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Individuals with moderate-to-severe atopic dermatitis who attain treatment goals after 16 weeks of tralokinumab are likely to maintain stable clinical benefit for up to 3 years of continued use, according to new data, even if individual response patterns fluctuate.

These new late-breaking findings on tralokinumab were announced by LEO Pharma and presented at the 

2025 European Academy of Dermatology and Venereology (EADV) Congress

 in Paris, France. They were presented at EADV by investigator Andrew Blauvelt, MD, MBA, the president of the Oregon Medical Research Center,

Atopic dermatitis flare-ups are a hallmark of the condition, and durable disease control is viewed as a treatment priority among both patients and clinicians. Tralokinumab was designed as a high-affinity monoclonal antibody that can selectively inhibit interleukin (IL)-13, a central mediator of atopic dermatitis inflammation. In this analysis, Blauvelt and colleagues assessed the durability of response with long-term tralokinumab use, given with optional topical corticosteroids (TCS), and identified sustained benefit predictors.

In this post-hoc study, investigators evaluated patients included in the phase 3 ECZTRA 3 trial (NCT03363854) who were shown to have responded at the 16-week mark to tralokinumab 300 mg every 2 weeks (Q2W) with optional TCS. These subjects subsequently carried on with their treatment in the open-label extension ECZTEND (NCT03587805). At 16 weeks, responders were defined as those who attained at least a single one of the following: a Dermatology Life Quality Index score of 0 or 1 (DLQI 0/1), ≥75% or 90% reduction from baseline in their Eczema Area and Severity Index (EASI-75 or EASI-90) scores, or a combined EASI-90 plus DLQI 0/1 response.

Blauvelt et al described those who reached EASI-90 as “super responders.” They evaluated patients’ outcomes through Week 120 of the ECZTEND study, representing up to 3 years of treatment with the drug. Absolute EASI scores were assessed at the 16-week mark as predictors of long-term outcomes among EASI-75 and EASI-90 responder subgroups.

By the 16-week mark in ECZTRA 3, Blauvelt and coauthors found that response rates among subjects were as follows: 56% attained EASI-75, 33% attained EASI-90, 25% attained DLQI 0/1, and 15% attained both EASI-90 and DLQI 0/1. Among these individuals, 86%, 92%, 81%, and 90%, respectively, entered the ECZTEND study. At least 60% of subjects in each category of response, by the 120-week mark, remained on the medication.

The investigative team noted that discontinuations due to lack of efficacy or adverse events did not go over 13%. Among both the EASI-75 responders and those labeled as super responders, a stable trajectory of ≥90% improvement in mean EASI scores from baseline throughout ECZTEND was observed.

Among these participants, the team concluded that lower absolute EASI values at the 16-week mark were strongly predictive of long-term improvement (

 < .0001). Among individuals who attained scores of EASI-90 with DLQI 0/1 at 16 weeks, Blauvelt and colleagues concluded that more than 48% were able to sustain this composite response at each of the subsequent assessments up to the 120-week mark.

For any additional information on late-breaking data presented at EADV, view the 

Blauvelt A, Ardern-Jones M, Guttman-Yassky E, et al. Initial “Super Response” to Tralokinumab Leads to Stable Long-term Response in Patients with Moderate-to-Severe Atopic Dermatitis: Responder and Predictor Analysis from the ECZTRA 3 & ECZTEND Trials. September 19, 2025. Accessed September 20, 2025. Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.


Articles

Tralokinumab demonstrates sustained clinical benefits for individuals with moderate-to-severe atopic dermatitis over a three-year period, despite fluctuating individual response patterns. The findings, presented at the 2025 EADV Congress, highlight tralokinumab's role in inhibiting IL-13, a key mediator of atopic dermatitis inflammation. The study evaluated patients from the ECZTRA 3 trial who responded to tralokinumab at 16 weeks and continued treatment in the ECZTEND extension. Lower absolute EASI scores at 16 weeks were predictive of long-term improvement, with a significant portion maintaining their response over 120 weeks.

These data from the ECZTRA 3 and ECZTEND trials highlight tralokinumab’s impact on patients with atopic dermatitis long-term.

