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Reviews on Recent Clinical Trials

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ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

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Research Article

PSSD and Biologic Therapy: Real-Life Data in 417 Patients with Moderate to Severe Psoriasis

Author(s): Ilaria Proietti*, Nicoletta Bernardini*, Nevena Skroza, Alessandra Mambrin, Ersilia Tolino, Anna Marchesiello, Federica Marraffa, Giovanni Rossi, Salvatore Volpe and Concetta Potenza

Volume 17, Issue 3, 2022

Published on: 18 October, 2022

Page: [171 - 176] Pages: 6

DOI: 10.2174/1574887117666220623161751

Price: $65

Abstract

Background: Psoriasis is a chronic relapsing immune-mediated disease leading to a strong impact on patient’s quality of life. The treatment of psoriasis has undergone a revolution with the advent of biological therapies. Currently, Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores are in use to assess the overall severity of pathology. A new self-administered questionnaire, the Psoriasis Symptoms and Signs Diary (PSSD), assesses the severity of six psoriasis symptoms (itch, skin tightness, burning, stinging, and pain,) and five signs (dryness, cracking, scaling, shedding/flaking, redness, and bleeding).

Objective: To evaluate and compare the efficacy of biologic therapies through PSSD in patients with moderate to severe psoriasis.

Methods: The PSSD questionnaire was administered to all the patients at the beginning and after 6 months of biologic therapy (anti-TNFalpha, anti-IL17, anti-IL23, anti-IL12/23 and phhosphodiesterase-4 Inhibitors).

Results: The study population included 417 adult patients with moderate to severe psoriasis in treatment with biologic drugs. All the drugs contributed to a significant improvement in mean total PSSD at t 24; anti-IL17 and anti-IL23 led to a significantly greater reduction at t 24 mean PSSD when compared to other therapies.

Conclusion: The PSSD, is a new validated instrument useful for capturing psoriasis patient’s quality of life and evaluating treatment efficacy. In our study, this score has been useful to put in evidence significant differences between biological drugs.

Keywords: Psoriasis, biologic therapy, PSSD, quality of life, anti-TNFalpha, anti- IL17, anti- IL23

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[1]
Parisi R, Symmons DPM, Griffiths CEM, Ashcroft DM. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol 2013; 133(2): 377-85.
[http://dx.doi.org/10.1038/jid.2012.339] [PMID: 23014338]
[2]
Boehncke WH, Schön MP. Psoriasis. Lancet 2015; 386(9997): 983-94.
[http://dx.doi.org/10.1016/S0140-6736(14)61909-7] [PMID: 26025581]
[3]
Cottone M, Sapienza C, Macaluso FS, Cannizzaro M. Psoriasis and inflammatory bowel disease. Dig Dis 2019; 37(6): 451-7.
[http://dx.doi.org/10.1159/000500116] [PMID: 31079092]
[4]
Marquis P, Arnould B, Acquadro C, et al. Patient-reported outcomes and health-related quality of life in effectiveness studies: Pros and cons. Drug Dev Res 2006; 67: 193-201.
[http://dx.doi.org/10.1002/ddr.20077]
[5]
Svoboda SA, Ghamrawi RI, Owusu DA, Feldman SR. Treatment goals in psoriasis: Which outcomes matter most? Am J Clin Dermatol 2020; 21(4): 505-11.
[http://dx.doi.org/10.1007/s40257-020-00521-3] [PMID: 32424692]
[6]
Armstrong A, Puig L, Langley R, et al. Validation of psychometric properties and development of response criteria for the Psoriasis Symptoms and Signs Diary (PSSD): Results from a phase III clinical trial. J Dermatolog Treat 2018; 11: 1-31.
[PMID: 28797188]
[7]
Lebwohl M, Swensen AR, Nyirady J, Kim E, Gwaltney CJ, Strober BE. The psoriasis symptom diary: Development and content validity of a novel patient-reported outcome instrument. Int J Dermatol 2014; 53(6): 714-22.
[http://dx.doi.org/10.1111/j.1365-4632.2012.05798.x] [PMID: 23557000]
[8]
Martin ML, McCarrier KP, Chiou CF, et al. Early development and qualitative evidence of content validity for the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure of psoriasis symptom severity. J Dermatolog Treat 2013; 24(4): 255-60.
[http://dx.doi.org/10.3109/09546634.2012.759639] [PMID: 23249143]
[9]
Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims 2009. http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf
[10]
Armstrong April, Puig Luis, Langley Richard, et al. Validation of psychometric properties and development of response criteria for the psoriasis symptoms and signs diary (PSSD): Results from a phase 3 clinical trial journal of dermatological treatment 2019; 30(1): 27-34.
[11]
Mathias SD, Feldman SR, Crosby RD, Colwell HH, McQuarrie K, Han C. Measurement properties of a patient-reported outcome measure assessing psoriasis severity: The psoriasis symptoms and signs diary. J Dermatolog Treat 2016; 27(4): 322-7.
[http://dx.doi.org/10.3109/09546634.2015.1114567] [PMID: 26634943]
[12]
Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): Further data. Dermatology 2015; 230(1): 27-33.
[http://dx.doi.org/10.1159/000365390] [PMID: 25613671]
[13]
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.
[http://dx.doi.org/10.1186/1477-7525-4-71] [PMID: 17005043]
[14]
Armstrong AW, Reich K, Foley P, et al. Improvement in patient-reported outcomes (dermatology life quality index and the psoriasis symptoms and signs diary) with guselkumab in moderate-to-severe plaque psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 studies. Am J Clin Dermatol 2019; 20(1): 155-64.
[http://dx.doi.org/10.1007/s40257-018-0396-z] [PMID: 30417277]
[15]
Mattei PL, Corey KC, Kimball AB. Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI): The correlation between disease severity and psychological burden in patients treated with biological therapies. J Eur Acad Dermatol Venereol 2014; 28(3): 333-7.
[http://dx.doi.org/10.1111/jdv.12106] [PMID: 23425140]
[16]
Strober BE, Nyirady J, Mallya UG, et al. Item-level psychometric properties for a new patient-reported psoriasis symptom diary. Value Health 2013; 16(6): 1014-22.
[http://dx.doi.org/10.1016/j.jval.2013.07.002] [PMID: 24041351]
[17]
Feldman SR, Mathias SD, Schenkel B, et al. Development of a patient reported outcome questionnaire for use in adults with moderate to severe plaque psoriasis: The Psoriasis Symptoms and Signs Diary. J Dermatol Dermatol Surg 2016; 20: 19-26.
[http://dx.doi.org/10.1016/j.jdds.2015.07.004]
[18]
Langley RG, Krueger GG, Griffiths CE. Psoriasis: Epidemiology, clinical features, and quality of life. Ann Rheum Dis 2005; 64(2): ii18-23.
[http://dx.doi.org/10.1136/ard.2004.033217]
[19]
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): 707-13.
[http://dx.doi.org/10.1111/j.1365-2133.2006.07389.x] [PMID: 16965419]
[20]
United States Food and Drug Administration. Guidance for industry: Patient reported outcome measures: Use in medical product development to support labelling claims Available from: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf

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