effect of colonoscopy screening on risks of colorectal cancer and related death. N Engl J Med. 2022;387(17):1547–1556.

van den Berg DMN, Nascimento de Lima P, Knudsen AB, et al. NordICC trial results in line with expected colorectal cancer mortality reduction after colonoscopy: a modeling study. Gastroenterology. 2023;165(4):874–882.

Once-only screening colonoscopy invitation in the NordICC randomized trial (ages 55–64 years) produced a durable colorectal cancer incidence reduction at 13 years, with stronger effects among those who underwent the procedure. Incidence decreased overall and was driven primarily by distal tumors, with minimal proximal benefit. CRC-specific mortality was numerically lower but not statistically significant in intention-to-screen analyses; limited power likely contributed, as control-group CRC mortality was substantially below design assumptions. Approximately 42% uptake diluted intention-to-screen estimates, emphasizing compliance-sensitive efficacy interpretation.

Updated results from the NordICC trial build upon previous 10 year findings and shed further light on once-only colonoscopy as a primary screening modality.

NordICC: Single Colonoscopy Cuts Colorectal Cancer Incidence but Not Mortality at 13 Years

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Abrocitinib therapy leads to clinically meaningful outcomes and improvements in patient-reported outcomes (PROs) among patients with 

 with up to 2 years of use, new data suggest.

These findings resulted from the ongoing phase 3 long-term extension trial, JADE EXTEND, a study designed to assess the sustained efficacy of oral abrocitinib in patients with moderate-to-severe atopic dermatitis. It was authored by such investigators as Melinda Gooderham, MD, dermatologist and medical director of the SKiN Centre for Dermatology in Ontario, Canada.

Gooderham et al’s study involved adolescent and adult patients who had previously completed qualifying abrocitinib trials. These included JADE MOA, JADE MONO-1, JADE MONO-2, JADE COMPARE, JADE TEEN, and JADE DARE.

“A planned interim efficacy analysis of abrocitinib treatment for up to 48 weeks reported clinically meaningful improvements in itch and skin clearance in patients with moderate-to-severe [atopic dermatitis],” Gooderham and colleagues wrote.1,2 “Here, we report an update on abrocitinib efficacy and patient-reported outcomes for up to 2 years in JADE EXTEND.”

In the analysis, those involved as participants were treated with once-daily oral abrocitinib treatment at doses of 200 mg or 100 mg. Outcomes related to efficacy were monitored by Gooderham and coauthors from Week 2 - Week 112, encompassing a wide array of clinician-reported and patient-reported endpoints. Some of the key measures included by the team were the proportion of participants attaining an Investigator’s Global Assessment (IGA) score of clear or almost clear (0/1) with a 2-point improvement from baseline at a minimum.

Skin clearance was further evaluated using the Eczema Area and Severity Index (EASI), including thresholds of ≤7, as well as percentage improvements of 75%, 90%, and complete clearance (EASI-75, -90, and -100). Symptom relief was assessed using the Peak Pruritus Numerical Rating Scale (PP-NRS), including both ≥4-point improvement and achievement of minimal itch (scores of 0 or 1).

Quality of life and patient-centered outcomes were also evaluated. Among adults, a Dermatology Life Quality Index (DLQI) score of 0 or 1 was evaluated in those showing baseline scores of ≥2. Gooderham and colleauges assessed adolescents via the Children’s DLQI (CDLQI). In their additional endpoints, they included Patient Global Assessment (PtGA) scores of 0 or 1 as well as improvements of 4 points at least in participants’ Patient-Oriented Eczema Measure (POEM) scores. Composite endpoints, such as attainment of both high-level skin clearance levels (EASI-90) and minimal pruritus (PP-NRS 0/1), with or without normalization of quality of life (DLQI 0/1), were also evaluated.

Any disease severity shifts over time were tracked by the investigative team using participants’ EASI scores, alongside least squares mean changes in EASI, CDLQI, DLQI, and POEM. By September 5, 2022, the time of cutoff, not all of those evaluated had reached 112 weeks of abrocitinib use. However, 42% of those included in the 200 mg arm and 56% of those in the 100 mg arm had completed at least 112 weeks of treatment. By the 112-week mark, Gooderham and coauthors noted IGA 0/1 responses among 57% and 52% of those in the 200 mg and 100 mg cohorts, respectively.

They also found EASI ≤7 in 81% and 77% of these individuals, respectively, while EASI-75 responses were seen in 84% and 78%. Higher thresholds of clearance showed EASI-90 in 61% and 54%, respectively, as well as complete clearance (EASI-100) among 26% and 21% of subjects. Pruritus, or itch, improvements were also highlighted by the team, with 70% and 58% gaining a ≥4-point reduction in PP-NRS, respectively. Additionally, they found 43% and 33% achieved scores of 0 or 1, respectively.

