Jose Clemente, PhD, associate professor of Genetics and Genomics and Immunology at the Icahn School of Medicine at Mount Sinai

Susanne Brix Pedersen, professor at DTU Bioengineering

Nicole Chase, MD, is a board-certified allergist/immunologist at St. Paul Allergy Asthma, Minneapolis VA Health Care System (part-time), and an associate professor of medicine at the University of Minnesota Medical School.

The Early-Life Window: Can Food Allergy Be Prevented Before It Begins?

 in early life was the standard advice. However, new research shows this is not always the case.

A growing body of research now suggests that early exposure, rather than avoidance, may reduce the risk of food allergy and promote immune tolerance during a critical developmental period.

The change began with the Learning Early About Peanut Allergy (LEAP) trial, which showed that by 5 years old, 3.2% of the consumption group and 17.2% of the avoidance group had developed a peanut allergy.

 This represented an approximately 80% relative risk reduction in peanut-exposed children.

Follow-up studies demonstrated that this protection persisted even after a period of peanut avoidance, suggesting durable immune tolerance. A study published in October 2025 analyzed data from > 85,000 children across nearly 50 pediatric practices and found a 27% drop in peanut allergies following the 2015 early introduction guidelines (

 <.001) and a 43% drop after the 2017 addendum (

Building on this dietary prevention model, newer research is expanding attention to early-life immune programming. One area of focus is the infant microbiome, which begins forming at birth and may influence downstream immune responses.

Investigators studying cesarean-delivered infants have examined vaginal microbial transfer as a strategy to partially restore maternal microbial exposure.

 In the ACTIVATE trial, vaginal seeding altered early microbiome composition, shifting bacterial profiles toward those seen after vaginal delivery. Infants who received the intervention also showed differences in food sensitization during infancy, suggesting early microbial exposure may influence allergic risk, although long-term outcomes remain under study.

Mechanistic work has linked microbial activity to immune regulation. Certain bifidobacteria produce aromatic lactate metabolites associated with reduced development of food allergen–specific immunoglobulin E, providing a potential biological pathway connecting microbiome composition to tolerance.

Moreover, translational research examining dietary antigens has identified discrete food-derived proteins recognized by intestinal regulatory T cells; these proteins were found in corn, wheat, and soybean.

 These antigen-specific populations emerge around the time of weaning, when infants first encounter solid foods, and early consumption has been associated with tolerance responses.

These data suggest multiple early-life pathways may influence allergy risk. Microbial colonization, bacteria-derived metabolites, and exposure to dietary antigens each appear to contribute to immune training. This suggests that prevention strategies may extend beyond feeding practices alone to broader early immune development.

: Associate professor of Genetics and Genomics and Immunology at the Icahn School of Medicine at Mount Sinai

An allergist/immunologist at St. Paul Allergy & Asthma and associate professor of medicine at the University of Minnesota Medical School

Clemente J. Vaginal Seeding Partially Modifies Infant Microbiome in ACTIVATE, With Jose Clemente, PhD. HCPLive. Published on March 1, 2026. Accessed on April 13, 2026. 

https://www.hcplive.com/view/vaginal-seeding-partially-modifies-infant-microbiome-activate-jose-clemente-phd

Brix-Pedersen S. Early-Life Bifidobacteria Linked to Lower Food Allergy Risk, With Susanne Brix Pedersen. 

Published on February 4, 2026. Accessed on April 13, 2026. 

https://join.hcplive.com/view/early-life-bifidobacteria-linked-lower-food-allergy-risk-susanne-brix-pedersen

Blum, J. Dietary Epitopes Drive Oral Tolerance, With Jamie Blum, PhD. HCPLive. Published on March 26, 2026. Accessed on April 13, 2026. 

https://www.hcplive.com/view/dietary-epitopes-drive-oral-tolerance-jamie-blum-phd

Gabryszewski S, Gupta R, and Hernandez-Trujillo V. Peanut Allergy Rates Plummet 10 Years After AAP Early Introduction Guidelines. 

