⚡First CSU Approval in a Decade

Good morning — it's Saturday, Apr. 26, and we're covering the first FDA-approved therapy for chronic spontaneous urticaria since omalizumab, new DELTA FORCE trial results published in The Lancet, and more.

First time reading? Sign up here.

Enjoying the newsletter? Share it with a friend or colleague — here’s the link.

P.S. You can send me feedback at [email protected]

Need To Know

Dupilumab Approved as First New CSU Therapy in Over a Decade

The FDA has approved Dupixent (dupilumab) for patients aged 12 years and older with chronic spontaneous urticaria who remain symptomatic despite antihistamine treatment. The biologic becomes the first new targeted therapy approved for chronic spontaneous urticaria in more than 10 years.

The FDA’s decision was based on results from replicate trials (Study A and Study C) of the LIBERTY-CUPID Phase 3 program. In both trials, antihistamine-resistant, omalizumab-naïve patients were randomized to receive dupilumab or placebo while continuing background antihistamines. At week 24, 41%–46% of those treated with dupilumab achieved well-controlled disease (UAS7 ≤6) versus 23%–24% on placebo (P < 0.05). Approximately 30% of dupilumab-treated patients achieved complete symptom resolution (UAS7 = 0).

Study B evaluated dupilumab in patients who were inadequately responsive or intolerant to omalizumab, demonstrating smaller improvements in urticaria activity that reached only marginal statistical significance. Following an interim analysis, the trial team stopped the study early due to futility.

Safety results across all three trials were consistent dupilumab’s known profile.

Dupixent is now approved for seven diseases driven by type 2 inflammation, potentially offering a single therapy for patients with multiple overlapping conditions. It is already approved for chronic spontaneous urticaria in Japan, the United Arab Emirates, and Brazil.

Quick Hits

> Topical Delgocitinib Outperforms Oral Alitretinoin in Chronic Hand Eczema Trial: The DELTA FORCE phase 3 trial, published in The Lancet, confirmed the superiority of topical delgocitinib cream over oral alitretinoin for severe chronic hand eczema in patients with an inadequate response or contraindication to topical corticosteroids. Among 503 randomized participants, 39% of delgocitinib-treated patients achieved at least a 90% reduction in hand eczema severity (HECSI-90) at week 12, compared to 26% on alitretinoin (p=0.003). Clear or almost clear skin (IGA-CHE 0/1 with ≥2-step improvement) was attained by 27% of patients on delgocitinib versus 17% on alitretinoin (p=0.004). Safety favored delgocitinib, with fewer adverse events (49% vs 76%). Discontinuation due to adverse events was also five-fold lower with delgocitinib (2% vs 10%). Delgocitinib is now approved in the European Union and United Kingdom, offering a topical alternative to alitretinoin—the previously sole approved systemic treatment for severe chronic hand eczema.

> AVAVA’s MIRIA Laser Earns FDA Clearance for Acne Scarring: AVAVA’s MIRIA laser system, powered by proprietary Focal Point Technology™, has received FDA clearance for treating acne scarring. The 1550 nm laser uses a conical beam to create precise, deeper zones of intradermal coagulation while sparing the epidermis. FDA Clearance was supported by a prospective, multi-center trial of 47 adults. More than 90% of participants showed improvement, with a median 50% reduction in scar severity. Several patients achieved complete response. Notably, 87% of patients were treated at energy levels of 120 mJ or higher, and some reached 150 mJ—thresholds beyond the safe delivery range of conventional lasers. Redness and swelling resolved within two days. Pain scores averaged just 3 out of 10. With 75% of trial participants identifying as Black, Asian, or Hispanic, MIRIA may help close a long-standing gap in acne scar management—offering an effective solution that is safe across all skin tones.

> Higher Sunscreen Cost Reduces Use: A cross-sectional study published in JAAD suggests that higher sunscreen cost may influence how much product people apply, raising concerns about the affordability of adequate sun protection. The study enrolled 88 adults using 32 different sunscreen brands. Using linear regression, researchers found that for every $10 increase in cost, participants applied 11.5% less sunscreen. Only price and application site—not age, gender, or SPF—were significantly associated with the amount applied. In a sample of four comparable sunscreens—each with similar SPF and active ingredients—prices varied dramatically, from $0.58 to $20 per ounce. The authors urge clinicians to consider price when advising on sunscreen use.