Composite outcomes of EASI-90 combined with minimal itch were attained by 37% and 30% of individuals included in the respective dosing cohorts. Patient-reported outcomes at the 112-week mark included DLQI 0/1 in 43% and 41% of adults, CDLQI 0/1 in 59% and 39% of adolescents, PtGA 0/1 in 75% and 72%, and clinically meaningful POEM improvements in 88% and 81% of those receiving 200 mg and 100 mg, respectively.

Conclusions on Long-Term Abrocitinib Use in Atopic Dermatitis

Overall, the investigative team noted, following rapid onset, dose-dependent clinician-reported efficacy measures continued to improve through 2 years of abrocitinib use. They highlighted the substantial number of individuals who achieved high-threshold endpoints along with a minimal level of disease activity.

“Results for patient-reported outcomes complemented the clinical efficacy findings and demonstrate that long-term abrocitinib treatment through 2 years confers meaningful improvements in patient-reported symptoms and quality of life,” Gooderham and colleagues concluded.

Gooderham MJ, Silverberg JI, De Bruin-Weller M, et al. Long-term efficacy of abrocitinib in patients with moderate-to-severe atopic dermatitis to 2 years. J Eur Acad Dermatol Venereol. 2026; 00: 1–10. 

Reich K, Silverberg JI, Clibborn C, et al. Abrocitinib efficacy and safety in patients with moderate-to-severe atopic dermatitis: Results from phase 3 studies, including the long-term extension JADE EXTEND study. J Eur Acad Dermatol Venereol. 2023 Oct;37(10):2056-2066. doi: 10.1111/jdv.19280. Epub 2023 Jul 11. Erratum in: J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2608-2609. doi: 10.1111/jdv.19563. PMID: 37335885.

Sustained once-daily oral abrocitinib (100 mg or 200 mg) produced durable, clinically meaningful improvements in moderate-to-severe atopic dermatitis through 112 weeks in a long-term extension population previously enrolled in pivotal JADE trials. Responses were observed across stringent clinician-reported endpoints (IGA 0/1; EASI ≤7; EASI-75/90/100) and pruritus metrics (PP‑NRS). Patient-reported outcomes aligned with clinical efficacy, demonstrating improvements in quality of life (DLQI/CDLQI), global status (PtGA), and symptom burden (POEM), including composite targets combining high-level clearance and minimal itch.

In the ongoing JADE EXTEND trial, long-term treatment with abrocitinib led to sustained skin clearance and other improvements through 112 weeks.

Atopic Dermatitis

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Abrocitinib Therapy Effective in Patients with Atopic Dermatitis at 2 Years

Johnson & Johnson has announced phase 2b results for the investigational co-antibody JNJ-4804 in adults with moderately to severely active 

ulcerative colitis (UC) or Crohn disease (CD)

 who had inadequate response or intolerance to systemic therapies, including a heavily pretreated subgroup with failure of at least 2 systemic therapy classes. 

Data from the DUET-CD and DUET-UC studies were presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, and showed the fixed-dose combination outperformed golimumab and was numerically higher than guselkumab on several week-48 efficacy measures in the overall study populations, with larger relative differences described in the highly refractory subgroup.

"Despite many treatment advances for Crohn's disease over the past two decades, many patients do not achieve long-term disease control with the currently available options, even after trying multiple monotherapies with different classes,"  Bruce Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine, and Chief, Division of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Health System and presenting author of the DUET-CD study, said in a statement. "The results from DUET-CD are particularly promising because they show meaningful clinical and endoscopic improvements in patients who have exhausted existing options.”

The rationale for JNJ-4804 reflects persistent unmet need in refractory IBD, where patients may cycle through anti-TNF, anti-integrin, IL-12/23 or IL-23 inhibitors, Janus kinase inhibitors, and sphingosine-1-phosphate receptor modulators yet still fail to achieve durable symptom control and mucosal improvement. 

Phase 2b DUET Findings in Ulcerative Colitis and Crohn Disease

DUET-CD and DUET-UC are randomized, double-blind, dose-ranging phase 2b trials comparing JNJ-4804 with placebo and active comparator arms including guselkumab and golimumab. The studies enrolled adults with moderately to severely active disease and prior inadequate response or intolerance to ≥ 1 conventional or advanced systemic therapy, with approximately half of participants described by the company as having failed 2 or more therapy classes. JNJ-4804 combines guselkumab, an interleukin-23 inhibitor, and golimumab, a tumor necrosis factor inhibitor, in a single subcutaneous injection.

