NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Clinical Review Report: Halobetasol Propionate and Tazarotene (Duobrii): (Bausch Health, Canada Inc.): Indication: Psoriasis, moderate-to-severe plaque [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 Dec.

References

1.
CDR submission: duobrii (halobetasol propionate (0.01%) and tazarotene (0.045%) lotion, once daily [CONFIDENTIAL sponsor’s submission]. Laval (QC): Bausch Health, Canada Inc.; 2020 Feb 3.
2.
Blauvelt A, Ehst B. Pathophysiology of psoriasis. UpToDate. Waltham (MA): UpToDate; 2019: www​.uptodate.com. Accessed 2019 Oct 15.
3.
Papp K, Gulliver W, Lynde C, Poulin Y, Ashkenas J, Canadian Psoriasis Guidelines Committee. Canadian guidelines for the management of plaque psoriasis: overview. J Cutan Med Surg. 2011;15(4):210–219. [PubMed: 21781627]
4.
Canadian Psoriasis Guidelines Committee. Canadian guidelines for the management of plaque psoriasis. Ottawa (ON): Canadian Dermatology Association; 2009: https://www​.dermatology​.ca/wp-content/uploads​/2012/01/cdnpsoriasisguidelines.pdf. Accessed 2019 Oct 15.
5.
Canadian Dermatology Association. Psoriasis-diagnosing different forms of psoriasis. 2019; https://dermatology​.ca​/public-patients/skin/psoriasis/. Accessed 2020 Mar 23.
6.
Canadian Psoriasis Guidelines Addendum Committee. 2016 Addendum to the Canadian guidelines for the management of plaque psoriasis 2009. J Cutan Med Surg. 2016;20(5):375–431. [PMC free article: PMC5014087] [PubMed: 27421294]
7.
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. [PubMed: 19217694]
8.
National Institute for Health Care and Excellence. Psoriasis: assessment and management. (Clinical guideline CG153) 2012; https://www​.nice.org.uk/guidance/cg153. Accessed 2020 May 26.
9.
Duobrii (halobetasol propionate and tazarotene lotion 0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) [product monograph]. Laval (QC): Bausch Health, Canada Inc.; 2020 Jun 8.
10.
Clinical Study Report: V01-118A-301. A phase 3, multicenter, double-blind, randomized, vehicle controlled clinical study to assess the safety and efficacy of IDP-118 in the treatment of plaque psoriasis [CONFIDENTIAL internal sponsor’s report]. Petaluma (CA): Valeant Pharmaceuticals North America LLC; 2017 Feb 28.
11.
Clinical Study Report: V01-118A-302. A phase 3, multicenter, double-blind, randomized, vehicle controlled clinical study to assess the safety and efficacy of IDP-118 in the treatment of plaque psoriasisTitle of report [CONFIDENTIAL internal sponsor’s report]. Petaluma (CA): Valeant Pharmaceuticals North America LCC; 2017 Feb 28.
12.
Weisman S, Pollack CR, Gottschalk RW. Psoriasis disease severity measures: comparing efficacy of treatments for severe psoriasis. J Dermatolog Treat. 2003;14(3):158–165. [PubMed: 14522626]
13.
Elmets CA, Leonardi CL, Davis DMR, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities. J Am Acad Dermatol. 2019;80(4):1073–1113. [PubMed: 30772097]
14.
Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445–1486. [PubMed: 32119894]
15.
Van Voorhees AS, Feldman SR, Lebwohl MG, Mendelin A, Ritchlin C. The psoriasis and psoriatic arthritis pocket guide. Treatment algorithms and management options. Portland (OR): National Psoriasis Foundation; 2018: https://www​.psoriasis​.org/sites/default/files​/npf_pocketguide_2018.pdf. Accessed 2019 Oct 15.
16.