 Published October 30, 2025. Accessed on April 13, 2026. 

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

Videos

Early allergen introduction, microbiome research, and immune programming studies suggest food allergy prevention may begin during infancy.

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 The Early-Life Window: Can Food Allergy Be Prevented Before It Begins?

Professor and Chair of the Department of Dermatology and Professor of Internal Medicine in the Division of Rheumatic Diseases and in the Peter O'Donnell Jr. School of Public Health at UT Southwestern Medical Center in Dallas

Joints, Weight, and Mental Health: Ixekizumab + Tirzepatide for PsA, With Joseph Merola, MD

Combination treatment with ixekizumab (Taltz) and tirzepatide (Zepbound) produced superior joint outcomes compared with ixekizumab alone in a population of patients with difficult-to-treat 

Joseph F. Merola, MD, MMSc, FAAD, professor and chair of the Department of Dermatology and professor of internal medicine in the Division of Rheumatic Diseases and in the Peter O'Donnell Jr. School of Public Health at UT Southwestern Medical Center in Dallas, presented these findings, from the TOGETHER-PsA trial, as a late-breaking oral at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

 held in Denver, Colorado, from March 27-31. The results were simultaneously published in 

TOGETHER-PsA (NCT06588296) was a 52-week, randomized, open-label, assessor-blinded phase 3b trial enrolling 271 adults with active PsA and obesity (BMI ≥30 kg/m²) or overweight (BMI 27–29.9 kg/m²) with at least 1 weight-related comorbidity. The trial population reflected the clinical reality that an estimated 65–82% of patients with PsA in the United States meet overweight or obese criteria. Participants had a mean age of 55.0 years (SD, 11.9), mean baseline weight of 106.1 kg (SD, 24.8), and mean BMI of 37.6 kg/m² (SD, 7.6). Both arms received diet and exercise counseling; patients were randomized 1:1 to ixekizumab plus tirzepatide or ixekizumab alone.

Merola emphasized several features of the enrollment that distinguished TOGETHER-PsA from earlier PsA trials. Approximately 70% of participants were women — a group he noted is historically harder to treat in PsA — and more than 60% had prior exposure to at least 1 advanced therapy, with at least 20% having received 2 or more prior treatments. A substantial proportion carried BMI levels in the class III obesity range. Despite this treatment-experienced, high-burden population, the combination arm still demonstrated meaningful separation from monotherapy across multiple endpoints.

The composite primary endpoint — simultaneous achievement of ACR50 and ≥10% weight reduction at week 36 — was met by 31.7% of patients on combination therapy versus 0.8% on ixekizumab alone (

 <.001). On ACR50 alone, combination therapy achieved 33.5% versus 20.4% (

 = .02). Merola highlighted the early onset of separation between arms — detectable by week 4, before clinically meaningful weight loss had accrued — as mechanistically provocative, suggesting tirzepatide may act through direct modulation of the adipokine and cytokine milieu that drives psoriatic inflammation rather than exclusively through weight reduction. Consistent improvements were observed across joint inflammation, pain, physical function, and health-related quality of life.

Among the secondary findings Merola called out specifically, the improvement in the SF-36 mental component score (MCS) stood out as clinically meaningful. Mental health measures frequently remain static across PsA clinical trial programs — either because they are not collected, or because the data are not highlighted on the assumption they will not change. In TOGETHER-PsA, the MCS did improve, a finding Merola attributed to the multidomain nature of the intervention: simultaneous improvement in skin, joints, and body weight appears to carry a psychological benefit that single-domain therapy may not replicate. He raised the additional possibility, acknowledged as speculative, that reduced systemic inflammation may itself carry direct central nervous system effects. On safety, the combination regimen was well tolerated. GI adverse events led to discontinuation in 2.9% of patients in the combination arm versus 1.0% on ixekizumab monotherapy — a rate Merola cited as reassuring, noting that the great majority of patients remained on treatment and derived benefit across multiple domains.

