75th AAD Annual Meeting Poster nº 4873 A phase 3 randomized, double-blind, trial comparing the efficacy and safety of the fixed combination calcipotriene 0.005% (Cal) and betamethasone dipropionate 0.064% (BD) aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in patients with plaque psoriasis methodology of the PSO-LONG study M Lebwohl, 1 L Stein Gold, 2 A Snel, 3 K Reich 4 1 Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 2 Henry Ford Health System, Detroit, MI, USA; 3 LEO Pharma A/S, Ballerup, Denmark; 4 Dermatologikum Hamburg, Hamburg, Germany
Conflicts of interest and Funding M Lebwohl: An employee of the Mount Sinai Medical Center, which receives research funds from AbGenomics, Amgen, Anacor, Boehringer Ingelheim, Celgene, Ferndale, Lilly, Janssen Biotech, Kadmon, LEO Pharma, Medimmune, Novartis, Pfizer, Sun Pharmaceuticals and Valeant L Stein Gold: Advisory board: Celgene, LEO Pharma, Promius; Investigator: Celgene, LEO Pharma, Novartis; Speaker: Celgene, LEO Pharma, Novartis A Snel: Employee: LEO Pharma K Reich: Advisory board and/or Consultant and/or Speaker and/or Investigator: AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Covagen, Forward Pharma, GSK, Janssen-Cilag, LEO Pharma, Lilly, Medac, Merck Sharp & Dohme Corp., Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB Pharma, Xenoport This study is sponsored by LEO Pharma. Editorial assistance was provided by Andrew Jones PhD from Mudskipper Business Ltd, funded by LEO Pharma
Background Psoriasis is a chronic inflammatory skin disease that requires long-term management for most patients Flare treatment Long-term proactive management Study purpose: To evaluate the efficacy of a twice-weekly maintenance regimen with Cal/BD aerosol foam compared to vehicle in the prevention of relapse in patients with psoriasis vulgaris
PSO-LONG: Rationale When psoriasis treatment is discontinued, lesions will likely recur Optimal management of psoriasis must be initial rapid relief of symptoms + long-term maintenance of remission Convenient proactive management: one product for clearance and maintenance Positive impact on adherence Fixed combination therapy with Cal/BD aerosol foam is more effective than ointment and topical suspension formulations and the active individual ingredients, and treatment is well tolerated 1 5 1 Koo et al. J Dermatolog Treat 2016;27:120 127; 2 Lebwohl et al. J Clin Aesthet Dermatol 2016;9:34 41; 3 Leonardi et al. J Drugs Dermatol 2015;14:1468 1477; 4 Paul et al. J Eur Acad Dermatol Venereol 2017;31:119 126; 5 Menter et al. SKINmed 2016 (in press)
PSO-LONG: Study design ~700 patients Randomization of responders (~60%) (clear or almost clear) Cal/BD foam 4 weeks Cal/BD foam 2 x weekly, Cal/BD foam at relapse* (4 weeks), ~200 patients Vehicle 2 x weekly, Cal/BD foam at relapse* (4 weeks), ~200 patients 0 w 4 w 6 m 12 m *Relapse defined as a PGA score of at least mild
PSO-LONG: Objectives and endpoints Primary objective: To evaluate the efficacy of a twice-weekly maintenance regimen with Cal/BD foam compared to vehicle in the prevention of relapse in patients with psoriasis vulgaris Secondary objectives: To evaluate the long-term efficacy of Cal/BD foam (up to 52 weeks) when used in a twice-weekly maintenance regimen To evaluate the long-term safety of Cal/BD foam (up to 52 weeks) in patients with psoriasis vulgaris Primary endpoint: Time to first relapse Secondary endpoints: Number of days being clear / almost clear Number of relapses
PSO-LONG: Population and design rationale Patients: Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2 30% of the body surface area Rationale for twice weekly regimen Other trials have investigated this, but never with a once-daily treatment 3 or 4 days between applications has been selected based on a discussion with a panel of dermatologists The stratum corneum can act as a reservoir for topically-applied drugs that can reduce the frequency of applications Rationale for a duration of 12 months Allows an assessment of prevention of relapse over a period of time, during which relapse would be expected to occur on a regular basis
Summary Psoriasis is a chronic disease that requires long-term management Psoriatic inflammation tends to recur in the same skin locations Optimal management of psoriasis must include a strategy for initial rapid relief of symptoms, as well as a long-term strategy to maintain remission = one product for clearance and maintenance The superior efficacy of Cal/BD foam compared with ointment, topical suspension or the individual active ingredients is achieved without compromising tolerability PSO-LONG will evaluate the efficacy of a twice-weekly maintenance regimen with Cal/BD foam compared to vehicle in the prevention of relapse; impact on adrenal function will be assessed using ACTH stimulation testing ACTH, adrenocorticotropic hormone