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ECZTEND: Tralokinumab Use Leads to Stable Long-Term Effects in Atopic Dermatitis

Stephan Weidinger, MD, PhD, professor and chair for Dermatology at the Christian-Albrechts-University and director of the Department of Dermatology and Allergy at the University Hospital Schleswig-Holstein.

European Academy of Dermatology and Venereology (EADV) 2025 Congress

 suggest that temtokibart, an investigational monoclonal antibody targeting the IL-22RA1 receptor subunit, may represent a novel therapeutic strategy for adults with moderate-to-severe 

“These results are promising, as they provide further evidence of the value of targeting the IL-22 pathway in AD, via IL-22RA1 , offering a potential novel approach to the currently existing therapies used to treat atopic dermatitis” said Stephan Weidinger, MD, PhD, professor and chair for Dermatology at the Christian-Albrechts-University, director of the Department of Dermatology and Allergy at the University Hospital Schleswig-Holstein,

The late-breaking phase 2b trial randomized 262 adult patients with moderate-to-severe atopic dermatitis to 1 of 4 temtokibart dose arms or placebo. The study was designed to evaluate efficacy, measured by percent change in Eczema Area and Severity Index (EASI) from baseline to week 16, and safety, assessed by treatment-emergent adverse events.

At week 16, temtokibart demonstrated significant improvements in EASI scores compared with placebo across multiple dosing groups:

Investigators pointed out improvements emerged as early as week 1 with the 450 mg (−22.3%; P < .01) and 300 mg (−19.6%; P < .05) doses, and by week 2 with the 600 mg arm (−35.0%; P < .05), while placebo achieved −8.0% at week 1 and −22.7% at week 2. Efficacy was maintained through week 32 in the 600 mg (−59.1%; P < .05) and 300 mg (−60.6%; P < .05) cohorts, despite no treatment beyond week 14.

In a companion presentation, investigators shared results from a biomarker analysis of the phase 2b trial. Among 22 patients randomized to temtokibart, gene expression data from 14 patients out to 16 weeks revealed a 97% improvement in immune gene expression and significant restoration of epidermal barrier–related genes. Reductions in EASI and SCORAD scores correlated with decreases in Th2 and Th17/22 markers (P ≤ .05), while improvements in DLQI and POEM correlated with reductions in key T-cell and inflammatory markers.

For more on the results of this study and how it informs the potential of temtokibart in atopic dermatitis, check out our interview with Weidinger from the conference floor at EADV 2025.

Understanding Temtokibart's Potential in Atopic Dermatitis, With Stephan Weidinger, MD, PhD

Relevant disclosures for Weidinger include AbbVie, Almirall, Galderma, Kymab, LEO Pharma, Eli Lilly and Company, Pfizer, Regeneron, La Roche Posay, and Sanofi.

Leo Pharma. LEO Pharma presents two late-breaking abstracts for temtokibart reporting positive Phase 2b efficacy, safety and biomarker results in moderate-to-severe atopic dermatitis at the 2025 EADV Annual Meeting in Paris. Leo-pharma.com. Published September 17, 2025. Accessed September 18, 2025. 

https://www.leo-pharma.com/media-center/news/2025-temtokibart-late-breaker-press-release

 IL-22RA1 antagonism with temtokibart provides significant early and sustained improvements in atopic dermatitis: results from a phase 2b dose-finding trial

. Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

 Temtokibart, an IL-22RA1 Monoclonal Antibody broadly dampens gene expression markers of activated immune pathways in Atopic Dermatitis: Results from a Phase 2b Trial Subgroup Analysis. 

Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

Videos

Weidinger discusses results from a pair of late-breaking presentations on temtokibart in atopic dermatitis from EADV 2025.

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New 3-year data from the ALLEGRO clinical trial program, presented at the 

, highlight the sustained efficacy and safety of ritlecitinib (Litfulo) for 

“We see retention of clinical benefit achieved at month 12 maintained at month 36 in approximately 90% of patients, but, again, we see achievement of SALT score zero, so 0% terminal scalp hair loss in about 30% of patients out at month 36,” said study presenter Brett King, MD, PhD, associate professor of Dermatology in the Department of Dermatology at Yale University School of Medicine, in an interview with HCPLive. “So really, really important data and tells us a lot about what we can do or what we can expect with treatment with ritlecitinib, for our patients with severe alopecia areata.”

