Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: 2026 AACE Guidelines for Type 2 Diabetes

On March 17, 2026, the American Association of Clinical Endocrinology (AACE) released a consensus statement, which features an algorithm for the management of 

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, review the newly released 2026 American Association of Clinical Endocrinology (AACE) type 2 diabetes treatment algorithm, positioning it as an evolution of the 2023 update that integrates a growing body of clinical trial evidence into a more comprehensive, complications-focused framework. They emphasize a paradigm shift away from glucose-centric management alone, highlighting the importance of addressing comorbidities, including 

metabolic dysfunction–associated steatotic liver disease (MASLD)

The discussion outlines the guideline’s structure, including its 10 guiding principles, which reinforce lifestyle intervention as foundational, promote individualized glycemic targets (with a preference for A1c ≤6.5% when safely achievable), and strongly encourage early use of continuous glucose monitoring (CGM). The hosts underscore the emphasis on avoiding therapeutic inertia, minimizing hypoglycemia risk, and managing cardiometabolic comorbidities alongside glycemia as part of routine care.

A key highlight is the introduction of a diabetes classification algorithm aimed at reducing misdiagnosis, particularly distinguishing type 1 from type 2 diabetes and identifying less common etiologies. Within this framework, the guidelines newly prioritize screening for hypercortisolism, informed by findings from the CATALYST trial, which demonstrated a higher-than-expected prevalence among patients with difficult-to-control diabetes. Isaacs and Bellini note that recognizing and treating underlying hypercortisolism may significantly improve glycemic control and, in some cases, reduce the need for diabetes-specific therapies.

The episode further reviews updated algorithms for cardiovascular risk reduction, dyslipidemia, and hypertension, emphasizing aggressive, individualized targets and the continued central role of lifestyle modification. Pharmacologic recommendations reflect robust recent evidence, prioritizing SGLT2 inhibitors and GLP-1 receptor agonists (including dual GIP/GLP-1 agents) for patients with cardiorenal or metabolic comorbidities, while also incorporating emerging indications such as heart failure with preserved ejection fraction and MASLD.

Isaacs and Bellini also discuss the guideline’s glucose-centric algorithm for patients without major comorbidities, highlighting patient-centered decision-making based on factors such as hypoglycemia risk, weight considerations, and cost/access. They reinforce recommendations for early combination therapy when A1c is significantly above target and appropriate use of insulin, including guidance on avoiding overbasalization and incorporating prandial strategies.

The conversation concludes with commentary on the guideline’s practical strengths, including clear visual algorithms, concise format, and detailed pharmacotherapy tables summarizing efficacy, safety, and organ-specific benefits. The hosts emphasize that the updated AACE algorithm provides clinicians with an actionable, evidence-based roadmap for delivering holistic, individualized diabetes care that extends beyond glycemic control to address the full spectrum of cardiometabolic risk.

Editor’s Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Samson SL, Vellanki P, Blonde L, et al. American Association of Clinical Endocrinology Consensus Statement: Algorithm for Management of Adults With Type 2 Diabetes - 2026 Update. 

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This episode discusses the recently released algorithm for T2D from the American Association of Clinical Endocrinology.

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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.

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Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

The first quarter of 2026 established a brisk regulatory pace that Q2 shows no signs of slowing. In the span of 3 months, the 

United States Food and Drug Administration

 (US FDA) cleared deucravacitinib for psoriatic arthritis (PsA) — the first TYK2 inhibitor approved for the indication — navepegritide for achondroplasia, and sublingual epinephrine film as the first needle-free epinephrine option for anaphylaxis. The Commissioner's National Priority Voucher program continued to make headlines, most recently with the fastest New Molecular Entity (NME) approval since 2002 in early April.

