Top 5 Articles of the Week: September 28-October 3

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1. FDA Approves Remibrutinib, First Oral BTK Inhibitor for CSU

The FDA has approved remibrutinib (Rhapsido; Novartis), the first oral Bruton’s tyrosine kinase inhibitor (BTKi) for adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1-antihistamines, marking a major advance in care. Approval was supported by the phase 3 REMIX-1 and REMIX-2 trials, which showed rapid and sustained improvements in itch, hives, and overall disease activity, with some patients achieving complete symptom resolution by week 12. Offering a convenient oral option beyond antihistamines and injectable biologics, remibrutinib demonstrated a favorable safety profile and requires no lab monitoring, while ongoing studies are exploring its potential in other immune-mediated conditions.

2. EADV 2025: Full Congress Recap

At EADV 2025 in Paris, France, dermatology researchers presented a wide array of advances spanning inflammatory disease, biologics, novel therapies, and quality-of-life data. Key highlights included promising results for roxatinlimab (anti-OX40) in atopic dermatitis, sustained efficacy of bimekizumab in psoriasis out to 4 years, and early success with oral STAT6 degrader KT-621, which showed biomarker changes comparable to dupilumab. Other notable findings included new data on ruxolitinib cream in prurigo nodularis, delgocitinib cream in adolescent hand eczema, and several oral and biologic options showing durability across psoriasis, hidradenitis suppurativa, and urticaria subtypes.

3. MoonLake Shares Findings from Dual Phase 3 Trials of Sonelokimab

MoonLake Immunotherapeutics has reported week 16 interim data from its phase 3 VELA-1 and VELA-2 trials of the investigational nanobody sonelokimab in adults with moderate to severe hidradenitis suppurativa (HS), the first phase 3 dataset to use the stringent HiSCR75 endpoint. Across 838 patients, sonelokimab significantly outperformed placebo (35.4% vs 21.6%, p<0.001) with consistent improvements in lesion counts, pain, and quality of life, and benefits seen as early as week 4. VELA-1 met its primary endpoint under both analytic strategies, while VELA-2 narrowly missed significance under the composite strategy due to a high placebo response. Safety was manageable, with no new concerns. Although the disclosure triggered a sharp drop in MoonLake’s stock and a shareholder investigation, the results suggest IL-17A/F inhibition may be a promising strategy for HS, with longer-term outcomes and regulatory review still to come.

4. FDA Approves Guselkumab for Pediatric Plaque Psoriasis and Psoriatic Arthritis

The FDA has approved guselkumab (Tremfya; Johnson & Johnson) for children aged 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor available for these pediatric conditions. Supported by the PROTOSTAR trial, guselkumab showed strong efficacy, with over half of patients achieving near-complete skin clearance by week 16. Experts emphasized this approval as a major advance, addressing important unmet needs for thousands of children affected each year and offering a safe, effective therapy with infrequent dosing every 8 weeks.

5. Jerry Shapiro, MD’s Step-by-Step Guide to Diagnosing and Managing Hair Loss

At the Maui Derm NP+PA Fall Conference, Jerry Shapiro, MD, of NYU Langone, shared his structured approach to diagnosing and managing hair loss, with a focus on scarring alopecia, which causes permanent follicular destruction and requires early intervention. He emphasized detailed evaluation using history, dermoscopy, and classification by inflammatory type, with treatments ranging from intralesional steroids and compounded topicals to low-dose doxycycline, pioglitazone, low-dose naltrexone, and emerging JAK inhibitors. For female pattern hair loss, Shapiro highlighted combining low-dose oral minoxidil with anti-androgens, while also reviewing PRP (with maintenance every 6 to 9 months if effective), the limited utility of dutasteride mesotherapy, and early promise of exosomes and FDA-cleared non-ablative lasers. He outlined a stepwise algorithm progressing from medical therapy to PRP, transplantation, or prostheses depending on severity. Shapiro stressed early diagnosis, personalized regimens, and patient education as central to improving outcomes across hair disorders.