> Hoth Therapeutics Reports Interim Success With HT-001 for EGFR-Related Itch: Hoth Therapeutics announced positive interim Phase 2a results for HT-001, a topical neurokinin-1 receptor antagonist developed to relieve pruritus associated with epidermal growth factor receptor inhibitor therapy in cancer patients. In the open-label phase of the CLEER-001 study, patients experienced a 50% decrease in mean itch scores by Day 21. Early improvements were visible by Day 7, and several patients achieved complete itch resolution. No treatment-related serious adverse events were reported. HT-001 blocks the Substance P–neurokinin-1 receptor pathway, a key driver of neurogenic inflammation. The ongoing trial includes a randomized, double-blind phase to further validate these findings. 

> Tofacitinib’s Pros and Cons in Prurigo Nodularis: In a prospective, 16-week study of 24 adults with refractory prurigo nodularis, tofacitinib showed early efficacy, though its therapeutic effect diminished over time. Mean Investigator Global Assessment (IGA) scores improved to 2.4 at week 12 before declining to 1.9 by the end of the study. The IGA scale ranges from –5 (worsening) to +5 (marked improvement), with positive scores reflecting clinical response. Similarly, although 75% of patients achieved a ≥4-point reduction in itch severity on the WI-NRS (0–10 scale) by week 12, this figure declined to 67% at week 16. No serious adverse events were reported. While findings are encouraging, the small sample, lack of controls, and waning efficacy over time underscore the need for randomized trials.

Derm Picks

Quizzes, cases, and perspectives to sharpen your clinical eye.

🖼️ Image Challenge

• A 24-year-old with brown atrophic patches following Blaschko’s lines (View)

• A 3-year-old with papules and ulcerated plaques on his left leg (View)

• A large pruritic plaque in a patient with two kidney transplants (View)

• Plaques and ulcers on the lower legs of a 58-year-old woman (View)

🔎 Under the Dermatoscope

• Dermoscopy of nailfold capillaries and Gottron's papules (View)

📚 Guides & Reviews

• Digital photography guide for dermatologists (paywall restricted) (Read)

• Canadian consensus guidelines for the management of vitiligo (Read)

• Augmented intelligence and dermatology (paywall restricted) (Read Part I and Part II)

• All things acids: a primer on alpha hydroxy, beta hydroxy, and polyhydroxy acids (Read)

More News To Know

In a multicenter real-world study of adults aged over 50 with moderate-to-severe atopic dermatitis treated with upadacitinib, 66% achieved minimal disease activity by week 16; among the 13 with available data at week 52, 85% maintained response. Adverse events were mild across the cohort, with only one discontinuation due to headache (More)

In a global multicenter, propensity-matched cohort of 6,316 women with alopecia areata or atopic dermatitis on JAK inhibitors, oral contraceptive use did not increase venous thromboembolism risk (hazard ratio 0.977), with ≤10 events reported in each group (More)

In a case series of four patients undergoing autologous toe-to-finger free nail unit transplantation for nail unit deformities or loss, three achieved normal nail appearance at one year—see surgical images and videos in the article (More)

A cross-sectional review of best-selling topical diaper preparations found that 21 of 25 products (84%) contained one or more potential contact allergens based on pediatric patch test lists—see the article for four products with no identified allergens (paywall restricted) (More)

In a prospective cohort study of 23 adults receiving immune checkpoint inhibitors for active cancer, the average number of actinic keratoses fell from 47 to 14 at 12 months, while the total number of keratinocyte carcinomas dropped to 17 during the treatment year, down from 42 in the preceding year (More)

Measles cases in Europe more than doubled in 2024 compared to 2023, reaching 127,350—the highest total since 1997—driven by declining vaccine coverage (More)

Pelage Pharmaceuticals, backed by $14 million in funding led by Google Ventures, has launched a Phase 2 trial of PP405—a topical treatment designed to activate dormant hair follicle stem cells in androgenetic alopecia (More)

Attovia raises $90 million to advance two half-life extended biologics: ATTO-1310, an anti-interleukin-31 agent for chronic pruritus, and ATTO-3712, a bispecific interleukin-13/interleukin-31 inhibitor for atopic dermatitis (More)