associated with less tolerable agents, it is crucial that a wide
range of options be accessible so that treatment may be tailored
to suit individual needs. Cal/BD foam has been shown to be an
effective treatment option with potential for cost savings and
a role in adjunctive therapy for appropriate patients. Cal/BD
foam cannot replace orals and biologics in the management
of psoriasis. However, its inclusion among the list of available
options for beyond-mild psoriasis can confer benefits to patients
who seek fast symptom relief and/or prefer the convenience of a
once-daily, user-friendly, and easily applied spray foam.
DISCLOSURES
Leon Kircik has served either as an investigator, consultant, or
an advisor for LEO Pharma. Linda Stein Gold is a consultant/
investigator/advisor for LEO Pharma, Dermavant, Arcutis, Ortho
Derm, Novartis, AbbVie, Lilly, and Celgene. Joyce Teng is an
investigator for LEO Pharma. Angela Moore has received funds
as an investigator, advisory board member, and speaker for LEO
Pharma. Wendy Cantrell has nothing to disclose. Javier Alonso-
Llamazares is an investigator for LEO Pharma, speaker for Eli
Lilly, Celgene (Amgen), Dermira (Eli Lilly), Ortho Derm and UCB,
and serves on Advisory Boards for LEO Pharma. John Koo is a
consultant, speaker, and advisor for LEO Pharma, Novartis, Eli
Lilly, Janssen, AbbVie, Ortho Dermatologic, Sun Pharma, Pfizer,
Regeneron/Sanofi, and UCB.
ACKNOWLEDGMENT
p-value communications provided medical writing, editing, and
publication assistance and was funded by LEO Pharma.
REFERENCES
1. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
2. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60(4):643-659.
3. Gisondi P, Del Giglio M, Girolomoni G. Treatment approaches to moderate to severe psoriasis. Int J Mol Sci. 2017;18(11).
4. American Academy of Dermatology Work Group, Menter A, Korman NJ, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
5. Paul C, Leonardi C, Menter A, et al. Calcipotriol plus betamethasone dipropionate aerosol foam in patients with moderate-to-severe psoriasis: sub-group analysis of the PSO-ABLE study [published correction appears in Am J Clin Dermatol. 2017;18:591]. Am J Clin Dermatol. 2017;18(3):405-411.
6. Lebwohl MG, Sugarman JL, Stein Gold L, et al. Efficacy, safety, and tolerability of a halobetasol 0.01%/tazarotene 0.045% fixed combination in the treatment of severe localized plaque psoriasis: post hoc analysis of two phase III randomized controlled trials. J Drugs Dermatol. 2019;18(10):1012- 1018.
7. Payne J, Habet KA, Pona A, Feldman SR. A review of topical corticosteroid foams. J Drugs Dermatol. 2019;18(8):756-770.
8. Frieder J, Kivelevitch D, Menter A. Calcipotriene betamethasone dipropionate aerosol foam in the treatment of plaque psoriasis: a review of the literature. Ther Deliv. 2017;8(9):737-746.
9. Asche CV, Kim M, Feldman SR, et al. Budget impact model in moderateto- severe psoriasis vulgaris assessing effects of calcipotriene and betamethasone dipropionate foam on per-patient standard of care costs. J Med Econ. 2017;20(9):1000-1006.
10. Enstilar® (calcipotriene and betamethasone dipropionate) [package insert]. Madison, NJ: LEO Pharma Inc.; 2019.
11. Lind M, Nielsen KT, Schefe LH, et al. Supersaturation of calcipotriene and betamethasone dipropionate in a novel aerosol foam formulation for topical treatment of psoriasis provides enhanced bioavailability of the active ingredients. Dermatol Ther (Heidelb). 2016;6(3):413-425.
\12. Paul C, Stein Gold L, Cambazard F, et al. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. 2017;31(1):119-126.
13. Leonardi C, Bagel J, Yamauchi P, et al. Efficacy and safety of calcipotriene plus betamethasone dipropionate aerosol foam in patients with psoriasis vulgaris--a randomized phase III study (PSO-FAST). J Drugs Dermatol. 2015;14(12):1468-1477.
14. Lebwohl M, Tyring S, Bukhalo M, et al. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) is more efficacious than Cal or BD aerosol foam alone for psoriasis vulgaris: a randomized, double-blind, multicenter, three-arm, phase 2 study. J Clin Aesthet Dermatol. 2016;9(2):34-41.
15. Koo J, Tyring S, Werschler WP, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study. J Dermatolog Treat. 2016;27(2):120-127.
