Vice Chief of Education, Fellowship Program Director

Division of Gastroenterology and Hepatology at UNC Health Care

Can Crohn’s Induction Move Beyond Infusions? AFFIRM Trial Insights

New data from the AFFIRM trial suggest that a fully subcutaneous induction strategy with risankizumab (Skyrizi) may deliver strong efficacy while offering a more convenient treatment pathway for patients with Crohn’s disease, adding to the growing body of evidence supporting IL-23 inhibition in this patient population.

First approved for Crohn’s disease in 2022, risankizumab has historically required intravenous induction before transitioning to subcutaneous maintenance dosing. In an interview discussing the AFFIRM results, lead investigator Millie Long, MD, MPH, chief of the division of gastroenterology and hepatology at the University of North Carolina, Chapel Hill noted that evaluating a subcutaneous induction approach represents an important step toward making effective therapy more accessible.

“Previously, risankizumab had been incredibly promising,” Long told 

. “This is obviously an approved agent, but it required IV induction, and so now allowing for a very effective therapy in a subcutaneous load allows us to reach more patients and to potentially get drug in the hands of patients quicker in terms of not having to wait for infusion center chairs, and hopefully will allow us to improve outcomes for those patients.”

The global, phase 3, randomized, placebo-controlled, double-blind AFFIRM study assessed the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active Crohn's disease, with co-primary endpoints of percentage of participants with CDAI Clinical Remission (CDAI < 150) and percentage of participants with endoscopic response at week 12.

“In any induction clinical trial, we look at co primary endpoints, meaning we want to make sure that patients are feeling better in terms of clinical remission, but we also want to make sure that there is an endoscopic response, meaning that the actual inflammation visualized at the level of the endoscopy is improving,” Long explained.

In AFFIRM, a total of 289 patients were randomly assigned in a 2:1 ratio to risankizumab SC or placebo. Results showed significantly greater proportions of patients treated with risankizumab SC induction achieved CDAI clinical remission (55% vs 30%; P <.0001) and endoscopic response (44% vs 14%; P <.0001) at week 12 compared to placebo. Among patients with clinical response after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.

Long called attention to results in the advanced therapy-naïve population of the study, noting those treated with subcutaneous risankizumab achieved a 73.1% clinical remission rate and a 61.2% endoscopic response rate. She additionally cited encouraging results in patients with prior advanced therapy failure, further supporting risankizumab’s efficacy across patient populations. However, with the particularly strong results in biologic-naïve patients, Long suggests it may have potential as a first-line advanced therapy option in Crohn’s disease.

During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab SC was consistent with the safety profile observed in Crohn's disease with no new safety risks observed.

Although the AFFIRM trial focused on a 12-week induction period, Long emphasized that durability and long-term safety data for risankizumab are supported by the broader clinical program evaluating the therapy and the IL-23 inhibitor class.

“The entire risankizumab portfolio and program now has many years of use and that's where the safety data really shine, that this is a highly effective, very safe drug where we're not seeing significant adverse effects in terms of infectious complications, we're not seeing malignancy risks, and really that long term data are what is so reassuring for the risankizumab portfolio,” Long said.

Editors’ Note: Long reports relevant disclosures with AbbVie, Bristol Myers Squibb, Celltrion, Eli Lilly, Intercept, Janssen, Pfizer, Prometheus, Roivant, Sanofi, Takeda, and Target RWE.

Brooks A. AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease. HCPLive. March 2, 2026. Accessed March 11, 2026. 

https://www.hcplive.com/view/affirm-risankizumab-skyrizi-subcutaneous-induction-achieves-primary-endpoints-in-crohn-s-disease

Walter, K. FDA Approves Risankizumab For Crohn’s Disease. HCPLive. June 17, 2022. Accessed March 11, 2026. 

https://www.hcplive.com/view/fda-appropves-risankizumab-crohns-disease

Videos

Long discusses AFFIRM data showing strong clinical and endoscopic outcomes with SC risankizumab (Skyrizi) induction in Crohn’s disease.

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Risankizumab Subcutaneous Induction for Crohn’s Disease: Insights From the AFFIRM Trial, With Millie Long, MD, MPH

Omalizumab or Oral Immunotherapy for Food Allergy, With Robert Wood, MD

Stage 3 data from the OUtMATCH trial established that both omalizumab and multi-food oral immunotherapy (OIT) enabled successful dietary consumption of allergenic foods in more than 60% of dietary consumption (DC) plans at 12 months with no significant differences between groups — but the tolerability gap separating the 2 treatments remains a central factor patient decision making.

sat down with Robert A. Wood, MD, Chief of the Eudowood Division of Pediatric Allergy and Immunology at Johns Hopkins Children's Center and Professor of Pediatrics at the Johns Hopkins University School of Medicine in Baltimore at the 

American Academy of Allergy, Asthma & Immunology (AAAAI)

 2026 Annual Meeting held in Philadelphia, Pennsylvania, from February 27 to March 2, where he presented the latest data from OUtMATCH, to learn more.

