Main Article Content
psoriasis, topical therapy, clinical trials
Although psoriasis patients have benefited from the advent of biologic treatments over the past two decades, these medications are not appropriate for all patients and can be augmented by additional therapy. Differences among the manifold options can be difficult to parse, though essential for matching treatment with an individual patient. UV-light therapies, including both UV-B and psoralen with UV-A light, continue to play an important role in treatment, as do non-biologic systemic options including methotrexate, cyclosporine, apremilast, and acitretin. Recent years have seen a dramatic expansion in available topical therapies, the most common modality for the treatment of psoriasis, including new foam, spray, lotion, and cream formulations of topical corticosteroids (TCS) and new fixed-dose combination offerings of TCS with tazarotene and calcipotriene. Newer advances, including the oral tyrosine kinase 2 inhibitor deucravacitinib and non-steroidal topicals such as roflumilast, a PDE-4 inhibitor, and tapinarof, a first-in-class non-steroidal small-molecule, will soon provide even more options for treatment. It is vital for clinicians to remain aware of this ever-expanding armamentarium, allowing for more productive shared decision-making with patients, improved satisfaction, and better disease control.
2. Coates LC, Merola JF, Grieb SM, Mease PJ, Callis Duffin K. Methotrexate in Psoriasis and Psoriatic Arthritis. The Journal of Rheumatology. 2020;96:31.
3. West J, Ogston S, Foerster J. Safety and efficacy of methotrexate in psoriasis: a meta-analysis of published trials. PloS one. 2016;11(5):e0153740.
4. Liu Q, Wu DH, Han L, et al. Roles of microRNAs in psoriasis: Immunological functions and potential biomarkers. Exp Dermatol. 2017;26(4):359-367.
5. Matsuda S, Koyasu S. Mechanisms of action of cyclosporine. Immunopharmacology. 2000;47(2):119-125.
6. Sbidian E, Chaimani A, Garcia-Doval I, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta‐analysis. Cochrane Database of Systematic Reviews. 2021(4).
7. Hill BJ, Rosentel K, Bak T, et al. Exploring Individual and Structural Factors Associated with Employment Among Young Transgender Women of Color Using a No-Cost Transgender Legal Resource Center. Transgend Health. 2017;2(1):29-34.
8. Geiger JM. Efficacy of acitretin in severe psoriasis. Skin Therapy Lett. 2003;8(4):1-3, 7.
9. Sbidian E, Maza A, Montaudié H, et al. Efficacy and safety of oral retinoids in different psoriasis subtypes: a systematic literature review. Journal of the European Academy of Dermatology and Venereology. 2011;25(s2):28-33.
10. Balak DMW, Gerdes S, Parodi A, Salgado-Boquete L. Long-term Safety of Oral Systemic Therapies for Psoriasis: A Comprehensive Review of the Literature. Dermatol Ther (Heidelb). 2020;10(4):589-613.
11. Paul C, Cather J, Gooderham M, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe plaque psoriasis over 52 weeks: a phase III, randomized controlled trial (ESTEEM 2). Br J Dermatol. 2015;173(6):1387-1399.
12. Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015;73(1):37-49.
13. Reich K, Gooderham M, Green L, et al. The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
14. Berekmeri A, Mahmood F, Wittmann M, Helliwell P. Tofacitinib for the treatment of psoriasis and psoriatic arthritis. Expert Rev Clin Immunol. 2018;14(9):719-730.
15. Papp K, Gordon K, Thaçi D, et al. Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis. N Engl J Med. 2018;379(14):1313-1321.
16. Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast) [press release]. April 23, 2021.
17. Coven TR, Burack LH, Gilleaudeau P, Keogh M, Ozawa M, Krueger JG. Narrowband UV-B produces superior clinical and histopathological resolution of moderate-to-severe psoriasis in patients compared with broadband UV-B2. Archives of dermatology. 1997;133(12):1514-1522.
18. Zhang P, Wu MX. A clinical review of phototherapy for psoriasis. Lasers in Medical Science. 2018;33(1):173-180.
19. Weatherhead SC, Farr PM, Reynolds NJ. Spectral effects of UV on psoriasis. Photochemical & Photobiological Sciences. 2013;12(1):47-53.
20. Stein Gold LF. Topical Therapies for Psoriasis: Improving Management Strategies and Patient Adherence. Semin Cutan Med Surg. 2016;35(2 Suppl 2):S36-44; quiz S45.
21. Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, Treatment Trends, and Treatment Dissatisfaction Among Patients With Psoriasis and Psoriatic Arthritis in the United States: Findings From the National Psoriasis Foundation Surveys, 2003-2011. JAMA Dermatology. 2013;149(10):1180-1185.
22. Brown KK, Rehmus WE, Kimball AB. Determining the relative importance of patient motivations for nonadherence to topical corticosteroid therapy in psoriasis. J Am Acad Dermatol. 2006;55(4):607-613.
23. Bark C, Brown C, Svangren P. Systematic literature review of long-term efficacy data for topical psoriasis treatments. Journal of Dermatological Treatment. 2021:1-11.
24. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470.
25. Florek AG, Wang CJ, Armstrong AW. Treatment preferences and treatment satisfaction among psoriasis patients: a systematic review. Archives of Dermatological Research. 2018;310(4):271-319.
26. Hong C-H, Papp KA, Lophaven KW, Skallerup P, Philipp S. Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO-INSIGHTFUL study. Journal of the European Academy of Dermatology and Venereology. 2017;31(11):1876-1883.
