Recapping the “Must-Know” Information From the 2026 AAD Late-Breaker Sessions—Part 1

The hustle and bustle of the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, may be over, but the frantic pace of therapeutic innovation in dermatology is not slowing down. Two late-breaker sessions at the AAD meeting covered more than 20 unique therapies across at least 13 different diseases. Here, I will recap some key information that dermatology providers should be aware of, along with how the new data are impacting the field.

Atopic Dermatitis

With the approval of dupilumab in 2017, the ability to effectively treat moderate to severe atopic dermatitis (AD) has significantly advanced. As AD management embraces the treat-to-target framework, striving for optimal treatment outcomes and minimal disease activity, along with improved safety profiles, remains a priority driving therapeutic innovation in the AD space.

Rademikibart (Connect Biopharma), a next-generation IL-4 receptor α (IL-4Rα) inhibitor with 2-fold stronger binding than dupilumab and an optimized epitope on IL-4Rα,¹ was studied as monotherapy in a 1-year phase 3 randomized trial (RADIANT-AD) in adolescents and adults with moderate to severe AD.^2,3 With a 600-mg loading dose followed by every-2-week subcutaneous injection, rademikibart demonstrated rapid and strong efficacy at week 16, with 47.7% of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (vs 17.6% placebo, 30.1% change from baseline), 43.0% achieving an 90% reduction in Eczema Area and Severity Index score (EASI90; vs 14.5% placebo, 28.5% change from baseline), and 74.2% achieving EASI75 (vs 34.4% placebo, 39.8% change from baseline). Itch, the most critical AD patient-reported outcome, was reduced by 3 points or more (on a 0-10 numerical rating scale) in 54.7% of patients (vs 27.5% placebo, 27.2% change from baseline). During the 36-week open-label extension, rademikibart showed increasing efficacy and durability, with 87.1% of week 16 responders maintaining an IGA score of 0 or 1 at week 52, 85.3% maintaining EASI90, and 96.6% maintaining EASI75. Importantly, the enhanced binding properties of rademikibart may translate into clinical safety advantages, as there was a very low conjunctivitis rate over the first 16 weeks (3.9%, not significantly different from placebo).²

MG-K10 (Chime Biologics) is another next-generation IL-4Rα inhibitor with extended half-life due Fc region modifications⁴ that was studied for 52 weeks in patients with AD.⁵ After a 600-mg loading dose, MG-K10 was dosed at 300 mg every 4 weeks and achieved strong efficacy responses at week 16: 59.8% achieved EASI75 (vs 22.9% placebo, 36.9% change from baseline), and 32.7% achieved an IGA score of 0 or 1 with a 2-point or more improvement (vs 7.2% placebo, 25.5% change from baseline). Increasing and durable efficacy was observed out to week 52.⁵

The goal of targeting the OX40-OX40L pathway is to stop AD early by tackling upstream events (antigen-presenting cell interactions with activated T cells as a costimulatory signal) to reduce the production of multiple cytokines, reduce memory T cells, and enhance regulatory T cells.⁶ Data on the 24-week efficacy and safety of amlitelimab (Sanofi), an OX40L-targeted biologic, from the pivotal COAST 1 (NCT06130566), COAST 2 (NCT06181435), and SHORE (NCT06224348) phase 3 trials demonstrated increasing efficacy with no evidence of a plateau. Using every-12-week dosing, 22.5% of patients achieved a validated IGA for AD (vIGA-AD) score of 0 or 1 (vs 9.2% placebo, 13.3% change from baseline), 39.1% achieved EASI75 (vs 19.1% placebo, 20% change from baseline), and 24.5% achieved a reduction of 4 points or more in itch Numeric Rating Scale (NRS) score (vs 12.7% placebo, 11.8% change from baseline). The promise of every-12-week dosing frequency in AD is encouraging, and amlitelimab’s efficacy with this dosing schedule was similar to that in the every-4-week arm.⁷ 

Another therapy that may redefine dosing frequency in the treatment of AD is zumilokibart, an IL-13 targeted monoclonal antibody with a modified lebrikizumab-like epitope and YTE Fc-engineered extended half-life technology. What was new at AAD 2026 was the presentation of week 52 data from part A of the phase 2 APEX trial (NCT06395948). For patients who achieved EASI75 at week 16, a remarkable 85% maintained EASI75 on a dosing regimen of 360 mg every 12 weeks, and 75% maintained EASI75 on a dosing regimen of 360 mg every 24 weeks; similar rates (78%-86%) were observed for maintenance of an IGA score of 0 or 1. EASI90 achievement deepened over time, with 48% (every 24 weeks) and 75% (every 12 weeks) of patients hitting this mark at week 52 (as observed). EASI100 was achieved by 41% of patients receiving zumilokibart 360 mg every 12 weeks. Substantial reductions in itch from baseline were also observed at week 52: 64% (every 24 weeks) and 73% (every 12 weeks). Together, these data show that extended half-life technologies are not just about decreasing the dosing frequency of biologics, but they also may translate into deeper clinical responses and elevate the standard of care for patients with AD.⁸

