AAD Annual Meeting Showcases New Topical Treatments and More

New topical treatments for atopic dermatitis (AD) and for molluscum contagiosum (MC) were among noteworthy developments discussed at the American Academy of Dermatology (AAD) Annual Meeting, held March 17-21 in New Orleans, LA. Advances targeting hidradenitis suppurativa (HS) also made news.

Announced just ahead of the AAD meeting, topline results from one of two double-blind, randomized, Phase 3 trials from Dermavant (ADORING 2) were a buzzworthy topic. The trial showed that 46.4% of patients with AD as young as 2 years old treated with VTAMA (tapinarof) cream 1% once daily for eight weeks achieved Validated Investor Global Assessment for Atopic Dermatitis (vIGA-AD) scores of “clear” or “almost clear” with at least a two-grade improvement from baseline.¹ The corresponding figure among vehicle-treated patients was 18.0%. Lawrence F. Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at the University of California, San Diego, and Rady Children’s Hospital-San Diego, says that the study’s efficacy and safety findings were especially impressive considering that patients had heavy disease burden, and a large percentage of patients were children.

“And the side effect profile looked quite good,” he adds. Adverse events were mild to moderate, and only a handful of patients withdrew in both the active and placebo groups. “In some patients,” Dr. Eichenfield predicts, “VTAMA cream 1% will be used as a replacement for topical steroids. For others, it may be mixed or matched with them.”

Regarding MC, pivotal phase 3 results showed that 32.4% of patients treated with berdazimer gel 10.3% once daily for 12 weeks achieved complete clearance, versus 19.8% of vehicle-treated patients.² Some patients cleared as early as two weeks, says Novan President and CEO Paula Brown Stafford, and investigators observed statistical significance versus placebo at four, eight, and 12 weeks. With no treatments currently FDA approved for MC, Stafford adds, berdazimer may provide a much-needed option for patients, in the form of an easily applied topical treatment that can be administered by patients or parents. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 5, 2024, for the potential first-in-class nitric-oxide-releasing topical agent, which Novan believes exerts antiviral effects.³  

Treatments under investigation for HS include small molecules, biologics, and Janus kinase (JAK) inhibitors:

• Izokibep (Acelyrin Inc.): Phase 2b/3 research showed that 65% of patients treated with this small-molecule IL-17A inhibitor achieved at least 50% reductions in abscesses and inflammatory nodules (Hidradenitis Suppurativa Clinical Response/HiSCR50) at week 12.⁴
• Bimekizumab (UCB): In Phase 3, patients treated with this interleukin (IL)-17A and IL-17F blocker for 16 weeks achieved statistically significant, clinically meaningful improvements over placebo.⁵
• Upadacitinib (AbbVie): Phase 2 results revealed that 38.3 % of patients achieved HiSCR50 at week 12, versus 23.8% of placebo-treated patients.⁶

References:

1. https://www.dermavant.com/dermavant-reports-positive-topline-results-from-adoring-2-atopic-dermatitis-phase-3-trial-of-vtama-tapinarof-cream-1-once-daily-in-adults-and-children-as-young-as-2-years-old.

2. https://am2023.aad.org/sessions/4245.

3. https://novan.com/fda-accepts-novans-nda-for-berdazimer-gel-10-3-for-the-treatment-of-molluscum-contagiosum-with-a-pdufa-goal-date-of-january-5-2024.

4. https://acelyrin.com/press/izokibep-achieves-hiscr100-responses-12-weeks-moderate-severe-hidradenitis-suppurativa.

5. https://www.ucb.com/stories-media/press-releases/article/bimekizumab-phase-3-data-in-hidradenitis-suppurativa-show-clinically-meaningful-deep-and-maintained-response-over-48-weeks.

6. https://aad-eposters.s3.amazonaws.com/am2023/poster/43799/efficacy+and+safety+of+upadacitinib+in+moderate-to-severe+hidradenitis+suppurativa+a+phase+2+randomized+placebo-controlled+study.pdf.