Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study

Abstract

Background: Fixed-combination calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Cal/BD) aerosol foam is a new topical treatment for psoriasis. Although moderate-to-severe psoriasis is typically treated with systemic/biologic therapies, a topical treatment that is efficacious in these patients may be a significant cost-saving alternative to systemic therapy.

Objective: The objective of this study was to assess the response to Cal/BD foam and gel in patients with moderate-to-severe psoriasis enrolled in the phase III, 12-week PSO-ABLE study.

Methods: Patients eligible for this analysis had moderate-to-severe psoriasis, defined by the 'Rule of Tens': body surface area ≥10% or Psoriasis Area and Severity Index (PASI) [excluding head; modified PASI (mPASI)] >10 or Dermatology Life-Quality Index >10. Endpoints included: proportion of patients achieving mPASI75 or mPASI90; change in body surface area; proportion of patients clear/almost clear with a ≥2 grade improvement (i.e., treatment success); change in Dermatology Life-Quality Index.

Results: Seventy-seven Cal/BD foam patients and 82 gel patients had moderate-to-severe psoriasis. A greater proportion achieved mPASI75 and mPASI90 with Cal/BD foam than gel at weeks 4, 8, and 12 (57.1 vs. 35.4%; p = 0.006 and 15.6 vs. 12.2% at week 12, respectively); overall reduction in mPASI from baseline to week 12 was 64% with the foam vs. 51% with the gel. Overall reduction in body surface area at week 12 was 50% with the foam and 39% with the gel. Treatment success rates were higher with the Cal/BD foam than the gel at weeks 1, 2, 4, 8 (p = 0.0089), and 12, and a greater proportion of foam patients achieved a Dermatology Life-Quality Index score of 0/1 at weeks 4 (p = 0.004), 8, and 12 (p = 0.001).

Conclusion: Cal/BD foam can be considered as a treatment option in some patients with moderate-to-severe psoriasis who are potential candidates for systemic therapy. CLINICALTRIALS.

Gov identifier: NCT02132936.

Conflict of interest statement

Funding

This study was sponsored by LEO Pharma.

Conflict of interest

Carle Paul has been an investigator and consultant for AbbVie, Amgen, Boehringer Ingelheim, Celgene, GSK, Janssen Cilag, LEO Pharma, Lilly, Novartis, and Pfizer. Craig Leonardi has been a consultant for LEO Pharma, AbbVie, Amgen, Dermira, Lilly, Janssen, Sandoz, UCB, and Pfizer, received honoraria from AbbVie, Amgen, Dermira, Lilly, Sandoz, UCB, Pfizer, Celgene, and Novartis, and has participated in speakers’ bureaus for AbbVie and Celgene. Alan Menter reports grants and honoraria from AbbVie, Allergan, Amgen, Boehringer Ingelheim, Genentech, Janssen Biotech, LEO Pharma, Novartis, Pfizer, and Syntrix, honoraria from Convoy Therapeutics, Lilly, Vitae, Wyeth, and Xenoport, and grants from Celgene, Merck, and Symbio/Maruho. Kristian Reich reports receiving grants and/or honoraria from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Covagen, Forward Pharma, GSK, Janssen-Cilag, Lilly, LEO Pharma, Medac, Novartis, Pfizer, Regeneron, Takeda, UCB Pharma, and Xenoport. Linda Stein Gold has been an investigator and advisor for LEO Pharma. Richard B. Warren has acted as a consultant and or speaker for Amgen, AbbVie, Janssen, LEO Pharma, Lilly, Novartis, and Pfizer and has received grant support from AbbVie, Janssen, Novartis, and Pfizer. Anders Møller is an employee of LEO Pharma. Mark Lebwohl is 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.

Ethics approval

The institutional review board or independent ethics committee of all investigational sites approved the protocol and the study was performed in accordance with the Declaration of Helsinki and Good Clinical Practice. All patients provided written informed consent.

Figures

Fig. 1

Proportion of patients with moderate-to-severe psoriasis achieving. a mPASI75 and b mPASI90 during treatment (last observation carried forward). Cal/BD calcipotriol 50 μg/g plus betamethasone 0.5 mg/g, mPASI modified Psoriasis Area and Severity Index, ns not significant. p values based on the Chi square test

Fig. 2

Change in BSA affected by psoriasis from baseline in moderate-to-severe patients (observed cases). BSA body surface area, Cal/BD calcipotriol 50 μg/g plus betamethasone 0.5 mg/g. *p = 0.02; **p = 0.04; p values based on the Wilcoxon test

Fig. 3

Proportion of moderate-to-severe patients achieving treatment success during treatment (observed cases). BL baseline, Cal/BD calcipotriol 50 μg/g plus betamethasone 0.5 mg/g. *p = 0.0089; p values based on the Chi square test

Fig. 4

Proportion of patients achieving a DLQI score of 0/1 (observed cases). Cal/BD calcipotriol 50 μg/g plus betamethasone 0.5 mg/g, DLQI Dermatology Life-Quality Index, ns not significant. p values based on the Chi square test