Q3 2025 Recap: Dermatology News and Updates

As Q3 draws to a close, the HCPLive team reviews pivotal updates across the field of dermatology, with new findings advancing the treatment landscape in psoriasis, atopic dermatitis, alopecia areata, and hidradenitis suppurativa (HS) having been released in this period. This quarter saw encouraging data from research into topical and systemic therapies alike, including recent safety findings on roflumilast cream 0.05% in infants and toddlers with atopic dermatitis, promising biomarker-driven outcomes seen in phase 2b trials on temtokibart, and more.

In all, these recent findings underscore the continued expansion of targeted and age-inclusive dermatologic disease treatment options for chronic inflammatory skin conditions. This quarter also delivered significant decisions by US Food and Drug Administration (FDA) officials, broadening the armamentarium of dermatologic therapies and marking continued progress toward personalized, patient-centered care. The following review highlights some of the most notable news coverage from the months of July, August, and September in dermatology:

Q3 FDA Decisions

Delgocitinib (Anzupgo) Scores FDA Approval for Chronic Hand Eczema

Delgocitinib (Anzupgo) cream was approved in Q3 for patients with moderate-to-severe chronic hand eczema (CHE). The FDA's July decision regarding LEO Pharma's topical option for CHE, allows for a new addition to the treatment armamentarium in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. The approval of delgocitinib was based upon DELTA 1 and DELTA 2 clinical study findings.

FDA Approves Remibrutinib for Chronic Spontaneous Urticaria

In a September decision by the FDA, remibrutinib (Rhapsido), a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, was approved for adult patients with with chronic spontaneous urticaria (CSU). The September 30 announcement by Novartis highlighted that patients with CSU will now be given access to an alternative, oral option for their CSU, assuming their symptoms have remained uncontrolled despite their use of antihistamines.

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

Another FDA approval from Q3 was for guselkumab (Tremfya) by Johnson & Johnson, indicated for children ≥ 6 years of age who weigh ≥ 40 kg (88 lbs) and have moderate to severe plaque psoriasis. This approval by the FDA made guselkumab the first and only interleukin (IL)-23 inhibitor approved for these pediatric indications, building upon earlier FDA approval in adults living with moderate to severe plaque psoriasis in 2017. Patients who qualify, according to the announcement by J&J, will be candidates for systemic therapy or phototherapy.

FDA Approves Ruxolitinib Cream for Pediatric Patients with Atopic Dermatitis

The Incyte Corporation’s ruxolitinib cream (OPZELURA) was approved in September for children in the age range of 2 - 11 years with moderate-to-severe atopic dermatitis. This indication for ruxolitinib cream in those with atopic dermatitis specified the drug's use in the short-term and for non-continuous chronic treatment among children who are non-immunocompromised and aged ≥ 2 years. This decision by the FDA follows positive phase 3 TRuE-AD3 trial findings.

FDA Approves Beremagene Geperpavec-svdt (Vyjuvek) Label Update in DEB

Krystal Biotech released a label update in September 2025 for beremagene geperpavec-svdt (Vyjuvek), expanding the medication's eligible patient population to include individuals living with dystrophic epidermolysis bullosa (DEB) from the time of their birth. The label update allows individuals with this condition full flexibility in the application of beremagene geperpavec-svdt application. It also allows for flexibility with wound dressing management, given that those with the condition are now permitted to remove as part of the next dressing change rather than waiting 24 hours.

Q3 Updates in Atopic Dermatitis

Safety of Roflumilast Cream 0.05% in Infants and Toddlers with Atopic Dermatitis, with Adelaide Hebert, MD

In an interview conducted in Q3, Adelaide Hebert, MD, professor and director of pediatric dermatology with McGovern Medical School at UTHealth Houston, spoke about roflumilast cream 0.05% (Zoryve) and findings suggesting the drug as safe for patients aged 2 - 5 years with atopic dermatitis. These phase 2 findings resulted from the INTEGUMENT-INFANT trial program and were presented in a poster during the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference.

Phase 3 Data Show Amlitelimab Effective in Adults, Adolescents with Atopic Dermatitis

In findings released in September, amlitelimab treatment, administered every 4 or every 12 weeks, was shown to result in significant skin clearance as well as reduction in severity versus placebo among those with atopic dermatitis at the 24-week mark. Announced by Sanofi SA, these findings were the result of the global COAST 1 study assessing amlitelimab, a fully human, non–T-cell depleting monoclonal antibody directed against OX40-ligand (OX40L).