Q2 now arrives with a calendar that spans nephrology, endocrinology, cardiology, pulmonology, and dermatology — and that carries several decisions with genuine first-in-class or first-in-indication stakes. April brings what could be a long-awaited milestone for the rare kidney disease community, with a ruling expected on sparsentan in focal segmental glomerulosclerosis, a condition affecting more than 40,000 patients in the US for which no approved pharmacologic therapy currently exists. May narrows to a single high-profile call on whether to approve inhaled insulin for children and adolescents ages 4–17 — a decision that, if favorable, would represent the first needle-free insulin option for pediatric patients in over a century of insulin therapy. June closes the quarter with 3 decisions clustered near month's end: cytisinicline's potential to become the first new smoking cessation pharmacotherapy in nearly 20 years, a pediatric label expansion for roflumilast cream, and a pair of cardiometabolic rulings on olezarsen and baxdrostat that could introduce first-in-class mechanisms to severe hypertriglyceridemia and treatment-resistant hypertension, respectively. 

Here are the 6 FDA decisions to watch in Q2 2026, listed chronologically by expected decision date.

 Focal segmental glomerulosclerosis (FSGS) in adults

 The FDA extended the review timeline for the supplemental New Drug Application (sNDA) of sparsentan (Filspari) for focal segmental glomerulosclerosis, pushing the PDUFA date from January 13, 2026, to April 13, 2026, following Travere's submission of additional data requested by the FDA to further characterize the drug's clinical benefit — with no safety or manufacturing concerns raised. Sparsentan is a non-immunosuppressive, oral medication that directly targets podocyte injury by selectively blocking the endothelin A receptor and the angiotensin II subtype 1 receptor, with the sNDA supported by the phase 3 DUPLEX and phase 2 DUET studies. While DUPLEX achieved its pre-specified interim FSGS partial remission of proteinuria endpoint with statistical significance at 36 weeks, it did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment. Two-year DUPLEX data published in the 

 showed significant proteinuria reduction, higher remission rates, and a lower rate of end-stage kidney disease compared to active control irbesartan.

2. Insulin Human Inhalation Powder (Afrezza) 

 Type 1 or type 2 diabetes in children and adolescents aged 4–17 years

 MannKind's sBLA for Afrezza in pediatric patients is supported by phase 3 INHALE-1 study results, which compared Afrezza in combination with a basal insulin against multiple daily injections in children and adolescents with type 1 or type 2 diabetes. Notably, the INHALE-1 study did not meet its primary endpoint of noninferiority with respect to HbA1c, but investigators reported greater treatment satisfaction and reduced weight gain in the Afrezza arm — points the FDA will weigh in its benefit-risk assessment. If approved, Afrezza would offer young children and teenagers with diabetes a potential alternative to multiple daily injections or an insulin pump system — representing the first needle-free insulin option for pediatric patients since insulin therapy was first developed over a century ago.

 Nicotine dependence for smoking cessation in adults

 The NDA for cytisinicline is supported by data from more than 2,000 participants in the phase 3 ORCA-2 and ORCA-3 trials, where cytisinicline demonstrated significantly higher smoking abstinence rates compared to placebo. Cytisinicline is a plant-derived alkaloid that acts on nicotinic acetylcholine receptors, reducing nicotine craving and the rewarding properties of tobacco use. Its receptor selectivity profile has been associated with a lower rate of nausea than older agents, a tolerability advantage the company has emphasized ahead of the review. The drug carries Breakthrough Therapy designation for the separate indication of e-cigarette or vaping cessation. If approved for smoking cessation, cytisinicline has the potential to become the first new FDA-approved treatment option in nearly 20 years — entering a market still anchored by varenicline and nicotine replacement therapy.

 Hard-to-control hypertension as add-on to antihypertensive therapy in adults

 The BaxHTN trial demonstrated a −14.5 to −15.7 mmHg change in systolic blood pressure with baxdrostat compared to −5.8 mmHg with placebo, and AstraZeneca expects the FDA to act on the NDA during Q2 2026 following Priority Review acceptance and the use of a Priority Review voucher. Baxdrostat selectively inhibits aldosterone synthase (CYP11B2), reducing aldosterone production without meaningfully affecting cortisol — a mechanistic specificity that distinguishes it from older antihypertensive classes. The phase 3 BaxHTN results, published simultaneously in the 

 and presented at the European Society of Cardiology 2025, met the primary and all secondary endpoints. If approved, baxdrostat would become the first aldosterone synthase inhibitor authorized for clinical use.