“This is not something where patients are running for the hills because of GI side effects, just the opposite. The vast majority of patients stayed in this study and saw multiple benefits. I think that's important to highlight,” Merola emphasized.

Merola also addressed the question of who should prescribe GLP-1/GIP receptor agonists in this setting. He framed the minimum expectation as ensuring dermatologists and rheumatologists initiate the conversation with patients about concurrent use, leaving the prescribing decision to individual clinician comfort — whether that means owning the prescription directly or co-managing with endocrinology or primary care. Week 52 data from TOGETHER-PsA and the companion TOGETHER-PsO skin trial are forthcoming.

Merola’s disclosures include Amgen, Astra-Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Abbvie, Dermavant, Eli Lilly, Moonlake, Novartis, Janssen, Oruka, UCB, Sanofi, Regeneron, Sun Pharma, Galderma, Biogen and Pfizer.

Merola JF, et al. Ixekizumab with tirzepatide achieved greater disease control than ixekizumab alone in adults with psoriatic arthritis and overweight or obesity: results from a randomized clinical trial. 

Eli Lilly and Company. Phase 3b data presented at AAD Annual Meeting show Lilly's Taltz (ixekizumab) plus Zepbound (tirzepatide) delivered superior efficacy for adults with psoriatic arthritis and obesity. Press release. March 28, 2026. 

https://investor.lilly.com/news-releases/news-release-details/phase-3b-data-presented-aad-annual-meeting-show-lillys-taltz

The combination showed efficacy in a predominantly female, treatment-experienced, high-BMI population.


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Sophia Schneider, MD, MS, is an internal medicine resident at Brigham and Women’s Hospital.

Sleep Apnea Associated With Worsening HF Outcomes, With Sophia Schneider, MD, MS

 is associated with a higher risk of cardiovascular mortality and 

 events, according to an analysis of the FINEARTS-HF trial.

American College of Cardiology (ACC) Scientific Sessions 2026

 in New Orleans, Louisiana, by Sophia Schneider, MD, MS, an internal medicine resident at Brigham and Women’s Hospital.

“I think that the immediate impact is related to heightened recognition,” Schneider told 

 in an exclusive interview. “When we see patients with HFpEF and HFmrEF who have recurrent decompensations, difficult-to-control hypertension, or disproportionately high symptom burden, that should raise red flags for clinicians to be thinking about screening for sleep apnea to potentially get patients started on treatment.”

FINEARTS-HF was an international, double-blind trial enrolling patients with HF and a left ventricular ejection fraction (LVEF) ≥40%, who were assigned in a 1:1 ratio to either finerenone or placebo on top of standard therapy. Finerenone was administered at a maximum dose of either 20 or 40 mg once daily; placebo doses were matched. The primary outcome was a composite of total worsening HF events – defined as a first or recurrent unplanned hospitalization or urgent visit for HF – and cardiovascular death.

A total of 6001 patients were included in the trial, with 3003 assigned to receive finerenone and 2998 assigned to placebo. Over the course of the 32-month program, investigators recorded 1083 primary-outcome events in 624 patients in the finerenone arm compared to 1283 events among 719 patients in the placebo group (rate ratio [RR], 0.84; 95% CI, 0.74-0.95; 

 = .007). The total number of worsening HF events was 842 in the finerenone arm and 1024 in the placebo arm (RR, 0.82; 95% CI, 0.71-0.94; 

 = .006). The percentage of cardiovascular mortalities was 8.1% and 8.7%, respectively (HR, 0.93; 95% CI, 0.78-1.11).

In the present analysis, Schneider and colleagues created a primary composite endpoint of cardiovascular death and total HF events. Secondary outcomes included total HF events, cardiovascular death, KCCQ change, and all-cause mortality. Among the 6001 patients enrolled in the original trial, the presence or history of sleep apnea was investigator-reported.

