Baseline characteristics of patients with moderate-to-severe psoriasis according to previous systemic treatment exposure: the PROSE study population.


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:
Nov 2020
Historique:
received: 16 12 2019
accepted: 10 03 2020
pubmed: 3 4 2020
medline: 15 5 2021
entrez: 3 4 2020
Statut: ppublish

Résumé

Psoriatic disease is associated with considerable impairment of Quality of Life (QoL). The PROSE study (NCT02752776) examined the impact of secukinumab on patient-reported outcomes in patients with moderate-to-severe psoriasis (PsO) stratified by previous exposure to systemic treatment. In this prospective, non-randomized, multicentre study, patients were categorized at baseline according to previous exposure to systemic treatment: naïve [naïve to any systemic treatment (N = 663)], conventional systemic [previously exposed to ≥1 conventional systemic therapy (N = 673)] and biologics [previously exposed to ≥1 biologic (N = 324)]. Baseline demographics including age, gender, race, body weight and body mass index, disease characteristics and patient-reported QoL outcomes [Dermatology Life Quality Index (DLQI), Family DLQI (F-DLQI)] of patients enrolled in the study are reported here. Baseline demographic characteristics were well balanced across the three subpopulations. Naïve patients had a shorter time since diagnosis (15.5 ± 12.1 years) compared with the conventional systemic (19.1 ± 12.5 years) and biologic patients (23.0 ± 12.5 years), and lower rates of psoriatic arthritis (6.6% vs. 17.4% and 27.8%, respectively). Metabolic syndrome (37.6-43.5%), obesity (16.9-19.1%), hyperlipidaemia (15.3-21.9%) and diabetes mellitus (6.8-14.2%) were reported at numerically higher rate in the biologic group. The mean PASI (19.7 ± 7.9), affected Body Surface Area (28.2 ± 15.3%) as well as the Investigator Global Assessment score (patients with score 4: 33.7%) indicated severe disease at baseline and were comparable for the three groups. QoL impairment was evident from mean DLQI (14.1 ± 7.1: naïve = 13.5 ± 6.8; conventional systemic = 14.3 ± 7.0; biologic = 14.8 ± 7.7) and mean F-DLQI (11.5 ± 7.0: naïve = 11.3 ± 7.1; conventional systemic = 11.4 ± 6.7; biologic = 12.1 ± 7.7) also indicated derangement of QoL of patients and their families. Patients naïve to systemic treatment had shorter disease journey compared with patients previously exposed to systemic treatments; despite this, the severe impact of disease on patient and family QoL outcomes can be as apparent in naïve patients as in systemically treated patients at baseline.

Identifiants

pubmed: 32239541
doi: 10.1111/jdv.16400
doi:

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

2548-2556

Subventions

Organisme : Novartis Pharma AG

Informations de copyright

© 2020 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

LangleyRG, KruegerGG, GriffithsCE. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis 2005; 64(Suppl 2): ii18-ii23.
GrozdevI, KormanN, TsankovN. Psoriasis as a systemic disease. Clin Dermatol 2014; 32: 343-350.
MrowietzU, SteinzK, GerdesS. Psoriasis: to treat or to manage? Exp Dermatol 2014; 23: 705-709.
Martinez-GarciaE, Arias-SantiagoS, Valenzuela-SalasI, Garrido-ColmeneroC, Garcia-MelladoV, Buendia-EismanA. Quality of life in persons living with psoriasis patients. J Am Acad Dermatol 2014; 71: 302-307.
EghlilebAM, DaviesEE, FinlayAY. Psoriasis has a major secondary impact on the lives of family members and partners. Br J Dermatol 2007; 156: 1245-1250.
ArmstrongAW, SchuppC, WuJ, BeboB. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003-2011. PLoS ONE 2012; 7: e52935.
EskinM, SavkE, UsluM, KucukaydoganN. Social problem-solving, perceived stress, negative life events, depression and life satisfaction in psoriasis. J Eur Acad Dermatol Venereol 2014; 28: 1553-1559.
FriederJ, KivelevitchD, FioreCT, SaadS, MenterA. The impact of biologic agents on health-related quality of life outcomes in patients with psoriasis. Expert Rev Clin Immunol 2018; 14: 1-19.
KaramataVV, GandhiAM, PatelPP, SutariaA, DesaiMK. A study of the use of drugs in patients suffering from psoriasis and their impact on quality of life. Indian J Pharmacol 2017; 49: 84-88.
SinghS, TaylorC, KornmehlH, ArmstrongAW. Psoriasis and suicidality: a systematic review and meta-analysis. J Am Acad Dermatol 2017; 77: 425-440.e2.
FinlayAY. Broader concepts of quality of life measurement, encompassing validation. J Eur Acad Dermatol Venereol 2017; 31: 1254-1259.
World Health Organization. Global Report on Psoriasis. World Health Organization, Ginebra, 2016. URL https://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf?sequence=1&isAllowed=y (last accessed: 29 November 2019).
EghlilebAM, BasraMK, FinlayAY. The psoriasis family index: preliminary results of validation of a quality of life instrument for family members of patients with psoriasis. Dermatology 2009; 219: 63-70.
BasraMK, EdmundsO, SalekMS, FinlayAY. Measurement of family impact of skin disease: further validation of the Family Dermatology Life Quality Index (FDLQI). J Eur Acad Dermatol Venereol 2008; 22: 813-821.
BasraMK, Sue-HoR, FinlayAY. The Family Dermatology Life Quality Index: measuring the secondary impact of skin disease. Br J Dermatol 2007; 156: 528-538.
SampognaF, FinlayAY, SalekSS et al. Measuring the impact of dermatological conditions on family and caregivers: a review of dermatology-specific instruments. J Eur Acad Dermatol Venereol 2017; 31: 1429-1439.
AugustinM, RadtkeMA, ZschockeI et al. The patient benefit index: a novel approach in patient-defined outcomes measurement for skin diseases. Arch Dermatol Res 2009; 301: 561-571.
BlomeC, AugustinM, BehechtnejadJ, RustenbachSJ. Dimensions of patient needs in dermatology: subscales of the patient benefit index. Arch Dermatol Res 2011; 303: 11-17.
PappKA, LangleyRG, SigurgeirssonB et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study. Br J Dermatol 2013; 168: 412-421.
LangleyRG, ElewskiBE, LebwohlM et al. Secukinumab in plaque psoriasis-results of two phase 3 trials. N Engl J Med 2014; 371: 326-338.
PaulC, ReichK, GottliebAB et al. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol 2014; 28: 1670-1675.
ArmstrongAW, VenderR, KircikL. Secukinumab in the treatment of palmoplantar, nail, scalp, and pustular psoriasis. J Clin and Aesthet Dermatol 2016; 9(6 Suppl 1): S12-S16.
PaulC, LacourJP, TedremetsL et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol 2014; 29: 1082-1090.
McInnesIB, MeasePJ, KirkhamB et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 386: 1137-1146.
PuigL, AugustinM, BlauveltA et al. Effect of secukinumab on quality of life and psoriasis-related symptoms: a comparative analysis versus ustekinumab from the CLEAR 52-week study. J Am Acad Dermatol 2018; 78: 741-748.
KormanNJ, SofenH, FretzinS et al. Secukinumab provides better relief from the impact of psoriasis on daily activities and personal relationships than etanercept: results of two phase 3 placebo-controlled randomized clinical trials in moderate-to-severe psoriasis. J Dermatolog Treat 2017; 28: 384-389.