Bhole VM, Choi HK, Burns LC, et al. Differences in body mass index among individuals with PsA, psoriasis, RA and the general population. Rheumatology (Oxford). 2012;51(3):552–556. [PubMed: 22120603]
17.
Dowlatshahi EA, Wakkee M, Arends LR, Nijsten T. The prevalence and odds of depressive symptoms and clinical depression in psoriasis patients: a systematic review and meta-analysis. J Invest Dermatol. 2014;134(6):1542–1551. [PubMed: 24284419]
18.
Eder L, Chandran V, Shen H, et al. Incidence of arthritis in a prospective cohort of psoriasis patients. Arthritis Care Res (Hoboken). 2011;63(4):619–622. [PubMed: 21452273]
19.
Kimball AB, Guerin A, Latremouille-Viau D, et al. Coronary heart disease and stroke risk in patients with psoriasis: retrospective analysis. Am J Med. 2010;123(4):350–357. [PubMed: 20362755]
20.
Li W, Han J, Hu FB, Curhan GC, Qureshi AA. Psoriasis and risk of type 2 diabetes among women and men in the United States: a population-based cohort study. J Invest Dermatol. 2012;132(2):291–298. [PMC free article: PMC3743422] [PubMed: 21993559]
21.
Samarasekera EJ, Neilson JM, Warren RB, Parnham J, Smith CH. Incidence of cardiovascular disease in individuals with psoriasis: a systematic review and meta-analysis. J Invest Dermatol. 2013;133(10):2340–2346. [PubMed: 23528816]
22.
Wan J, Wang S, Haynes K, Denburg MR, Shin DB, Gelfand JM. Risk of moderate to advanced kidney disease in patients with psoriasis: population based cohort study. BMJ. 2013;347:f5961. [PMC free article: PMC3805477] [PubMed: 24129480]
23.
National Psoriasis Foundation. What’s tops in, topical steroid treatments? Just looking for the topical steroid potency chart? https://www​.psoriasis​.org/about-psoriasis​/treatments/topicals​/steroids/potency-chart. Accessed 2020 May 26.
24.
Kragballe K. Topical corticosteroids: mechanisms of action. Acta Derm Venereol Suppl (Stockh). 1989;151:7–10; discussion 47–52. [PubMed: 2533778]
25.
Silkis (calcitriol): 3 μg/g ointment [product monograph]. Thornhill (ON): Galderma Canada Inc.; 2017 Oct 17.
26.
Dovonex (calcipotriol): cream and ointment, 50 mcg/g scalp solution, 50 mcg/mL [product monograph]. Thornhill (ON): LEO Pharma Inc.; 2007 Oct 9.
27.
Dovobet gel (calcipotriol and betamethasone dipropionate gel): 50 mcg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate) gel [product monograph]. Thornhill (ON): LEO Pharma Inc.; 2020 Feb 25.
28.
Dovobet (calcipotriol and betamethasone dipropionate): ointment, 50 mcg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate) [product monograph]. Thornhill (ON): LEO Pharma Inc.; 2016 Apr 4.
29.
Enstilar (calcipotriol and betamethasone dipropionate aerosol foam): 50 mcg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate) [product monograph]. Thornhill (ON): LEO Pharma Inc.; 2020 Jan 22.
30.
Duobrii (halobetasol propionate and tazarotene lotion): 0.01% w/w halobetasol propionate and 0.045% w/w tazarotene [product monograph]. Laval (QC): Bausch Health, Canada Inc.; 2020 Mar 19. Accessed 2020 May 8.
31.
McGowan J, Sampson M, Salzwedel DM, Cogo E, Foerster V, Lefebvre C. PRESS Peer Review of Electronic Search Strategies: 2015 guideline statement. J Clin Epidemiol. 2016;75:40–46. [PubMed: 27005575]
32.
Grey matters: a practical tool for searching health-related grey literature. Ottawa (ON): CADTH; 2019: https://www​.cadth.ca/grey-matters. Accessed 2020 Mar 6.