Of the original patients, 400 (6.7%) had sleep apnea. These patients were more often men (64% vs 54%), had a higher body mass index (BMI) (34 vs 29 kg/m2), and had a higher prevalence of diabetes (57% vs 40%). Over a follow-up period of 2.6 years, the team noted that sleep apnea was associated with a higher risk of the primary outcome (RR, 1.57; 95% CI, 1.38-1.79; 

 <.001). This correlation was consistent regardless of adjustment for age, sex, region, BMI, and diabetes history.

Ultimately, the apparent solidity of these data belies the small proportion of patients in the study with confirmed sleep apnea. Schneider acknowledges this limitation, noting that sleep apnea was not confirmed with polysomnography, and details on the severity of the condition and its treatment status were not collected. This naturally limits the study’s broad applicability and, in Schneider’s opinion, calls for further research with a more structured definition of sleep apnea.

“I think that this overlap between these conditions suggests that there is a potential mechanism of intervention,” Schneider said. “Finerenone is likely one of these, especially given the outcomes that we saw in our study showing improved clinical outcomes in both patients with and without sleep apnea.”

Editors’ Note: Schneider reports no relevant disclosures.

Schneider S, Pabon M, Lu H, et al. Sleep Apnea in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: the FINEARTS-HF Trial. Abstract presented at the American College of Cardiology Scientific Sessions 2026, New Orleans, LA. March 28-30, 2026.

Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in heart failure with mildly reduced or preserved ejection fraction. 

Schneider discusses her analysis of the FINEARTS-HF trial, noting the apparent efficacy of finerenone regardless of sleep apnea presence.

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Credit: Skin and Cancer Associates and The Center for Cosmetic Enhancement

Advances in topical dermatologic medications are quickly reshaping how clinicians manage chronic inflammatory skin diseases, providing them with new options designed to extend beyond the long-standing reliance on corticosteroids.

In a new interview, Brad Glick, DO, MPH, a board-certified dermatologist and the director of the dermatology residency training program at the Larkin Health System Palm Springs campus in Florida, reflected on this topic in light of data he presented in his recent presentation at the 

American Academy of Dermatology (AAD) Annual Meeting

In this session and in his subsequent Q&A interview with 

’s editorial team, Glick highlighted emerging nonsteroidal therapies and their growing role in clinical practice:

What were some of the topical therapies you elected to discuss in this talk, titled ‘What’s New in Dermatology’?

First of all, it's such an honor to be able to be at the podium at the Academy, and I've had that opportunity the last few years to do so. But one of my favorite sessions at virtually the end of the meeting is this. When my colleague, Dr. Mark Lebwohl, invited me last year to be at the podium to do this very same topic. One of the things he told me was to make sure everything is pretty brand spanking new. So I tried to do that. What did I talk about?...I spoke on steroidal topical therapies, which are really in Vogue now. We still need our topical corticosteroids, but we can use them more effectively, even more now than we did before.

Now we have three topical non steroidal therapies, roflumilast, ruxolitinib, and tapinarof, which was the first one to be approved down to the age of 2 for treating our kiddos with atopic dermatitis. Roflumilast has multiple indications: psoriasis, seborrheic dermatitis, atopic dermatitis. And we have things in our toolbox now that we can use for our recommendations for our patients once or twice a day where they don't have what I like to call that ‘saw-tooth’ pattern that we get with corticosteroids. Someone has a bad rash, we still prescribe topical corticosteroids, but for something that is chronic, what is the solution for them?

When we tell them, ‘Okay, use it for 2 or 3 weeks and then take a break,’ we have to have some substantive substitute for that particular product so that they can continue with their therapy. Otherwise, we run into what I talked about in my lecture, which was not only the common side effects that we're concerned about with the chronic use of topical corticosteroids…and not just atrophy of the skin and broken blood vessels, telangiectasias, and maybe steroid acne and steroid rosacea, particularly when topical steroids are used in the face, but what has become a topic of significant discussion. There've been multiple articles published in this last year…steroid withdrawal syndrome. We have hundreds of thousands of patients that have been using topical steroids for many years, some of them for reasonably moderate periods of time, but many of them have this phenomenon over longer periods of time because that's what they were given, or that's what they found successful, transiently.

