Efficacy and safety of proactive treatment with twice-weekly topical Cal/BD foam in patients with plaque psoriasis undergoing HPA-axis testing: a PSO-LONG subgroup analysis

Abstract

Objective

In PSO-LONG, long-term proactive management (PAM) of psoriasis with fixed-dose combination calcipotriol 50 µg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) aerosol foam was superior to conventional reactive management. This post-hoc analysis investigated long-term PAM with Cal/BD foam in PSO-LONG patients who could be more susceptible to corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression.

Methods

Efficacy and safety of PAM with Cal/BD foam (twice-weekly) versus reactive management (twice-weekly vehicle foam), with once-daily rescue Cal/BD foam for four weeks following relapse, was assessed in the HPA subgroup (n = 66); patients had moderate-to-severe psoriasis (physician global assessment score ≥3; 10–30% body surface area affected). Primary endpoint was time to first relapse.

Results

PAM with Cal/BD foam was associated with longer median time to first relapse (111 versus 31 days), reduced risk of first relapse (hazard ratio: 0.49; p = .029), greater proportion of days in remission (17%; p = .001) and reduced rate of relapse (60% reduction; p < .001) than reactive management. Adverse events occurred in 37.5% (PAM) and 47.1% (reactive management) of patients, with no new safety signals. No clinically significant HPA-axis suppression was observed.

Conclusion

Efficacy of PAM with Cal/BD foam is maintained in patients with moderate-to-severe psoriasis, with no new safety signals.

Keywords:

• Calcipotriol
• corticosteroid
• long-term
• proactive management
• psoriasis

Acknowledgments

Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Gregor Fyfe, PhD, of Ashfield MedComms, an Ashfield Health company, and funded by LEO Pharma.

Disclosure statement

Kim Papp: Consultant for AbbVie, Akros, Amgen, Arcutis, Atellas, Avillion, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Can-Fite Biopharma, Celgene, Coherus, Dermavant, Dermira, Dow Pharma, Eli Lilly and Company, Evelo, Galapagos, Galderma, Genentech, Incyte, Janssen, Kyowa Hakko Kirin, Leo Pharma A/S, Merck (MSD), Merck Serono, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Takeda, UCB. Received research grants from Anacor, Gilead, GSK, MedImmune, Moberg Pharma and Sun Pharma. Scientific officer for Akros, Anacor, Arcutis, Dice Pharmaceuticals and Kyowa Hakko Kirin. Consultant for Dice Pharmaceuticals, Meiji Seika Pharma and Mitsubishi Pharma. Speaker, received honoraria and participated in steering committees and advisory boards for AbbVie, Amgen, Bausch Health/Valeant, Celgene, Eli Lilly and Company, Janssen, Merck (MSD), Novartis, Pfizer and Sanofi-Aventis/Genzyme. Speaker for Astellas, Galderma, Incyte, Kyowa Hakko Kirin and Leo Pharma A/S. Participated in steering committees for Boehringer Ingelheim, Kyowa Hakko Kirin, Merck Serono and Regeneron. Participated in advisory boards for Astellas, Boehringer Ingelheim, Bristol-Myers Squibb, Dow Pharma, Galderma, Regeneron, Sun Pharma and UCB. Received honoraria from Akros, Boehringer Ingelheim, Coherus, Galderma, Kyowa Hakko Kirin, Merck Serono, Mitsubishi Pharma, PRCL Research, Takeda and UCB.

Zygmunt Adamski: Investigator in clinical trials sponsored by LEO Pharma.

Lyn Guenther: Consultant, investigator, and speaker for AbbVie, Amgen, Bausch Health, Celgene, Eli Lilly and Company, Janssen, Leo Pharma, Merck, Pfizer and UCB. Speaker and consultant for Miravo.

Monika Liljedahl: Is an employee of LEO Pharma.

Agnieszka Miasik-Pogodzinska: Investigator in clinical trials sponsored by LEO Pharma.

Anna Szponar-Bojda: Investigator in clinical trials sponsored by LEO Pharma.

Charles Lynde: Consultant, speaker and investigator for AbbVie, Amgen, AnaptysBio, Bausch Health, Bristol Meyers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Galderma, Genentech, GSK, Janssen, Leo Pharma, L'Oreal, Merck, Novartis, Pfizer, Sanofi Genzyme, and UCB. Investigator for Asana Biosciences, Concert, Dermira, Glenmark, Incyte, and Kyowa.

Terri Nutt: Investigator in clinical trials sponsored by LEO Pharma.

Marie Holst Mørch: Is an employee of LEO Pharma.

Stephen Tyring: Investigator in clinical trials sponsored by LEO Pharma.

William Werschler: Consultant, independent contractor or speaker for Abbvie, Allergan, Celgene, Eskata, Leo Pharma, Merz, Prescriber’s Choice, Pfizer, Suneva, Ulthera, and Xoft. Received honoraria from Abbvie, Celgene, Continued Med, llergan, Leo Pharma, Merz, Prescriber’s Choice and Suneva.

Adam Reich: Principal Investigator or Subinvestigator in clinical trials sponsored by AbbVie, Drug Delivery Solutions Ltd, Galderma, Genentech, Janssen, Kymab Limited, Leo Pharma, Menlo Therapeutics, MetrioPharm, MSD, Novartis, Pfizer, and Trevi. Consultant or speaker for AbbVie, Bioderma, Celgene, Chema Elektromet, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Medac, Menlo Therapeutics, Novartis, Pierre-Fabre, Sandoz, and Trevi.

Neil Sadick: Consultant for Allergan Inc., Cutera Inc., Lypolysis Robotics, Lumisque, Prescriber’s Choice and Venus Concept; has received honoraria from Allergan, Endo International plc, Storz and Venus Concept.

Irina Turchin: Consultant, speaker or investigator for Abbvie, Amgen, Arcutis, Bausch Health, Celgene, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, Sun Pharma, and UCB.

Jean-Philippe Lacour: Received grant and consulting fees from AbbVie, Amgen, Boehringer-Ingelheim, Celgene, Eli Lilly and Company, Galderma International, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Pierre Fabre, and Sanofi.

Additional information

Funding

This work was supported by Leo Pharma.