Quality of life and patient-perceived symptoms in patients with psoriasis undergoing proactive or reactive management with the fixed-dose combination Cal/BD foam: A post-hoc analysis of PSO-LONG.


Journal

Journal of the European Academy of Dermatology and Venereology : JEADV
ISSN: 1468-3083
Titre abrégé: J Eur Acad Dermatol Venereol
Pays: England
ID NLM: 9216037

Informations de publication

Date de publication:
Jan 2022
Historique:
received: 25 06 2021
accepted: 13 08 2021
pubmed: 21 9 2021
medline: 15 12 2021
entrez: 20 9 2021
Statut: ppublish

Résumé

Psoriasis has important physical and psychosocial effects that extend beyond the skin. Understanding the impact of treatment on health-related quality of life (HRQoL) and patient-perceived symptom severity in psoriasis is key to clinical decision-making. This post hoc analysis of the PSO-LONG trial data assessed the impact of long-term proactive or reactive management with fixed-dose combination calcipotriene 50 µg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) foam on patient-reported outcomes (PROs) in patients with psoriasis vulgaris. Five hundred and twenty-one patients from the Phase 3, randomized, double-blind PSO-LONG trial were included. An initial 4-week, open-label phase of fixed-dose combination Cal/BD foam once daily (QD) was followed by a 52-week maintenance phase, at the start of which patients were randomized to a proactive management arm (Cal/BD foam twice weekly) or reactive management arm (vehicle foam twice weekly). Patient-perceived symptom severity and HRQoL were assessed using the Psoriasis Symptom Inventory (PSI), the Dermatology Life Quality Index (DLQI) and the EuroQol-5D for psoriasis (EQ-5D-5L-PSO). Statistically and clinically significant improvements were observed across all PRO measures. The mean difference (standard deviation) from baseline to Week 4 was -8.97 (6.18) for PSI, -6.02 (5.46) for DLQI and 0.11 (0.15) for EQ-5D-5L-PSO scores. During maintenance, patients receiving reactive management had significantly higher DLQI (15% [p = 0.007]) and PSI (15% [p = 0.0128]) and a numerically lower EQ-5D-5L-PSO mean area under the curve score than patients receiving proactive management (1% [p = 0.0842]). Cal/BD foam significantly improved DLQI, EQ-5D-5L-PSO and PSI scores during the open-label and maintenance phases. Patients assigned to proactive management had significantly better DLQI and PSI scores and numerically better EQ-5D-5L-PSO versus reactive management. Additionally, baseline flare was associated with worse PROs than the start of a relapse, and patients starting a relapse also had worse PROs than patients in remission.

Sections du résumé

BACKGROUND BACKGROUND
Psoriasis has important physical and psychosocial effects that extend beyond the skin. Understanding the impact of treatment on health-related quality of life (HRQoL) and patient-perceived symptom severity in psoriasis is key to clinical decision-making.
OBJECTIVES OBJECTIVE
This post hoc analysis of the PSO-LONG trial data assessed the impact of long-term proactive or reactive management with fixed-dose combination calcipotriene 50 µg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) foam on patient-reported outcomes (PROs) in patients with psoriasis vulgaris.
METHODS METHODS
Five hundred and twenty-one patients from the Phase 3, randomized, double-blind PSO-LONG trial were included. An initial 4-week, open-label phase of fixed-dose combination Cal/BD foam once daily (QD) was followed by a 52-week maintenance phase, at the start of which patients were randomized to a proactive management arm (Cal/BD foam twice weekly) or reactive management arm (vehicle foam twice weekly). Patient-perceived symptom severity and HRQoL were assessed using the Psoriasis Symptom Inventory (PSI), the Dermatology Life Quality Index (DLQI) and the EuroQol-5D for psoriasis (EQ-5D-5L-PSO).
RESULTS RESULTS
Statistically and clinically significant improvements were observed across all PRO measures. The mean difference (standard deviation) from baseline to Week 4 was -8.97 (6.18) for PSI, -6.02 (5.46) for DLQI and 0.11 (0.15) for EQ-5D-5L-PSO scores. During maintenance, patients receiving reactive management had significantly higher DLQI (15% [p = 0.007]) and PSI (15% [p = 0.0128]) and a numerically lower EQ-5D-5L-PSO mean area under the curve score than patients receiving proactive management (1% [p = 0.0842]).
CONCLUSIONS CONCLUSIONS
Cal/BD foam significantly improved DLQI, EQ-5D-5L-PSO and PSI scores during the open-label and maintenance phases. Patients assigned to proactive management had significantly better DLQI and PSI scores and numerically better EQ-5D-5L-PSO versus reactive management. Additionally, baseline flare was associated with worse PROs than the start of a relapse, and patients starting a relapse also had worse PROs than patients in remission.