But [for some] it then seems to backfire, where they get this rebound type of change, worsening of their rash and profound involvement of their face. It may not always be where the corticosteroid is being utilized. So all that told we've had this need for topical, non-steroidals and I talked a lot about newer ones like delgocitinib, which was recently approved for chronic hand eczema. It will have some other uses. I talk a lot about off-label uses of all of these new non-steroidals, so whether it's tapinarof for things like seborrheic dermatitis, there is some data around that for vitiligo that's in progress.

JAK inhibitors [too] are becoming like the Windex of dermatology. We can use them for almost anything right now, although there are obviously FDA-approved indications, such as those for ruxolitinib 1.5% cream for atopic dermatitis down to the age of two, and also for adolescents and adults for non-segmental vitiligo. But there are off-label uses for these therapeutics as well. Palmoplantar postulosis is being studied with a number of these topical non-steroidals.

The punchline is, for our cutaneous, inflammatory, immune-mediated diseases, we now can shift our therapy to more long-term solutions, because patients can use these therapies for longer periods of time compared to, for instance, higher potency corticosteroids. Hopefully, that was an exciting part of my talk. But there are new things that are coming as well, that are exciting for disease states that have been very difficult to treat. Let's talk about one of them, frontal fibrosing alopecia. We've largely used hydroxychloroquine orally and intralesional corticosteroids, but now we may be able to use some of these topical, for instance, Janus kinase inhibitors, to treat that condition. We also have some therapies that may be coming for treatment.

In certain conditions, like cutaneous T-cell lymphoma, and from a topical perspective, we have a certain topical like hypericin gel, which may be beneficial in combination with photodynamic therapy, meaning we use a light source to allow this particular substance, which appears to work just about as well as one of our topical nitrogen mustards. And then this is a fairly uncommon condition, CTCL, cutaneous T cell lymphoma. Nevertheless, the toolbox is not there and is very full. We'll mostly use phototherapy and topical corticosteroids. And of course, for advanced disease, we've had to either use topical retinoids in combination with phototherapy or even systemic retinoids. And so this is a unique and novel agent that's still under study.

Its mechanism of action is to downregulate a lot of these inflammatory changes that are leading to the chronic inflammatory change that we see in CTCL, which leads to the development of these atypical lymphocytes that we see in this particular condition. So stay tuned on that. But hyperson gel, in combination with photodynamic therapy, a light source used with this agent, may have some benefit in the treatment of CTCL, so that's particularly exciting. And actually, there's some thought that maybe even some of the topical Janice kinase inhibitors that I talked about may play some role in the treatment of CTCL, albeit a little bit controversial, and we have to stay tuned there.

Would you go a bit more in depth about JAK inhibitors covered in your talk? Do you feel clinicians are more open to their use now that some of the JAK safety data has been cleared up?

Let's answer question number one first. There's really three reasonable, reasonably accessible topical Janus kinase inhibitors. So let's start with topicals first, and then I'll answer part, part two of the question second, because your question involves the orals and the topicals, which is pertinent. There are 3 topical therapies. Two of them are FDA approved, one that we can get from compounding pharmacies that are primarily used. There are others that are on the horizon. I gave a talk about some of them, providing a list. I mentioned the pan-JAK inhibitor in delgocitinib. It's a pan-JAK inhibitor that's approved for chronic hand eczema first and only, currently approved for adults only. But I can tell you, there was the DELTA-TEEN study that was done. I did talk about it in one slide in my talk…We saw treatment success versus vehicle in the clinical trials for chronic hand eczema, and hopefully it will be approved soon down to the age of 12. That's one to highlight.

The second one, which is the originator topical JAK that was first approved for atopic dermatitis, now approved down to the age of 2, is ruxolitinib 1.5% cream. Use it twice daily. That's also one to highlight, highly effective in the treatment of atopic dermatitis in that age spectrum of 2 years and above. And then finally, for topical tofacitinib…[It] has been evaluated topically for the treatment of various forms of alopecia, including alopecia area and frontal fibrosine alopecia. Our audience will know that the initial discovery for the benefits of JAK inhibitor started with oral tofacitinib, and so many of us have used it for many years in a variety of different settings.

