psoriasis: results from the Psoriasis SELECT Patient Study Zhang J 1 - - PowerPoint PPT Presentation

Patient reported symptoms of psoriasis: results from the Psoriasis SELECT Patient Study

Zhang J1, Swensen A1, DiBonaventura M2, Pierce A3, Nyirady J1

1Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 2Health Sciences Practice, Kantar Health, New York City, New York 3Yale University, New Haven, Connecticut

Presented at the AAD 2010 Summer Academy Meeting, Chicago, Illinois, August 4-8, 2010

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Abstract

• Background: Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA)

are used frequently to assess treatment benefit in clinical trials for psoriasis treatment. Patient reported symptoms are seldom utilized as a tool to evaluate the benefit of new treatments.

• Objectives: In order to better understand the unmet needs of psoriasis patients, a survey was

conducted to assess the frequency and importance of patient reported psoriasis symptoms.

• Methods: Potential respondents were identified through the 2009 U.S. National Health and Wellness

Survey (NHWS) who were 18 and years older with moderate to severe psoriasis (>10% body surface area).

• Results: A total of 251 responders with moderate to severe plaque psoriasis completed the survey.

The mean age was 49 (20-78) and 63% were female. Of the psoriasis symptoms typically experienced by these patients, 86% were itch, 85% were dry skin, 84% were scaling, 77% were skin redness, 58% were inflammation, and 43% were pain. Of these patients who reported pain, 42% reported non-joint pain, among them, the frequency of the pain were from sometimes to continuous for 87% of the patients, and 81% stated the severity were somewhat painful to extremely painful. In addition, 72% of patients talked to the physician about their non-joint pain, 58% of them used some types of pain relief medications.

• Conclusion: Patient reported psoriasis symptoms are important and should be assessed in

evaluation of treatment benefit.

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Background

• Psoriasis is the most prevalent autoimmune disease in the U.S., affecting 7.5

million Americans.1

• Direct and indirect healthcare costs are calculated at 11.25 billion annually,

with work loss accounting for 40% of that burden.2

• 60% of psoriasis patients report the disease as a large problem in everyday

life,3 and 60% of people afflicted with psoriasis miss an average of 26 days of work due to their illness annually.4

• Current clinical trial endpoints do not include daily patient self-reported

symptoms such as itching, stinging, burning, pain due to cracking, general pain, or scaling.

• However, these patient reported symptoms may drive treatment selection for

patients due to their burden on daily life and should be included as part of the evaluation in clinical trials.

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Objective

In order to better understand the prevalence of these psoriasis symptoms and their impact on patients’ daily lives and activities, a patient survey was conducted to assess:

• severity and botherness of patient self-reported psoriasis

related itching, stinging, burning, cracking pain, general pain, and scaling

• the effect of psoriasis symptoms on daily life
• work productivity

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Methods

• A total of 21417 subjects were invited

to participate from both National Health and Wellness Survey (NHWS) and The Lightspeed Research (LSR) Ailment Panel (conducted in the U.S. from December 4, 2009- January 7, 2010).

• Eligibility criteria: 1) 18 years or older;

2) diagnosis of psoriasis; 3) greater than 10% body surface area currently affected by psoriasis; 4) psoriasis categorized as plaque psoriasis or inverse psoriasis.

• The recall period for the psoriasis

symptoms and their impact on daily life was 1 day, and the recall period for work productivity questions was 7 days.

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21,417 Participants

8257 Respondents

1238 Eligible

251 Surveys Completed

13,160: Non-responders 3,333: Mild psoriasis 1,551: Incorrect type of psoriasis 2,110: Did not have Psoriasis 613: Quit during screening 374: Refused informed consent 25: Other reasons

Final Survey Enrollment

Demographic Profile

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Characteristics Total n = 251 Gender Female 63% Mean Age (range, SD) 48 years (18-77, 13.4) Mean Height (range, SD) 1.70 m (1.50-1.96, 0.09) Mean Weight (range, SD) 90.2 kg (39.5-204.1, 26.7) Mean BMI (SD) 31 (9) Currently Using Medication for Treatment of Psoriasis 89.6%

BMI was calculated by dividing the mass of each individual (kg) by his or her height in meters

• squared. Height and mass were self-reported by those who took the survey.

Patient reported psoriasis symptoms

Majority of patients (80% to 94%) reported psoriasis symptoms within 24 hours period with a severity and botherness score between 3.6-5.2 on a scale of 0-10.

Severity and botherness were reported on a 0-10 scale with 0= no symptoms and 10= symptoms as bad as you can imagine.

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Itching Stinging Burning Skin Cracking Pain Scaling Frequency (%) 94 82 78 81 80 93 Severity (SD) 5.1 (2.7) 4.0 (3.0) 3.6 (3.0) 3.7 (2.9) 3.8 (2.9) 5.3 (2.8) Botherness (SD) 5.1 (2.8) 3.9 (2.9) 3.7 (3.1) 3.8 (3.1) 3.8 (3.1) 5.2 (3.0)

Strong correlations between different patient reported psoriasis symptoms

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Itching Stinging Burning Cracking Pain General Pain Severity of Stinging 0.72 Severity of Burning 0.67 0.82 Severity of Cracking Pain 0.66 0.64 0.67 Severity of General Pain 0.62 0.67 0.70 0.83 Severity of Scaling 0.64 0.57 0.56 0.65 0.60

Strong correlations between severity and botherness of each

• f the patient reported psoriasis symptoms
• The regression lines from the other

symptoms can be seen below.

