Reviewing Late-Breaking Research From AAD 2024

The 2024 American Academy of Dermatology (AAD) Annual Meeting concluded earlier this month in San Diego, California. Numerous late-breaking research sessions were presented, highlighting the latest updates on new therapeutics and their efficacy. Dermatology Times' late-breaking research coverage included upadacitinib for vitiligo, home phototherapy for psoriasis, lutikizumab for hidradenitis suppurativa, roflumilast cream .05% for pediatric atopic dermatitis, delgocitinib for chronic hand eczema, nemolizumab for prurigo nodularis, injectable polidocanol for submental fat reduction, povorcitinib for prurigo nodularis, and amlitelimab for atopic dermatitis.

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Upadacitinib for Vitiligo Achieves Skin Repigmentation Through Week 52

In a phase 2 trial evaluating the efficacy and safety of upadacitinib in adults with non-segmental vitiligo (NSV), 185 patients (68% baseline total vitiligo area scoring index (T-VASI) >10; 71% active vitiligo) were randomized to upadacitinib (UPA) 6mg (n=49), 11mg (n=47), 22mg (n=43), or placebo (n=43).

Through weeks 24 to 52, patients treated with UPA6 (n=38), UPA11 (n=38), and UPA 22 (n=39) continued treatment, while placebo patients switched to a pre-assigned upadacitinib dose PBO-UPA11 [n=19], PBO-UPA22 [n=21]).

The study authors found that skin re-pigmentation as measured by facial (F)-VASI and T-VASI occurred in all upadacitinib-treated patients from week 0 to 24, therefore meeting the primary end point, and continued without plateau through week 52 with achievement of F-VASI75 in 37%/29% of UPA6 (n=14), 63%/51% of UPA11 (n=24), 38%/26% of UPA22 (n=11) and achievement of T-VASI50 in 32%/25% (n=12), 40%/32% (n=15), and 41%/28% (n=12), respectively.

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Making Psoriasis Treatment More Accessible: LITE Study Shows Home Phototherapy Success

In a late-breaking research session at the 2024 American Academy of Dermatology Annual Meeting in San Diego, the Light Treatment Effectiveness study ushered in a new era for the treatment of psoriasis. The study, a collaboration between the National Psoriasis Foundation, the University of Pennsylvania Perelman School of Medicine, and the University of Utah, presented compelling evidence that home phototherapy is as effective as office-based treatment for psoriasis. Joel Gelfand, MD, MSCE, FAAD, James J. Leyden Professor of dermatology and epidemiology at the University of Pennsylvania Perelman School of Medicine in Philadelphia, Pennsylvania, shared a sneak peek of the LITE study with Dermatology Times last month and presented in-depth results at AAD.

The LITE study, launched in 2019 and concluding in December 2023, enrolled 783 patients across 42 dermatology practices in the United States. The findings challenge the traditional reliance on office-based phototherapy, showcasing that home phototherapy is non-inferior in terms of both effectiveness and safety.

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Lutikizumab Shows Positive Results in Difficult-to-Treat HS After Failed TNF Therapy

New data on lutikizumab, a dual-variable-domain interleukin 1α/1β antagonist, for difficult-to-treat moderate to severe hidradenitis suppurativa (HS) was presented in a late-breaking data session at AAD 2024. Kimball et al assessed the safety and efficacy of lutikizumab 300 mg every week, 300 mg every other week, and 100 mg every other week versus placebo for the treatment of signs and symptoms of moderate to severe HS in adult patients who have failed anti-TNF therapy.

153 patients were randomized across 54 sites. The majority of patients (70.6%) had severe baseline Hurley Stage 3 disease. While the response rate for libivirumab 100 mg was 27.0%, both lutikizumab 300 mg every other week (59.5%) and 300 mg every week (48.7%) showed greater response rates over placebo (35.0%) in the primary end point, HiSCR 50 at week 16, with a posterior probability of observing a positive treatment difference versus placebo of 98.5% and 89.3%, respectively. Greater efficacies were also observed in the secondary end point of the achievement of pain NRS30 among baseline NRS ≥ 3 (34.5% and 34.8%, respectively, versus 12.9% of placebo) and an additional endpoint, HiSCR 75 (45.9% and 38.5%, respectively, versus 17.5% of placebo).

