Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT

Arcutis Biotherapeutics — 30th European Academy of Dermatology and Venereology Congress 2021

12 slides from Arcutis Biotherapeutics's conference presentation, September 2021

  1. Slide 1: Roflumilast Cream 0.3% Improved the Severity and Impact of Itch in Plaque Psoriasis

    Roflumilast Cream 0.3% Improved the Severity and Impact of Itch in Patients With Chronic Plaque Psoriasis in the Phase 3 DERMIS-1 and DERMIS-2 Studies Melinda J. Gooderham,1 Javier Alonso-Llamazares,2 Jerry Bagel,3 John C. Browning,4 Zoe D. Draelos,5 Kimberly K. Grande,6 Adelaide A. Hebert,7 H. Chih

  2. Slide 2: Introduction and Study Design

    Introduction and Study Design • Itch is the most burdensome and frequently reported symptom of psoriasis1,2 • Roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for various dermatologic conditions – Roflumila

  3. Slide 3: Baseline Disease Characteristics (ITT Population)

    Baseline Disease Characteristics (ITT Population) DERMIS-1 DERMIS-2 Roflumilast Cream Roflumilast Cream 0.3% Vehicle 0.3% Vehicle (n=286) (n=153) (n=290) (n=152) Psoriasis-affected BSA, mean % (SD) 6.3 (4.38) 7.4 (4.76) 7.1 (4.84) 7.7 (5.05) IGA score, n (%) 2 (mild) 51 (17.8) 20 (13.1) 50 (17.2) 24

  4. Slide 4: Roflumilast Cream Demonstrated Statistical Superiority in IGA Success Over Vehicle

    Roflumilast Cream Demonstrated Statistical Superiority in IGA Success Over Vehicle in Both Phase 3 Studies IGA Success = Clear or Almost Clear plus ≥2-grade improvement from baseline The primary endpoint was achieved in both DERMIS-1 and DERMIS-2 (Week 8) 100% IGA Success 100% IGA Success 90% DERMIS

  5. Slide 5: LS Mean Change From Baseline in WI-NRS Significantly Greater with Roflumilast

    LS Mean Change From Baseline in WI-NRS Was Significantly Greater with Roflumilast Cream Improvements in LS mean change from baseline with roflumilast cream occurred as early as Week 2 (first timepoint evaluated) LS mean change from baseline in WI-NRS: Patient’s assessment of worst itch over the past

  6. Slide 6: Greater Percentages Achieved ≥4-Point Reduction in WI-NRS at Week 8

    Significantly Greater Percentages of Roflumilast-Treated Patients Achieved ≥4-Point Reduction in WI-NRS at Week 8 Among patients with baseline WI–NRS score ≥4, more than two-thirds of roflumilast-treated patients achieved ≥4-point reduction in WI–NRS Proportion of patients who achieved a ≥4-point im

  7. Slide 7: Reduced the Patient-Reported Severity of Itch

    Roflumilast Cream Reduced the Patient-Reported Severity of Itch LS mean percentage change from baseline in Psoriasis Symptom Diary item 1: How severe was your psoriasis-related itching over the past 24 hours? DERMIS-1 DERMIS-2 Baseline Week 2 Week 4 Week 6 Week 8 Baseline Week 2 Week 4 Week 6 Week 8

  8. Slide 8: Significantly Reduced Patient-Reported Burden of Itch at All Timepoints

    Roflumilast Cream Significantly Reduced Patient-Reported Burden of Itch at All Timepoints LS mean percentage change from baseline in Psoriasis Symptom Diary item 2: How bothered were you by your psoriasis-related itching over the past 24 hours? DERMIS-1 DERMIS-2 Baseline Week 2 Week 4 Week 6 Week 8

  9. Slide 9: Improved Patient Quality of Life

    Roflumilast Cream Improved Patient Quality of Life LS mean change from baseline in DLQI total scores favored roflumilast over vehicle across both studies LS mean percentage change from baseline in DLQI Baseline mean (SD) DLQI score: DERMIS-1 Baseline mean (SD) DLQI score: DERMIS-2 Roflumilast 0.3%:

  10. Slide 10: Few Patients Discontinued Due to Adverse Events

    Patient Disposition: Few Patients Discontinued Due to Adverse Events DERMIS-1 DERMIS-2 Roflumilast Cream 0.3% Vehicle Roflumilast Cream 0.3% Vehicle Patients, n (%) (n=286) (n=153) (n=290) (n=152) Completed 255 (89.2) 133 (86.9) 264 (91.0) 131 (86.2) Prematurely discontinued 31 (10.8) 20 (13.1) 26 (

  11. Slide 11: Safety and Tolerability of Roflumilast Cream Were Similar to Vehicle

    Safety and Tolerability of Roflumilast Cream Were Similar to Vehicle DERMIS-1 DERMIS-2 • Roflumilast cream demonstrated low rates of Roflumilast Roflumilast cream 0.3% Vehicle cream 0.3% Vehicle application site AEs, treatment- n (%) (n=286) (n=153) (n=290) (n=152) related AEs, and discontinuations

  12. Slide 12: Conclusions

    Conclusions • Once-daily treatment with roflumilast cream 0.3% provided significant, consistent, and sustained improvements in the severity and burden of itch and QoL in patients with chronic plaque psoriasis – Onset of action of patient-reported improvements were observed as early as the first time

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