16. Sbidian E, Chaimani A, Afach S, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2020;1:CD011535.
17. Iversen L, Kurvits M, Snel-Prentø AM, Menter A. Efficacy and safety of calcipotriol plus betamethasone dipropionate cutaneous foam treatment for psoriasis in patients with body surface area 5–15% and Physician’s Global Assessment ≥3. Presented at: EADV 2019 Congress in Dermatology and Venereology; October 9-13, 2019; Madrid, Spain.
18. Del Rosso JQ, Kircik LH. The effect of calcipotriene-betamethasone dipropionate aerosol foam versus vehicle on target lesions in moderate severity plaque psoriasis: focus on elbows and knees. J Drugs Dermatol. 2019;18(4):358-361.
19. Kircik L. Efficacy and safety of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam in combination with apremilast in patients with moderate plaque psoriasis. Presented at: 17th Annual South Beach Symposium; February 7-10, 2019; Miami Beach, Florida.
20. Bagel J, Zapata J, Nelson E. A prospective, open-label study evaluating adjunctive calcipotriene 0.005%/betamethasone dipropionate 0.064% foam in psoriasis patients with inadequate response to biologic therapy. J Drugs Dermatol. 2018;17(8):845-850.
21. Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65-68; discussion ii69-73.
22. Schmitt J, Wozel G. The Psoriasis Area and Severity Index is the adequate criterion to define severity in chronic plaque-type psoriasis. Dermatology. 2005;210(3):194-199.
23. Langley RG, Feldman SR, Nyirady J, et al. The 5-point Investigator's Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015;26(1):23-31.
24. Finlay AY. Current severe psoriasis and the rule of tens. Br J Dermatol. 2005;152(5):861-867. 25. Pascoe VL, Enamandram M, Corey KC, et al. Using the Physician Global Assessment in a clinical setting to measure and track patient outcomes. JAMA Dermatol. 2015;151(4):375-381.
26. Robinson A, Kardos M, Kimball AB. Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis. J Am Acad Dermatol. 2012;66(3):369-375.
27. Armstrong AW, Parsi K, Schupp CW, et al. Standardizing training for psoriasis measures: effectiveness of an online training video on Psoriasis Area and Severity Index assessment by physician and patient raters. JAMA Dermatol. 2013;149(5):577-582.
28. Krueger GG, Feldman SR, Camisa C, et al. Two considerations for patients with psoriasis and their clinicians: what defines mild, moderate, and severe psoriasis? What constitutes a clinically significant improvement when treating psoriasis? J Am Acad Dermatol. 2000;43(2 Pt 1):281-285.
29. Feldman SR, Goffe B, Rice G, et al. The challenge of managing psoriasis: unmet medical needs and stakeholder perspectives. Am Health Drug Benefits. 2016;9(9):504-513.
30. Acquadro C, Perret C, Arnould B. Does health-related quality of life evaluation in psoriasis matter? A review of labels of psoriasis products approved by the FDA and the EMA. Value in Health. 2015;18(7):A427.
31. Strober B, Ryan C, van de Kerkhof P, et al. Re-categorization of psoriasis severity: Delphi Consensus from the International Psoriasis Council. J Am Acad Dermatol. 2020;82(1):117-122.
2. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60(4):643-659.
3. Gisondi P, Del Giglio M, Girolomoni G. Treatment approaches to moderate to severe psoriasis. Int J Mol Sci. 2017;18(11).
4. American Academy of Dermatology Work Group, Menter A, Korman NJ, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
5. Paul C, Leonardi C, Menter A, et al. Calcipotriol plus betamethasone dipropionate aerosol foam in patients with moderate-to-severe psoriasis: sub-group analysis of the PSO-ABLE study [published correction appears in Am J Clin Dermatol. 2017;18:591]. Am J Clin Dermatol. 2017;18(3):405-411.
6. Lebwohl MG, Sugarman JL, Stein Gold L, et al. Efficacy, safety, and tolerability of a halobetasol 0.01%/tazarotene 0.045% fixed combination in the treatment of severe localized plaque psoriasis: post hoc analysis of two phase III randomized controlled trials. J Drugs Dermatol. 2019;18(10):1012- 1018.
7. Payne J, Habet KA, Pona A, Feldman SR. A review of topical corticosteroid foams. J Drugs Dermatol. 2019;18(8):756-770.
8. Frieder J, Kivelevitch D, Menter A. Calcipotriene betamethasone dipropionate aerosol foam in the treatment of plaque psoriasis: a review of the literature. Ther Deliv. 2017;8(9):737-746.
