Association between disease severity and body mass index in psoriasis patients enrolled in the Corrona Psoriasis Registry

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1 4385 Association between disease severity and body mass index in psoriasis patients enrolled in the Corrona Psoriasis Registry Bruce Strober 1, 2, Chitra Karki 3, Marc Mason 3, Jeffrey D Greenberg 3,4, Mark Lebwohl 5 1 University of Connecticut, Farmington, CT; 2 Probity Medical Research, Waterloo, Ontario, Canada; 3 Corrona, LLC, Southborough, MA; 4 NYU School of Medicine, New York, NY; 5 Icahn School of Medicine at Mount Sinai, New York, NY. Background Recent studies have shown strong association between obesity and psoriasis (PsO) disease activity that may lead to implications in disease management. The objective of this study is to examine the association between body mass index (BMI) (an index for adiposity) and PsO disease severity in an observational cohort of PsO patients. E-poster presented at American Academy of Dermatology Annual Meeting 2017, Orlando, FL This study is sponsored by Corrona, LLC

2 Data Source and Study Population Data Source: Corrona Psoriasis Registry The Corrona PsO registry, in collaboration with the National Psoriasis Foundation (NPF), was launched in April 2015 targeting to recruit approximately 200 sites with ~10,000 patients and an expected follow-up of at least 8 years and to study the comparative effectiveness, safety and treatment patterns of approved systemic therapies in a real world setting. As of October , the National Psoriasis Foundation and Corrona have recruited 90 private and academic practice sites across 33 states in the United States, with 189 participating dermatologists. There are n=2095 patients with psoriasis participating in the registry. Data is collected from both the participating dermatologists and patients approximately every 6 months during routine outpatient visits. Study Population: All patients aged 18 years with dermatologist-diagnosed psoriasis enrolled in the Corrona Psoriasis Registry as of May 31 st 2016 were included. Additional eligibility criteria included initiation of a systemic biologic or non-biologic psoriasis treatment: - On the enrollment date (incident users), OR - Within the 12 months preceding the enrollment date (prevalent users). 2

3 Study Measures and Assessments Demographics * Age Gender Height Weight Education Body Mass Index (BMI) Work status Insurance type Smoking Status Patient Reported Treatment History Disease Characteristics Patient Reported Outcomes Prior Medication (Biologic and Non-biologic systemics) Treatment initiation at enrollment visit (incident user) Treatment initiation in the previous 12 months (prevalent user) Disease Severity: Body Surface Area (BSA) Investigator s Global Assessment (IGA) Psoriasis Area and Severity Index (PASI): 0-72 Psoriasis disease duration History of comorbidities Pain, Itch and Fatigue (VAS 0-100) Euro-QoL Overall health state VAS (0-100) Dermatology Quality of Life Index (DLQI) Work Productivity and Activity Impairment (WPAI) Physician Reported Patient Reported BSA: Affected percent of body surface area 0-100%. IGA: 0= Clear, 1= Almost Clear, 2= Mild, 3= Moderate, 4= Severe. EQ-VAS: Self-rated health state today is reported on a visual analogue scale from The recall period is 1 day. DLQI: Dermatology Quality of Life Index. Overall DLQI scores range from 0 30; higher scores indicate greater effect on the patient s life (lower QoL). The recall period is 1 week. WPAI: Four subdomains measure absenteeism, presenteeism, work productivity, and activity impairment. WPAI scores range from 0 100%; higher scores indicate greater impairment and less productivity. The recall period is 1 week. *All Demographics are patient reported with the exception of height, weight and BMI. 3

4 Methods Population Cohorts: Patients were categorized using body mass index (BMI) classifications * : Normal: BMI < 25 Overweight: 25 BMI < 30 Obese: 30 BMI Statistical Analysis: Descriptive analysis: demographic, disease severity, comorbidities, QoL measures and PROs are presented descriptively for the overall population and BMI cohorts at registry enrollment. Means and standard deviations (SD) are reported for continuous variables. Medians and interquartile ranges (IQR) are reported for other variables in addition to mean (SD). Statistical comparisons among the cohorts were made using ANOVA for continuous variables and chi-squared for categorical variables. Modeling: Multi-variable logit regression analysis was conducted to examine the relationship between BMI and disease severity as measured by Psoriasis Area Severity Index (PASI) at enrollment. Models were adjusted for age, sex, duration of PsO and incident/prevalent use of the drug. *BMI Categorical is based on CDC cut-offs with Underweight classification group included in Normal classification due to small sample size: 4

