Twice-weekly topical calcipotriene/betamethasone dipropionate foam as proactive management of plaque psoriasis increases time in remission and is well tolerated over 52 weeks (PSO-LONG trial) - 10/04/21
Doi : 10.1016/j.jaad.2020.09.037
Mark Lebwohl, MD a, ⁎ 
, Leon Kircik, MD a, Jean-Philippe Lacour, MD, PhD b, Monika Liljedahl, MD, PhD c, Charles Lynde, MD, FRCPC d, e, Marie Holst Mørch, MS c, Kim A. Papp, MD, FRCPC, PhD f, Jean-Luc Perrot, MD, PhD g, Linda Stein Gold, MD h, Amrit Takhar, MBChB, MRCGP i, Diamant Thaçi, MD, PhD j, Richard B. Warren, MBChB, FRCP, PhD k, Andreas Wollenberg, MD l
, Leon Kircik, MD a, Jean-Philippe Lacour, MD, PhD b, Monika Liljedahl, MD, PhD c, Charles Lynde, MD, FRCPC d, e, Marie Holst Mørch, MS c, Kim A. Papp, MD, FRCPC, PhD f, Jean-Luc Perrot, MD, PhD g, Linda Stein Gold, MD h, Amrit Takhar, MBChB, MRCGP i, Diamant Thaçi, MD, PhD j, Richard B. Warren, MBChB, FRCP, PhD k, Andreas Wollenberg, MD l a Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York
b Department of Dermatology, University Hospital of Nice, Nice, France
c LEO Pharma Ballerup, Ballerup, Denmark
d Lynde Dermatology, Probity Medical Research, Markham, Ontario, Canada
e Department of Medicine, University of Toronto, Toronto, Ontario, Canada
f K. Papp Clinical Research, Waterloo, Ontario, Canada
g Department of Dermatology, University Hospital of St-Etienne, St-Etienne, France
h Department of Dermatology, Henry Ford Hospital, Detroit, Michigan
i Wansford and Kings Cliffe Practice, Wansford, Cambridgeshire, United Kingdom
j Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany
k Dermatology Centre, Salford Royal National Health Service Foundation Trust, Manchester National Institute for Health Research Biomedical Research Centre, University of Manchester, Manchester, United Kingdom
l Department of Dermatology and Allergology, Ludwig Maximilian University Munich, Munich, Germany
∗Correspondence and reprint requests to: Mark Lebwohl, MD, Department of Dermatology, 1 Gustave L. Levy Place, Box 1048, New York, NY 10029.Department of Dermatology1 Gustave L. Levy PlaceBox 1048New YorkNY10029
Abstract |
Background |
Topical psoriasis treatment relies on a reactive rather than a long-term proactive approach to disease relapse.
Objective |
Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam.
Methods |
Phase III trial (NCT02899962) included a 4-week open-label lead-in phase (Cal/BD foam once daily) and a 52-week, randomized, double-blind, maintenance phase. A total of 545 patients achieved treatment success (physician's global assessment “clear”/“almost clear,” ≥2-grade improvement from baseline) and were randomized to proactive management (Cal/BD foam; n = 272) or reactive management (vehicle foam; n = 273) twice-weekly, with rescue treatment of Cal/BD foam once daily for 4 weeks upon relapse. Primary endpoint was time to first relapse (physician's global assessment “mild” or higher).
Results |
A total of 251 randomized patients (46.1%) completed the trial. Median time to first relapse was 56 days (proactive) and 30 days (reactive). Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < .001). Number of relapses per year of exposure was 3.1 (proactive) and 4.8 (reactive). Cal/BD foam was well tolerated.
Limitations |
Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis.
Conclusion |
Long-term proactive management with Cal/BD foam demonstrated superior efficacy vs reactive management.