In CD, the company reported co-primary week-48 endpoints of clinical remission and endoscopic response. In the overall population, the high-dose JNJ-4804 group achieved clinical remission in 50.8% of patients compared with 25.4% for golimumab and 42.5% for guselkumab; endoscopic response rates were 38.1%, 19.8%, and 33.9%, respectively. 

Clinical remission was defined as Crohn’s Disease Activity Index score < 150, and endoscopic response as > 50% improvement from baseline in Simple Endoscopic Score for Crohn’s Disease or a score of ≤ 2 by central reading. 

In UC, the primary endpoint was week-48 clinical remission. Reported remission rates in the overall population were 41.0% with JNJ-4804, 11.5% with golimumab, and 34.0% with guselkumab.

For the subgroup with inadequate response to ≥ 2 systemic therapy classes, Johnson & Johnson reported JNJ-4804 showed clinically meaningful improvements across multiple clinical and endoscopic endpoints in both diseases, including remission rates nearly double the highest comparator in CD and almost 60% higher than the closest comparator in UC.

"There is a major unmet need for patients who either don't respond or are no longer responding to current UC treatments," said Maria Abreu, MD, Executive Director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai in Los Angeles and presenting author of DUET-UC. "The ongoing symptoms patients face when their UC is uncontrolled can profoundly impact their lives. The improvements we saw in DUET-UC are very encouraging, offering a potential new approach for patients with few options for long-term disease control."

Safety findings in both DUET studies were generally consistent with the known profiles of the component monotherapies. 

In DUET-CD, exposure-adjusted safety events with JNJ-4804 were overall similar to or lower than placebo or golimumab. Across groups, most SAEs were GI-related and serious infection rates were low. Safety in the subpopulations was comparable to that in the overall population.

In DUET-UC, safety events per 100 patient-years in the JNJ-4804 groups were overall similar to or lower than in other groups. Like DUET-CD, across groups, most SAEs were GI-related and serious infection rates were low, and JNJ-4804 safety in the subpopulations was similar to the overall population.

Johnson & Johnson described plans to initiate phase 3 DUET ENCORE-CD and DUET ENCORE-UC trials. 

Johnson & Johnson. Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease. PR Newswire. Published May 05, 2026. Accessed May 05, 2026. 

https://www.prnewswire.com/news-releases/johnson--johnson-investigational-co-antibody-therapy-jnj-4804-shows-potential-to-raise-the-bar-for-clinical-efficacy-in-treating-refractory-inflammatory-bowel-disease-302761831.html

Abreu MT, Sands BE, Vermeire S, et al. EFFICACY AND SAFETY OF THE FIRST CO-ANTIBODY THERAPY, JNJ-78934804, IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS REFRACTORY TO SYSTEMIC THERAPIES. Presented at Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

Sands BE, D’Haens G, Dotan I, et al. EFFICACY AND SAFETY OF THE FIRST CO-ANTIBODY THERAPY, JNJ-78934804, IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE REFRACTORY TO SYSTEMIC THERAPIES. Presented at Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

ClinicalTrials.gov. A study of combination therapy with guselkumab and golimumab in participants with moderately to severely active Crohn’s disease (DUET-CD). NCT05242471. Accessed May 05, 2026. 

https://clinicaltrials.gov/study/NCT05242471

Johnson & Johnson reported phase 2b DUET-CD and DUET-UC results for JNJ-4804, a fixed-dose subcutaneous co-antibody combining guselkumab (IL-23) and golimumab (anti-TNF), in moderately to severely active Crohn disease and ulcerative colitis after inadequate response/intolerance to systemic therapies. At week 48, high-dose JNJ-4804 exceeded golimumab and was numerically higher than guselkumab across multiple efficacy measures, with larger relative benefits in patients failing ≥2 therapy classes. Safety was consistent with component biologics, with low serious infection rates. Phase 3 programs are planned.

JNJ-4804 phase 2b results showed higher week-48 remission rates in refractory ulcerative colitis and Crohn disease.

JNJ-4804 Phase 2b Data Show Higher Week-48 Remission in Refractory UC, Crohn Disease

Results from the randomized, double-blind phase of the phase 4 REMODEL trial indicate that dupilumab significantly improved esophageal distensibility in adults with active eosinophilic esophagitis (EoE) compared with placebo at 24 weeks.