Of 81 eligible OUtMATCH participants, 80 qualified for DC plans following mOIT (n = 29) or omalizumab (n = 51), covering 83 and 139 individual allergen DC plans respectively. Success was defined as consuming a median of ≥300 mg/day of allergenic food at both 3 and 6 months by daily diary, with additional study team evaluations across all 12 months. By daily diary, DC success rates across all foods were statistically equivalent between groups at both 3 months (post-mOIT 77% vs. post-omalizumab 66%; 

= .77), with peanut-specific outcomes following the same pattern (

Study evaluations told a consistent story across all 12 months — success rates tracked closely between arms at every timepoint (post-mOIT: 90%, 82%, 75%, 67%; post-omalizumab: 91%, 82%, 69%, 63%; 

 = .44–1.00) with no differences on individual allergen analysis (

= .13–1.00). Among the 52 participants who maintained DC plans for all three foods through 12 months (n = 22 post-mOIT; n = 30 post-omalizumab), adverse event rates were similar — 86% (19/22) post-mOIT and 93% (28/30) post-omalizumab — with 2 serious adverse events during the open feeding transition from mOIT and 1 case of eosinophilic esophagitis post-omalizumab.

Wood discussed the practical treatment decision framework he applies in clinic, where omalizumab's ability to block all IgE-mediated reactions regardless of the specific trigger gives it a meaningful advantage for multi-food allergic patients over OIT protocols that require daily consumption of each individual allergenic food. OIT remains competitive for patients with a single dominant allergy, particularly peanut, where an FDA-approved product exists, but no FDA-approved multi-allergen OIT product currently exists, adding regulatory and practical complexity.

“With the oral immunotherapy, we know from all kinds of different studies that some patients will have reactions to the treatment. The reactions can be very trivial, or they can be enough that it's impossible to continue the treatment. So when we're sort of balancing the risk versus benefit,” Wood said.

Looking ahead, Wood was direct that no meaningfully new options are likely within 4 to 5 years as next-generation approaches remain in early-phase investigation, while the 10-year horizon, with potentially up to 10 distinct treatment options in the pipeline, promises to fundamentally reshape how clinicians and families navigate food allergy management together.

Wood’s disclosures include Aimmune, ALK, DBV Technologies, FARE, Genentech, NIAID, Novartis, Regeneron, Siolta, and Aravax.

1. Chinthrajah RS, Lanser B, Leung D, et al. Evaluation of dietary consumption feasibility following treatment with multi-food oral immunotherapy or omalizumab in OUtMATCH. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Abstract #L22

2. Smith T. FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults. Article. HCPLive. February 16, 2024. 

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

3. FDA. PALFORZIA. Updated August 1, 2024. 

https://www.fda.gov/vaccines-blood-biologics/allergenics/palforzia

Wood discussed factors that go into shared decision making for multi-food allergy.

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Food Allergy

Daniel DiGiacomo, MD, a clinical immunologist at Hackensack Meridian Jersey Shore University Medical Center.

AI, Genetic Testing May Advance Precision Care in Immunology, With Daniel DiGiacomo, MD

2026 American Academy of Allergy, Asthma & Immunology (AAAAI) 

annual meeting in Philadelphia, Daniel DiGiacomo, MD, a clinical immunologist at Hackensack Meridian Jersey Shore University Medical Center, discussed how emerging artificial intelligence (AI) technologies could complement genetic testing and help clinicians better understand complex immune disorders.

, DiGiacomo explained that AI may help clinicians interpret the growing volume of genetic data now available in clinical practice, particularly for rare immune conditions known as Inborn Errors of Immunity. Although advances in sequencing have accelerated the discovery of single-gene defects linked to these disorders, identifying and interpreting the clinical significance of genetic variants remains challenging.

“Things have started to plateau a little bit, so leveraging AI or machine learning or new methods to further understand different, more complicated genetic inheritance patterns certainly is… [helpful],” DiGiacomo said.

AI tools can support genetic interpretation through computational analyses that model how specific genetic changes may alter downstream biological processes, including RNA expression or protein structure. In conditions where rare genetic variants are detected, these tools may help clinicians better determine whether a mutation is likely to contribute to disease.

