Multidimensional Assessment of Psoriasis Burden: Results from Dermatologist and Patient Survey

1. A multidimensional assessment of the burden of psoriasis: Results from a multinational dermatologist and patient survey C.E.M. Griffiths1, S.J. Jo2, L. Naldi3, R. Romiti4, E. Guevara-Sangines5, T. Howe6, G. Pietri7, I. Gilloteau8, C. Richardson8, H. Tian9, M. Augustin10 Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; Department of Dermatology, Seoul National University Hospital, Seoul, Korea; Department of Dermatology, AziendaOspedaliera papa Giovanni XXIII, Bergamo, Italy; Department of Dermatology, Hospital das Clínicas, University of São Paulo (USP), Brazil; Hospital Regional "Lic. Adolfo LópezMateos" ISSSTE México City, Mexico; GfK, London, UK; Data Pyxis Ltd., St Albans, UK Novartis Pharma AG, Basel, Switzerland; Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States; University Medical Centre Hamburg, Hamburg, Germany British Journal of Dermatology. DOI: 10.111/bjd.16332

2. Introduction:What’s already known about this topic? • Psoriasis is a chronic, immune-mediated inflammatory disease which causes great physical, emotional and social burden • Psoriasis is associated with a higher risk of physical and psychological comorbidities; along with bothersome symptoms such as itch and the presence of psoriatic lesions on visible and sensitive body areas • The presence of associated comorbidities, itch and lesions on visible and sensitive body areas in psoriasis patients are closely related to decreased psychosocial well-being and impact on quality of life

3. Objective In this large and multinational real-world survey, we aimed to investigate the incremental burden of: • physical and psychological comorbidities (cardiovascular disease [CVD], psoriatic arthritis [PsA], obesity, type II diabetes [T2D] and anxiety or depression), • itch, and • presence of psoriatic lesions on visible and sensitive body areas among systemic therapy eligible psoriasis patients compared to those without these conditions

4. Methods • Data source: Growth from Knowledge (GfK) Disease Atlas global real-world evidence programme in psoriasis • Survey conducted in 9 countries: Brazil, France, Germany, Italy, Mexico, Russia, Spain, South Korea, and the United Kingdom [UK] • Duration: From September 2015 to January 2016 • Enrolled patients had or ever had moderate-to-severe psoriasis as reported by their dermatologists, and must have been receiving prescription treatments at the time of the survey • The survey captured patient data through online patient record forms (PRFs) completed by the dermatologist, and a paper survey completed by patients at the end of the consultation for collection of patient-reported outcomes (PROs) data • Statistical analyses: Multivariable generalised linear regression models with appropriate statistical distributions and link functions were developed in each psoriasis patient subgroup to assess the incremental impact of comorbidities, itch and the type of body areas affected, on psoriasis symptoms, quality of life (QoL) measures, percentage of overall work impairment and medical resource utilisation

5. Overall, 524 dermatologists and 3,821 psoriasis patients from 9 countries participated in this survey - Incremental impact of psoriasis was studied in following subgroups * CVD: cardiovascular disease (inclusive of myocardial infarction, peripheral vascular disease, cerebral vascular disease and other cardiovascular disease/s); ** Visible body areas were defined as body areas not covered by clothing and therefore visible to the patient’s entourage; sensitive body areas were defined as body areas where the skin is thinner and may be more sensitive to treatment (Psoriasis Associationdefinition); PsA: Psoriatic arthritis.

6. Psoriasis patients with comorbidities experienced worse QoL and greater work impairment than patients without comorbidities SF-12 Physical Score SF-12 Mental Score -3.0 [-4.8; -1.2]** -6.4 [-8.8; -4.1]*** -5.0 [-6.2; -3.9]*** -2.8 [-4.7; -0.9]** -3.2 [-4.4; -2.0]*** Adjusted % difference in percentage of overall work impairment DLQI Score * ** ** * p<0.05; ** p<0.01; *** p<0.0001 SF-12 Physical and Mental scores (range from 0 [maximum QoL impairment] to 100 [no QoL impairment]); DLQI Scores (range from 0 [no QoL impairment] to 30 [maximum QoL impairment]).

7. -1.5 [-2.3; -0.7]** -1.4 [-2.3; -0.5]** Presence and greater severity of itch was associated with significant decrease in QoL and work productivity Association between presence of itch and QoL Association between severity of itch and QoL Adjusted % difference in percentage of overall work impairment 1.3 [0.7; 1.9]*** *** *** * * p<0.05; ** p<0.01; *** p<0.0001

8. Psoriasis patients with lesions on visible and sensitive skin areas were more likely to have decreased QoL and increase in medical resource use Association between visible body areas and QoL Association between sensitive body areas and QoL Adjusted % difference in number of psoriasis consultations *** *** * p<0.05; ** p<0.01; *** p<0.0001

9. What does this study add? • Results suggest that the clinical, humanistic and economic burden of psoriasis is complex and multidimensional, and not just determined by the severity of disease • Multiple aspects of psoriasis such as associated physical and psychological comorbidities, itch and type of body areas affected by psoriasis contribute to increase this burden further

10. Conclusion • Psoriasis patients with physical and psychological comorbidities, itch and, affected visible and sensitive body areas had lower QoL, and greater work impairment compared to those without these conditions. • Further research using longitudinal data will help to confirm these findings and to define and tailor patient-centric care programmes for psoriasis.

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