Identifiants

pubmed: 34543474
doi: 10.1111/jdv.17673
pmc: PMC9298373
doi:

Substances chimiques

Dermatologic Agents 0
Drug Combinations 0
Betamethasone 9842X06Q6M

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

60-67

Subventions

Organisme : LEO Pharma

Informations de copyright

© 2021 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.

Références

J Am Acad Dermatol. 2014 May;70(5):871-81.e1-30
pubmed: 24576585
Chin J Integr Med. 2012 Mar;18(3):179-85
pubmed: 22466941
Patient Relat Outcome Meas. 2015 Jul 07;6:167-77
pubmed: 26185476
J Am Acad Dermatol. 2008 May;58(5):826-50
pubmed: 18423260
Arch Dermatol. 2012 Jan;148(1):95-102
pubmed: 22250239
Adv Ther. 2020 Nov;37(11):4730-4753
pubmed: 32965655
Qual Life Res. 2014 Apr;23(3):897-906
pubmed: 24052326
Br J Dermatol. 2017 Jul;177(1):e4-e7
pubmed: 28555722
J Drugs Dermatol. 2017 Dec 1;16(12):1209-1222
pubmed: 29240856
J Eur Acad Dermatol Venereol. 2017 Apr;31(4):576-593
pubmed: 27879008
J Am Acad Dermatol. 2016 Jul;75(1):77-82.e7
pubmed: 27206759
JAMA Dermatol. 2013 Oct;149(10):1180-5
pubmed: 23945732
J Am Acad Dermatol. 2021 May;84(5):1269-1277
pubmed: 32950546
J Dermatolog Treat. 2022 Feb;33(1):111-120
pubmed: 32091278
Dermatol Ther (Heidelb). 2020 Jun;10(3):413-430
pubmed: 32193842
Pharmacoeconomics. 2012 Nov 1;30(11):1005-13
pubmed: 22994598
Value Health. 2013 Dec;16(8):1156-62
pubmed: 24326169
Int J Dermatol. 2020 May;59(5):566-571
pubmed: 32250451
Am Health Drug Benefits. 2016 Dec;9(9):504-513
pubmed: 28465778
J Invest Dermatol. 2010 Jul;130(7):1785-96
pubmed: 20445552
Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii18-23; discussion ii24-5
pubmed: 15708928
J Eur Acad Dermatol Venereol. 2015 Oct;29(10):2002-10
pubmed: 25885420
J Cutan Med Surg. 2016 Jul;20(4):293-303
pubmed: 27207348
J Am Acad Dermatol. 2014 Mar;70(3):512-6
pubmed: 24388724
Dermatol Ther (Heidelb). 2019 Mar;9(1):5-18
pubmed: 30578464
J Eur Acad Dermatol Venereol. 2012 Mar;26 Suppl 2:3-11
pubmed: 22356630
Am J Clin Dermatol. 2020 Aug;21(4):505-511
pubmed: 32424692
J Investig Dermatol Symp Proc. 2004 Mar;9(2):140-7
pubmed: 15083781
PLoS One. 2012;7(12):e52935
pubmed: 23285231
J Dermatolog Treat. 2013 Oct;24(5):356-60
pubmed: 23092173

Auteurs

A Jalili (A)

Dermatology & Skin Care Clinic, Buochs, Switzerland.

P Calzavara-Pinton (P)

Department of Dermatology, University of Brescia, Brescia, Italy.

L Kircik (L)

Indiana University School of Medicine, Indianapolis, IN, USA.
Physicians Skin Care, PLLC, Louisville, KY, USA.
Icahn School of Medicine at Mount Sinai, New York, NY, USA.

D Lons-Danic (D)

Department of Dermatology, Fondation Hôpital Saint Joseph, Paris, France.

A Pink (A)

St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.

S Tyring (S)

Department of Dermatology, University of Texas Health Science Center at Houston, Houston, TX, USA.

P de la Cueva (P)

Department of Dermatology, University Hospital Infanta Leonor de Madrid, Madrid, Spain.

M Gooderham (M)

Division of Dermatology, Department of Medicine, School of Medicine, Queen's University, Kingston, Ontario, Canada.

S Segaert (S)

Consultant Dermatologist, Bonheiden, Belgium.

N Nyholm (N)

LEO Pharma A/S, Ballerup, Denmark.

H Thoning (H)

LEO Pharma A/S, Ballerup, Denmark.

B Petersen (B)

LEO Pharma A/S, Ballerup, Denmark.

D Thaçi (D)

Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH