Once-daily roflumilast foam 0.3% for scalp and body psoriasis: a randomized, double-blind, vehicle-controlled phase IIb study.

Autor:	Kircik LH; Icahn School of Medicine at Mount Sinai, New York, NY, USA.; Indiana Medical Center, Indianapolis, IN, USA.; Physicians Skin Care PLLC, Louisville, KY, USA.; Skin Sciences PLLC, Louisville, KY, USA., Alonso-Llamazares J; Driven Research LLC, Coral Gables, FL, USA., Bhatia N; Therapeutics Clinical Research, San Diego, CA, USA., Bukhalo M; Arlington Dermatology, Rolling Meadows, IL, USA., Devani AR; Dermatology Research Institute, Calgary, AB, Canada.; Skin Health and Wellness Centre, Calgary, AB, Canada.; Probity Medical Research, Calgary, AB, Canada., Draelos ZD; Dermatology Consulting Services, High Point, NC, USA., DuBois J; DermResearch Inc., Austin, TX, USA., Gooderham MJ; SkiN Centre for Dermatology, Peterborough, ON, Canada.; Probity Medical Research, Peterborough, ON, Canada.; Queen's University, Peterborough, ON, Canada., Kempers SE; Minnesota Clinical Study Center, Fridley, MN, USA., Lain E; Sanova Dermatology, Austin, TX, USA., Lee M; Progressive Clinical Research, San Antonio, TX, USA., Moore A; Arlington Research Center, Arlington, TX, USA.; Baylor University Medical Center, Dallas, TX, USA., Murrell DF; Faculty of Medicine, University of NSW, Sydney, Australia., Papp KA; Probity Medical Research, Waterloo, ON, Canada.; K. Papp Clinical Research, Waterloo, ON, Canada., Pariser DM; Eastern Virginia Medical School, Norfolk, VA, USA.; Virginia Clinical Research Inc., Norfolk, VA, USA., Sinclair R; Sinclair Dermatology, East Melbourne, Australia., Zirwas M; Dermatologists of the Central States, Probity Medical Research, Bexley, OH, USA.; Ohio University, Bexley, OH, USA., Burnett P; Arcutis Biotherapeutics Inc., Westlake Village, CA, USA., Higham RC; Arcutis Biotherapeutics Inc., Westlake Village, CA, USA., Krupa D; Arcutis Biotherapeutics Inc., Westlake Village, CA, USA., Berk DR; Arcutis Biotherapeutics Inc., Westlake Village, CA, USA.
Jazyk:	angličtina
Zdroj:	The British journal of dermatology [Br J Dermatol] 2023 Sep 15; Vol. 189 (4), pp. 392-399.
DOI:	10.1093/bjd/ljad182
Abstrakt:	Background: Scalp psoriasis affects most patients with psoriasis, but it can be difficult to treat. Objectives: To evaluate the efficacy and safety of once-daily roflumilast foam 0.3% on scalp and body psoriasis. Methods: In a phase IIb randomized controlled trial, adults and adolescents aged ≥ 12 years with scalp and body psoriasis were randomized (2 : 1) to roflumilast foam 0.3% or vehicle for 8 weeks. The primary efficacy endpoint was scalp Investigator Global Assessment (S-IGA) success (score of 'clear' or 'almost clear' plus ≥ 2-grade improvement from baseline) at week 8. Safety and tolerability were also evaluated. Results: Significantly more roflumilast-treated patients (59.1%) than vehicle-treated patients (11.4%) achieved S-IGA success at week 8 (P < 0.001); differences favoured roflumilast as early as the first postbaseline visit at week 2 (P < 0.001). Significant improvements were also seen for secondary endpoints, including body IGA success, Scalp Itch Numeric Rating Scale and the Psoriasis Scalp Severity Index. The safety of roflumilast was generally similar to vehicle. Patients treated with roflumilast experienced low rates of treatment-emergent adverse events (AEs), with few discontinuations due to an AE. Few patients with skin of colour (11%) and few adolescents (0.7%) were included. Conclusions: The results support the further development of roflumilast foam for treating scalp and body psoriasis. Competing Interests: Conflicts of interest: L.H.K. has