The findings, which were presented at Digestive Disease Week (DDW) 2026 in Chicago, IL, by Evan Dellon, MD, a professor of medicine and adjunct professor of epidemiology at the University of North Carolina School of Medicine in Chapel Hill, suggest that the IL-4/IL-13 pathway inhibitor not only addresses mucosal inflammation in EoE but also produces measurable improvements in a functional marker of fibrostenotic disease, a dimension of EoE pathology that has historically lacked dedicated therapeutic evidence.

“For patients who have eosinophilic esophagitis, if the disease remains untreated, it can progress to narrowing of the esophagus, more severe symptoms, such as food impaction, and the need for esophageal dilation,” Dellon said in a statement. “[Dupilumab] showed a potential to modify the course of eosinophilic esophagitis – by improving esophageal size at just 6 months – the magnitude of this improvement corresponded to the benefit that could be seen from an esophageal dilation procedure. It also reduced hallmark endoscopic and histologic signs of disease, which further strengthens the evidence that type 2 inflammation plays an important role in the biology of this disease. The ongoing study will allow us to learn the even longer-term impact of [dupilumab] on the scarring and narrowing of the esophagus in EoE.”

EoE affects an estimated 1 in 850 individuals in developed countries and is characterized by type 2 inflammatory infiltration of the esophageal mucosa that, when inadequately treated, can progress to subepithelial fibrosis, esophageal strictures, and narrowing sufficient to cause food impaction.

Despite the availability of dupilumab as an FDA-approved therapy for EoE since 2022 in patients 12 years and older, and extended in January 2024 to children as young as 1 year weighing at least 15 kg, prospective data directly assessing the drug's impact on esophageal remodeling and distensibility in a randomized, controlled design had been limited.

REMODEL Trial Design and Primary Endpoint

The REMODEL trial enrolled 69 adults with active EoE who were randomly assigned in a 2:1 ratio to dupilumab 300 mg once weekly subcutaneously (n = 46) or placebo (n = 23) for 24 weeks. Stratification was based on prior dilation history. Baseline demographic and disease characteristics were described as generally comparable across treatment groups.

The primary endpoint was the absolute change from baseline in the esophageal distensibility plateau (DP), measured using the endoluminal functional lumen imaging probe (EndoFLIP). The DP is defined as the narrowest fixed diameter, in millimeters, of the distal esophageal body in response to increasing volume and pressure. EndoFLIP quantifies esophageal compliance and has emerged as an objective tool for identifying fibrostenotic changes in EoE that may not be fully apparent on standard endoscopy or histology alone.

Hierarchical secondary endpoints included percent change from baseline in DP, followed by changes in the Endoscopic Reference Score (EREFS) and EoE Histologic Scoring System (EoEHSS) grade and stage scores at week 24. Safety was also assessed.

Distensibility and Structural Outcomes at Week 24

At 24 weeks, results showed dupilumab produced a statistically significant improvement in esophageal distensibility relative to placebo. The least squares mean (LSM) change from baseline in DP diameter was +1.28 mm (SE, 0.29) in the dupilumab group versus −0.01 mm (SE, 0.42) in the placebo group, yielding an LSM difference of 1.30 mm (95% CI, 0.31–2.29; 

 <.05). The LSM difference in percent change from baseline in DP also reached significance at 7.78% (95% CI, 1.13–14.43; 

A notable subgroup finding emerged among patients with abnormal baseline DP below 17 mm, a threshold generally considered indicative of meaningful fibrostenotic impairment. In this subset, the between-group difference was larger than in the overall population: dupilumab patients gained a mean of +1.76 mm while placebo patients declined by −0.49 mm (LSM difference, 2.25 mm; 95% CI, 0.75–3.75).

Improvements in endoscopic and histologic outcomes were also observed. The LSM difference in EREFS score favored dupilumab over placebo by −4.96 points (95% CI, −6.06 to −3.85; 

 <.0001). The EoEHSS grade and stage scores similarly improved: LSM differences were −0.71 (95% CI, −0.86 to −0.57; 

 <.0001) and −0.65 (95% CI, −0.80 to −0.51; 

Dellon ES, Carlson DA, Greuter T, et al. DUPILUMAB IMPROVES ESOPHAGEAL DISTENSIBILITY IN ADULTS WITH EOSINOPHILIC ESOPHAGITIS: 24-WEEK RESULTS FROM THE RANDOMIZED, PLACEBO-CONTROLLED REMODELING WITH DUPILUMAB IN EOSINOPHILIC ESOPHAGITIS LONG-TERM (REMODEL) TRIAL. Presented at Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

Regeneron. Dupixent® (dupilumab) Demonstrates Improved Esophageal Function in Eosinophilic Esophagitis (EoE) Phase 4 Trial. May 5, 2026. Accessed May 5, 2026. 

https://newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-demonstrates-improved-esophageal-function

Dupilumab demonstrated statistically significant improvement in esophageal distensibility at 24 weeks in adults with active eosinophilic esophagitis, providing randomized evidence of benefit on a functional marker of fibrostenotic remodeling. In REMODEL (n=69; 2:1 randomization), EndoFLIP distensibility plateau increased versus placebo, with larger effects in patients with baseline DP <17 mm. Parallel reductions were observed in endoscopic activity (EREFS) and histologic severity (EoEHSS grade and stage), supporting type 2 cytokine blockade across inflammatory and structural disease domains.