…Question two was that you asked about the risk adverse nature of some of our colleagues where JAK inhibitors are concerned, because the systemic agents of which there are now 3 that are approved for alopecia areata in baricitinib, ritlecitinib, and now deuruxolitinib, and then also our originator products in baricitinib for alopecia areata, but also upadacitinib for atopic dermatitis down to the age of 12, of getting those approvals correctly. Abrocitinib is also approved for adolescents. These are unique therapies, but all of them, and including one of the topical therapies, which is ruxolitinib cream…The point is that I think with more use, yes, we're starting to see a steady uptake of the use of the orals and certainly the topicals. I think that our expert dermatology colleagues feel quite comfortable that these topical therapies, unless someone is swimming in it and using all over their body, 100%.

The quotes used in this Q&A interview summary were edited for clarity.

Glick has served as an adviser, consultant, speaker, or investigator for Amgen, AbbVie, AstraZeneca, Almirall, Arcutis, Bausch Health/Valeant, Ortho Dermatologics, Boehringer Ingelheim, Bristol-Myers Squibb, Brickell Biotech, Cara, ChemoCentryx, Dermavant, Dermira, Eli Lilly, EPI/Novan, Incyte, Janssen Pharmaceuticals, LEO Pharma, Galderma, Nimbus Lakshmi, Inc, Novartis, Sun Pharma, Pfizer, Sanofi, Regeneron, UCB and the CorEvitas AD, CorEvitas PSO, and PROSE Registries and is a shareholder of Top MD

Glick B, et al. S065 What's New in Dermatology. Session presented at: 2026 American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, CO.


Articles

Topical dermatologic management is shifting toward steroid-sparing, longer-horizon strategies for chronic inflammatory disease control. Newer nonsteroidals—roflumilast, ruxolitinib cream, tapinarof, and emerging agents like delgocitinib—aim to reduce reliance on intermittent corticosteroid cycles and mitigate risks such as atrophy, telangiectasias, acne/rosacea, and topical steroid withdrawal. Topical JAK inhibition is expanding across approved indications and off-label exploration, with increasing clinician comfort as safety understanding matures. Pipeline approaches also include novel topical options for difficult diseases, including CTCL.

This Q&A interview from AAD 2026 covers a number of notable tips for clinicians in dermatology regarding topical therapies.

What's New in Topical Dermatology Drugs, With Brad Glick, DO, MPH

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.

Spyre Therapeutics has announced positive 12-week induction data from Part A of the phase 2 SKYLINE trial of SPY001, a potential best-in-class anti-α4β7 being investigated for the treatment of moderate-to-severely active ulcerative colitis (UC).

In the April 13, 2026, press release, the Company additionally announced that recruitment for Part A of SKYLINE is now closed and enrollment is open for Part B, which includes 3 monotherapy cohorts (SPY001, SPY002, and SPY003) and 3 combination cohorts (SPY120, SPY130, and SPY230) into which participants may be randomized versus a shared placebo. Proof-of-concept induction data for the remaining cohorts of Part A are now expected mid-2026 (SPY002) and Q3 2026 (SPY003), while Part B induction data for all cohorts remain on track for 2027.

“SPY001 was designed to improve upon vedolizumab’s proven activity in IBD by matching its epitope and potency while increasing target coverage through an extended half-life and greater induction dosing. Our data today support the hypothesis that this approach could lead to a best-in-class anti-α4β7 product across safety, efficacy, and convenience,” said Deanna Nguyen, MD, SVP of Clinical Development and SKYLINE study lead.

 “Beyond SPY001’s potential as a monotherapy, we continue to believe that its gut-selective mechanism makes it an ideal backbone for combination therapy alongside our cytokine-targeting investigational antibodies SPY002 (anti-TL1A) or SPY003 (anti-IL23). We have begun enrolling these combinations globally and look forward to unveiling proof-of-concept data next year.”

