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Arcutis' Flagship Psoriasis Treatment Shows Sustained Efficacy, Clearance For Median Of 10 Months

  • Arcutis Biotherapeutics Inc ARQT announced new safety and efficacy durability data from its open-label Phase 2 long-term safety study of roflumilast cream (0.3%) in adults with chronic plaque psoriasis. 
  • Roflumilast cream 0.3% (Zoryve) is a once-daily steroid-free topical phosphodiesterase-4 inhibitor approved by the FDA in July 2022.
  • The study showed that during the trial, 57.1% (n=185) of roflumilast cream-treated patients achieved an Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1) at any time.
  • The participants had a median duration of IGA of clear or almost clear of more than ten months (40.1 weeks). 
  • IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve participants. IGA success was defined as clear/almost clear plus 2-grade improvement from baseline.
  • 42% of participants previously treated with roflumilast cream and 47.5% of roflumilast-naïve participants achieved an IGA score of clear or almost clear (IGA 0/1) at Week 52.
  • 66.7% of participants in Cohort-21 achieved Intertriginous-IGA (I-IGA) success, defined as clear or almost clear plus 2-grade improvement from baseline.
  • No tachyphylaxis occurred, and efficacy was consistent over time among participants who achieved an IGA of clear or almost clear.
  • Safety data showed low discontinuation rates due to AEs, and ≥97% of patients showed no irritation.
  • Price Action: ARQT shares closed higher by 2.24% at $14.12 on Friday.
  • Photo Via Company

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