9. Asche CV, Kim M, Feldman SR, et al. Budget impact model in moderateto- severe psoriasis vulgaris assessing effects of calcipotriene and betamethasone dipropionate foam on per-patient standard of care costs. J Med Econ. 2017;20(9):1000-1006.
10. Enstilar® (calcipotriene and betamethasone dipropionate) [package insert]. Madison, NJ: LEO Pharma Inc.; 2019.
11. Lind M, Nielsen KT, Schefe LH, et al. Supersaturation of calcipotriene and betamethasone dipropionate in a novel aerosol foam formulation for topical treatment of psoriasis provides enhanced bioavailability of the active ingredients. Dermatol Ther (Heidelb). 2016;6(3):413-425.
\12. Paul C, Stein Gold L, Cambazard F, et al. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. 2017;31(1):119-126.
13. Leonardi C, Bagel J, Yamauchi P, et al. Efficacy and safety of calcipotriene plus betamethasone dipropionate aerosol foam in patients with psoriasis vulgaris--a randomized phase III study (PSO-FAST). J Drugs Dermatol. 2015;14(12):1468-1477.
14. Lebwohl M, Tyring S, Bukhalo M, et al. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) is more efficacious than Cal or BD aerosol foam alone for psoriasis vulgaris: a randomized, double-blind, multicenter, three-arm, phase 2 study. J Clin Aesthet Dermatol. 2016;9(2):34-41.
15. Koo J, Tyring S, Werschler WP, et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study. J Dermatolog Treat. 2016;27(2):120-127.
16. Sbidian E, Chaimani A, Afach S, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2020;1:CD011535.
17. Iversen L, Kurvits M, Snel-Prentø AM, Menter A. Efficacy and safety of calcipotriol plus betamethasone dipropionate cutaneous foam treatment for psoriasis in patients with body surface area 5–15% and Physician’s Global Assessment ≥3. Presented at: EADV 2019 Congress in Dermatology and Venereology; October 9-13, 2019; Madrid, Spain.
18. Del Rosso JQ, Kircik LH. The effect of calcipotriene-betamethasone dipropionate aerosol foam versus vehicle on target lesions in moderate severity plaque psoriasis: focus on elbows and knees. J Drugs Dermatol. 2019;18(4):358-361.
19. Kircik L. Efficacy and safety of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam in combination with apremilast in patients with moderate plaque psoriasis. Presented at: 17th Annual South Beach Symposium; February 7-10, 2019; Miami Beach, Florida.
20. Bagel J, Zapata J, Nelson E. A prospective, open-label study evaluating adjunctive calcipotriene 0.005%/betamethasone dipropionate 0.064% foam in psoriasis patients with inadequate response to biologic therapy. J Drugs Dermatol. 2018;17(8):845-850.
21. Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65-68; discussion ii69-73.
22. Schmitt J, Wozel G. The Psoriasis Area and Severity Index is the adequate criterion to define severity in chronic plaque-type psoriasis. Dermatology. 2005;210(3):194-199.
23. Langley RG, Feldman SR, Nyirady J, et al. The 5-point Investigator's Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015;26(1):23-31.
24. Finlay AY. Current severe psoriasis and the rule of tens. Br J Dermatol. 2005;152(5):861-867. 25. Pascoe VL, Enamandram M, Corey KC, et al. Using the Physician Global Assessment in a clinical setting to measure and track patient outcomes. JAMA Dermatol. 2015;151(4):375-381.
26. Robinson A, Kardos M, Kimball AB. Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis. J Am Acad Dermatol. 2012;66(3):369-375.
27. Armstrong AW, Parsi K, Schupp CW, et al. Standardizing training for psoriasis measures: effectiveness of an online training video on Psoriasis Area and Severity Index assessment by physician and patient raters. JAMA Dermatol. 2013;149(5):577-582.
28. Krueger GG, Feldman SR, Camisa C, et al. Two considerations for patients with psoriasis and their clinicians: what defines mild, moderate, and severe psoriasis? What constitutes a clinically significant improvement when treating psoriasis? J Am Acad Dermatol. 2000;43(2 Pt 1):281-285.
29. Feldman SR, Goffe B, Rice G, et al. The challenge of managing psoriasis: unmet medical needs and stakeholder perspectives. Am Health Drug Benefits. 2016;9(9):504-513.
30. Acquadro C, Perret C, Arnould B. Does health-related quality of life evaluation in psoriasis matter? A review of labels of psoriasis products approved by the FDA and the EMA. Value in Health. 2015;18(7):A427.
31. Strober B, Ryan C, van de Kerkhof P, et al. Re-categorization of psoriasis severity: Delphi Consensus from the International Psoriasis Council. J Am Acad Dermatol. 2020;82(1):117-122.