Advances in genetics are also influencing treatment strategies across allergy and immunology. As researchers better characterize the molecular pathways underlying immune-mediated disease, new biologic therapies are being developed to target specific components of those pathways. DiGiacomo noted that conditions such as hereditary angioedema (HAE) illustrate how improved understanding of disease biology can translate into targeted therapies that affect pathways involved in bradykinin metabolism and contact system activation.

These advances have led to the development of monoclonal antibodies, RNA-based therapeutics, and other targeted treatments designed to modulate specific immune pathways, DiGiacomo said. In some cases, emerging therapies are also expanding treatment options beyond injectable medications to oral alternatives or novel molecular strategies.

DiGiacomo suggested that continued progress in genetic testing and biomarker research could eventually shift allergy and immunology toward more predictive and preventative models of care. Identifying patients who are genetically predisposed to immune disorders or allergic diseases may allow clinicians to intervene earlier in the disease course.

New diagnostic approaches, including advanced immune profiling techniques such as detailed flow cytometry panels and cytokine analysis, are also helping clinicians identify the immune pathways driving disease in individual patients.

“Genetic testing has been easier to order. It's become more available, and it's been integrated specifically in the immunology realm,” DiGiacomo said. “Understanding the basic aspects of how to order it, why you're ordering it, how to counsel patients, how to interpret some of those findings, and how to leverage it to best treat the patient should definitely be integrated into teaching.”

DiGiacoma D. Practical and Hands-On Guidance Regarding Genetic Testing. Presented at the American Academy of Allergy, Asthma, & Immunology (AAAAI) on February 27 – March 2, 2026

Invitae Hereditary Angioedema Panel - Clinical Genetic Test - GTR - NCBI. Nih.gov. Published 2021. Accessed March 11, 2026. 

https://www.ncbi.nlm.nih.gov/gtr/tests/593409/

At AAAAI 2026, DiGiacomo discussed how artificial intelligence, genetic testing, and biomarkers could improve diagnosis and precision care.


Caleb Alexander, MD, MS, is a professor of epidemiology and medicine at Johns Hopkins University School of Medicine and co-founder and principal of Stage Analytics.

GLP-1 RA Effects are Largely Homogeneous but Stronger in Women than Men, With Caleb Alexander, MD, MS

The efficacy of GLP-1 receptor agonists (GLP-1 RAs) in 

 favors women over men, despite being largely consistent across other key patient subgroups.

Despite a long history of proven efficacy, past GLP-1 RA trials have included a substantial minority of individuals who failed to achieve weight loss. Because of this, clinicians have suggested a potential variance in efficacy based on patient characteristics, including age, sex, race, ethnicity, baseline body mass index, and baseline hemoglobin A1c.

“All too often during the course of clinical trials, one really doesn’t learn whether or not a product, such as a GLP-1, is similarly efficacious across different populations of patients,” Caleb Alexander, MD, MS, a professor of epidemiology and medicine at Johns Hopkins University School of Medicine and co-founder and principal of Stage Analytics, told 

 in an exclusive interview. “In other words, trials deliver information, on average, about a product, but don’t allow one to really understand whether or not the product may work similarly well across important subpopulations. Our results should reassure clinicians that some of these populations, which may have been excluded from clinical trials, still stand to gain from GLP-1s.”

Alexander and colleagues searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from their respective inceptions through July 26, 2024. Trials including semaglutide, lixisenatide, exenatide, liraglutide, and dulaglutide, as well as GLP-1 or insulin combination products, were eligible. Tirzepatide trials were excluded due to its status as a dual GIP or GLP-1 receptor agonist.

Phase 3 randomized controlled trials (RCTs) of adult patients ≥18 years with weight as a primary outcome were included – additionally, investigators required trials to compare GLP-1 RAs with placebo or non-GLP-1 RAs. Trials that did not report subgroup analyses or had an analysis without estimates for the non-GLP-1 RA group were excluded.

A total of 41 articles were ultimately included, representing 64 RCTs. The mean population of participants was 1181 between the 48 RCTs reporting study-level data (standard deviation [SD] 2513). The most frequently evaluated GLP-1 was semaglutide (21 [43.8%]), followed by dulaglutide (9 [18.8%]).