5 Patient demographics at registry enrollment by BMI categories There were n=1517 patients with non-missing BMI included in the study; 23.4% with normal BMI, 31.2% overweight, and 45.4% obese. Demographics Characteristics BMI < 25 Normal N=355 BMI Cohorts 25 BMI < 30 Overweight N=473 BMI 30 Obese N=689 Age (yrs), mean (SD) 48.8 ± ± ±13.5 Sex: Male, n (%) 160 (45%) 291 (62%) 355 (52%) Body weight (kg), mean (SD) 64.3 ± ± ±20.7 BMI (kg/m 2 ), mean (SD) 22.5 ± ± ±5.9 Insurance Type*, n (%) Private 254 (72%) 358 (76%) 512 (74%) Medicare 60 (17%) 87 (18%) 131 (19%) Medicaid 50 (14%) 49 (10%) 82 (12%) No Insurance 13 (4%) 14 (3%) 25 (4%) p-value <0.05; BMI Categorical is based on CDC cut-offs: *Total of all insurance types may not add up to N (100%), as patients can have multiple insurance coverage. 5

6 Patient demographics at registry enrollment by BMI categories Education level, work status and smoking status differed among the groups as seen in the table below. BMI Cohorts Characteristics BMI < 25 Normal 25 BMI < 30 Overweight BMI 30 Obese Education, n (%) n=355 n=473 n=689 12th grade or less 35 (10%) 29 (6%) 51 (7%) High school graduate/ged 63 (18%) 93 (20%) 179 (26%) Some college/assoc. degree 95 (27%) 161 (34%) 232 (34%) College graduate or higher 162 (46%) 190 (40%) 227 (33%) Work Status, n (%) n=355 n=473 n=687 Full time 190 (54%) 280 (59%) 391 (57%) Part time 32 (9%) 42 (9%) 51 (7%) Work at home 33 (9%) 26 (5%) 44 (6%) Student 16 (5%) 6 (1%) 15 (2%) Disabled 18 (5%) 34 (7%) 73 (11%) Retired 66 (19%) 85 (18%) 113 (16%) Smoking, n (%) n=354 n=469 n=685 Current smoker 76 (21%) 95 (20%) 96 (14%) Former smoker 97 (27%) 152 (32%) 270 (39%) Never smoked 181 (51%) 222 (47%) 319 (47%) p-value <0.05 6

7 Disease characteristics at registry enrollment by BMI categories Patients had an overall mean disease duration of 15.8 years. Overall 40% of patients had concurrent PsA diagnosis with the highest proportion in the obese category (47%). Overall, about half of patients have a history of cardiovascular disease or diabetes risk factors and about one-fifth reported depression and anxiety. A lower proportion of patients in the obese category were biologic naïve (42%) compared to overweight and normal BMI categories (48% and 51% respectively). Disease Characteristics BMI < 25 Normal BMI Cohorts 25 BMI < 30 Overweight BMI 30 Obese Psoriasis duration (yrs), n * n=354 n=471 n=688 mean (SD) 14.3 ± ± ±13.8 median (IQR) 10.0(5.0,21.0) 11.0(5.0,24.0) 13.0(5.0,25.0) Psoriatic Arthritis diagnosis, n (%)* 114 (32%) 176 (37%) 323 (47%) Comorbidities** CVD, n (%) * 24 (7%) 58 (12%) 100 (15%) CV/Diabetes risk factors, n (%) * 116 (33%) 225 (48%) 391 (57%) Diabetes Mellitus, n (%)* 22 (6%) 61 (13%) 131 (19%) Lymphoma / Malignancy, n (%) 33 (9%) 46 (10%) 65 (9%) Crohn s Disease, n (%) 2 (1%) 3 (1%) 3 (0%) Depression, n (%) * 50 (14%) 68 (14%) 172 (25%) Anxiety, n (%) * 48 (14%) 65 (14%) 161 (23%) Prior Medication Biologic Naïve, n (%)* 182 (51%) 226 (48%) 287 (42%) Prior non-biologic systemic usage count, Count of patients, n (%)* 151 (43%) 207 (44%) 333 (48%) Count of drugs: median (IQR) 1.0(1.0,2.0) 1.0(1.0,2.0) 1.0(1.0,2.0) *p-value <0.05; **Comorbidities, physician reported; CVD: Revascularization procedures (CABG, stent, angioplasty), Ventricular arrhythmia, Cardiac arrest, Acute coronary syndrome, Coronary artery disease, Transient ischemic attack, Hemorrhage with/without hospitalization (serious bleed), Deep vein thrombosis, Peripheral arterial disease, Pulmonary embolism, Carotid artery disease. Malignancy: Breast, Lung, Skin (excluding non-melanoma skin cancer) & Other. 7

