Updates from the 2023 AAD Annual Meeting

The 2023 American Academy of Dermatology Annual Meeting was buzzing with exciting news and breakthrough studies. Clinicians, researchers, students, and many more gathered to learn about these latest updates, eager to find out what treatments could be coming down the pipeline soon.

Povorcitinib For Vitiligo

Results from a Phase 2 study evaluating the safety and efficacy of povorcitinib in patients with extensive vitiligo have demonstrated significant repigmentation. During the study, 171 patients were randomly assigned to receive povorcitinib at various doses, 45 mg, 75 mg, 15 mg, or placebo once daily. Total Vitiligo Area Scoring Index (T-VASI) results showed a 19.1% change with 15 mg povorcitinib, 17.8% change with 45 mg, and 15.7% change with 75 mg, in comparison to 2.3% with placebo. Povorcitinib was generally well tolerated with researchers concluding that no serious treatment-emergent adverse events were related to treatment with povorcitinib.

Risankizumab For Plaque Psoriasis

A 52-week, Phase 3, open-label study evaluated the efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis who had previously been treated with interleukin-(IL) 17A. A total of 252 participants were given 150 mg of risankizumab at zero, four, and once every subsequent 12 weeks until the endpoint of 52 weeks. At the end of the study, results demonstrated that 63% of participants had achieved a Physician’s Global Assessment score (sPGA) of zero or one, indicating clear or almost clear skin. A further 26.2% had an sPGA score of zero.

Topical Roflumilast For Plaque Psoriasis

Two Phase 3 trials evaluating the safety and efficacy of topical roflumilast for the treatment of chronic plaque psoriasis have successfully achieved their primary endpoint. Clinical trials, DERMIS-1 and DERMIS-2 included two groups, the roflumilast active treatment group, which received 0.3% roflumilast cream applied daily for eight weeks, and the vehicle group. Using the Investigator Global Assessment (IGA), results at 8 weeks saw that the group treated with roflumilast was at 42.4% compared to the vehicle group at 6.1% in trial one, and 37.5% compared to 6.9% in trial two.

Berdazimer Gel and Molluscum Contagiosum

A randomized, double-blind study of 1,598 patients has revealed that berdazimer gel 10.3% is both safe and effective in the treatment of molluscum contagiosum.  A total of 917 patients were assigned to berdamizer treatment and 681 to the vehicle for a period of 12 weeks. Results showed that berdamizer gel resulted in a greater complete clearance rate, 30%, compared to vehicle 19.8%.

Bimekizumab and Hidradenitis Suppurativa

Two randomized, double-blind, placebo-controlled Phase 3 studies, HEARD I and HEARD II, evaluated the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS). The study evaluated two dose regimens of bimekizumab, 320 mg every two weeks [Q2W] and 320 mg every four weeks. Results demonstrated that patients treated with bimekizumab (Q2W) achieved the Hidradenitis Suppurativa Clinical Response (HiSCR50), the primary endpoint, at week 16 compared to placebo, 47.8% vs 28.7%, and 52.0% vs 32.2% respectively.

LEO 138559 and Atopic Dermatitis

Late-breaking Phase 2a data on the investigational agent, LEO 138559, for the treatment of adults with moderate-to-severe atopic dermatitis (AD), was recently announced. A total of 58 patients received either LEO 138559 at 450 mg every other week (Q2W) or placebo for 16 weeks. Results demonstrated a significant improvement compared to placebo across multiple endpoints including Eczema Area and Severity Index (EASI)-75 (41.6% vs 13.7%), EASI-90 (30.8% vs 3.5%), EASI-100 (20.9% vs 0%), and Validated Investigator Global Assessment Scale for Atopic Dermatitis 0/1 (27.3% vs 7.0%).

Izokibep and Hidradenitis Suppurativa

According to a study, patients with HS treated with izokibep achieved higher rates of HiSCR 75 and above. Data from the single-arm, open-label part A of a Phase 2b/3 clinical trial of 30 patients received 160 mg of izokibep subcutaneously every week. At week 12, results demonstrated that 71% of subjects had achieved a HiSCR of 50, 57% achieved a HiSCR of 75, 38% a HiSCR of 90, and 33% achieved a HiSCR of 100. Part B of the study is ongoing and a Phase 3 trial is planned.