The vast majority of subgroups saw homogeneous effects from GLP-1 treatment: Alexander and colleagues provided an example of the 7 RCTs reporting stratified analyses by age. Among these 4314 patients, the mean weight loss among those <65 years was 1.98 (95% CI, 0.8-3.15) kg and 1.97 (95% CI, 1.15-2.79) kg among patients ≥65 years (between-group heterogeneity, 

However, 4 of the 6 RCTs reporting percentage change in weight by sex saw statistically significantly greater weight loss among women than men. Of the 6 RCTs, including 19,906 patients, the mean reduction was 10.9% (95% CI, 7-14.8%) among women and 6.8% (95% CI, 4.6-9%) among men (between-group heterogeneity, 

The team provides several possible explanations for this disparity between men and women. The synergy between GLP-1 RAs and estrogens could potentially increase their effectiveness, as could lower average body weight among women. Both may alter the pharmacokinetics of the treatment, allowing for greater response and increased efficacy by comparison.

Alexander and colleagues highlighted the implications of these data for both patients and clinicians. Although several patient populations have been underrepresented in or excluded from GLP-1 RA trials, these data indicate the overall homogeneity of treatment effects among most subcategories. Additionally, the team believes that the findings of this trial underscore the importance of examining heterogeneity of similar drugs across underrepresented patient groups. The team also calls for further research into whether these heterogeneity findings extend to other GLP-1 RA indications, including diabetes management, 

 are a transformational product; they are really a once-in-a-lifetime medical innovation,” Alexander said. “But the value of medicines isn’t an inherent function of the product itself – it depends on how it’s used in the real world. We still need to figure out how to optimize their value and ensure that the patients who get them are those who stand to gain the most from them.”

Editors’ Note: Alexander reports being past chair of the Peripheral and Central Nervous System Advisory Committee (US Food and Drug Administration) and a cofounding principle and equity holder in Stage Analytics outside the referenced work.

Alexander GC, Xiao X, Dilek S, et al. Heterogeneity of treatment effects of glucagon-like peptide-1 receptor agonists for weight loss in adults. JAMA Internal Medicine. Published online March 2, 2026. 

Wong HJ, Sim B, Teo YH, et al. Efficacy of GLP-1 Receptor Agonists on Weight Loss, BMI, and Waist Circumference for Patients With Obesity or Overweight: A Systematic Review, Meta-analysis, and Meta-regression of 47 Randomized Controlled Trials. Diabetes Care. 2025;48(2):292-300. 

Alexander discusses his recent study comparing 61 trials of 4 main GLP-1 RAs, highlighting their increased efficacy for weight loss in female patients.

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Dominic Sisti, PhD, is an associate professor in the Department of Medical Ethics & Health Policy and the director of the Scattergood Program for the Applied Ethics of Behavioral Health Care. Sisti is also the host of 

, our monthly multimedia series on medical ethics in modern healthcare. 

Medical Ethics Unpacked: Ethical Challenges of Carceral Healthcare

, hosts Dominic Sisti, PhD, a bioethicist from Penn Medicine, and Steve Levine, MD, a psychiatrist from Compass Pathways, unpack the ethical and clinical challenges of carceral healthcare, a topic many clinicians encounter in practice but rarely receive formal training in. The discussion features Rose Onyeali, MD, clinical assistant professor at Penn Medicine, and Penn student Chinelo Osakwe, who collaborate on initiatives aimed at improving health education and advocacy for incarcerated populations.

The episode explores how incarceration, particularly solitary confinement, can have lasting physical, 

l, and neurological effects. Onyeali described how deprivation of movement, sunlight, and social interaction can accelerate both cognitive and physical decline among incarcerated individuals.

Osakwe, a neuroscience major planning to pursue medicine, highlighted the neurological implications of prolonged isolation. She explained that extended periods without social interaction can alter brain structure and function, contributing to chronic stress responses and long-term mental health consequences after individuals leave solitary confinement.

“Humans are inherently social primates,” Osakwe said. “Your amygdala gets a little bit bigger; your hippocampus gets a little bit smaller. All these little things that are happening, your fight or flight, your hypothalamus, it's running like crazy…and then you come out…but you're still kept from outside the world. It has a big impact. Something as small as brushing your teeth with your non-dominant hand…can break apart the overly structured carceral environment. You can make it a little challenge. It's a little game now, and it's something that won't get you in trouble, won't get you put in the hole, or get your privileges revoked, because you're not doing anything outside of the structure. At the one hand, it's fun, it's a game, but on the other hand, it is literally good for your cognition.”

A major focus of the conversation is the rapidly aging prison population. Onyeali explained that correctional systems often classify individuals > 50 years as geriatric because incarceration accelerates aging and increases the prevalence of chronic disease and cognitive impairment. Yet clinicians working inside and outside correctional facilities may lack training to recognize conditions such as dementia in this population.

