Symptom Severity, Quality of Life and Work Productivity of US Psoriasis Patients During Periods of Flare and Remission 93 Korman, NJ 1, Zhao, Y 2, Roberts, J 3 Pike, J 3, Lu, J 2, Tran, MH 2 (Please see authors affiliations on the last panel) Background Psoriasis is a chronic skin condition where patients experience unpredictable periods of flare and remission. 1. Key clinical symptoms include mild to severe itching, painful skin, and scaling. 2. In addition to the physical symptoms, psoriasis is also associated with a considerable reduction in quality of life (QoL) and work productivity. 2 Prolonged remission is an important treatment goal in psoriasis. 3 A number of studies have investigated how well different treatment approaches achieve this. 4-6. However, very little is known about how disease burden varies depending on whether or not a patient is currently in remission.
Study Design Study Objectives: To compare psoriasis overall disease severity, symptom severity for pain, itching, and scaling, QoL and work productivity between patients in remission, patients with active disease but not, and patients with active disease and. Study Design: Observational survey Data Source: Data were drawn from the 2011 and 2013 Adelphi Psoriasis Disease Specific Programmes, 7 two Real World cross-sectional surveys conducted in the US. Sample Selection: A geographically representative sample of 180 dermatologists participated. Physician inclusion criteria: dermatologist as primary speciality, qualified as a physician between 1973 and 2010, sees at least 10 psoriasis patients per month and is actively involved in the treatment of psoriasis. Physicians were asked to complete detailed Patient Record Forms (PRFs) for 7 consecutive patients consulting with psoriasis during the study period. These same patients were invited to complete a Patient Self-Complete Form (PSC). Patient inclusion criteria: either moderate-severe psoriasis, or >10% BSA affected, or prescribed systemic therapy, at some point in their disease history.
Study Measures Physician Reported Patient Reported Age Gender Ethnicity Body mass index (BMI) Years since diagnosis Demographics Disease Characteristics Quality of Life (QoL) Disease status: remission, active not, active and. Severity of overall disease (mild, moderate, severe) Severity of itching, pain, & scaling (none, mild, moderate/severe). EuroQoL 5 Dimension Health Questionnaire (EQ-5D) Dermatology Quality of Life Index (DLQI) Work Productivity and Activity Impairment (WPAI) % body surface area affected EQ-5D: Five dimensions assessing mobility, self-care, usual activities, pain/discomfort and anxiety/depression. DLQI: Dermatology specific quality of life questionnaire. Six subdomains assess symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. WPAI: Four subdomains measure absenteeism, presenteeism, work productivity, and activity impairment Data Analysis Remission, active not,and active and patient groups were constructed. Physicians were asked is this patient in remission with response options being yes/no (yes = remission group). If no, physicians indicated whether this patient was currently experiencing an acute episode (yes =active and group, no = active not group). EQ-5D 8, DLQI 9 and WPAI 10 scores, and the severity of itching, pain and scaling were compared between patients in remission, active not, and active and. Means and standard deviations (SD) were reported for continuous variables. Frequencies (%) were reported for categorical variables. Statistical comparisons between patients groups were conducted with Kruskal-Wallis or Mann-Whitney tests for continuous variables and Fishers Exact or Chi-Squared tests for categorical variables. Multiple linear/logistic/ordered logistic regressions were used to assess the relationship between disease status (remission, active not, active and ), disease/symptom severity, QoL and work productivity, controlling for demographics (age, gender, ethnicity) and comorbidities (possible psoriatic arthritis, hypertension, elevated cholesterol, anxiety, depression, obesity and diabetes).
Demographics and Disease Characteristics were Similar between Patient Groups Total sample Remission Active not Active (n=681) (n=163) (n=419) (n=99) Gender, female, n (%) 306 (45.0) 71 (43.6) 182 (43.5) 53 (53.5) Age (years), mean (SD) 44.0 (15.6) 43.8 (14.6) 44.1 (15.8) 43.7 (16.7) Race, n (%) Caucasian 589 (87.5%) 145 (89.5) 361 (87.2) 83 (85.6) Black 23 (3.4) 5 (3.4) 15 (3.6) 3 (3.1) Other 61 (9.1) 12 (7.4) 38 (9.2) 11 (11.4) Body mass index, mean (SD) 27.3 (5.4) 27.1 (5.2) 27.4 (5.1) 27.1 (6.6) Years since diagnosis, mean (SD) 5.6 (7.9) 6.5 (8.0) 5.1 (8.0) 6.1(7.1) Body surface area affected, mean %, (SD) 9.7 (11.3) 3.2 (8.5) 11.0 (10.7) 14.8 (12.9) p<0.05 (compared to remission). SD: Standard deviation