8 Median % Involvement BSA Percentage of Patients by BSA Category Disease severity (BSA) at registry enrollment by BMI categories Overall, median (IQR) BSA was 5.0 % (2, 10), with comparable disease severity across the BMI categories (figure). Mean scores for worst BSA ever was higher in obese patients compared to overweight and normal BMI patients (25.0 vs 23.5 and 22.1 respectively). Higher proportions of patients in the obese and overweight categories had moderate/severe BSA involvement compared to patients in the normal BMI category (figure). Median BSA Score by BSA Categories by BMI 6 100% % 80% 18% 20% 25% % 60% 50% 40% 48% 44% 42% % 20% 10% 34% 36% 33% 0% 0 Mild Moderate Severe BSA Category * p-value <0.05; Body Surface Area (BSA): A disease severity measure characterized by the amount of body surface area affected. It is reported as percent involvement on a scale of 0-100%. 8

9 Median IGA Score Proportion of Patients Disease severity (IGA) at registry enrollment by BMI categories Overall median (IQR) IGA was 2 (2, 3), with comparable disease severity across normal and overweight categories and slightly higher in the obese category: 2 (1,3) vs 3 (2,3) respectively. Proportion of patients in moderate/severe IGA categories were comparable across the BMI categories; however slightly lower percentage of obese patients were in clear/almost clear category: 22% vs 26% and 28% in normal and overweight categories respectively Median Overall IGA Score by % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% IGA Categorical by BMI 8% 10% 12% 40% 38% 38% 26% 24% 14% 15% 29% 13% 12% 13% 9% Clear Almost clear Mild Moderate Severe IGA Category Investigator Global Assessment (IGA): A 5-point tool used to measure disease severity on a scale of 0-4, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe. 9

10 Median PASI Disease severity (PASI) at registry enrollment by BMI categories Median PASI scores were: 3.3, 3.5 and 3.6 for normal, overweight and obese weight patients respectively. Proportion of patients among PASI categories (used in ordinal regression modeling) was comparable across the 3 BMI categories. Median PASI by Categorical PASI by % 90% 80% 70% % 2 50% 40% % % 10% 0% Mild Moderate Severe Very Severe PASI Category PASI: Psoriasis Area Severity Index (0-72); PASI was categorized as Mild: 0 PASI 5; Moderate: 5 < PASI 12; Severe: 12 < PASI 20; Very Severe: PASI >

11 Mean VAS score (0-100) Patient reported pain, itch and fatigue at registry enrollment by BMI categories Mean scores for overall fatigue were significantly higher in the obese group compared to overweight and normal BMI patients: 33.6 vs 29.7 and 28.2 respectively. Mean scores for overall itch and pain were comparable across the BMI categories as seen in the figure Fatigue, Itch and Pain Score by * Patient Overall Fatigue Patient Overall Itch Patient Overall Pain *p<0.05. Patient reported fatigue, pain and itch are measured on a visual analogue scale The recall period is 1 week. 11

12 Mean Percent (%) WPAI due to PsO Work productivity and activity impairment (WPAI) at registry enrollment by BMI categories The overall percent of patient work hours affected by psoriasis significantly decreases from those in the normal BMI category to those in the overweight or obese category: 16.8% to 12.2% or 12.1% respectively. The percent of impairment while working from psoriasis decreases while BMI increases. WPAI domains by % Work Hours Missed % Impairment while Working Overall % Work Hours Affected* % Daily Activites Impaired *p<0.05; WPAI: Four subdomains measure absenteeism, presenteeism, work productivity, and activity impairment. WPAI scores range from 0 100%; higher scores indicate greater impairment and less productivity. The recall period is 1 week. 12