Phase 4 dupilumab data show improvements in esophageal distensibility and disease-related structural changes and inflammation in the esophagus in EoE.

REMODEL: Dupilumab Improves Esophageal Distensibility in EoE at 24 Weeks

Stephanie Gold, MD, is an instructor of medicine at the Icahn School of Medicine at Mount Sinai and a gastroenterologist at the Mount Sinai Hospital.

Videos

Stephanie Gold, MD, explains prospective IBD-Metabolic Clinic data show GLP-1 RAs are safe and effective for weight management in IBD, with added benefits for bowel function and fatigue.

Strategic Alliance Partnership

Adding GLP-1 RA Therapy to Lifestyle Counseling Drives Weight Loss, Improves Outcomes in IBD

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

Catch up on 5 nephrology headlines you missed in April 2026, including WCN coverage, FDA updates, and trial data. 

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Focal Segmental Glomerulosclerosis

The HCPLive focal segmental glomerulosclerosis page is a resource for medical news and expert insights on FSGS. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in FSGS, and more. 

FDA News

5 Nephrology Headlines You Missed in April 2026

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Catch up on any data and perspectives presented at the American Association of Clinical Endocrinology Annual Meeting 2026.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Type 1 Diabetes

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

AACE 2026 Recap: 5 Key Presentations to Know

Syed-Mohammed Jafri, MD, is a Gastroenterologist and Transplant Hepatologist at Henry Ford Hospital.

New research underscores the risks and daily burden of TPN in SBS, with focus shifting toward reducing dependence and complications.

Time Off TPN Emerging as Key Goal in Short Bowel Syndrome Care, With Syed-Mohammed Jafri, MD

Noreen Galaria, MD, is a board-certified and fellowship-trained dermatologist based in the Washington, D.C. area with over 20 years of experience. She is the founder of Inner Glow Vitamins and practices at Galaria Plastic Surgery & Dermatology.

Podcasts

In this new Skin of Color Savvy podcast, Noreen Galeria, MD, discusses topics such as patient, misinformation, her career, and research on natural remedies.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Skin of Color Savvy: Misinformation, Holistic Dermatology, and Skin of Color, With Noreen Galaria, MD

April 2026 saw further updates from ACC.26, plus key trial results, guideline updates, and more.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Cardiomyopathy

Atherosclerotic Cardiovascular Disease

7 Cardiology Headlines You Missed in April 2026

Gil Melmed, MD, is affiliated with Cedars-Sinai Inflammatory Bowel Disease Center.

Gil Melmed, MD, breaks down real-world data showing risankizumab has the lowest switch rates in Crohn’s over 24 months, highlighting strong persistence vs other biologics.

Real-World Data Favor Risankizumab for Long-Term Persistence in Crohn's Disease

Anat Shoshani, PhD, professor at Reichman University and chief psychologist at Kai.ai.

Shoshani discusses RCT data showing AI reduces anxiety and improves well-being, with outcomes comparable to those of group therapy. 

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Conversational AI for Anxiety Matches Group Therapy Outcomes, With Anat Shoshani, PhD

In this segment from the April episode of The Medical Sisterhood podcast, the speakers discussed simple ways for physicians to get involved in community service without feeling overwhelmed.

How to Get Involved in Community Service in Dermatology, With Elizabeth Kiracofe, MD

Volixibat reduced cholestatic pruritus in phase 2b primary sclerosing cholangitis data, with diarrhea and liver test elevations reported.

Hepatology

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

Latest News

Guselkumab Shows Efficacy in Perianal Fistulizing Crohn's Disease in Phase 3 FUZION Trial

NordICC: Single Colonoscopy Cuts Colorectal Cancer Incidence but Not Mortality at 13 Years

Abrocitinib Therapy Effective in Patients with Atopic Dermatitis at 2 Years

JNJ-4804 Phase 2b Data Show Higher Week-48 Remission in Refractory UC, Crohn Disease

REMODEL: Dupilumab Improves Esophageal Distensibility in EoE at 24 Weeks