% of patients Disease Severity Increased with More Active Disease Overall psoriasis disease severity by disease activity 1.2 4.3 4.4 21.2 94.5 56.4 67.7 Severe Moderate Mild Overall psoriasis disease severity was described as mild, moderate or severe p<0.05 (compared to remission patients) 39.2 11.1 Remission Active not Active and Ordered Logistic Regressions Results Variable Odds Ratio 95% Confidence Interval Active not 1 25.9 12.6 53.2 Active and 1 132.2 54.1 323.2 1 An ordered logistic regression was performed to examine the impact of disease activity (reference = remission) on overall disease severity p<0.05
% of patients Symptom Severity Increased with More Active Disease Severity of itching, pain and scaling by disease activity 5.6 42.9 Itching 36 60.6 1.9 15.7 Pain 12.3 35.1 22.2 10.3 4.4 52.8 Scaling 43.5 83.8 Moderate-to-severe symptoms Mild symptoms 51.6 43.2 20.8 Remission Active not 27.3 12.1 Active 82.4 65.5 Remission Active not 54.6 Active 42.9 44.5 12 Remission Active not 13.1 3 Active No symptoms p<0.05. Significant difference in severity level compared to remission patients Ordered Logistic Regressions Results Outcomes Itching Variable Odds ratio 95% Confidence Interval Active not 1 4.8 3.1 7.4 Active and 1 11.3 5.7 22.4 Active not 2 2.3 1.3 3.9 Pain Active and 2 4.8 2.1 10.9 Active not 3 7.5 4.6 12.3 Scaling Active and 3 50.1 24.5 102.2 Symptom severity was described as none, mild or moderate-to-severe for itching, pain and scaling 1,2,3 Three separate Ordered Logistic regressions were performed to examine the impact of disease activity (reference = remission) on symptom severity for itching, pain and scaling p<0.05
Mean EQ5D scores EQ-5D Scores Decreased with More Active Disease EQ-5D by disease activity Remission Active not Active 0.93 0.90 EQ-5D = EuroQoL 5 Dimension Health Questionnaire 0.82 EQ-5D scores range from 0 1; 1 is perfect health and lower scores indicate lower QoL. p<0.05 compared to remission patients EQ-5D Linear Regressions Results Variable Coefficient 95% Confidence Interval Active not 1-0.03-0.05-0.01 Active and 1-0.10-0.13-0.07 1 A linear regression was performed to examine the impact of disease activity (reference = remission) on EQ-5D scores p<0.05
Mean DLQI scores DLQI Scores Increased with More Active Disease DLQI by overall disease activity Remission Active not Active 8.7 DLQI = Dermatology Quality of Life Index 2.0 5.0 Overall DLQI scores range from 0-30; higher scores indicate lower QoL. 0-1 = no effect on the patient s life 2-5 = small effect 6-10 = moderate effect 11-20 / 21-30 = very large / extremely large effect p<0.05 compared to remission patients DLQI Linear Regressions Results Variable Coefficient 95% Confidence Interval Active not 1 2.7 1.9 3.4 Active and 1 6.6 5.1 8.1 1 A linear regression was performed to examine the impact of disease activity (reference = remission) on DLQI scores p<0.05
Mean WPAI Scores WPAI Scores Increased with More Active Disease WPAI by disease activity Remission Active not Active 26.9 5.9 14.8 WPAI = Work Productivity and Activity Impairment WPAI scores range from 0-100%; higher scores indicate greater impairment and less productivity p<0.05 compared to remission patients Linear Regressions Results Variable Coefficient 95% Confidence Interval Active not 1 9.0 4.7 13.2 Active and 1 21.1 13.1 29.1 1 A linear regression was performed to examine the impact of disease activity (reference = remission) on WPAI scores p<0.05
Conclusions Among US patients with psoriasis, Overall disease severity and the severity of itching, painful skin and scaling increased with more active disease. More active psoriasis was associated with reduced HRQoL and work productivity. Remission is an important treatment goal. Not only was remission associated with improved physical symptoms, there was also a benefit seen on Qol and work productivity outcomes. References 1. Carey W et al. J Am Acad Dermatol 2006; 54:S171-181 2. De Korte J et al. J Invest Derm Symp Proc 2004; 9: 140 147. 3. Lebwohl M. J Am Acad Dermatol 2005; 53: S59-69. 4. Coimbra S. J Clin Dermatol 2013; 14: 49-53. 5. Koo J & Lebwohl M. J Am Acad Dermatol 1999; 41: 51-59. 6. Langley RG & Gordon KB. J Drugs Dermatol 2007; 6: 1205-1212. 7. Anderson P et al. Curr Med Res Opin 2008; 24: 3063-3072. 8. EuroQol Group. Health Policy Amst Neth 1990; 16:199 208. 9. Finlay AY et al. Clin Exp Dermatol 1994;19:210 216. 10. Reilly MC et al. PharmacoEconomics 1993;4:353 65. Author Affiliations 1 University Hospitals Case Medical Center, Cleveland, OH 2 Novartis Pharmaceuticals Corporation, East Hanover, NJ 3 Adelphi Real World, Manchester, UK This study was sponsored by Novartis Pharmaceuticals Corporation, East Hanover, NJ. Disclosures: N. Korman, received grant funding for his participation in this project; investigator for Abbvie, Amgen, Celgene, Eli Lily, Genentech, Janssen, and Pfizer; advisory boards for Amgen, Astellas, Baxter, Celgene, Eli Lily, Genentech, Janssen, Novartis, and Pfizer; consultant for Apopharma and Astellas; speaker for Abbvie, Amgen, Astellas, Genentech, and Janssen; Y. Zhao, employee of Novartis Pharmaceuticals Corporation.