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Atopic Dermatitis Provider Toolkit

Adult Immunization Provider Toolkit

Dermatology Hot Topics

1rem

Authors

"Seemingly insignificant impacts on a patient can really change the trajectory of their life so it's very important to treat [atopic dermatitis] early."

Why is Early Treatment of Atopic Dermatitis So Important? Mona Shahriari, MD, Says it Could Change a Life

 Revolutionizing Atopic Dermatitis (RAD) 2025 

meeting in Nashville this month, Mona Shahriari, MD, assistant clinical professor of 

 at the Yale University School of Medicine, gave a presentation titled, "The Psychosocial Impact of Atopic Dermatitis" that focused on the cumulative life course impairment associated with the disease. During an interview at the meeting, 

 asked Shahriari what she hoped might be different in understanding of the emotional 

 if she made the same presentation at RAD 2026. 

"One moment during the session really struck me. I asked the audience how many were familiar with the term cumulative life course impairment. Only 3 or 4 hands went up. That was eye-opening," she said. Her hope for what might be different about this talk next year reflects what she hopes dermatologists at this year's meeting took home with them: 

When a patient with AD walks into your clinic, it might feel like just another rash on the schedule. But for them, it could be the reason they don’t leave the house. It could be the reason they don’t fall in love. It could be the reason they stop dreaming. Taking the time to ask the right questions, to understand the full burden of disease, and to start effective treatment—those things can genuinely transform lives.

Shahriari said she hopes that the research in the area of cumulative life course impairment in AD will have progressed and awareness increased so that when she asks the same question next year, there will be just 3 or 4 hands that do not go up. 

Mona Shahriari, MD is an assistant clinical professor of dermatology at Yale University School of Medicine in New Haven, CT and co-founder of Central Connecticut Dermatology in Cromwell, CT. 

For more RAD 2025 meeting coverage, please click here.

Atopic dermatitis is not just "another rash on the schedule. It could be the reason that patient doesn't leave the house," Shahriari says.

Clinical Topics

Toolkits

Why Is Early Treatment of Atopic Dermatitis So Important? Mona Shahriari, MD, Says It Could Change a Life

In the phase 3 ROCKET-SHUTTLE clinical trial, the 

, given every 4 weeks with background topical corticosteroids (TCS) and/or calcineurin inhibitors (TCIs), achieved significant improvements in signs and symptoms of 

compared with placebo, according to findings presented Thursday in a late-breaking abstract session at the European Academy of Dermatology and Venerology 2025 Annual Meeting in Paris, September 17-20, 2025.

At week 24, presenting author Eric Simpson, MD, professor of Dermatology, Oregon Health & Science University, Portland, Oregon, and colleagues observed Eczema Area and Severity Index (EASI)-75 responses in 52.3% of study participants receiving rocatinlimab 300 mg and 54.1% of those on 150 mg, vs approximately half that number (23.5%) among placebo-treated participants (

 <.001 for both). Similarly, 26.1% and 25.8% of participants in the respective active treatment arms achieved validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear), with a 2-point or greater reduction from baseline, compared with 12.2% of placebo-treated participants (

ROCKET-SHUTTLE enrolled 746 adults with inadequate response to prior medium-to-high potency topical corticosteroids or topical calcineurin inhibitors, nearly 60% of whom had previously received systemic therapy and one quarter prior biologics or JAK inhibitors. 

Simpson et al randomly assigned participants to rocatinlimab 300 mg, rocatinlimab 150 mg, or placebo in a 5:4:4 ratio. In all cases, background low-to-medium potency topical agents were tapered according to clinical response.

The late-stage trial also met key secondary endpoints, including EASI-90 and earlier achievement of EASI-75 and vIGA-AD 0/1 at week 16. Investigators observed progressive improvement without evidence of plateau at week 24, suggesting the potential for continued benefit beyond the treatment window studied, according to the study abstract.

Simpson and the research team reported adverse events (AEs) at similar rates across arms (71.5% in both rocatinlimab groups vs 67.2% in the placebo group). Results showed that infections also occurred in approximately similar proportions of each group: 35.4% of the 300-mg group, 39.9% of the 150-mg group, and 38.0% of the placebo group. The authors also observed serious adverse events more frequently with rocatinlimab (3.1% at 300 mg; 4.4% at 150 mg) than with placebo (0.9%). However, no specific event category was reported in more than 1 participant. Discontinuations due to severe AEs was reportedly infrequent (1.8% or less across groups).

These findings add to earlier monotherapy results from the 

 trials, supporting the therapeutic potential of OX40 receptor blockade in AD. 

The pathogenesis of atopic dermatitis is closely tied to T-cell–driven immune dysregulation, with OX40 signaling on activated T cells serving as a central amplifier of chronic inflammation and disease flares. Rocatinlimab (Amgen, Kyowa Kirin) is a first-in-class, humanized monoclonal antibody that targets the OX40 receptor to reduce pathogenic T-cell activity and restore immune balance. It is by interrupting this co-stimulatory pathway that the therapy both reduces  inflammation and, importantly, also to influence the long-term course of disease. 

"In a diverse, treatment-experienced AD patient population failing prior topicals, [rocatinlimab] with concomitant TCS (low-to-medium potency)/TCI demonstrated statistically significant and clinically meaningful improvements vs [placebo] in AD clinical signs and symptoms with progressive efficacy and no plateau at week 24," Simpson et al concluded in the study abstract.

Rocatinlimab’s ability to enhance disease control when combined with standard topical treatments underscores its potential role as a T-cell–rebalancing therapy in a treatment landscape increasingly guided by immunologic endotypes.

Simpson E. Rocatinlimab with concomitant topical therapy significantly improved clinical signs and symptoms of atopic dermatitis in adults: Results from the phase 3 ROCKET-SHUTTLE trial. Presented at: 2025 European Academy of Dermatology and Venerology Congress; September 17-20; Paris, France.

Abdelhalim A, Yilmaz O, Berair ME, Torres T. A narrative review of the OX40-OX40L pathway as a potential therapeutic target in atopic dermatitis: Focus on rocatinlimab and amlitelimab. 

 (Heidelb). 2024;12:3197-3210. doi:10.1007/s13555-024-01308-8

EADV 2025: Phase 3 ROCKET-SHUTTLE results showed the T-cell rebalancing therapy significantly improved AD signs and symptoms in treatment-experienced adults. 

OX40 Inhibitor Rocatinlimab Shows Significant Response in Combination with Topical Therapy for AD 

 brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The 

provides a concise summary of one of the website's leading stories you may not have seen.

On August 15, 2025, we reported on the US FDA approval of semaglutide 2.4 mg (Wegovy; Novo Nordisk) for the treatment of noncirrhotic metabolic dysfunction–associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (stages F2 to F3), in combination with a reduced-calorie diet and increased physical activity.

The accelerated approval for semaglutide was based on part 1 of the phase 3 ESSENCE trial, which met its primary endpoints. At week 72, 36.8% of patients receiving semaglutide achieved improvement in liver fibrosis with no worsening of steatohepatitis compared with 22.4% receiving placebo. Resolution of steatohepatitis with no worsening of liver fibrosis occurred in 62.9% of patients in the semaglutide group compared with 34.3% in the placebo group.

ESSENCE is a two-part, 240-week trial randomizing 1,200 adults with MASH and F2–F3 fibrosis to semaglutide 2.4 mg or placebo in addition to standard of care. Part 1 assessed histologic outcomes at 72 weeks; part 2 will evaluate whether semaglutide reduces the risk of liver-related clinical events, with results expected in 2029.

Wegovy was first approved in 2021 for chronic weight management in adults with obesity or overweight with weight-related comorbidities, and its indications have since expanded to include adolescents with obesity and cardiovascular risk reduction in certain adults with obesity or overweight.

Your daily dose of the clinical news you may have missed.

FDA News

FDA OKs Semaglutide 2.4 mg for Treatment of MASH Without Cirrhosis: Daily Dose

Routine corticosteroid use after emergency department (ED) discharge for mild to moderate pediatric anaphylaxis offered no significant benefit in preventing return visits within 7 days, according to recent findings published in the journal  

The researchers found that 4.4% of children who received dexamethasone revisited a healthcare facility compared with 6.7% of those who received placebo, yielding an absolute risk reduction of just 2.3% (95% CI, –5.8 to 8.3%) and an estimated number needed to treat (NNT) of 44 (95% CI, 12 to ∞; 

Corticosteroids remain a common adjunct to epinephrine and antihistamines in the treatment of anaphylaxis, particularly in hospitalized patients, study authors wrote. Observational studies have suggested that steroids may shorten hospital stay for severe cases, but evidence for their role after ED discharge has been lacking. They pointed out that clinical practice guidelines from both US and European professional organizations recommend  corticosteroids as optional therapy for children following an ED stay for anaphylaxis. 

Do OCS Offer Meaningful Protection Against Recurrence? 

Previous research, specifically a large 2015 retrospective cohort study including 5052 children discharged from an ED following anaphylaxis, found that fully two-thirds (66%) received corticosteroids.

 Within 3 days, the study authors emphasized, 5% of both steroid-treated and untreated children returned to the ED, punctuating the question of whether or not steroids offer meaningful protection against post-discharge symptom recurrence.

“To our knowledge, this is the first randomized clinical trial to test the effect of steroids in decreasing anaphylactoid reaction in pediatric patients treated for mild-moderate anaphylaxis,” study investigators Rafah Al Sayyed, MD, from Hamad Medical Corporation, and Khalid Alansari, MD, FRCPC, FAAP, from Weill Cornell Medical College and Qatar University Medical College," wrote.

Corticosteroids following resolution of anaphylaxis should be chosen with clear, clinical rationale and reserved for select children, study authors concluded.

Grace Halsey

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