Le texte complet de cet article est disponible en PDF.Key words : betamethasone dipropionate, calcipotriene, Enstilar, fixed-dose, foam, long-term, maintenance, proactive, psoriasis vulgaris, relapse, topical preparation
Abbreviations used : AEs, BSA, Cal/BD, HPA, m-PASI, PGA
Plan
| Funding sources: This trial was funded by LEO Pharma, Ballerup, Denmark. LEO Pharma supported the trial concept and design. Dr Warren is supported by the Manchester National Institute for Health Research Biomedical Research Centre. |
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| Conflicts of interest: Dr Lebwohl is an employee of Mount Sinai and receives research funds from AbbVie Inc, Amgen, Arcutis Biotherapeutics, Boehringer Ingelheim, Dermavant Sciences Ltd, Eli Lilly and Company, Incyte, Janssen Research & Development, LLC, LEO Pharma, Ortho Dermatologics, Pfizer, and UCB, Inc, and is a consultant for Aditum Bio, Allergan, Almirall, Arcutis Biotherapeutics, Avotres Therapeutics, BirchBioMed Inc, BMD Skincare, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, Kyowa Kirin, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy's Laboratories, Serono, Theravance, and Verrica. Dr Kircik has served as an investigator, speaker, consultant, or an advisory board member for AbbVie Inc, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, LEO Pharma, Mayne Pharma, Novartis, Ortho Dermatologics Inc, Sun Pharmaceutical Industries Ltd, Arcutis Biotherapeutics, Dermavant Sciences Ltd, Pfizer, Dr Reddy's Laboratories, and UCB. Dr Lacour has received grants/research support as an investigator from AbbVie Inc, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Dermira, Galderma, Janssen Pharmaceuticals, Eli Lilly and Company, LEO Pharma, Merck, Novartis, Regeneron Pharmaceuticals, and Roche and has also received honoraria, advisory board, or consulting fees from AbbVie Inc, Bristol-Myers Squibb, Celgene, Galderma, Eli Lilly and Company, LEO Pharma, Novartis, and Sanofi. Dr Liljedahl and author Mørch are employees at LEO Pharma. Dr Lynde has served as an investigator, speaker, consultant, or advisory board member for AbbVie Inc, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galderma, Janssen Pharmaceuticals, Eli Lilly and Company, LEO Pharma, Merck, Novartis, Regeneron Pharmaceuticals, Sanofi, Bausch Health, and Sun Pharmaceutical Industries Ltd. Dr Papp has received honoraria for advisory board, speaker, and consultant services from AbbVie Inc, Actelion, Allergan, Amgen, Anacor Pharmaceuticals Inc, Astellas Pharma, Avillion, Bausch Health, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly and Company, EMD Serono, Galderma, Gilead, GlaxoSmithKline, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Kirin, LEO Pharma, Meiji Seika, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sanofi Genzyme, Sun Pharmaceutical Industries Ltd, Takeda Pharmaceutical Company, UCB Pharma, and Vertex Pharmaceuticals, and has received research grants for investigator services from AbbVie Inc, Actelion, Allergan, Amgen, Anacor Pharmaceuticals Inc, Astellas Pharma, Avillion, Bausch Health, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly and Company, EMD Serono, Galderma, Gilead, GlaxoSmithKline, Incyte Corporation, Janssen Pharmaceuticals, Kyowa Kirin, LEO Pharma, Meiji Seika, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sanofi Genzyme, Sun Pharmaceutical Industries Ltd, Takeda Pharmaceutical Company, and UCB Pharma. Dr Perrot has been an advisor and/or received speakers honoraria and/or received grants and/or participated in clinical trials of the following companies: Abbott/AbbVie Inc, Amgen, Celgene, Eli Lilly and Company, Galderma, Incyte Corporation, Janssen-Cilag Ltd, Johnson & Johnson, LEO Pharma, Merck Serono, Merck Sharp & Dohme, Novartis, Pierre Fabre, Pfizer, Sanofi-Aventis, Schering-Plough, and UCB Pharma. Dr Stein Gold has been an investigator, speaker, consultant, or an advisory board member for AbbVie Inc, Amgen, Arcutis Biotherapeutics, Inc, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, LEO Pharma, Mayne Pharma, Novartis, Ortho Dermatologics Inc, and Sun Pharmaceutical Industries Ltd. Author Takhar has received grants/research support and/or been a medical advisor for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cambridge and Peterborough Clinical Commissioning Group, Daiichi Sankyo, Dermal Laboratories, GlaxoSmithKline, LEO Pharma, Merck, Novartis, Pfizer, Roche, and Sanofi; Author Takhar has received grants/research support from National Institute of Health Research UK. Dr Thaçi has been a consultant and advisor and/or received speaking fees and/or grants and/or served as an investigator in clinical trials for AbbVie Inc, Almirall, Amgen, Asana, Bioskin, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermira, DS Biopharma, Eli Lilly and Company, Galapagos NV, Galderma, Janssen-Cilag Ltd, Kymab, LEO Pharma, Merck MorphoSys AG, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sandoz, Sanofi, Samsung, Merck Sharp & Dohme Corp, and UCB. Dr Warren receives research grants from AbbVie Inc, Almirall, Amgen, Celgene, Janssen Pharmaceuticals, Eli Lilly and Company, LEO Pharma, Novartis, Pfizer, and UCB and is a consultant for AbbVie Inc, Almirall, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Janssen Pharmaceuticals, LEO Pharma, Eli Lilly and Company, Novartis, Pfizer, Sanofi, and UCB. Dr Wollenberg has received grants, personal fees, or nonfinancial support from AbbVie Inc, Almirall, Beiersdorf, Bioderma, Chugai Pharmaceutical Co, Galapagos NV, Galderma, Hans Karrer, LEO Pharma, Eli Lilly and Company, L'Oréal, Maruho Co, Ltd, MedImmune, Novartis, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, Sanofi-Aventis, and Santen. |
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| IRB approval status: The protocol was approved by the Institutional Review Board or Independent Ethics Committee at each participating site. All patients provided written informed consent. |
© 2020
American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 84 - N° 5
P. 1269-1277 - mai 2021 Retour au numéro
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