SPY001 is an investigational, novel, extended half-life monoclonal antibody targeting α4β7 for the treatment of inflammatory bowel disease (IBD). It targets the same epitope as vedolizumab, which was approved by the US Food and Drug Administration for the treatment of both UC and Crohn’s disease in 2014, and has demonstrated equivalent potency and selectivity as vedolizumab in head-to-head preclinical studies.

Interim data from a previous phase 1 trial demonstrated that SPY001 was well tolerated and exhibited a human half-life of ~80 days, approximately 3-fold greater than vedolizumab and supporting potential quarterly or biannual SC maintenance dosing in a single autoinjector compared to vedolizumab's Q2W SC profile.

SKYLINE is a 2-part induction and maintenance platform trial of SPY001, SPY002, SPY003, as well as pairwise combinations thereof, totalling 6 investigational agents, in patients with moderately to severely active UC. Part A is an open-label assessment of the safety and efficacy of a single dose level of each investigational monotherapy, and Part B is a randomized and placebo-controlled assessment of the safety and efficacy of investigational monotherapies (2 dose levels) and combinations.

Results showed SPY001 achieved the primary endpoint, demonstrating a statistically significant reduction in the Robart’s Histopathology Index score of 9.2 points (P <.0001). Rates of key secondary endpoints of clinical remission and endoscopic improvement were clinically meaningful and support SPY001’s potential best-in-class profile.

SPY001 was well tolerated with a safety profile consistent with the α4β7 class. There were 6 subjects with treatment-emergent adverse events (TEAEs) during the induction treatment period, with one serious adverse event (SAE) deemed not drug-related. The most common AE (occurring in ≥ 2 patients) was back pain (n = 2).

“On behalf of the Spyre team, I’d like to thank the patients and investigators whose partnership has made this progress possible as we advance the study with the goal of delivering paradigm-changing combinations for IBD patients,” Sheldon Sloan, MD, MBE, Chief Medical Officer of Spyre Therapeutics, said in a statement.

 “Thanks to our team’s outstanding execution, we enrolled Part A with exceptional speed and now transition to Part B. We expect heightened investigator enthusiasm given these promising results for SPY001, a low placebo allocation for the remainder of the trial, and a unique opportunity to evaluate perhaps the three most promising combinations in development.”

Spyre Therapeutics. Spyre Announces Potential Best-in-Class SPY001 Part A Induction Results from SKYLINE Trial in Moderate-to-Severe Ulcerative Colitis Patients. April 13, 2026. Accessed April 13, 2026. 

https://ir.spyre.com/news-releases/news-release-details/spyre-announces-potential-best-class-spy001-part-induction

Spyre Therapeutics. Spyre Therapeutics Announces Poster Presentations at Digestive Disease Week (DDW) 2025 Including Up to Eight months of Follow-up from an Ongoing Phase 1 Trial of SPY001. May 5, 2025. Accessed April 13, 2026. 

https://ir.spyre.com/news-releases/news-release-details/spyre-therapeutics-announces-poster-presentations-digestive

Drugs.com. FDA Approves Entyvio (vedolizumab) to treat Ulcerative Colitis and Crohn's Disease. May 20, 2014. Accessed April 13, 2026. 

https://www.drugs.com/newdrugs/fda-approves-entyvio-vedolizumab-ulcerative-colitis-crohn-s-4040.html

Spyre Therapeutics reported positive 12-week induction results from Part A of the phase 2 SKYLINE trial evaluating SPY001, an extended half-life anti-α4β7 monoclonal antibody for moderate-to-severe ulcerative colitis. Part A enrollment is complete, and Part B has opened with randomized monotherapy and combination cohorts versus shared placebo. SPY001 met the primary endpoint with a statistically significant Robarts Histopathology Index reduction and showed clinically meaningful remission and endoscopic improvement. Safety was consistent with the α4β7 class, with limited TEAEs and one non–drug-related SAE.