Ritlecitinib is part of a wave of JAK inhibitors transforming the treatment landscape for alopecia areata, a disease that had no US Food and Drug Administration (FDA)-approved therapies until 2022. Since then, baricitinib (Olumiant), ritlecitinib, and deuruxolitinib (Leqselvi) have all gained regulatory approval, marking a rapid revolution in therapeutic options.

The analysis at EADV 2025 demonstrated that 65.1% of patients (observed) and 47.1% (LOCF) maintained a SALT score ≤20 at 36–38 months. Among those achieving this threshold at 12 months, nearly 90% maintained response through three years, underscoring the durability of treatment. Importantly, 29.8% of patients achieved complete scalp hair regrowth (SALT = 0), with more than 60% of this group maintaining regrowth without relapse at later visits.

Additional endpoints presented at EADV Congress 2025 reinforced the findings. Among patients who achieved complete regrowth at least once during the study, 84.2% sustained a SALT score ≤5 at later time points. Improvements were also observed in eyebrow and eyelash regrowth, with approximately 60% of patients demonstrating response at 36–38 months.

The long-term safety profile of ritlecitinib was consistent with earlier reports, with no new safety signals emerging during the follow-up period.

For more on the significance of these findings, check out our interview with King from the floor at EADV Congress 2025.

Long-Term Treatment with Ritlecitinib for Alopecia Areata, With Brett King, MD, PhD

Relevant disclosures for King include AbbVie, AltruBio Inc, Almirall, Amgen, AnaptysBio, Apogee Therapeutics, Arena Pharmaceuticals, Aslan Pharmaceuticals, BiologicsMD, Bristol Meyers Squibb, Concert Pharmaceuticals, Eli Lilly, Equillium, Horizon Therapeutics, Eli Lilly and Company, Incyte, Janssen Pharmaceuticals, LEO Pharma, Merck, Otsuka/Visterra, Pfizer, Q32 Bio, Regeneron, Sanofi Genzyme, Sun Pharma, Takeda, TWi Biotechnology, and Ventyx Biosciences.

 Long-term efficacy and complete scalp hair regrowth in patients with alopecia areata receiving ritlecitinib 50 mg QD up to 3 years in the ALLEGRO clinical trial program

. Presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

Pfizer Inc. FDA Approves Pfizer’s LITFULO

 (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata | Pfizer. www.pfizer.com. Published June 23, 2023. Accessed September 19, 2025. 

https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-litfulotm-ritlecitinib-adults-and

Eli Lilly and Company. FDA Approves Lilly and Incyte’s OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata | Eli Lilly and Company. Eli Lilly and Company. Published June 13, 2022. Accessed September 19, 2025. 

https://investor.lilly.com/news-releases/news-release-details/fda-approves-lilly-and-incytes-olumiantr-baricitinib-first-and

National Alopecia Areata Foundation. FDA Approves LEQSELVI

 for Adults with Severe Alopecia Areata - National Alopecia Areata Foundation | NAAF. National Alopecia Areata Foundation | NAAF. Published July 26, 2024. Accessed September 19, 2025. 

https://www.naaf.org/news/fda-approves-leqselvi-deuruxolitinib-for-adults-with-severe-alopecia-areata/

New data reveals ritlecitinib's long-term efficacy for alopecia areata, showing sustained hair regrowth in 30% of patients after 3 years.

Alopecia

Chih-ho Hong, MD, FRCPC, is a board certified dermatologist from Vancouver, BC, who runs a community based dermatology clinic with a focus on clinical investigations.

 suggest temtokibart, an investigational monoclonal antibody designed to target the interleukin (IL)-22RA1 receptor subunit, was linked with significant improvements in different measures of disease severity and activity for atopic dermatitis biomarkers.

These data were announced by LEO Pharma and presented at the 

 team sat down with Chih-ho Hong, MD, FRCPC, a trial investigator on this phase 2b randomized, double-blind trial (NCT05923099), to discuss the findings on temtokibart.