The episode also highlights systemic gaps in care for people transitioning out of incarceration. Even when individuals qualify for compassionate release or medical parole, many struggle to access housing, long-term care facilities, or coordinated medical follow-up. As Onyeali noted, “There's transition for people who…have drug issues or HIV, things of that nature…but there isn't a transition for especially the older adults with these chronic issues.”

In this episode, experts discuss solitary confinement, aging in prison, and gaps in care for incarcerated populations.

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Medical Ethics Unpacked

Medical Ethics Unpacked is a regular multimedia series hosted by Dominic Sisti, PhD, and Steve Levine, MD, spotlighting a spectrum of topics within the field of medical ethics. Throughout the year, hosts will sit down for an in-depth discussion on a specific ethical dilemma within modern healthcare, with some episodes also featuring a special guest. 

Check back throughout the year for discussions on a variety of topics, including data privacy in health apps, euthanasia and medical assistance in dying, reproductive rights and technologies, and more!

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Explore emerging IBD treatments—TL1A blockers, microRNA, stem cells—and new small-bowel imaging, plus team-based care improving access.

UChicago Advances IBD Trials With Focus on Microbiome and Access

Senior Allergy Dietitian at the Royal Children’s Hospital, Clinician-Scientist Fellow at MCRI & Honorary Senior Research Fellow at Melbourne University,

McWilliam discussed findings from the TreEat study at AAAAI 2026.

Multi-Nut OFC Feasible, Comparable to Home Introduction in Infants With Peanut Allergy, With Vicki McWilliam, MND, PhD

Salvatore Viscomi, MD, is the chief executive officer of Carna Health.

Salvatore Viscomi, MD on closing CKD health disparities through community testing, AI equity, and accessible care for underserved populations.

Nephrology

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Chronic Kidney Disease

Enhancing CKD Early Detection in High-Risk Populations Via Community Programs, AI, With Salvatore Viscomi, MD

María José Torres Jaén, MD, PhD, from Hospital Regional Universitario de Málaga.

At AAAAI 2026, Torres highlighted phase 3 peach immunotherapy research, nanostructure preclinical models, and a phase 2 prebiotic trial for LTP allergy.

Immunomodulation for Plant-Based Food Allergy, With María José Torres Jaén, MD, PhD

This interview highlights the significance of the potential FDA approval of imsidolimab for patients with generalized pustular psoriasis (GPP).

Plaque Psoriasis

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What Is the Significance of New Data on Imsidolimab for GPP? With Neal Bhatia, MD

Bernard Kadosh, MD, is the medical director of the ventricular assist device and cardiogenic shock programs at NYU Langone Health.

Kadosh and Gorodeski discuss the value of including non-specialists in HF care and the challenges of prescribing 4 pills in a time of increasing medical distrust.

Cardiology

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Multidisciplinary Care and Addressing Pill Burden in HF, With Bernard Kadosh, MD, and Eiran Gorodeski, MD, MPH

from Charité-Universitätsmedizin Berlin.

At AAAAI 2026, Magerl discusses phase 2 data showing BW-20805 reduced hereditary angioedema attacks by up to 100% with dosing intervals of up to 6 months.

BW-20805 Reduces HAE Attacks in Phase 2 Trial, With Markus Magerl, MD

Mohan Satish, MD, is a cardiology fellow at NYP-Weill Cornell.

Satish discusses his recent study highlighting significant increases in first AMI in-hospital mortality among young adults, particularly in women.

AMI Mortality Increasing Among Young Adults With Nontraditional Risk Factors, With Mohan Satish, MD

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.

Articles

These data, resulting from the INTEGUMENT-OLE trial, highlight the efficacy and safety of roflumilast cream (ZORYVE) 0.05% in children aged 2 - 5 years.

Atopic Dermatitis

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

New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children

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.

The approval comes after the FDA requested GSK submit an sNDA for leucovorin for the treatment of CFD-FOLR1.

FDA News

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Latest News

Risankizumab Subcutaneous Induction for Crohn’s Disease: Insights From the AFFIRM Trial, With Millie Long, MD, MPH

Omalizumab or Oral Immunotherapy for Food Allergy, With Robert Wood, MD

AI, Genetic Testing May Advance Precision Care in Immunology, With Daniel DiGiacomo, MD

GLP-1 RA Effects are Largely Homogeneous but Stronger in Women than Men, With Caleb Alexander, MD, MS

Medical Ethics Unpacked: Ethical Challenges of Carceral Healthcare