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Lawrence Eichenfield, MD: Outlining Late-Breaking INTEGUMENT-PED Data for Roflumilast in Pediatric Patients

At AAD 2024, Lawrence Eichenfield, MD, shared a late-breaking clinical trial presentation on roflumilast cream 0.05% in children 2 to 5 years of age with atopic dermatitis from the pivotal INTEGUMENT-PED phase 3 randomized controlled trial. Eichenfield, professor of dermatology and pediatrics at Rady Children's Hospital and the University of California San Diego, spoke with Dermatology Times to discuss the background and methods of the study, key takeaways for clinicians, and potential real-world and clinical implications of the study.

"Using the medicine once a day over a pretty short 4-week time period, about 25% of patients made it to the treatment success, clear or almost clear at 2 steps as compared to about 11% of the ones in the vehicle group, and that marked statistical significance at week 2 as well as week 1. So a quick response and consistent response...The safety data was very consistent with what we've seen in the atopic dermatitis patients 6 years of age and older, which is very low adverse events," said Eichenfield.

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Discussing Late-Breaking INTEGUMENT-PED Data With Arcutis' Chief Medical Officer, Patrick Burnett, MD, PhD, FAAD

At AAD 2024, Arcutis and researchers presented late-breaking clinical trial data from the phase 3 INTEGUMENT-PED study of roflumilast 0.05% cream in a pediatric population with atopic dermatitis (AD). The study examined the use of 0.05% roflumilast cream in 2 to 5-year-olds with mild to moderate AD. Patients were racially diverse and had significant skin involvement and itchiness at baseline.

The treatment showed significant improvement compared to the vehicle cream, with about 25% achieving clear or almost clear skin at 2 steps by week 2. Similar positive responses were observed across various outcome measures, including EASI improvement and itch reduction.

"Following these very promising results, I am quite hopeful of the real-world impact roflumilast cream 0.05% can have, if approved, for this young pediatric population (ages 2-5) afflicted with atopic dermatitis. The impact of this disease on the quality of life for both patients and the family is quite dramatic," said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis.

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Long-Term Safety and Efficacy of Delgocitinib Cream for Chronic Hand Eczema

At AAD 2024, Melinda Gooderham, MSc, MD, FRCPC, presented late-breaking data on the long-term safety and efficacy of delgocitinib for moderate to severe chronic hand eczema (CHE). Patients who completed 16 weeks of treatment in DELTA 1 and DELTA 2 were then treated in the DELTA 3 open-label extension trial with twice daily delgocitinib cream as needed to control their CHE for 36 weeks. The DELTA 3 extension trial (n=801) evaluated the long-term safety of as-needed delgocitinib. No new safety concerns were identified in the DELTA 3 extension trial, which showed consistency with the safety profile from DELTA 1 and DELTA 2.

Key secondary end points were also consistent with DELTA 1 and DELTA 2, including the proportion of patients achieving an Investigator's Global Assessment for CHE score of 0 (clear) or 1 (almost clear) and a ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) improved from baseline (24.6%, 51.8%, and 31.8%, respectively) to week 36 (30.0%, 58.6%, and 36.6%, respectively) among delgocitinib cream-treated patients in DELTA 1 and DELTA 2.

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Long-Term Safety and Efficacy of Largest Prurigo Nodularis Study Ever Conducted

“To give context to this study, we're here at the largest dermatology meeting in the history of the world, and I just presented the largest and longest prurigo nodularis study in the history of the world. We've never had a prurigo nodularis study going longer than 6 months,” said Shawn Kwatra, MD, in an interview after his late-breaking data presentation at AAD 2024.