CBP-201 and Atopic Dermatitis

Results from stage one of a randomized, double-blind, pivotal trial evaluating the efficacy of CBP-201 in adults with moderate-to-severe AD showed 30.3% of patients achieving an IGA of 0 or 1 compared to 7.5% of placebo. The study included 255 patients who were randomly assigned to receive CBP-201 300 mg or placebo once every 2 weeks.

Upadacitinib and Hidradenitis Suppurativa

During a Phase 2, multicenter, randomized, placebo-controlled, double-blind study, adults with moderate-to-severe HS were randomly assigned to receive 30 mg of upadacitinib or placebo once daily. After 12 weeks, patients on placebo were switched to upadacitinib 15 mg through to week 48. The primary endpoint was defined as a HiSCR reduction of at least 50% in inflammatory nodule count without an increase in abscess or draining fistula count. Results demonstrated that 38.3% of upadacitinib-treated patients achieved the primary endpoint compared with 23.8% of the placebo group at week 12.

Baricitinib and Lichen Planus

In a first-in-human, open-label, single-arm trial of 12 patients with lichen planus (LP) who were treated with baricitinib twice daily for 16 weeks, researchers found that after one week of treatment, 37.5% of patients had a physician global assessment (PGA) response of clear or almost clear. At week 12, 100% of patients showed a PGA of clear or almost clear. Improvements in all secondary endpoints were also observed.

Deuruxolitinib and Alopecia Areata

Data from a second Phase 3 trial of deuruxolitinib in the treatment of moderate-to-severe alopecia areata in adults, has confirmed the efficacy and tolerability of the drug. Patients with 50% or greater hair loss were randomly assigned to receive 8 mg of deuruxolitinib, 12 mg of deuruxolitinib, or placebo twice a day. The Severity of Alopecia Tool (SALT) was used to track treatment efficacy with the primary endpoint being a proportion of patients achieving a score of 20 or less at week 24. Results showed 33% of the 8 mg treatment group and 38% of the 12 mg treatment group achieved the primary endpoint compared to 1% of the placebo group.

Nemolizumab and Prurigo Nodularis

In a recent study, the OLYMPIA 2 Phase 2 trial, 274 patients with prurigo nodularis received nemolizumab or placebo every four weeks for 16 weeks to assess the efficacy of the drug. Patients who received nemolizumab showed significant improvement in itch, sleep disturbance, and lesions. A 4-point or greater improvement in Peak Pruritis Numerical Rating Scale was reported in 56.3% of the treatment group as compared to 20.9% of placebo group. Furthermore, 37.7% of the treatment group saw IGA success compared to 11% of the placebo group.

  • https://www.dermatologytimes.com/view/recent-povorcitinib-2b-study-shows-improved-repigmentation
  • https://www.dermatologytimes.com/view/risankizumab-efficacious-in-clearing-improving-plaque-psoriasis
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9490499/
  • https://www.dermatologytimes.com/view/roflumilast-safe-and-efficient-for-patients-with-chronic-plaque-psoriasis
  • https://www.healio.com/news/dermatology/20230319/berdazimer-gel-shows-favorable-molluscum-contagiosum-results-in-phase-3-study
  • https://www.dermatologytimes.com/view/phase-3-data-for-bimekizumab-shows-well-maintained-response
  • https://www.dermatologytimes.com/view/investigational-leo-pharma-il-22-receptor-improves-easi-scores-in-ad
  • https://www.healio.com/news/dermatology/20230324/izokibep-shows-promise-in-early-phase-2-hidradenitis-suppurativa-trial
  • https://www.healio.com/news/dermatology/20230323/cbp201-shows-favorable-atopic-dermatitis-results-in-pivotal-trial
  • https://www.healio.com/news/dermatology/20230322/patients-with-hidradenitis-suppurativa-sustain-clearance-up-to-40-weeks-with-upadacitinib
  • https://www.healio.com/news/dermatology/20230321/patients-with-lichen-planus-show-improvement-with-baracitinib
  • https://www.healio.com/news/dermatology/20230320/deuruxolitinib-transforming-lives-in-treatment-of-alopecia-areata
  • https://www.healio.com/news/dermatology/20230319/prurigo-nodularis-improvement-seen-with-nemolizumab-monotherapy


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