33.
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210–216. [PubMed: 8033378]
34.
Shikiar R, Willian MK, Okun MM, Thompson CS, Revicki DA. The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health Qual Life Outcomes. 2006;4:71. [PMC free article: PMC1615869] [PubMed: 17005043]
35.
Long CC. Finlay AY AR. The rule of hand: 4 areas = 2 FTU = 1 g. Arch Dermatol. 1992;128(8):1129–1130. [PubMed: 1497374]
36.
Merola JF, Amato DA, See K, et al. Evaluation of sPGA x BSA as an Outcome Measure and Treatment Target for Clinical Practice. J Invest Dermatol. 2018;138(9):1955–1961. [PubMed: 29577919]
37.
Smith CH, Jabbar-Lopez ZK, Yiu ZZ, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017 Br J Dermatol. 2017;177:628–636. [PubMed: 28513835]
38.
Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994–2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008;159(5):997–1035. [PubMed: 18795920]
39.
Efficacy of topical therapies for plaque psoriasis: a systematic literature review and network meta-analysis In: CDR submission: duobrii (halobetasol propionate (0.01%) and tazarotene (0.045%) lotion, once daily [CONFIDENTIAL sponsor’s submission]. Laval (QC): Bausch Health, Canada Inc.; 2020 Feb 3.
40.
Clinical Study Report: V01-118A-303. A phase 3, multicenter, open label study to evaluate the long term safety of IDP-118 lotion in the treatment of plaque psoriasis [CONFIDENTIAL internal sponsor’s report]. Petaluma (CA): Valeant Pharmaceuticals North America LCC; 2017 Jul 10.
41.
Clinical Study Report: V01-118A-201 A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis [CONFIDENTIAL internal sponsor’s report]. 2015. [PubMed: 28301614]
42.
Center for Drug Evaluation and Research. Multi-discipline review. Duobrii (halobetasol and tazarotene lotion, 0.01%/0.045%). Company: Bausch Health, Canada Inc. Application No.:209354. Approval date: 04/15/2019. Rockville (MD): U. S. Food and Drug Administration (FDA); 2019 Apr 24: URL. Accessed 2020 May 27.
43.
Bausch Health Canada response to February 11 2020 request for additional information regarding duobrii CDR review: CSR for the pooled analysis. [CONFIDENTIAL additional sponsor’s information]. Laval (QC): Bausch Health, Canada Inc.; 2020 Feb 19.
44.
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159–174. [PubMed: 843571]
45.
Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013;22(8):1889–1905. [PubMed: 23288613]
46.
Cohen J. A power primer. Psychol Bull. 1992;112(1):155–159. [PubMed: 19565683]
47.
Melilli L, Shikiar R, Thompson C. Minimal clinically important difference in Dermatology Life Quality Index in moderate to severe plaque psoriasis patients treated with adalimumab. Journal of American Academy of Dermatology. 2006;54(AB221(P2894)).
48.
Ali FM, Salek MS, Finlay AY, Piguet V. Validation of the electronic PASI application: establishing measurement equivalence. J Am Acad Dermatol. 2019;19:19. [PubMed: 31228524]
49.
Reolid A, Servitje O, Ginarte M, et al. Validation of an optical pencil method to estimate the affected body surface area in psoriasis. Actas Dermo Sifiliograficas. 2019;28:28. [PubMed: 31472926]
50.
Chandran V, Gottlieb A, Cook RJ, et al. International multicenter psoriasis and psoriatic arthritis reliability trial for the assessment of skin, joints, nails, and dactylitis. Arthritis Rheum. 2009;61(9):1235–1242. [PubMed: 19714610]
51.
Puzenat E, Bronsard V, Prey S, et al. What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature. J Eur Acad Dermatol Venereol. 2010;24 Suppl 2:10–16. [PubMed: 20443995]
52.