Discussing Phase 2b Findings on Temtokibart for Atopic Dermatitis, With Chih-ho Hong, MD, FRCPC

“Temtokibart is a new molecule that's being looked at for treatment of moderate-to-severe atopic dermatitis,” Hong explained. “It's a monoclonal antibody that specifically blocks the IL-22 receptor alpha subunit. It blocks IL-22 signaling, but it also blocks some other cytokines that use this receptor as well. So there's going to be some downstream modulation of a number of cytokines because of the blockade of temtokibart. In this phase 2 dose-ranging study, there were four different doses that were looked at compared to placebo.”

The primary endpoint Hong and coauthors had evaluated was patients’ percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 16. A key secondary endpoint was the number of treatment-emergent adverse events at the same timepoint.

“We found that temtokibart was able to reduce the EASI score in different doses compared to placebo,” Hong said. “So that was very helpful in validating that this is a pathway that's relevant in atopic dermatitis. By blocking this pathway, we can achieve a clinical and therapeutic effect in patients with atopic dermatitis, suggesting that a larger phase three program should be done to fully elucidate the efficacy and safety of this molecule.”

Hong also highlighted the significance of the findings for atopic dermatitis, noting the current prevalence of biologics blocking IL-13 signaling.

“We know that IL-22 is highly expressed by keratinocytes in the epidermal layer, and so potentially targeting something in the epidermis that's keratinocyte-related is another mechanism of action that we can utilize for our patients,” Hong said. “One of the challenges right now is that not all patients respond to the level that we would like with the currently available biologics, and some patients will develop adverse events. One of the notable findings from the phase two temtokibart study is that conjunctivitis and ocular side effects were not really identified in patients treated with temtokibart, which makes it quite different than the currently available biologics.”

For any additional information on late-breaking findings presented at EADV, view the latest coverage of the conference.

Hong has reported serving as an investigator, speaker, consultant, and advisory board member for Abbvie, Amgen, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Leo Pharma, Medimmune, Novartis, Pfizer, Roche, Regeneron, Sanofi Genzyme, and Valeant.

Leo Pharma. LEO Pharma presents two late-breaking abstracts for temtokibart reporting positive Phase 2b efficacy, safety and biomarker results in moderate-to-severe atopic dermatitis at the 2025 EADV Annual Meeting in Paris. Leo-pharma.com. Published September 17, 2025. Accessed September 20, 2025. 

Campbell P. Temtokibart Shows Benefit, Effect on Biomarkers in Phase 2b Atopic Dermatitis Trial. HCPLive. September 18, 2025. Accessed September 20, 2025. 

https://www.hcplive.com/view/temtokibart-shows-benefit-effect-on-biomarkers-in-phase-2b-atopic-dermatitis-trial

In this interview at EADV, Hong speaks about his team’s findings on IL-22RA1 antagonism with temtokibart and its impact on atopic dermatitis.

New findings from the BRAVE-AA clinical trial program presented at the 

 highlight the potential of baricitinib (Olumiant) to deliver not only significant scalp regrowth but also complete scalp hair restoration in both adults and adolescents with severe 

“It just gives us so much hope of truly changing the lives forever of these very young people who are suffering a really devastating disease,” explained study presenter Brett King, MD, PhD, associate professor of Dermatology in the Department of Dermatology at Yale University School of Medicine, in an interview with HCPLive.

Baricitinib, a selective JAK inhibitor and the first FDA-approved systemic therapy for severe alopecia areata in adults, was studied in adolescents aged 12 to <18 years through the BRAVE-AA-PEDS trial.

This analysis focused on patients who achieved a Severity of Alopecia Tool (SALT) score ≤20 and evaluated deeper response thresholds of SALT ≤10 and SALT ≤5 over time.

Among adults treated with baricitinib 4 mg, 74.6% of responders achieved SALT ≤10 by week 36, with rates remaining stable at 75.0% at week 52. Similarly, 55.2% achieved SALT ≤5 at Week 36, increasing to 62.7% by week 52.