received investigator fees, speaker fees, clinical research grants and/or honoraria from Abbott Laboratories, Ablynx, Acambis, Allergan, Almirall, Amgen, AnaptysBio, Aqua, Arcutis, Astellas Pharma US, Asubio Pharmaceuticals, Bayer Consumer Healthcare Pharmaceuticals, Beiersdorf, Biogen, BioLife, Biopelle, Boehringer Ingelheim, Botanix Pharmaceuticals, Breckenridge Pharma, Bristol Myers Squibb, Cassiopea, Celgene, Cellceutix, Centocor Ortho Biotech, ChemoCentryx, CollaGenex Pharmaceuticals, ColBar LifeScience, Connetics Corporation, Coria Laboratories, Dermavant Sciences, Dermik Laboratories (a business of Sanofi-Aventis US), Dow Pharmaceutical Sciences, DUSA Pharmaceuticals, Embil Pharmaceutical, EOS, Ferndale Laboratories, Galderma Laboratories, Genentech, GlaxoSmithKline, Healthpoint, Incyte Corporation, Intendis, Isdin, Johnson & Johnson Consumer Products Company, Laboratory Skin Care, LEO Pharma, 3M Pharmaceuticals, MC2 Therapeutics, Medical International Technologies, Medicis Pharmaceutical, Merck & Co., Merck-Serono, Merz Pharmaceuticals, NanoBio Corporation, Novartis Pharmaceuticals, Nucryst, Obagi Medical Products, Ortho Dermatologics, Onset Dermatologics, Pfizer, PharmaDerm, Promius Pharma, PuraCap Pharmaceutical, QLT, Sandoz (a Novartis company), SkinMedica, Stiefel Laboratories (a GSK company), Sun Pharmaceutical Industries, Taro Pharmaceutical Industries, TolerRx, Triax Pharmaceuticals, Valeant Pharmaceuticals International, Warner Chilcott, XenoPort and Zalicus. J.A.-L. is an investigator for Arcutis Biotherapeutics; a speaker for Celgene (Amgen), Dermira (Eli Lilly), Eli Lilly, Ortho Dermatologics and UCB Pharma; and serves on advisory boards for LEO Pharma. N.B. is an advisor, consultant and investigator for Arcutis Biotherapeutics, and received grants/research funding and honoraria. M.B. is an investigator for Arcutis Biotherapeutics, and received grants/research funding and honoraria. A.R.D. has received investigator fees, speaker fees and/or honoraria from AbbVie, Amgen, Arcutis Biotherapeutics, Bausch Health/Valeant Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant Sciences, Dermira, Eli Lilly, Galapagos, Galderma Laboratories, GSK, Incyte Corporation, Janssen Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Reistone Biopharma, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda and UCB Pharma. Z.D.D. received a research grant from Arcutis Biotherapeutics to contribute to the data presented in the paper. J.D. is an investigator for and receives grants/research funding from AbbVie, AiViva BioPharma, Allergan, Almirall, AnaptysBio, Arcutis Biotherapeutics, Bausch Health, Bellus Medical, Biofrontera, Brickell Biotech, Bristol Myers Squibb, Caliway Biopharmaceuticals, Cara Therapeutics, Croma-Pharma, Dermata Therapeutics, DermBiont, Dr. Reddy’s Laboratories, Endo Pharmaceuticals, Evommune, Galderma USA, Hexima, Incyte Corporation, LEO Laboratories (LEO Pharma), Merck, NFlection Therapeutics, Palvella Therapeutics, RAPT Therapeutics and Therapeutics; is an advisory board member for and receives honoraria from RAPT Therapeutics; and is an independent contractor for and receives other financial benefit from Vial Health Technology. M.J.G. has received investigator fees, speaker fees and/or honoraria from AbbVie, Akros, Amgen, AnaptysBio, Arcutis Biotherapeutics, Aristea Therapeutics, Aslan Pharmaceuticals, Bausch, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Dermavant Sciences, Dermira, Eli Lilly, Galderma Laboratories, GSK, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Kirin International, MedImmune, Meiji Seika Pharma, Merck, MoonLake Immunotherapeutics, Nimbus