American Academy of Dermatology

Incyte Announces Long-Term Extension Data from Phase 3 TRuE-V Program Demonstrating Long-Term Safety and Durability of Response of Opzelura® (Ruxolitinib) Cream in Vitiligo

Retrieved on: 
Saturday, March 18, 2023

The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.

Key Points: 
  • The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.
  • “The results presented today at AAD are significant because they provide important long-term efficacy and safety data for nonsegmental vitiligo patients treated with Opzelura,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
  • Approximately 29% of patients randomized to the withdrawal arm (i.e., applying vehicle cream) relapsed (
  • “Vitiligo is a chronic condition and these results demonstrate the long-term potential of this medical treatment for people with vitiligo who are interested in repigmentation.”

AAD 2023: Late-Breaking Phase III Results Demonstrate nemolizumab’s Significant Impact on Prurigo Nodularis

Retrieved on: 
Saturday, March 18, 2023

Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.

Key Points: 
  • Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.
  • The phase III OLYMPIA 2 trial met all primary endpoints, showing nemolizumab monotherapy significantly improved pruritus (itch) and skin lesions compared with placebo in adult patients with moderate to severe prurigo nodularis.
  • “We are so pleased that we’re able to bring so much powerful new data to this year’s AAD congress.
  • Its continued commitment to delivering science and innovation across a highly differentiated portfolio is reflected in its extensive presence at AAD.

Dupixent® (dupilumab) Late-Breaking Data at AAD Show Significant Improvements in Signs and Symptoms of Moderate-to-severe Atopic Hand and Foot Dermatitis

Retrieved on: 
Saturday, March 18, 2023

TARRYTOWN, N.Y. and PARIS, March 18, 2023 (GLOBE NEWSWIRE) --  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive results from the clinical trial assessing Dupixent® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis. The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting.

Key Points: 
  • The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints.
  • The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting.
  • There were significant improvements in measures of hand and foot skin pain, sleep, and hand eczema-related quality of life.
  • The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis.

Press Release: Dupixent® (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis

Retrieved on: 
Saturday, March 18, 2023

Positive results from the clinical trial assessing Dupixent® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented today.

Key Points: 
  • Positive results from the clinical trial assessing Dupixent® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented today.
  • The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints.
  • “Atopic hand and foot dermatitis can extensively disrupt the lives of patients, given the intense itch and painful skin lesions it causes on essential body areas.
  • There were significant improvements in measures of hand and foot skin pain, sleep and hand eczema-related quality of life.

Takeda Announces Positive Results in Phase 2b Study of Investigational TAK-279, an Oral, Once-Daily TYK2 Inhibitor, in People with Moderate-to-Severe Plaque Psoriasis

Retrieved on: 
Saturday, March 18, 2023

Takeda ( TSE:4502/NYSE:TAK ) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis.
  • Changes in laboratory parameters were consistent with known effects of allosteric TYK2 inhibition.1
    “These compelling TAK-279 data strengthen its potential for people with moderate-to-severe plaque psoriasis.
  • Results from the Phase 2b study have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2023 (Fiscal Year 2022).
  • *In the TAK-279 2mg arm, the PASI 90 response rate was 8% with a nominal p-value = 0.037 compared to placebo.1

Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting

Retrieved on: 
Saturday, March 18, 2023

Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

Key Points: 
  • Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.
  • Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch Numeric Scale (WI-NRS) Success at Week 4.
  • “Roflumilast cream was also shown to be safe and well-tolerated, critical considerations for the treatment of atopic dermatitis.
  • Local tolerability was favorable with more than 90% of those treated with roflumilast cream reporting no or mild sensation across arms in both trials at any timepoint.

Samsung Bioepis Presents Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting

Retrieved on: 
Friday, March 17, 2023

These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.

Key Points: 
  • These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.
  • In this Phase 1, randomized, double-blind, single-dose comparative pharmacokinetic study, a total of 201 subjects were randomized 1:1:1 to receive a single dose 45 mg of either SB17, EU-sourced reference ustekinumab, or US-sourced reference ustekinumab via subcutaneous injection.
  • The primary objective of this study was to demonstrate PK similarity by assessing area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax).
  • The secondary objectives were to investigate and compare the safety, tolerability, and immunogenicity between three treatment groups.

LEO Pharma Presents New Adbry™ (tralokinumab-ldrm) Data in Adolescent Population from ECZTRA 6 and ECZTEND Trials at AAD 2023 Annual Meeting

Retrieved on: 
Friday, March 17, 2023

The data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting.

Key Points: 
  • The data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting.
  • S. aureus is consistently found in the skin lesions of patients with AD and contributes to skin irritation and infections.
  • “In addition, the latest analysis of data from adolescents in the ECZTEND study shows the long-term safety and efficacy profile of Adbry.
  • Adtralza is approved for use in adults with moderate-to-severe AD in the U.S., United Arab Emirates, Switzerland, and Japan.

Alpine Immune Sciences to Present Povetacicept (ALPN-303) Phase 1 (RUBY-1) Study Data at the 2023 American Academy of Dermatology Annual Meeting

Retrieved on: 
Thursday, March 16, 2023

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, will present an ePoster with an oral presentation at the American Academy of Dermatology (AAD) Annual Meeting, highlighting clinical data from RUBY-1, a phase 1 healthy volunteer (HV) study of povetacicept, a dual B cell cytokine antagonist being developed for multiple B cell and/or autoantibody-related diseases.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, will present an ePoster with an oral presentation at the American Academy of Dermatology (AAD) Annual Meeting, highlighting clinical data from RUBY-1, a phase 1 healthy volunteer (HV) study of povetacicept, a dual B cell cytokine antagonist being developed for multiple B cell and/or autoantibody-related diseases.
  • Poster Title: Phase 1 Study in Healthy Adults of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Povetacicept (ALPN-303), a Dual BAFF/APRIL Antagonist for the Treatment of Autoimmune Blistering Diseases (RUBY-1)
    Presenter: Stanford Peng, MD, PhD, President and Head of Research and Development, Alpine Immune Sciences

AMERICAN ACADEMY OF DERMATOLOGY: HOW CLIMATE CHANGE AND WILDFIRE SMOKE CAN IMPACT THE SKIN

Retrieved on: 
Friday, March 17, 2023

NEW ORLEANS, March 17, 2023 /PRNewswire/ -- New research1,2,3 shows that as wildfires are increasing in frequency, intensity and extent, and affecting air quality across the U.S., they are having a detrimental effect on people with and without skin conditions. A board-certified dermatologist at the American Academy of Dermatology's Annual Meeting in New Orleans will discuss strategies to minimize the effect air pollution can have on your skin.

Key Points: 
  • A board-certified dermatologist at the American Academy of Dermatology's Annual Meeting in New Orleans will discuss strategies to minimize the effect air pollution can have on your skin.
  • Psoriasis occurs when the body makes skin cells too quickly, causing the cells to pile up and form visible patches or spots on the skin.
  • Dr. Wei noted there are no studies that have confirmed how to minimize the effects of wildfire air pollution on skin conditions like psoriasis and eczema.
  • If you have a skin concern, you should partner with a board-certified dermatologist, said Dr. Wei.