27. Stein Gold L, Jackson JM, Knuckles ML, Weiss JS. Improvement in Extensive Moderate Plaque Psoriasis With a Novel Emollient Spray Formulation of Betamethasone Dipropionate 0.05. J Drugs Dermatol. 2016;15(3):334-342.
28. Fowler JF, Jr., Hebert AA, Sugarman J. DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray, Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis. J Drugs Dermatol. 2016;15(2):154-162.
29. Bhatia N, Stein Gold L, Kircik LH, Schreiber R. Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis. J Drugs Dermatol. 2019;18(8):790-796.
30. Hebert A, Schrieber R, Glaab D, Eichenfield L. Phase IV Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol propionate Foam, 0.05% in Adolescent Subjects with Plaque Psoriasis. SKIN The Journal of Cutaneous Medicine. 2020;4(6):s77-s77.
31. Sugarman JL, Weiss JS, Tanghetti EA, et al. Safety and efficacy of halobetasol propionate lotion 0.01% in the treatment of moderate to severe plaque psoriasis: a pooled analysis of 2 phase 3 studies. Cutis. 2019;103(2):111-116.
32. Green LJ, Kerdel FA, Cook-Bolden FE, et al. Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3 Randomized Controlled Trials. J Drugs Dermatol. 2018;17(10):1062-1069.
33. Del Rosso JQ. Topical Corticosteroid Therapy for Psoriasis-A Review of Clobetasol Propionate 0.025% Cream and the Clinical Relevance of Penetration Modification. The Journal of clinical and aesthetic dermatology. 2020;13(2):22-29.
34. 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.
35. Stein Gold L, Lebwohl M, Menter A, Villumsen J, Rosen M, Koo J. Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies. J Drugs Dermatol. 2016;15(8):951-957.
36. Selmer J VB, Præstegaard M, and Gold LS. MC2-01 Cream Has Improved Overall Psoriasis Treatment Efficacy Compared to Calcipotriene Plus Betamethasone Dipropionate Topical Suspension. J Psoriasis Psoriatic Arthritis 2019;4(3):166-167.
37. Daniel D, Waddell A. Compliance with National Comprehensive Cancer Network anti-emesis guidelines in a Community Hospital Cancer Center. J Oncol Pharm Pract. 2016;22(1):26-30.
38. Gollnick H, Menter A. Combination therapy with tazarotene plus a topical corticosteroid for the treatment of plaque psoriasis. The British journal of dermatology. 1999;140 Suppl 54:18-23.
39. Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018;79(2):287-293.
40. Lebwohl MG, Sugarman JL, Gold LS, et al. Long-term safety results from a phase 3 open-label study of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2019;80(1):282-285.
41. Li H, Zuo J, Tang W. Phosphodiesterase-4 Inhibitors for the Treatment of Inflammatory Diseases. Front Pharmacol. 2018;9:1048.
42. Arcutis Announces Positive Topline Results from Pivotal DERMIS-1 and -2 Phase 3 Trials of Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis. https://www.biospace.com/article/releases/arcutis-announces-positive-topline-results-from-pivotal-dermis-1-and-2-phase-3-trials-of-topical-roflumilast-cream-arq-151-in-plaque-psoriasis/. Published 2021. Updated February 1. Accessed.
43. Kircik LH, Moore A, Bhatia N, et al. Once-daily Roflumilast foam 0.3% for scalp and body psoriasis: a randomized, double-blind, vehicle-controlled phase 2b study. American Academy of Dermatology Virtual Meeting Experience; 2021.
44. Gold LS, Blauvelt A, Armstrong A, et al. Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Secondary Efficacy Outcomes from Two Pivotal Phase 3 Trials. American Academy of Dermatology Virtual Meeting Experience; 2021.
45. Dermavant: Promising Interim Analysis from Third Phase 3 Trial for Tapinarof in Psoriasis.
https://practicaldermatology.com/news/dermavant-promising-interim-analysis-from-third-phase-3-trial-for-tapinarof-in-psoriasis. Published 2021. Updated February 18. Accessed.
46. Dogra S, Jain A, Kanwar AJ. Efficacy and safety of acitretin in three fixed doses of 25, 35 and 50 mg in adult patients with severe plaque type psoriasis: a randomized, double blind, parallel group, dose ranging study. J Eur Acad Dermatol Venereol. 2013;27(3):e305-311.
47. Maza A, Montaudié H, Sbidian E, et al. Oral cyclosporin in psoriasis: a systematic review on treatment modalities, risk of kidney toxicity and evidence for use in non-plaque psoriasis. Journal of the European Academy of Dermatology and Venereology. 2011;25(s2):19-27.
48. 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.
49. 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.
50. 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.
51. Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthet Dermatol. 2018;11(4):14-22.
52. Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A Phase 3, Randomized Trial Demonstrating the Improved Efficacy and Patient Acceptability of Fixed Dose Calcipotriene and Betamethasone Dipropionate Cream. J Drugs Dermatol. 2021;20(4):420-425.
53. Bissonnette R, Strober B, Lebwohl M, et al. Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Patient-reported Outcomes from Two Pivotal Phase 3 Trials. American Academy of Dermatology Virtual Meeting Experience; 2021.
54. Buechler CR, Veenstra J, Stein Gold L. New topical therapies for psoriasis. Dermatological Reviews. 2021.