Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: A 52-week, phase 2, open-label trial.

Background: Efficacy and/or safety profiles limit topical psoriasis treatments.
Objective: Evaluate long-term effects of once-daily roflumilast cream 0.3% in patients with psoriasis.
Methods: In this open-label phase 2 trial, adult patients (N = 332) with psoriasis who completed the phase 2b parent trial or were newly enrolled applied roflumilast once-daily for 52 weeks. Safety and effectiveness were assessed.
Results: Overall, 244 patients (73.5%) completed the trial; 13 patients (3.9%) discontinued due to adverse events (AEs) and 3 (0.9%) due to lack of efficacy. Twelve patients (3.6%) reported treatment-related AEs; none were serious. ≥97% of patients had no irritation. No tachyphylaxis was observed with 44.8% of the patients achieving Investigator Global Assessment (IGA) Clear or Almost Clear at Week 52.
Limitations: Intertriginous-IGA and Psoriasis Area and Severity Index (PASI) were not evaluated in all patients.
Conclusions: In this long-term trial, once-daily roflumilast cream was well-tolerated and efficacious up to 64 weeks in patients in the earlier trial, suggesting it is suitable for chronic treatment, including the face and intertriginous areas.
Competing Interests: Conflicts of interest Dr Stein Gold is an investigator, advisor and/or speaker for AbbVie, Amgen, AnaptyisBio, Arcutis, BMS, Cutera, Dermavant, Dermira, Dr Reddy, Eli Lilly and Company, Galderma, Leo, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, and UCB. Dr Adam has been an investigator, speaker, or advisory board member for AbbVie, Actelion, Amgen, Arcutis, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Coherus, Dermira, Dermavant, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma Inc, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. Dr Albrecht received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, Akros, Amgen, Arcutis, Avillion, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Cutanea, Dermavant, Dermira, Eli Lilly, Galderma, Glenmark, Hoffmann-La Roche, Janssen, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Sanofi, UCB, and Valeant/Bausch Health. Dr Alonso-Llamazares is an investigator for Arcutis; speaker for Celgene (Amgen), Dermira (Eli Lilly), Eli Lilly, Ortho Derm, and UCB Pharma; and serves on advisory boards for Leo. Dr Ferris received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, Amgen, BI, BMS, Dermavant, Eli Lilly, Janssen, Nimbus, Novartis, and UCB. Dr Gooderham received investigator fees, speaker fees and/or honoraria from AbbVie, Akros, Amgen, Arcutis, Aslan, BMS, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sun Pharma, UCB, and Valeant/Bausch. Dr Hong served as consultant and/or advisory board member and/or performed clinical trials for AbbVie, Amgen, Arcutis, Avillion, Bausch Health, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Celtrion, Cutanea, Dermira, Dermavant, DS Biopharma, Eli Lilly, Evelo Biosciences, Galderma, GSK, Incyte, Janssen, Leo Pharma, Medimmune, Merck, Mirimar, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, and UCB. Dr Kempers declares no competing interests. Dr Kircik received investigator fees, speaker's fees, clinical research grants, and/or honoraria from Abbott Laboratories, Ablynx, Acambis, Allergan, Inc, Almirall, Amgen, AnaptysBio, Aqua, Arcutis, Inc, Astellas Pharma US, Inc, Asubio Pharmaceuticals, Inc, Bayer Consumer Healthcare Pharmaceuticals, Beiersdorf, Inc, Biogen, Biolife, Biopelle, Inc, Boehringer Ingelheim, Botanix Pharmaceuticals, Breckinridge Pharma, Bristol-Myers Squibb, Cassiopea SpA, Celgene, Cellceutix, Centocor Ortho Biotech Inc, ChemoCentryx, ColBar LifeScience Ltd, CollaGenex Pharmaceuticals, Inc, Connetics Corporation, Coria Laboratories, Dermavant Sciences, Inc, Dermik Laboratories (a business of Sanofi Aventis U.S. LLC), Dow Pharmaceutical Sciences, Inc, DUSA Pharmaceuticals, Inc, Embil Pharmaceuticals, Co, Ltd, EOS, Ferndale Laboratories, Inc, Galderma Laboratories, L.P., Genentech, Inc, GlaxoSmithKline, Healthpoint, Incyte Corporation, Intendis, Inc, Isdin, Johnson & Johnson Consumer Products Company, Laboratory Skin Care, Inc, Leo Pharma Inc, 3M Pharmaceuticals, MC2 Therapeutics, Medical International Technologies, Medicis Pharmaceutical Corporation, Merck & Co, Inc, Merck Serono, Merz Pharmaceuticals, LLC, NanoBio Corporation, Novartis Pharmaceuticals Corp., Nucryst, Obagi Medical Products, Onset Dermatologics, Ortho Dermatologics, Pfizer Inc, Pharmaderm, Promius Pharma, LLC, PuraCap Pharmaceutical, QLT Inc, Sandoz (a Novartis company), SkinMedica, Inc, Stiefel (a GSK company), Sun Pharmaceutical Industries Ltd, Taro Pharm, TolerRx, Triax Pharmaceuticals, LLC, Valeant Pharmaceuticals International, Warner Chilcott, Xenoport, Inc, Zalicus. Dr Lebwohl receives research funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc, and is a consultant for Aditum Bio, Almirall, AltruBio Inc, AnaptysBio, Arcutis, Inc, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Dr Reddy's Laboratories, Evelo Biosciences, Evommune, Inc, Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verrica. Dr Loo has served as an investigator, speaker, advisor/consultant for and/or received grants/honoraria from AbbVie, Amgen, Arcutis, Bausch Health, BMS, Celgene, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Meiji Seika Pharma, Pediapharm, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, UCB, and Valeant. Dr Nahm is an investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr Papp received investigator fees, speaker fees, clinical research grants, and/or honoraria from AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Avillion, Bausch Health/Valeant, Baxalta, Biopharma, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Celgene, Celltrion, Coherus, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly and Company, Evelo, Forbion, Galapagos, Galderma, Genentech, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, Leo, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Reistone, Roche, Sandoz, Sanofi Aventis/Genzyme, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor. Dr Stewart is an investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr Toth is an investigator/serves on an advisory board for: AbbVie, Amgen, Arcutis, Avillion, Bausch Health Care, BI, BMS, Celgene, Dermavant, Dow Pharmaceutical, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Merck, Novartis, Pfizer, Regeneron/Sanofi, Sun Pharma, and UCB. Dr Zirwas received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, All Free Clear/Sun, Anaptys Bio, Arcutis, Asana, AsepticMD, Avillion, Bausch Health, Cara, Concert, Dermavant, Edessa Biotech, EPI Health, Fit Bit, Galderma, Genentech/Novartis, Incyte, Janssen, L'Oreal, Leo, Level-Ex, Lilly, LUUM, Oculus, Peloton, Pfizer, Regeneron/Sanofi, Sol-Gel, Trevi, UCB, and Vyne. Drs Krupa, Snyder, Burnett, Higham, and Berk are employees of Arcutis Biotherapeutics, Inc.
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