A new mechanism of action in the treatment of AD involves the degradation of STAT transcription factors, such as the STAT6 degrader KT-621. When IL-4 and IL-13 cytokines bind extracellularly to type I or II receptors,⁹ they facilitate recruitment of Janus kinase (JAK) enzymes, which in turn phosphorylate and activate STAT6, a key intracellular protein that translocates to the nucleus to impart a transcriptional program. In the BroADen phase 1b trial (NCT06945458) involving 22 patients treated with once-daily oral KT-621 (100 or 200 mg) over 28 days, KT-621 demonstrated nearly complete degradation of STAT6, with a 94% STAT6 reduction in the skin and 98% in the blood. There were deep reductions in type 2 inflammatory biomarkers, including a 74% reduction in TARC, a surprising 56% reduction in IL-31, and a 14% reduction in IgE. Clinically, 29% of patients achieved EASI75 at week 4, and 19% achieved an IGA score of 0 or 1 at week 4. Patients, on average, experienced a 49% reduction in body surface area involvement and 40% reduction in peak pruritus NRS. These significant responses at week 4 are encouraging for the long-term impact KT-621 may have on patients with moderate to severe AD. Parallel phase 2b trials of KT-621 in AD and asthma are ongoing.¹⁰

Children younger than 12 years with AD were also represented in the late-breaker sessions. Phase 2 data evaluating the IL-31R inhibitor nemolizumab plus topical therapy in children with AD aged 2 to 11 years were presented. Nemolizumab was weight-based dosed every 4 weeks in children, representing an advance in this age group, for which there are no FDA-approved therapies on-label for every-4-week dosing. Efficacy rates for skin clearance at week 16 ranged from 64% to 73% for EASI75 and from 41% to 47% for an IGA score of 0 or 1, meaning that almost half of the children treated with nemolizumab every 4 weeks achieved clear or almost clear skin. Data from week 52 showed strong maintenance of response in the pediatric age group; 91% of children completed all 52 weeks of the trial, reinforcing the combined efficacy and safety of nemolizumab. The skin clearance rates seen in this pediatric cohort are better than the phase 2 data seen in adults. Also, 56% to 72% of patients achieved an improvement of 4 points or more in itch NRS, with reports of fast onset as early as week 1.¹¹ This bodes well for itchy children who need sleep and their parents who need respite and sleep too. What I am looking forward to in future data releases is the impact of nemolizumab on pediatric growth.

One of the most important topics discussed in 2025 was the impact untreated AD has on children's growth, often stunting growth and reducing bone mineralization. Treatment of AD with dupilumab demonstrated decreases in systemic inflammation in these children, as well as improvements in growth (height and weight) and bone mineralization.¹² Understanding how biologics with different mechanisms of action from dupilumab impact the growth trajectory of pediatric patients is essential for better characterizing the impact of untreated AD on children, as well as the potential treatment options that can (or cannot) overcome AD’s detrimental effects on children's growth.

For very young children aged 3 to 24 months with mild to moderate AD, the INTEGUMENT-INFANT study (NCT06998056) evaluated topical roflumilast 0.05% cream once daily for 4 weeks. A vIGA-AD score of 0 or 1 and a 2-grade improvement was observed in 34.4% of infants at week 4, while EASI75 was achieved by 58.3% at week 4. Additionally, 67.5% of infants also achieved vIGA-scalp success. Some infants experienced itch relief within 10 minutes. Overall, 60.3% of infants achieved an improvement of 4 points or more in itch NRS at week 2, increasing to 72.7% by week 4, providing strong evidence of significant itch relief in infants using topical roflumilast.¹³

Chronic Hand Eczema

Chronic hand eczema (CHE) had a stellar year in 2025, thanks to the FDA-approved pan-JAK inhibitor delgocitinib hitting the market with no boxed warning. The innovation of JAK inhibitors in CHE therapy continues,¹⁴ with abrocitinib evaluated in a phase 2 trial for its ability to treat CHE signs and symptoms over 16 weeks.¹⁵ Treating both atopic and nonatopic CHE, abrocitinib overall demonstrated 81% (200-mg dose) and 78.1% (100-mg dose) reductions in modified Total Lesion Symptom Score (vs 46.5% placebo, 31.6%-34.5% change from baseline) at week 16. Similar results were obtained for atopic and nonatopic subtypes. An IGA score of 0 or 1 and a 2-grade improvement was observed in 55.6% (200 mg) and 44.4% (100 mg) of patients (vs 18.5% placebo, 25.9%-37.1% change from baseline);¹⁶ marked improvements in itch and pain were also observed. These findings are consistent with prior reports of another JAK1-selective inhibitor, upadacitinib, successfully treating the atopic subtype of CHE. Abrocitinib demonstrated in its trial that JAK1-selective inhibitors may also work in nonatopic subtypes.¹⁵