StroberB, GottliebAB, SherifB et al. Secukinumab sustains early patient-reported outcome benefits through 1 year: results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept. J Am Acad Dermatol 2017; 76: 655-661.
FinlayAY, KhanGK. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 210-216.
LjosaaTM, RustoenT, MorkC et al. Skin pain and discomfort in psoriasis: an exploratory study of symptom prevalence and characteristics. Acta Derm Venereol 2010; 90: 39-45.
NaegeliAN, FloodE, TuckerJ, DevlenJ, Edson-HerediaE. The Worst Itch Numeric Rating Scale for patients with moderate to severe plaque psoriasis or psoriatic arthritis. Int J Dermatol 2015; 54: 715-722.
EuroQol Group. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208.
AtkinsonMJ, SinhaA, HassSL et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004; 2: 12.
RadtkeMA, SchaferI, BlomeC, AugustinM. Patient benefit index (PBI) in the treatment of psoriasis-results of the National Care Study “PsoHealth”. Eur J Dermatol 2013; 23: 212-217.
BruceB, FriesJF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol 2003; 30: 167-178.
FriesJF, SpitzPW, YoungDY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 1982; 9: 789-793.
DeodharA, MeasePJ, McInnesIB et al. Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data. Arthritis Res Ther 2019; 21: 111.
ReichK, PuigL, SzepietowskiJC et al. Secukinumab dosing optimization in patients with moderate to severe plaque psoriasis: Results from the randomised, open-label OPTIMISE study. Br J Dermatol 2019; 182: 304-315.
MeasePJ. Biologic therapy for psoriatic arthritis. Rheum Dis Clin North Am 2015; 41: 723-738.
MeasePJ, KavanaughA, ReimoldA et al. Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open 2018; 4: e000723.
MeasePJ, ArmstrongAW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs 2014; 74: 423-441.
MeasePJ, McInnesIB, KirkhamB et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 2015; 373: 1329-1339.
CoatesLC, HelliwellPS. Psoriatic arthritis: state of the art review. Clin Med (Lond) 2017; 17: 65-70.
YeungH, TakeshitaJ, MehtaNN et al. Psoriasis severity and the prevalence of major medical comorbidity: a population-based study. JAMA Dermatol 2013; 149: 1173-1179.
RandaH, LomholtJJ, SkovL, ZachariaeR. Health-related quality of life in adolescents with psoriasis: an interview-based study. Br J Dermatol 2018; 178: 1404-1411.
AugustinM, RadtkeMA. Quality of life in psoriasis patients. Expert Rev Pharmacoecon Outcomes Res 2014; 14: 559-568.
SalmanA, YuceltenAD, SaracE, SaricamMH, Perdahli-FisN. Impact of psoriasis in the quality of life of children, adolescents and their families: a cross-sectional study. An Bras Dermatol 2018; 93: 819-823.
ThaciD, PuigL, ReichK et al. Secukinumab demonstrates sustained efficacy in clearing skin and improving patient-reported outcomes in patients with moderate-to-severe psoriasis through 2 years of treatment: Results from the CLEAR study. J Am Acad Dermatol 2019; 81: 1405-1409
BissonnetteR, LugerT, ThaciD et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol 2018; 32: 1507-1514.
KörberA, ThaçiD, vonKiedrowskiR et al. Secukinumab treatment of moderate to severe plaque psoriasis in routine clinical care: real-life data of prior and concomitant use of psoriasis treatments from the PROSPECT study. J Eur Acad Dermatol Venereol 2018; 32: 411-419.

Auteurs

M Augustin (M)

Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

E Dauden (E)

Department of Dermatology, Instituto de Investigación Sanitaria la Princesa (IIS-IP), Hospital Universitario la Princesa, Madrid, Spain.

U Mrowietz (U)

Department of Dermatology, Psoriasis-Center, University Medical Center Schleswig-Holstein, Kiel, Germany.

M P Konstantinou (MP)

Department of Dermatology, Paul Sabatier University, Toulouse, France.

S Gerdes (S)

Department of Dermatology, Psoriasis-Center, University Medical Center Schleswig-Holstein, Kiel, Germany.

M Rissler (M)

Novartis Pharma AG, Basel, Switzerland.

S Gathmann (S)

Novartis Pharma AG, Basel, Switzerland.

C Sieder (C)

Novartis Pharma AG, Basel, Switzerland.

D Baeumer (D)

Novartis Pharma AG, Basel, Switzerland.

R Orsenigo (R)

Novartis Farma S.p.A, Origgio, Italy.

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