Positive 12-week induction data from Part A of the phase 2 trial highlight the potential best-in-class safety and efficacy of SPY001, a novel anti-α4β7 therapy.

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SPY001, An Anti-α4β7, Shows Promise in Phase 2 SKYLINE Trial for Ulcerative Colitis

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.

Although the approval does not permit entrance into the market, this decision marks an important step to more universally accessible GLP-1 RAs.

Breaking News

FDA News

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.

Type 2 Diabetes

FDA Gives Tentative Approval of ANDA for Generic Semaglutide Injection

Ali Rezaie, MD, is medical director of the GI Motility Program at Cedars-Sinai.

Rezaie explains how IBS care has shifted from symptom-based treatment to targeted, mechanism-driven strategies.

Irritable Bowel Syndrome

On the HCPLive irritable bowel syndrome page, resources on the topics of medical news and expert insight into IBS can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBS, IBD, and more.

Rethinking IBS Management: The Shift Toward Precision Care, With Ali Rezaie, MD

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

This episode, titled "Exploring Network Meta-Analyses (NMA) in Psoriasis," features panelists discussing the value and limitations of network meta-analyses as a tool for comparing multiple psoriasis therapies across different clinical trials simultaneously.

Video Series

Exploring Network Meta-Analyses (NMA) in Psoriasis

In "Evaluating Psoriasis Therapies using MAICs," our panel delves into several recent and clinically meaningful MAIC analyses comparing biologic therapies for plaque psoriasis, examining what the data reveals about relative efficacy across treatment classes and how these analyses have been validated over time.

Evaluating Psoriasis Therapies using MAICs

Melissa Engel, PhD, a postdoctoral fellow at Feinberg School of Medicine at Northwestern Medicine.

Engel discusses ADAA 2026 findings identifying fear of social judgment as a distinct component of food allergy–related anxiety in adolescents.

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.

Social Anxiety May Influence Safety Behaviors in Teens With Food Allergy, With Melissa Engel, PhD

Stay updated with the latest healthcare breakthroughs, including FDA actions, in this week’s essential news roundup.

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

The HCPFive: Top News for Healthcare Providers from the Week of 04/05

This Q&A interview at AAD 2026 highlights a number of notable tips for clinicians in dermatology from the ‘Pearls: Diagnostic and Therapeutic’ talk.

Key Diagnostic and Therapeutic Pearls in Dermatology, With Brad P. Glick, DO, MPH

Chelsea Christensen, PA-C, is a cardiology physician assistant at Sentara Virginia Beach General Hospital.

Christensen discusses the mechanics and practical applications of the HFMS, emphasizing its success in predicting HF events based on pulmonary fluid levels.

ZOLL Heart Failure Management System Predicts Events Before Hospitalization, With Chelsea Christensen, PA-C

Nissen discusses his post-hoc analysis of the SURPASS-CVOT trial, comparing the 2 drugs for a 6-component composite endpoint of cardiorenal outcomes.

Atherosclerotic Cardiovascular Disease

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.

Tirzepatide Outperforms Dulaglutide in Cardiorenal Outcomes, With Steven Nissen, MD

Michael H. Gold, MD, is the founder and medical director of Gold Skin Care Center, Advanced Aesthetics Medical Spa, The Laser & Rejuvenation Center.

During this video interview at AAD 2026, Gold touches on key points made in his session titled ‘Complications of Cosmetic Procedures.’

Latest News

The Early-Life Window: Can Food Allergy Be Prevented Before It Begins?

Joints, Weight, and Mental Health: Ixekizumab + Tirzepatide for PsA, With Joseph Merola, MD

Sleep Apnea Associated With Worsening HF Outcomes, With Sophia Schneider, MD, MS

What's New in Topical Dermatology Drugs, With Brad Glick, DO, MPH

SPY001, An Anti-α4β7, Shows Promise in Phase 2 SKYLINE Trial for Ulcerative Colitis