 Severe hypertriglyceridemia (sHTG; triglycerides ≥500 mg/dL) in adults

 The sNDA for olezarsen in severe hypertriglyceridemia was granted Priority Review by the FDA on the strength of phase 3 CORE and CORE2 data, which across 1,061 patients demonstrated a placebo-adjusted mean reduction in triglycerides of up to 72.2% at 6 months and an 85% relative reduction in acute pancreatitis events — results published in the 

 and accompanied by the FDA's Breakthrough Therapy designation in November 2025. Olezarsen is an antisense oligonucleotide targeting apolipoprotein C-III, dosed once monthly by subcutaneous injection. The drug is already approved as Tryngolza for the rarer indication of familial chylomicronemia syndrome; the sHTG sNDA represents a meaningful expansion into a larger patient population.

 Plaque psoriasis in children aged 2 to 5 years

 The FDA accepted Arcutis's sNDA for roflumilast (Zoryve) cream 0.3% to expand the plaque psoriasis (PsO) indication to children aged 2–5 years, assigning a PDUFA date of June 29, 2026. Roflumilast cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. The sNDA is supported by a 4-week Maximal Usage Systemic Exposure study in children aged 2–5 demonstrating minimal-to-no systemic absorption, as well as long-term open-label data showing sustained efficacy and tolerability across age groups. Plaque psoriasis in this younger age group commonly affects sensitive areas including the face and intertriginous regions, where steroid use is particularly challenging. If approved, roflumilast cream 0.3% would be the first topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, adding to a portfolio that already includes approvals in atopic dermatitis (ages 2+) and seborrheic dermatitis.

Travere Therapeutics. Travere Therapeutics announces FDA acceptance of sNDA for FILSPARI® (sparsentan) in FSGS. Business Wire. May 2025. 

https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-Announces-FDA-Acceptance-of-sNDA-for-FILSPARI-sparsentan-in-FSGS/default.aspx

US Food and Drug Administration. FDA approves first new molecular entity under National Priority Voucher program. FDA.gov. April 1, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program

Articles

Q2 2026 continues an accelerated FDA cadence with six decision dates spanning nephrology, pediatrics/endocrinology, smoking cessation, cardiometabolic disease, and dermatology, several with first-in-class or first-in-indication implications. A pivotal near-term ruling targets FSGS with sparsentan amid mixed eGFR data but durable proteinuria and remission benefits. Pediatric inhaled insulin faces scrutiny after missing HbA1c noninferiority despite quality-of-life advantages. Late June concentrates potential launches: cytisinicline for nicotine dependence, baxdrostat for resistant hypertension, olezarsen for severe hypertriglyceridemia, and a roflumilast pediatric expansion.

Check out 6 FDA decisions to watch in Q2 2026, listed chronologically by expected decision date.

Nephrology

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Q2 2026 Preview: 6 FDA Decisions to Watch

Luke Laffin, MD, is the co-director of the Center for Blood Pressure Disorders, medical director of cardiac rehabilitation, and associate professor of medicine at Cleveland Clinic.

Tonlamarsen Lowers Angiotensinogen, Minimal Effects on Blood Pressure, With Luke Laffin, MD

Monthly tonlamarsen successfully reduced plasma angiotensinogen compared with a single tonlamarsen dose in patients with uncontrolled 

, but led to no additional blood pressure reduction, according to data from the Kardinal study.

American College of Cardiology (ACC) Scientific Sessions 2026

 in New Orleans, Louisiana, by Luke Laffin, MD, co-director of the Center for Blood Pressure Disorders, medical director of cardiac rehabilitation, and associate professor of medicine at Cleveland Clinic.

“It begs the question of whether you need that sustained angiotensinogen reduction to actually impact the pharmacodynamic marker of blood pressure long-term,” Laffin told 

 in an exclusive interview. “So how do we explain the changes in the angiotensinogen levels and the blood pressure levels in the study, which was not strictly placebo-controlled? We’ll have to establish that in future studies.”

