Psoriasis treat to target: defining outcomes in psoriasis using data from a real-world, population-based cohort study (the British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR).


Journal

The British journal of dermatology
ISSN: 1365-2133
Titre abrégé: Br J Dermatol
Pays: England
ID NLM: 0004041

Informations de publication

Date de publication:
05 2020
Historique:
accepted: 05 07 2019
pubmed: 10 7 2019
medline: 15 5 2021
entrez: 10 7 2019
Statut: ppublish

Résumé

The 'treat to target' paradigm improves outcomes and reduces costs in chronic disease management but is not yet established in psoriasis. To identify treatment targets in psoriasis using two common measures of disease activity: Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). Data from a multicentre longitudinal U.K. cohort of patients with psoriasis receiving systemic or biologic therapies (British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR) were used to identify absolute PASI thresholds for 90% (PASI 90) and 75% (PASI 75) improvements in baseline disease activity, using receiver operating characteristic curves. The relationship between PGA (clear, almost clear, mild, moderate, moderate-severe, severe) and PASI (range 0-72) was described, and the concordance between absolute and relative definitions of response was determined. The same approach was used to establish treatment response and eligibility definitions based on PGA. Data from 13 422 patients were available (58% male, 91% white ethnicity, mean age 44·9 years), including over 23 000 longitudinal PASI and PGA scores. An absolute PASI ≤ 2 was concordant with PASI 90 and an absolute PASI ≤ 4 was concordant with PASI 75 in 90% and 88% of cases, respectively. These findings were robust to subgroups of timing of assessment, baseline disease severity and treatment modality. PASI and PGA were strongly correlated (Spearman's rank correlation coefficient 0·92). The median PASI increased from 0 (interquartile range 0-0, range 0-23) to 19 (interquartile range 15-25, range 0-64) for PGA clear to severe, respectively. PGA clear/almost clear was concordant with PASI ≤ 2 in 90% of cases, and PGA moderate-severe severe was concordant with the National Institute for Health and Care Excellence PASI eligibility criteria for biologics in 81% of cases. An absolute PASI ≤ 2 and PGA clear/almost clear represent relevant disease end points to inform treat-to-target management strategies in psoriasis. What's already known about this topic? The most commonly used relative disease activity measure in psoriasis is ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90); however, it has several limitations including dependency on a baseline severity assessment. Defining an absolute target disease activity end point in psoriasis has the potential to improve patient outcomes and reduce costs, as demonstrated by treat-to-target approaches in other chronic diseases such as hypertension and diabetes. The Physician's Global Assessment (PGA) is a popular alternative measure of psoriasis severity in daily practice; however, its utility has not been formally assessed with respect to PASI. What does this study add? An absolute PASI ≤ 2 corresponds with PASI 90 response and is a relevant disease end point for treat-to-target approaches in psoriasis. There is a strong correlation between PASI and PGA. PGA moderate-severe/severe may serve as an alternative eligibility criterion for biologics to PASI-based definitions, and PGA clear/almost clear is an appropriate alternative absolute treatment end point. What are the clinical implications of this work? Absolute PASI ≤ 2 and PGA clear/almost clear represent relevant disease end points to inform treat-to-target management strategies in psoriasis.

Sections du résumé

BACKGROUND
The 'treat to target' paradigm improves outcomes and reduces costs in chronic disease management but is not yet established in psoriasis.
OBJECTIVES
To identify treatment targets in psoriasis using two common measures of disease activity: Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA).
METHODS
Data from a multicentre longitudinal U.K. cohort of patients with psoriasis receiving systemic or biologic therapies (British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR) were used to identify absolute PASI thresholds for 90% (PASI 90) and 75% (PASI 75) improvements in baseline disease activity, using receiver operating characteristic curves. The relationship between PGA (clear, almost clear, mild, moderate, moderate-severe, severe) and PASI (range 0-72) was described, and the concordance between absolute and relative definitions of response was determined. The same approach was used to establish treatment response and eligibility definitions based on PGA.
RESULTS
Data from 13 422 patients were available (58% male, 91% white ethnicity, mean age 44·9 years), including over 23 000 longitudinal PASI and PGA scores. An absolute PASI ≤ 2 was concordant with PASI 90 and an absolute PASI ≤ 4 was concordant with PASI 75 in 90% and 88% of cases, respectively. These findings were robust to subgroups of timing of assessment, baseline disease severity and treatment modality. PASI and PGA were strongly correlated (Spearman's rank correlation coefficient 0·92). The median PASI increased from 0 (interquartile range 0-0, range 0-23) to 19 (interquartile range 15-25, range 0-64) for PGA clear to severe, respectively. PGA clear/almost clear was concordant with PASI ≤ 2 in 90% of cases, and PGA moderate-severe severe was concordant with the National Institute for Health and Care Excellence PASI eligibility criteria for biologics in 81% of cases.
CONCLUSIONS
An absolute PASI ≤ 2 and PGA clear/almost clear represent relevant disease end points to inform treat-to-target management strategies in psoriasis. What's already known about this topic? The most commonly used relative disease activity measure in psoriasis is ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90); however, it has several limitations including dependency on a baseline severity assessment. Defining an absolute target disease activity end point in psoriasis has the potential to improve patient outcomes and reduce costs, as demonstrated by treat-to-target approaches in other chronic diseases such as hypertension and diabetes. The Physician's Global Assessment (PGA) is a popular alternative measure of psoriasis severity in daily practice; however, its utility has not been formally assessed with respect to PASI. What does this study add? An absolute PASI ≤ 2 corresponds with PASI 90 response and is a relevant disease end point for treat-to-target approaches in psoriasis. There is a strong correlation between PASI and PGA. PGA moderate-severe/severe may serve as an alternative eligibility criterion for biologics to PASI-based definitions, and PGA clear/almost clear is an appropriate alternative absolute treatment end point. What are the clinical implications of this work? Absolute PASI ≤ 2 and PGA clear/almost clear represent relevant disease end points to inform treat-to-target management strategies in psoriasis.