In adolescents, outcomes were even more robust. At week 36, 86.1% achieved SALT ≤10 and 61.1% achieved SALT ≤5. Of note, some patients in both groups reached these thresholds as early as week 8, which King suggests underscores the drug’s potential for rapid regrowth.

The findings reinforce the growing recognition that treatment goals in alopecia areata are shifting beyond partial regrowth toward full scalp restoration. For many patients, a SALT score of 10, 5, or even 0 represents the ultimate target, and baricitinib demonstrated the ability to deliver these outcomes across both adult and adolescent populations.

For more information on this study and its potential to inform the treatment of alopecia areata in adults and adolescents, check out our interview with King from the conference floor at EADV 2025.

Baricitinib Response Deepens Overtime in Alopecia Areata, With Brett King, MD, PhD

 Most Baricitinib Responders Achieved Full Scalp Hair Regrowth: Findings from Adult and Paediatric BRAVE-AA Trials

Adolescents with alopecia areata show promising treatment responses, highlighting the need for diverse therapeutic options to improve outcomes.

Baricitinib Response Deepens Over Time in Alopecia Areata, With Brett King, MD, PhD

This interview segment with Bunick at EADV highlights some of the significance of these recent findings on cardiovascular risk and upadacitinib use over 6 years. 

Significance of Cardiovascular Data on Upadacitinib for Atopic Dermatitis, With Christopher Bunick, MD, PhD

These late-breaking data at EADV highlight the impacts of ATI-2138, an oral small-molecule ITK/JAK3 inhibitor, on atopic dermatitis.

New Phase 2a Data Support Oral ATI-2138 as Treatment for Atopic Dermatitis

Abigail Brooks is an assistant 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 offers the flexibility of self-administration from the start of treatment for UC, building on the prior approval of SC induction in Crohn’s disease.

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FDA Approves Guselkumab (Tremfya) Subcutaneous Induction Regimen for Ulcerative Colitis

Chair, Department of Dermatology, Dartmouth Health, and Professor of Dermatology, Geisel School of Medicine, Dartmouth University

Chapman discussed further research to be done with PDT for basal cell carcinoma.

Going Deeper With Photodynamic Therapy for BCC, With M. Shane Chapman, MD, MBA

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EADV 2025 findings show patients with atopic eczema face greater risks of depression, anxiety, sleep disorders, and stigmatization.


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Atopic Eczema Linked to Suicidal Ideation in Global Study of 30,000 Adults

The guideline offers 12 conditional recommendations for the diagnosis and management of gastroparesis, emphasizing individualized care and calling for more research.

AGA Releases Gastroparesis Clinical Practice Guideline, Highlights Unmet Needs

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.

Investigators formulated a series of hypothetical situations to test the overall economic impact of introducing lonapegsomatropin into the growth hormone market.

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Lonapegosmatropin For Treatment of Pediatric GHD Reduces Overall US Health Plan Costs

In this EADV interview, Bunick touches on his team’s findings related to risk of VTE, MACE, and malignancy in patients with atopic dermatitis treated with upadacitinib for 6 years.

Cardiovascular Risk and Upadacitinib Treatment for Atopic Dermatitis, With Christopher Bunick, MD, PhD

Tessa Janovsky, PA-C, is a physician assistant at Arizona Liver Health.

Janovsky describes the importance of early identification, the new treatment options available for MASH, and the continued importance of diet and exercise.

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From Basics to Breakthroughs: Advances in MASH Care, With Tessa Janovsky, PA-C

In this analysis, the long-term cardiovascular safety of upadacitinib treatment for atopic dermatitis was highlighted.

Latest News

ECZTEND: Tralokinumab Use Leads to Stable Long-Term Effects in Atopic Dermatitis

Understanding Temtokibart's Potential in Atopic Dermatitis, With Stephan Weidinger, MD, PhD

Long-Term Treatment with Ritlecitinib for Alopecia Areata, With Brett King, MD, PhD

Discussing Phase 2b Findings on Temtokibart for Atopic Dermatitis, With Chih-ho Hong, MD, FRCPC

Baricitinib Response Deepens Over Time in Alopecia Areata, With Brett King, MD, PhD