Kardinal was a randomized, placebo-controlled trial investigating the safety and efficacy of 90 mg tonlamarsen delivered subcutaneously once a month for 5 months compared to a single dose of tonlamarsen and subsequent placebo. Patients were eligible for inclusion if they exhibited a systolic blood pressure >135 mmHg and were receiving 2-5 antihypertensive medications. Patients were excluded if they exhibited secondary causes of hypertension, an estimated glomerular filtration rate of <30 mL/min/1.73m2, or a serum potassium >5.1 mmol/L. The study included 2 primary endpoints – the between-group differences in change from baseline to week 20 in plasma angiotensinogen and in-office systolic blood pressure.

The study consisted of a 4-week placebo lead-in, a 4-week active run-in with 1 dose of tonlamarsen, and subsequent randomization to 4 further doses of either tonlamarsen or matching placebo for 16 weeks. Following enrollment, 270 patients received placebo lead-in, 206 received 90mg of tonlamarsen during an active run-in period, and 198 were eventually randomized to receive either placebo or continuous tonlamarsen doses. Mean blood pressure among these randomized participants before and after lead-in was 147/90 mmHg and 147/89 mmHg, respectively.

In the 20 weeks after the first dose of tonlamarsen, least squares (LS) mean percent change in plasma angiotensinogen levels were -23% (95% CI, -27.8 to 18.2) with a single dose and -67.2% (95% CI, -71.9 to -62.4) in patients receiving monthly doses, with a LS mean difference of -44.1% (97.5% CI, -51.9 to -36.4; 

 <.0001). LS mean changes in office systolic blood pressure were -6.7 mmHg (95% CI, -9.8 to -3.5) for patients receiving a single dose of tonlamarsen and subsequent placebo versus -6.7 mmHg (95% CI, -9.8 to -3.6) for those receiving monthly tonlamarsen, with a LS mean difference of -0.1 mmHg (95% CI, -4.5 to -4.4; 

Ultimately, despite the successful angiotensinogen reductions, Laffin and colleagues also observed negligible differences in office systolic blood pressure between treatment arms. The team determined that further placebo-controlled trials are necessary to determine the efficacy of tonlamarsen, assessing either single or multi-dose tonlamarsen regimens.

“The reason why new therapies for hypertension are so important is because, based on current guideline recommendations, less than 30% of Americans have their hypertension controlled,” Laffin said. “It’s great that we have a lot of generic options, but they’re not working for us right now. I think we need to think about different strategies, and I really believe that targeting angiotensinogen upstream is one such strategy that could be effective.”

Editors’ Note: Laffin reports disclosures with Medtronic, Novartis, Eli Lilly, Mineralys, Crispr Therapeutics, Idorsia, and others.

Laffin L, Sarraju A, Sclaich M, et al. Kardinal: A Phase 2 Study of Tonlamarsen for the Treatment of Uncontrolled Hypertension. Abstract presented at the American College of Cardiology Scientific Sessions 2026, New Orleans, LA. March 28-30, 2026.

Laffin L, Wang Q, Sarraju A, et al. Efficacy of Tonlamarsen in Patients with Uncontrolled Hypertension: The KARDINAL Phase 2 Randomized Clinical Trial. 

https://doi.org/10.1016/j.jacc.2026.03.034

Laffin discusses results from the Kardinal study, which investigated a single dose of tonlamarsen followed by placebo against monthly tonlamarsen treatment in hypertension.

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Eingun James Song, MD, is the director of clinical research for Frontier Dermatology. 

Discussing Future of Amlitelimab, OX40/OX40L Treatment, With Eingun James Song, MD

This interview with Eingun James Song, MD, the director of clinical research for Frontier Dermatology, highlights Song’s views on the OX40/OX40 ligand pathway and OX-40-targeted therapies such as amlitelimab.

2026 American Academy of Dermatology (AAD) Annual Meeting

 in Denver, Song was asked how he views the potential benefit of Sanofi's amlitelimab, for which they are moving ahead with regulatory submissions, in light of discontinuing rocatinlimab due to sarcoma cases.

“Everything that we have right now in atopic dermatitis is working on more downstream cytokines that are being released by these Th2 cells, by and large,” Song said. “...They are effective, but what oftentimes happens is when you stop the medication, the disease comes back relatively quickly.”