Bozek A, Reich A. The reliability of three psoriasis assessment tools: Psoriasis area and severity index, body surface area and physician global assessment. Adv. 2017;26(5):851–856. [PubMed: 29068583]
53.
Lewis V, Finlay AY. 10 years experience of the Dermatology Life Quality Index (DLQI). J Investig Dermatol Symp Proc. 2004;9(2):169–180. [PubMed: 15083785]
54.
Shikiar R, Bresnahan BW, Stone SP, Thompson C, Koo J, Revicki DA. Validity and reliability of patient reported outcomes used in psoriasis: results from two randomized clinical trials. Health Qual Life Outcomes. 2003;1:53. [PMC free article: PMC269993] [PubMed: 14613569]
55.
Mazzotti E, Picardi A, Sampogna F, Sera F, Pasquini P, Abeni D. Sensitivity of the Dermatology Life Quality Index to clinical change in patients with psoriasis. Br J Dermatol. 2003;149(2):318–322. [PubMed: 12932238]
56.
Both H, Essink-Bot ML, Busschbach J, Nijsten T. Critical review of generic and dermatology-specific health-related quality of life instruments. J Invest Dermatol. 2007;127(12):2726–2739. [PubMed: 17989733]
57.
Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64 Suppl 2:ii65–68; discussion ii69–73. [PMC free article: PMC1766877] [PubMed: 15708941]
58.
Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System Physician’s Global Assessment. J Am Acad Dermatol. 2004;51(4):563–569. [PubMed: 15389191]
59.
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. [PubMed: 22041254]
60.
Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. 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. [PubMed: 24354461]
61.
Callis Duffin K, Bushmakin AG, Cappelleri JC, Mallbris L, Mamolo C. A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies. BMC Dermatol. 2019;19(1):8. [PMC free article: PMC6555979] [PubMed: 31174539]
62.
Simpson MJ, Chow C, Morgenstern H, Luger TA, Ellis CN. Comparison of three methods for measuring psoriasis severity in clinical studies (Part 2 of 2): use of quality of life to assess construct validity of the Lattice System Physician’s Global Assessment, Psoriasis Area and Severity Index and Static Physician’s Global Assessment. J Eur Acad Dermatol Venereol. 2015;29(7):1415–1420. [PubMed: 25917214]
63.
Cappelleri JC, Bushmakin AG, Harness J, Mamolo C. Psychometric validation of the physician global assessment scale for assessing severity of psoriasis disease activity. Qual Life Res. 2013;22(9):2489–2499. [PubMed: 23475691]
64.
Berth-Jones J, Grotzinger K, Rainville C, et al. A Study examining inter- and intrarater reliability of three scales for measuring severity of psoriasis: Psoriasis Area and Severity Index, Physician’s Global Assessment and Lattice System Physician’s Global Assessment. Br J Dermatol. 2006;155(4):707–713. [PubMed: 16965419]
65.
Bozek A, Reich A. The reliability of three psoriasis assessment tools: Psoriasis area and severity index, body surface area and physician global assessment. Advances in clinical and experimental medicine : official organ Wroclaw Medical University. 2017;26(5):851–856. [PubMed: 29068583]
66.
Spuls PI, Lecluse LL, Poulsen ML, Bos JD, Stern RS, Nijsten T. How good are clinical severity and outcome measures for psoriasis?: quantitative evaluation in a systematic review. J Invest Dermatol. 2010;130(4):933–943. [PubMed: 20043014]
67.
Fleischer AB, Jr., Feldman SR, Dekle CL. The SAPASI is valid and responsive to psoriasis disease severity changes in a multi-center clinical trial. J Dermatol. 1999;26(4):210–215. [PubMed: 10343464]
68.
Rhodes J, Clay C, Phillips M. The surface area of the hand and the palm for estimating percentage of total body surface area: results of a meta-analysis. Br J Dermatol. 2013;169(1):76–84. [PubMed: 23448271]
Copyright © 2020 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK567527
Contents