Identifiants

pubmed: 31286471
doi: 10.1111/bjd.18333
pmc: PMC7317460
doi:

Substances chimiques

Biological Products 0
Immunologic Factors 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1158-1166

Subventions

Organisme : NIHR Newcastle Biomedical Research Centre
Pays : International
Organisme : Medical Research Council
ID : MR/S003126/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_PC_14119
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_PC_15059
Pays : United Kingdom
Organisme : NIHR Manchester Biomedical Research Centre
Pays : International
Organisme : Medical Research Council
ID : MR/T02383X/1
Pays : United Kingdom
Organisme : NIHR Biomedical Research Centre at King's College London/Guy's and St Thomas' NHS Foundation Trust
Pays : International
Organisme : Medical Research Council
ID : MR/L011808/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/N005872/1
Pays : United Kingdom

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2019 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Références

Br J Dermatol. 2012 Mar;166(3):545-54
pubmed: 22356636
Actas Dermosifiliogr. 2013 Oct;104(8):694-709
pubmed: 24018211
J Am Acad Dermatol. 2012 Mar;66(3):369-75
pubmed: 22041254
BMC Musculoskelet Disord. 2013 Dec 13;14:350
pubmed: 24330489
J Rheumatol. 2013 Aug;40(8):1423-4
pubmed: 23908537
J Eur Acad Dermatol Venereol. 2010 Apr;24 Suppl 2:10-6
pubmed: 20443995
J Am Acad Dermatol. 2019 Apr;80(4):1029-1072
pubmed: 30772098
Lancet. 2008 May 17;371(9625):1665-74
pubmed: 18486739
Lancet. 2001 Oct 20;358(9290):1305-15
pubmed: 11684211
J Dermatolog Treat. 2015 Feb;26(1):23-31
pubmed: 24354461
Lancet. 2005 Oct 15-21;366(9494):1367-74
pubmed: 16226614
Arch Dermatol Res. 2011 Jan;303(1):1-10
pubmed: 20857129
N Engl J Med. 2003 Nov 20;349(21):2014-22
pubmed: 14627786
Br J Dermatol. 2015 Aug;173(2):510-8
pubmed: 25989336
Clin Rev Allergy Immunol. 2016 Oct;51(2):240-7
pubmed: 27300248
Br J Dermatol. 2015;172(5):1371-83
pubmed: 25307931
Br J Dermatol. 2013 Feb;168(2):412-21
pubmed: 23106107
J Dermatolog Treat. 2018 Jun;29(4):334-346
pubmed: 29099667
Eur J Oral Sci. 2005 Aug;113(4):279-88
pubmed: 16048519
Br J Dermatol. 2014 Feb;170(2):435-44
pubmed: 24116868
J Am Acad Dermatol. 2008 Jan;58(1):106-15
pubmed: 17936411
J Am Acad Dermatol. 2017 Mar;76(3):377-390
pubmed: 28212759
Br J Dermatol. 2013 Jun;168(6):1303-10
pubmed: 23374051
Semin Immunopathol. 2016 Jan;38(1):11-27
pubmed: 26573299
J Dermatolog Treat. 2014 Feb;25(1):54-6
pubmed: 23210771
Br J Dermatol. 2017 Mar;176(3):786-793
pubmed: 27454758
Ann Rheum Dis. 2010 Apr;69(4):629-30
pubmed: 20237122
BMJ. 2014 Jan 31;348:g1081
pubmed: 24489381
Br J Dermatol. 2019 May;180(5):1069-1076
pubmed: 30155885
Br J Dermatol. 2017 Sep;177(3):628-636
pubmed: 28513835
J Dermatolog Treat. 2017 Sep;28(6):492-499
pubmed: 28266243

Auteurs

S K Mahil (SK)

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

N Wilson (N)

Institute of Health and Society, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, U.K.

N Dand (N)

Department of Medical and Molecular Genetics, King's College London, London, U.K.

N J Reynolds (NJ)

Dermatological Sciences, Institute of Cellular Medicine, Medical School, Newcastle University, Newcastle upon Tyne, U.K.
Department of Dermatology, Royal Victoria Infirmary, Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.

C E M Griffiths (CEM)

Dermatology Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, U.K.

R Emsley (R)

Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, U.K.

A Marsden (A)

Centre for Biostatistics, School of Health Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, U.K.

I Evans (I)

Dermatology Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, U.K.

R B Warren (RB)

Dermatology Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, U.K.

D Stocken (D)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, U.K.

J N Barker (JN)

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

A D Burden (AD)

Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, U.K.

C H Smith (CH)

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

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