Temtokibart Shows Benefit, Effect on Biomarkers in Phase 2b Atopic Dermatitis Trial

During the European Association of Dermatology and Venereology (EADV) 2025 Congress, new phase 2b data provided new findings on the impact of temtokibart on adult patients with moderate-to-severe atopic dermatitis. These late-breaking data suggested that temtokibart, LEO Pharma’s investigational monoclonal antibody designed to target IL-22RA1 receptor subunit, was linked to significant improvements in different measures of disease severity and activity. There was an additional analysis highlighting the impacts of atopic dermatitis biomarkers.

Q3 Updates in Psoriasis

Phase 3 Findings Suggest Icotrokinra Effective in Adults, Adolescents with Psoriasis

In findings released from the ICONIC-LEAD study, icotrokinra use was shown to result in high rates of clear/almost clear skin as well as relief from moderate-to-severe psoriasis symptoms. These data also suggested a lack of new safety signals identified through 24 weeks of use. These poster data were presented at the DERM 2025 NP/PA CME Conference, and the research was authored by such investigators as Robert Bissonnette, MD, chairman at Innovaderm Research in Montreal, Canada.

Roflumilast Cream 0.3% Effective for Psoriasis in Children Aged 2 to 11 Years

New research also pointed to roflumilast cream 0.3% as improving signs and symptoms of plaque psoriasis among individuals with the condition aged 2 - 11 years under maximal use conditions. Such findings highlighted the tolerability, overall safety, pharmacokinetics (PK), and efficacy of roflumilast cream and were consistent with previous phase 3 findings in studies that had assessed subjects aged ≥ 2 years and maximal usage results among those in the ≥ 12-year age range.

Bimekizumab Outperforms Active Comparators in Clearing Skin, Nail Psoriasis

In another study highlighted from Q3, bimekizumab treatment was shown to lead to greater rates of complete clearance of psoriasis across both skin and nails, compared with ustekinumab, secukinumab, and adalimumab. This assessment of concurrent nail clearance and complete skin clearance among patients living with moderate-to-severe plaque psoriasis who were treated with bimekizumab or active comparators was authored by investigators such as Joseph F. Merola, MD, MMSc, from the Department of Dermatology and Department of Medicine at UT Southwestern Medical Center.

ICONIC-ADVANCE: Icotrokinra Beats Deucravacitinib for Plaque Psoriasis

In head-to-head findings on icotrokinra, Johnson & Johnson’s first-in-class investigational targeted oral IL-23 inhibitor, the drug was found to be superior to deucravacitinib (Sotyktu) for attainment of skin clearance at the 16 and 24-week marks in individuals with moderate-to-severe plaque psoriasis. These findings further suggest icotrokinra had similar adverse event rates to placebo, and the findings are supported by 52-week data from the ICONIC-LEAD study. Both of these were presented at EADV 2025.

Other Q3 Dermatology Updates

No Risk Increase for VTE in 6 Months of Baricitinib Therapy for Alopecia Areata

Patients living with alopecia areata who are candidates for baricitinib therapy were shown in another Q3 study not to be at an increased risk of developing venous thromboembolism (VTE). This observational research, conducted by such investigators as Giacomo Caldarola, MD, PhD, from the Dipartimento di Scienze Mediche e Chirurgiche at the Fondazione Policlinico Universitario A. Gemelli—IRCCS in Rome, followed an alert on VTE risk issued in January 2023 by the European Medicines Agency (EMA) which was linked to the use of Janus kinase inhibitors (JAKi) in chronic inflammatory conditions.

ALLEGRO 3-Year Data Demonstrate Effectiveness in Alopecia Areata for Adults, Adolescents

In a Q3 evaluation of 3-year data from individuals with alopecia areata in the ritlecitinib (Litfulo) clinical trial program at EADV, findings highlight the long-term efficacy of this JAK inhibitor in both adults and in pediatric populations. Ritlecitinib was noted as having demonstrated long-term efficacy in alopecia areata, with 90% maintaining SALT score ≤20 over 36-38 months and 30% attaining complete scalp hair regrowth.

BE HEARD: Bimekizumab Benefit in Hidradenitis Suppurativa Persists for 3 Years

Bimekizumab’s use among patients with HS was linked in another Q3 analysis with disease control lasting up to 3 years. These data, presented at EADV, resulted from the BE HEARD trial program, with findings demonstrating improvements seen in Hidradenitis Suppurativa Clinical Response (HiSCR) 75, HiSCR90, and HiSCR100 that were also sustained out to 3 years. This EADV presentation also highlighted other key efficacy and safety outcomes.