Continue reading part 2

For more atopic dermatitis news and research, register to attend the 2026 Revolutionizing Atopic Dermatitis (RAD) conference in Nashville, Tennessee, held June 17-19. Use code DT40 for 40% off registration.

References

1. Shi Y, Nolden K, Ho M, et al. Crystal structure and molecular dynamics simulations of rademikibart Fab-IL-4Rα complex reveal biochemical basis for next-generation potent IL-4Rα inhibition in type 2 allergic and inflammatory diseases. bioRxiv. Published online April 13, 2026. doi:10.64898/2026.04.12.718052
2. Zhou C. Rademikibart monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD): a 1-year, phase III, randomized, double-blinded, placebo-controlled trial (RADIANT-AD). Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.
3. Rademikibart demonstrates best-in-class potential in phase 3 atopic dermatitis study. News release. Connect Biopharma. March 30, 2026. Accessed April 17, 2026. https://investors.connectbiopharma.com/news-releases/news-release-details/rademikibart-demonstrates-best-class-potential-phase-3-atopic
4. Amid-Toby G, Alani O, Bunick CG. Bispecific and trispecific antibodies in atopic dermatitis: a review of the emerging clinical pipeline. Front Drug Discov. 2026;6:1766021. doi:10.3389/fddsv.2026.1766021
5. Zhang J. Long-term efficacy and safety of MG-K10 for moderate-to-severe atopic dermatitis: 52-week results from a pivotal phase 3 trial. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.
6. Nolden K, Shi Y, Batista VS, Bunick CG. Molecular differentiation of OX40- and OX40L-targeted biologics using AlphaFold3 and molecular dynamics simulations. J Invest Dermatol. Published online February 4, 2026. doi:10.1016/j.jid.2026.01.024
7. Simpson E. Combined oral: efficacy and safety of monotherapy amlitelimab, a non-depleting anti-OX40 ligand antibody, in moderate-to-severe atopic dermatitis: 24-week results from the pivotal COAST 1 and COAST 2 phase 3 trials and efficacy and safety of amlitelimab, a non-depleting anti-OX40 ligand antibody, in combination with topical therapy in participants with moderate-to-severe atopic dermatitis: 24-week results from the SHORE phase 3 trial. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.
8. Guttman E. Zumilokibart (APG777) provides early and sustained improvements in the signs and symptoms of atopic dermatitis: results from the phase 2 APEX part a study. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.
9. Bunick CG. Biologic therapies targeting type 2 signaling in atopic dermatitis: a comparative review of structural and thermodynamic differences in mechanism of action. J Invest Dermatol. 2025;145(12):2950-2963.e4. doi:10.1016/j.jid.2025.06.1574
10. Kymera Therapeutics presents KT-621 BroADen data in late-breaking research session at the American Academy of Dermatology (AAD) Annual Meeting. News release. Kymera Therapeutics. March 28, 2026. Accessed April 17, 2026. https://investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-presents-kt-621-broaden-data-late-breaking
11. Stein Gold L. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.
12. Irvine AD, Poller AS, Siegrfried EC. Growth improvement in children 6 to 11 years with severe atopic dermatitis treated with dupilumab irrespective of TCS use. Presented at: 6th Annual Elevate-Derm Fall Conference; November 12-16, 2025; Tampa, FL.
13. Eichenfield L. INTEGUMENT-INFANT: once-daily roflumilast cream 0.05% in infants aged 3–<24 months with atopic dermatitis. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.
14. Bunick CG. When topicals fall short, oral Janus kinase inhibitors offer a needed solution in chronic hand eczema. JAAD Int. 2025;22:86-87. doi:10.1016/j.jdin.2025.06.007
15. Bissonnette R. Efficacy and safety of abrocitinib in patients with chronic hand eczema: a randomized, double-blind, multicenter, placebo-controlled trial. Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.
16. Alani O, Shqair L, Liszewski WJ, et al. Treating chronic hand eczema with upadacitinib: insights from clinical trials and real-world experience. J Drugs Dermatol. 2025;24(7):702-707. doi:10.36849/JDD.9156