Song discusses OX-40-targeted therapies as a newer approach, intervening at the place at which the antigen-presenting cells interact with T cells. The idea, Song expressed, is if one could block the process at this stage, then a more durable remission could take place even when patients discontinue a treatment. Song reiterated his view on this type of therapy as a novel approach.

“There's potential for at least amlitelimab, which is an OX40-ligand inhibitor, that you can dose these patients every four or even every twelve weeks,” Song explained. “...Now that being said, it's important to note that there are two drugs that work on this pathway. One is called rocatinlimab, which is an OX40 receptor blocker, but it's also a depleter. It depletes those T cells. And that could maybe explain some of the adverse events that we've seen with rocatinlimab.”

Overall, Song expressed optimism on amletilimab’s having a role in dermatology care. Its implementation in treatment sequencing remains to be seen, Song suggested, but he noted his cautious optimism for this drug’s benefits for the right patient.

Song has reported serving as an investigator, consultant, and/or speaker for AbbVie, Alphyn Biologics, Amgen, Apogee, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant, DermBiont, Galderma, Incyte, Janssen, LEO Pharma, MoonLake, Novartis, Ortho, Pfizer, Regeneron, Sanofi, Sun Pharmaceutical Industries, Timber Pharmaceuticals, and UCB.

Press Release: Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis. Sanofi.com. Published 2025. Accessed April 3, 2026. 

https://www.sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170

Kyowa Kirin announces discontinuation of rocatinlimab clinical trials. News release. Kyowa Kirin. March 3, 2026. Accessed April 3, 2026. 

https://www.globenewswire.com/news-release/2026/03/03/3248303/0/en/Kyowa-Kirin-Announces-Discontinuation-of-Rocatinlimab-Clinical-Trials.html

In this AAD interview, Song highlights how he views the potential benefit of amlitelimab in light of discontinuing rocatinlimab.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Atopic dermatitis commanded a substantial share of the late-breaking program at the 

 held in Denver, Colorado, from March 27-31, with data spanning the full arc of the therapeutic pipeline — from approved agents accumulating long-term real-world and extension data to investigational mechanisms that could reshape how the disease is managed altogether. Two themes ran through much of the atopic dermatitis  program: the continued push to extend treatment options to younger pediatric populations, where approved choices remain limited, and a growing body of evidence on durability that moves the field's benchmark from short-term response to sustained, multi-year disease control. Here are 6 updates from the meeting that clinicians managing atopic dermatitis should know.

Tapinarof Cream Clears Skin, Eases Itch Within 1 Week in Kids as Young as 2

Data from the pivotal phase 3 ADORING 1 and ADORING 2 trials, discussed at AAD 2026 by Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health System, showed that once-daily tapinarof cream 1% demonstrated early and sustained improvements in both disease signs and symptoms, including itch, in patients aged 2 years and older with moderate-to-severe atopic dermatitis — a population in which approximately 80% of trial participants were children or adolescents and the study cohort was racially and ethnically diverse with high representation of patients with skin of color. Clinical improvements were observed as early as week 1, with skin clearance and itch relief continuing to accrue over the full 8-week treatment period. The nonsteroidal mechanism addresses a longstanding need for steroid-sparing topical options that can be applied continuously to any body site, including the face, without the safety concerns that have historically limited corticosteroid use in young children.

Late-Breaking Data Highlight Nemolizumab Efficacy in Children With Atopic Dermatitis

Phase 2 data presented in a late-breaking session by Lawrence Eichenfield, MD, professor of dermatology and pediatrics at UC San Diego and chief of pediatric dermatology at Rady Children's Hospital, showed that nemolizumab was well tolerated and effective in children aged 2 to 11 years with moderate-to-severe atopic dermatitis, producing clinically meaningful and sustained reductions in skin lesions and itch for up to a year.  IGA 0/1 was observed as early as week 4, with 41–47% of patients achieving it by week 16 — responses sustained through week 52. Skin lesion reductions were considered clinically meaningful at week 4 and were sustained through week 52, and clinically meaningful reductions in itch were noted at week 1 and similarly sustained through week 52, with no serious adverse events reported. The findings extend nemolizumab's established profile in adults and adolescents down to a younger population with limited approved options, setting the stage for potential label expansion of the IL-31Rα antagonist.