Therapeutics, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sun Pharma and UCB Pharma. S.E.K. declares no conflicts of interests. E.L. is an investigator for Arcutis Biotherapeutics, and has received grants/research funding and honoraria. M.L. is an investigator for AbbVie, Arcutis Biotherapeutics, AstraZeneca, Bausch Health, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Dermavant Sciences, Dermira, Eli Lilly, Incyte Corporation, Janssen Pharmaceuticals, Kiniksa Pharmaceuticals, LEO Pharma, Pfizer, RAPT Therapeutics, Reistone Biopharma, Regeneron Pharmaceuticals and UCB Biopharma. A.M. is an investigator for and has received research funds or honoraria from AbbVie, Arcutis Biotherapeutics, Bristol Myers Squibb, Dermavant Sciences, Eli Lilly, Galderma Laboratories, Janssen Pharmaceuticals and Nimbus Therapeutics. D.F.M. is an advisory board member/investigator for Almirall, Amicus Therapeutics, Amgen, Amryt Pharma, AnaptysBio, Arcutis Biotherapeutics, Arena Pharmaceuticals, ArgenX, AstraZeneca, Azora Therapeutics, Castle Creek Biosciences, Dermira, Eli Lilly, Evelo Biosciences, Factor Bioscience, Galderma Laboratories, Innovaderm Research, Janssen Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Principia Biopharma, Regeneron Pharmaceuticals, Rheacell, Sanofi, Shire, Sienna Biopharmaceuticals, Sun Pharma, UCB Pharma and Xerion Healthcare. K.A.P. has received investigator fees, speaker fees, clinical research grants and/or honoraria from AbbVie, Akros, Amgen, Anacor Pharmaceuticals, Arcutis Biotherapeutics, Astellas Pharma US, Avillion, Bausch Health/Valeant Pharmaceuticals International, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite BioPharma, Celgene, Celltrion Healthcare, Coherus Biosciences, Dermavant Sciences, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo Biosciences, Forbion, Galapagos, Galderma Laboratories, Genentech, Gilead, GSK, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Hakko Kirin, LEO Pharma, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron Pharmaceuticals, Reistone Biopharma, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB Pharma, vTv Therapeutics and Xencor. D.M.P. is an investigator for and receives grants/research funding and/or honoraria from Almirall, Amgen, AOBiome, Asana BioSciences, Bickel Biotechnology, Celgene Corporation, Dermira, Eli Lilly and Company, LEO Pharma, Menlo Therapeutics, Novartis Pharmaceuticals, Novo Nordisk, Ortho Dermatologics, Pfizer and Regeneron Pharmaceuticals; is a consultant for and/or serves on an advisory board for and receives honoraria from Bickel Biotechnology, Biofrontera, Dermira, Novartis Pharmaceuticals, Pfizer, Regeneron Pharmaceuticals and Sanofi; and is on the Data Safety Monitoring Board for and receives honoraria from Bristol Myers Squibb. R.S. is an investigator for Arcutis Biotherapeutics and received grants/research funding and honoraria. M.Z. has received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, All Free Clear/Sun, AnaptysBio, Arcutis Biotherapeutics, Asana BioSciences, Aseptic, Avillion, Bausch Health, Cara Therapeutics, Concert Pharmaceuticals, Dermavant Sciences, Edesa Biotech, Eli Lilly, EPI Health, Fitbit, Galderma Laboratories, Genentech/Novartis, Incyte Corporation, Janssen Pharmaceuticals, LEO Pharma, Level Ex, L’Oréal, LUUM, Oculus, Peloton, Pfizer, Regeneron Pharmaceuticals/Sanofi, Sol-Gel, Trevi Therapeutics, UCB Pharma and VYNE Therapeutics. P.B., R.C.H., D.K. and D.R.B. are employees of Arcutis Biotherapeutics. This work was supported by Arcutis Biotherapeutics. (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.)
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