⚡Tralokinumab for atopic hand eczema

Good morning — it’s Saturday, November 29, and we’re covering a Phase 3b trial of tralokinumab in atopic hand eczema, new one-year data for guselkumab in psoriatic arthritis, and more.

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LEO Pharma announced positive topline results from the 32-week Phase 3b ADHAND trial evaluating the IL-13 inhibitor tralokinumab in adults with moderate-to-severe atopic dermatitis on the hands.

Hand involvement is common in atopic dermatitis and contributes substantially to pain, functional impairment, and emotional distress.

Investigators randomized participants to tralokinumab 300 mg every 2 weeks or placebo for 16 weeks, followed by open-label treatment through Week 32. All met criteria for systemic therapy.

At Week 16, 40% of tralokinumab-treated patients achieved clear or almost clear skin on the hands (IGA-AHE 0/1) versus 11% on placebo. Similar proportions reached ≥90% improvement in hand eczema severity (HECSI-90).

More patients on tralokinumab experienced a clinically meaningful ≥4-point reduction on the 0–10 HESD itch score (47% vs 21%).

Tralokinumab was generally well-tolerated. Similar rates of conjunctivitis, a known class-associated event, occurred in both arms (about 4%).

Although the trial also met all 32-week endpoints, LEO Pharma will only present full results at a later date.

ADHAND signals LEO Pharma’s push to refine and differentiate tralokinumab’s role in atopic dermatitis. The trial also reflects a broader effort to generate evidence for hard-to-treat sites such as the hands.

> Guselkumab sustains joint and skin responses through one year in psoriatic arthritis: One-year data from the Phase 3b APEX trial, presented at ISDS 2025, support the sustained efficacy of guselkumab (Tremfya) in active psoriatic arthritis. The study enrolled 1,020 biologic-naïve adults with an inadequate response to standard therapies. Participants were randomized to guselkumab every 4 or 8 weeks or placebo; at Week 24, patients on placebo switched to guselkumab. At Week 24, ACR50 was reached by 41–42% of those initially on guselkumab, rising to 51–56% at Week 48. ACR50 is defined as ≥50% improvement in tender and swollen joint counts and in at least three of five additional domains. Roughly 90% of patients with no radiographic progression at Week 24 maintained this status through Week 48. Skin clearance was also notable, with 74–80% reaching clear or almost clear skin (IGA 0/1). Safety was consistent with the drug’s known profile. Guselkumab is a dual-acting monoclonal antibody that blocks IL-23 and binds CD64 on IL-23–producing cells. It remains the only IL-23 inhibitor proven to slow structural joint damage in active psoriatic arthritis. Johnson & Johnson has submitted a supplemental application to the FDA to add inhibition of progression of structural damage to the Tremfya label for active psoriatic arthritis.

> Selective oral JAK1 inhibitor advances in chronic spontaneous urticaria: Incyte presented results from a Phase 2 trial at ACAAI showing that povorcitinib significantly and rapidly reduced hives and itch in antihistamine-refractory chronic spontaneous urticaria (CSU). Povorcitinib is a once-daily selective oral JAK1 inhibitor. Investigators randomized 136 adults with refractory CSU to daily povorcitinib 15–75 mg or placebo. At Week 12, 63% of patients receiving 75 mg achieved well-controlled disease (UAS7 ≤6) versus 29% on placebo. Notably, 43% experienced complete symptom resolution (UAS7 = 0) at this dose. Responses emerged as early as Day 3. The safety profile was also favorable. Acne, headache, and nasopharyngitis were the most common adverse events. All grade ≥3 events occurred in the placebo group. The treatment advantage over placebo appears similar to that seen with the BTK inhibitor remibrutanib, the only oral agent FDA-approved for antihistamine-refractory CSU. However, the modest sample size and short duration of this Phase 2 trial warrant caution until Phase 3 data mature. At EADV in September, Incyte also presented positive Phase 3 results for povorcitinib in hidradenitis suppurativa. Regulatory submissions in Europe and the U.S. for hidradenitis suppurativa are expected soon.

> First dedicated prenatal-only prebiotic trial finds no benefit for infant eczema: Antenatal prebiotic supplementation failed to protect against atopic dermatitis at 1 year in high-risk infants, according to the PREGRALL trial published in the BJD. Prebiotics are nondigestible fibers that feed beneficial gut bacteria, in contrast to probiotics, which deliver live microbes. Investigators hypothesized that modulating the maternal gut microbiome during pregnancy might shape immune imprinting in the fetus, lowering atopic risk. The study randomized 376 pregnant women with a history of atopy to a daily prebiotic or placebo from 20 weeks’ gestation to delivery. At 1 year, the prevalence of atopic dermatitis was identical in both groups (20% vs 20%; OR 1.01, 95% CI 0.59–1.74; P = 0.97). Rates of allergen sensitization and food allergy were also similar, though these outcomes were likely underpowered. Safety was comparable across both arms. The findings mirror the larger SYMBA trial, where prebiotics given during both pregnancy and lactation likewise failed to prevent infant eczema.

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