Tolerability of Roflumilast Cream 0.05% in Infants with Eczema, With Lawrence Eichenfield, MD

REZOLVE-AD: Rezpegaldesleukin Shows Consistent Efficacy Across Atopic Dermatitis Severity

Raj Chovatiya, MD, PhD, MSCI, FAAD, associate professor at Rosalind Franklin University and founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, presented phase 2b REZOLVE-AD findings showing rezpegaldesleukin achieved dose-dependent, statistically significant improvements in atopic dermatitis outcomes across both moderate and severe disease — with consistent EASI responses observed regardless of baseline severity, geographic region, or asthma comorbidity status. On the primary endpoint, the highest-dose arm achieved a 61% mean EASI reduction versus 31% for placebo (

 <.001). Chovatiya highlighted the consistency across baseline vIGA scores of 3 and 4 as a potential differentiator from standard-of-care biologics, which can show attenuated responses in more severe patients. The phase 3 ZENITH-AD program is in final planning with initiation expected in Q2 2026, with Chovatiya noting that the Treg-modulating mechanism raises the prospect of extended dosing intervals or treatment breaks — a meaningfully different proposition from the continuous cytokine inhibition model that defines the current standard of care.

REZOLVE-AD: Rezpegaldesleukin Shows Consistent Efficacy Across Atopic Dermatitis Severity, With Raj Chovatiya, MD, PhD

TRACE: Tralokinumab Data for Atopic Dermatitis in Skin of Color

A post-hoc analysis from the TRACE real-world study, presented by April Armstrong, MD, MPH, professor and chief of dermatology at UCLA's David Geffen School of Medicine, found that 80.4% of patients with skin of color and moderate-to-severe atopic dermatitis who were treated with tralokinumab achieved at least 1 clinically meaningful disease control endpoint — defined as IGA 0/1, EASI ≤7, or SCORAD <10 — at 12 months. Across the overall study population of 824 patients, 91% achieved at least 1 moderate treatment target after 12 months of tralokinumab use, with approximately three-quarters meeting both clinician-reported and patient-reported moderate endpoints and nearly half attaining optimal targets consistent with minimal disease activity. The skin of color analysis carries particular clinical weight given the historically underrepresented enrollment of Fitzpatrick type IV–VI patients in AD trials and the distinct disease manifestations — including lichenification and postinflammatory dyspigmentation — that can complicate assessment and management in this population.

TRACE: Tralokinumab Data for Atopic Dermatitis in Skin of Color, With April Armstrong, MD, MPH

RADIANT-AD: Rademikibart Effective Over 52 Weeks in Atopic Dermatitis

Cheng Zhou, MD, of Peking University People's Hospital and an investigator in the RADIANT-AD trial, described phase 3 results showing rademikibart produced rapid, clinically meaningful improvements in adults and adolescents with moderate-to-severe atopic dermatitis, with responses that continued to deepen and were sustained through 52 weeks rather than reaching an early plateau. EASI-75 response at week 16 was 74.2% versus 34.4% for placebo, with antipruritic effects and skin lesion clearance also observed at week 16 and maintained through week 52. Notably, rademikibart was associated with lower rates of conjunctivitis — 3.9% at week 16 and 6.3% at week 52 — compared with other agents in its class, addressing a known concern with IL-4/IL-13 pathway inhibition. No FDA submission timeline has been publicly disclosed, as the trial was conducted in China by partner Simcere Pharmaceutical.