The OLYMPIA open-label LTE study builds on the positive data from OLYMPIA 1 and OLYMPIA 2 and is an ongoing 184-week trial evaluating nemolizumab monotherapy in patients with moderate to severe prurigo nodularis. Overall, 69% of patients who had received continuous nemolizumab treatment and 65% of nemolizumab-naïve patients had reached clearance or almost-clearance of skin lesions, as measured by an Investigator’s Global Assessment score, as well as 89% of patients who had received continuous nemolizumab treatment and 83% of nemolizumab-naïve patients achieved a significant response on itch intensity as measured by an at least 4-point improvement on the peak-pruritus numerical rating scale.

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Late-Breaking Phase 2b Data Showed Efficacy of Injectable Polidocanol for Submental Fat Reduction

Kavita Darji, MD, FAAD, board-certified dermatologist and laser and cosmetic dermatologic surgery fellow at Cosmetic Laser Dermatology in San Diego, California, presented late-breaking data from a phase 2b clinical trial, shedding light on the safety and efficacy of injectable polidocanol for reducing excess submental fat during AAD 2024. Darji introduced the study product, a synthetic non-ionic detergent FDA-approved for sclerotherapy, demonstrating adipolytic properties and a favorable profile compared to deoxycholate. Polidocanol is currently being developed under 505(b)2 pathway showing less inflammation and release of cytokines TNFα and MCP-1 by macrophanges than deoxycholate.

The trial enrolled 51 subjects across 4 research sites, distributing them into 4 dose cohorts (2%, 3%, 4.5%, and a vehicle control) in a 1:1:1:1 ratio. Each subject received up to 6 treatments, administered four weeks apart, involving up to 50 injections of 0.2 ml each. Study endpoints included Clinician Submental Fat Score and Patient Submental Fat Score on a 0-4 point scale, alongside local skin reactions and safety assessments.

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Povorcitinib Significantly Improves Itch and Lesions in Prurigo Nodularis

New late-breaking data on phase 2 safety and efficacy data of oral povorcitinib for prurigo nodularis was presented at AAD 2024. In the phase 2 study of oral povorcitinib (NCT05061693), a small molecule JAK1-selective inhibitor, 126 adult patients with ≥20 pruriginous lesions, an Investigator’s Global Assessment (IGA) score of ≥3, prurigo nodularis for ≥3 months, and an average itch Numerical Rating Scale (NRS) score of ≥5 were randomized to receive once-daily povorcitinib (15, 45, or 75 mg) or placebo for 16 weeks.

The primary end point of the phase 2 study was a ≥4-point improvement in itch NRS score (NRS4) at week 16, which was achieved by significantly more patients who received povorcitinib (15mg: 36.1% [P=0.0066], 45mg: 44.4% [P=0.0006], 75mg: 54.1% [P<0.0001]) vs placebo (8.1%).

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Amlitelimab Demonstrates Sustained Improvements in Atopic Dermatitis Signs and Symptoms

Late-breaking data recently presented at AAD 2024 highlighted sustained off-drug improvements of atopic dermatitis (AD) signs and symptoms with amlitelimab for 28 weeks, supporting its role as a potential best-in-class maintenance therapy. At the conference, positive results from part 2 of the investigational amlitelimab phase 2b study STREAM-AD (NCT05131477) were shared, revealing sustained improvement of signs and symptoms for 28 weeks in adults with moderate to severe AD who had previously responded to amlitelimab and continued treatment. These findings shed light on the durability of response, supporting the evaluation of a less frequent dosing regimen.

The STREAM-AD phase 2b study enrolled 390 adult patients with moderate-to-severe AD across multiple countries. It was comprised of 2 parts, with part 1 focusing on a 24-week treatment period and part 2 exploring a 28-week maintenance/withdrawal phase.

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Click here to view all AAD 2024 coverage.