13 % Patients in each DLQI Category Dermatology life quality index (DLQI) and EQ-VAS at registry enrollment by BMI categories DLQI Proportion of patients reporting very large/extremely large effect on life were comparable across the categories (figure). Mean (SD) scores were also comparable across the categories: 6.8 (5.9) in obese patients vs 6.6 (6.5) in overweight and 6.2 (5.9) in patients with normal BMI. EQ-VAS Overall health status scores (VAS 0-100) were lower in the obese and overweight groups compared to the normal BMI group (mean (SD): 69.3 (21.8) and 74.8 (21.9) vs 76.4 (22.8) respectively). 100% Percentage of Patients in by DLQI 90% 80% 22% 25% 25% 70% 60% 21% 18% 21% 50% 40% 30% 34% 30% 33% 20% 10% 24% 26% 20% 0% Normal Overweight Obese None (0-1) Small (2-5) Moderate (6-10) Very Large/ Extremely Large (11-30) DLQI Category DLQI: Dermatology Life Quality Index. Overall DLQI scores range from 0 30; higher scores indicate greater effect on the patient s life (lower QoL). The recall period is 1 week. 13

14 Association of disease severity (PASI) and BMI The outcome variable PASI was categorized as Mild: 0 PASI 5; Moderate: 5 < PASI 12; Severe: 12 < PASI 20; Very Severe: PASI > 20. Increase in BMI resulted in higher odds of increase in disease severity as measured by PASI: OR (95% CI): 1.02 (1.00, 1.03), p=0.02. Increase in weight resulted in higher odds of increase in disease severity as measured by PASI: OR (95% CI): 1.03 (1.01, 1.05), p=0.02; which means that each 10kg increase in weight will result in a 3% greater odds of changing to a more severe PASI level. Results were consistent after controlling for treatment initiation at enrollment vs previous 12 months. Table: Association of BMI/Weight with disease severity as measured by PASI PASI Model Parameters Odds Ratio 95% Confidence Interval p-value BMI* 1.02 [1.00,1.03] Weight 1.03 [1.01, 1.05] *Models were adjusted for age, sex, duration of PsO and incident/prevalent use of the drug. Models were adjusted for height, age, sex, duration of PsO and incident/prevalent use of the drug. 14

15 CONCLUSIONS In this cross-sectional real-world study, patients had comparable disease activity across the BMI categories with higher proportion of concurrent PsA in the obese category at enrollment. However, adjusted models showed that increase in BMI was associated with higher disease severity measured by PASI. Acknowledgement This study is sponsored by Corrona, LLC. Corrona Psoriasis Registry is sponsored by Corrona LLC and is funded by AbbVie, Boehringer Ingelheim, Eli Lilly and Company and Novartis Pharmaceutical Corporation. Corrona, LLC has been supported through contracted subscriptions in the last two years by AbbVie, Amgen, AstraZeneca, BMS, Crescendo, Eli Lilly and Company, Genentech, GSK, Horizon Pharma USA, Janssen, Momenta Pharmaceuticals, Novartis, Pfizer, Roche and UCB. Author Disclosures BS: Speakers Bureau: AbbVie ; Consultant: AbbVie, Amgen, Celgene, Dermira, Forward Pharma, Janssen, Leo, Eli Lilly, Maruho, Medac, Novartis, Pfizer, Stiefel/GlaxoSmithKline, UCB; Investigator: AbbVie, Amgen, Novartis, Lilly, Janssen, Merck, XenoPort; Scientific Director: CORRONA Psoriasis Registry; Grant Support to the University of Connecticut for Fellowship Program: AbbVie, Janssen; CK: Employee at Corrona, LLC.; MM: Employee at Corrona, LLC; University of Delaware, Dept. of Behavioral Health and Nutrition Affiliate Faculty (Nonremunerative position); JDG: Remunerative: employee and shareholder - Corrona, LLC.; Consultant - AstraZeneca, Celgene, Genentech, Janssen, Novartis and Pfizer Non-Remunerative: NONE; ML: Employee of the Mount Sinai Medical Center which receives research funds from AbGenomics, AbbVie, Amgen, Anacor, Aqua, Canfite Biopharma, Celgene, Clinuvel, Coronado Biosciences, Ferndale, Lilly, Janssen Biotech, LEO Pharmaceuticals, Merz, Novartis, Pfizer, Sandoz, Sun Pharmaceuticals, and Valeant. 15

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