Lebrikizumab for Atopic Dermatitis Leads to 4 Years of Clearance, Itch Reduction

Interim findings from the first year of the ongoing phase 3b ADlong study, presented at AAD, showed that 94% of patients achieved meaningful skin improvement (EASI-75) with up to 4 years of lebrikizumab treatment, with 75% achieving near-complete skin clearance (EASI-90) and 78% experiencing meaningful itch relief (Pruritus NRS ≤4). Notably, these outcomes were largely achieved with monotherapy, as 77% of those assessed did not require concomitant systemic or topical treatments, and approximately 80% maintained disease control without the use of topical corticosteroids — with 80% of subjects achieving clinical responses while on once-monthly injections. Safety in the first year of ADlong was consistent with lebrikizumab's established profile, with no new signals identified. The ADlong study remains ongoing with an additional year of follow-up planned.

Atopic dermatitis innovation is accelerating across topicals, biologics, and immune-modulating approaches, with a clear focus on earlier-line use in pediatrics and demonstrating durable, multi-year disease control. Tapinarof 1% delivered rapid, steroid-sparing topical efficacy in children as young as 2, while nemolizumab extended sustained itch and lesion improvements to ages 2–11. New systemic options showed differentiated profiles: rezpegaldesleukin with severity-agnostic responses and potential intermittent dosing, rademikibart with sustained 52-week benefit and low conjunctivitis, and lebrikizumab supporting long-term control largely without adjunctive therapy.

Read 6 updates from the meeting that clinicians managing atopic dermatitis should know.

AAD 2026: 6 Atopic Dermatitis Trials to Know

Future directions in ISM, including evolving treatment goals, unanswered questions about osteoporosis, anaphylaxis, resistance, curative strategies, and the need to extend advances to pediatric populations.

Video Series

Future Directions in ISM: Long-term Outcomes, Unanswered Questions, and Pediatric Considerations

Explore evolving colorectal cancer screening, from colonoscopy to advanced DNA/RNA stool tests, plus risk-based strategies and shared decisions that boost early detection.

Key Takeaways in Colorectal Cancer Screening

Positive FIT/Cologuard? See why follow-up colonoscopy is often $0 and how navigation, rides, and time-off support boost screening.

Coordinating Care After Abnormal Colorectal Cancer Results

Michael E. Thase, MD, of the University of Pennsylvania

In part 3 of an interview, Michael E. Thase, MD, discusses retreatment timing, safety monitoring, and research priorities following phase 2b GH001 data.

Psychiatry

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Maintenance Dosing, Safety Shape GH001 Outlook, With Michael E. Thase, MD

Use of symptom and quality-of-life tools alongside biomarkers in PIONEER, principles of dose titration from 25 mg to 50 mg, and practical recommendations for longitudinal safety monitoring.

Measuring Response in ISM: PRO Tools, Biomarkers, and Dose Optimization With Avapritinib

Check out exclusive expert interviews of late breaking data from AAD 2026.

Hidradenitis Suppurativa

Hidradenitis Suppurativa condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatology research, treatment, and drug development.

Plaque Psoriasis

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

Vitiligo

Vitiligo condition center page is a comprehensive resource for clinical news and insights on the dermatologic condition. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for the affected skin of vitiligo patients.

Alopecia

AAD 2026: 7 Late-Breaking Data Updates to Know in Dermatology

Professor Stephen Nicholls is a world-renowned cardiologist, and leads the Victorian Heart Hospital (VHH) at Monash University.

Nicholls discusses his recent pooled analysis of safety data from the BROADWAY and BROOKLYN phase 3 trials, proving the tolerable safety of obicetrapib.

Dyslipidemia

Atherosclerotic Cardiovascular Disease

Obicetrapib is Safe and Well-Tolerated in HeFH and ASCVD, With Stephen Nicholls, MD

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.

Data presented at the World Congress of Nephrology highlight faster and higher rates of microscopic hematuria negativity with sibeprenlimab treatment.

IgA Nephropathy

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

New VISIONARY Analyses Reinforce Benefits of APRIL Inhibition With Sibeprenlimab in IgAN

Song speaks about JAK inhibitors and their safety in dermatology care settings, contextualizing previous data on adverse events.

Key Takeaways on JAK Inhibitors and Black Box Warnings, With Eingun James Song, MD

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

March 2026 allergy news: FDA label updates, mastocytosis NDA, and promising data for peanut patch, remibrutinib, and CRSwNP biologics.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Food Allergy

Seasonal Allergy

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

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