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• 2

2 4 6 8 10 12

• 2

2 4 6 8 10 12 Botherness of Itching (0-10) Self Reported Itching Severity (0-10)

Severity/Botherness of Itching

y= 0.99x +0.06 R= 0.93

Scaling y = 0.99x - 0.08 R = 0.92 Itching y = 0.99x + 0.06 R = 0.93 Stinging y = 0.91 + 0.28 R = 0.92 Cracking Pain y = 0.98x + 0.15 R²= 0.92 General Pain y = 1.00x + 0.04 R = 0.96 Burning y = 0.99x + 0.12 R = 0.96

1 2 3 4 5 6 7 8 9 10 2 4 6 8 10 Botherness of Symptom (0-10) Self Reported Symptom Severity (0-10)

Severity/Botherness of Symptom Larger bubble size indicates greater number of responses.

Moderate to strong correlation between severity of psoriasis symptom and avoidance of activity with other people

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Itching y = 0.59x + 0.48 R = 0.47 Stinging y = 0.57x + 1.14 R = 0.52 Burning y = 0.64x + 1.15 R = 0.58 Cracking Pain y = 0.64x + 1.06 R = 0.56 General Pain y = 0.60x + 1.19 R = 0.54 Scaling y = 0.50x + 0.80 R = 0.43

1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 Level of Avoidance of Others (0-10) Self Reported Severity of Symptom (0-10)

Severity vs. Avoidance of Activities

Moderate to strong correlation between the severity of psoriasis symptoms and embarrassment about psoriasis

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Stinging y = 0.65x + 1.29 R = 0.49 Itching y = 0.60x + 2.17 R = 0.51 Burning y = 0.62x + 2.34 R = 0.53 Cracking Pain y = 0.62x + 2.25 R = 0.52 General Pain y = 0.62x + 2.24 R = 0.53 Scaling y = 0.66x + 1.09 R = 0.53

1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 Level of Embarrassment About Psoriasis (0-10) Self Reported Severity of Symptom (0-10)

Severity vs. Embarrassment About Psoriasis

Impact of psoriasis on work productivity

• Ninety-three (53%) survey

responders are currently employed full-time.

• Of those employed full-time,

percentage of people in each division of work productivity loss (%

• verall work impairment due to

health, n=93) is shown. Among all the groups, the average productivity loss was 24% per person.

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None (0%) 31% Low (1-10%) 10% Medium (11-30%) 24% High (31%+) 23% Mean Productivity Lost per Person 24% Full-Time Employees Work Impairment Due to Severe Psoriasis % Absenteeism (%

work time missed due to health, n = 93)

5% % Presenteeism (%

work impairment due to health, n = 93)

22%

Moderate to strong correlation between the severity of psoriasis symptoms and productivity loss

• Self-reported severity of symptoms positively

correlated with lost productivity. An example of itching severity vs. productivity loss is seen

• below. Larger bubble sizes indicates greater

number of responses.

• The correlations of all symptoms vs.

productivity loss can be seen below.

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• 2

2 4 6 8 10

• 2

2 4 6 8 10 12 Productivity Loss (0-10) Self Reported Itching Severity (0-10)

Itching vs. Productivity Loss

y= 0.40x +0.24 R= 0.42 Itching y = 0.40x + 0.24 R = 0.42 Stinging y = 0.43x + 0.50 R = 0.51 Burning y = 0.51x + 0.33 R = 0.57 Cracking Pain y = 0.47x + 0.48 R = 0.52 General Pain y = 0.51x + 0.30 R = 0.57 Scaling y = 0.23x + 0.97 R = 0.25

1 2 3 4 5 6 7 8 9 10 2 4 6 8 10 Work Productivity Loss (0-10) Self Reported Severity of Symptom (0-10)

Severity vs. Work Productivity Loss

Moderate to strong correlation between the severity

• f psoriasis symptoms and hours of work missed

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Itching y = 0.40x - 0.59 R = 0.34 Stinging y = 0.37x - 0.14 R = 0.36 Burning y = 0.44x - 0.26 R = 0.41 Cracking Pain y = 0.44x – 0.30 R = 0.40 General Pain y = 0.50x - 0.51 R = 0.45 Scaling y = 0.27x - 0.09 R = 0.23

• 2

2 4 6 8 10 1 2 3 4 5 6 7 8 9 10 Number of Hours Missed Self Reported Severity of Symptom (0-10)

Severity vs. Hours of Work Missed

Summary

• Despite current treatment (89.6%), the majority of patients (80%-94%)

still reported variety of psoriasis symptoms within the previous 24 hours.

• The severity and botherness of these symptoms are moderate to high

(mean score between 3.6-5.2 on a scale of 0-10).

• There were moderate to strong correlations between severity of patient

reported psoriasis symptoms and

• their botherness to patients
• negative impact on patient’s daily life
• reduced work productivity
• Patient reported psoriasis symptoms are important to patients and

should be assessed as part of the evaluation of treatment benefit in clinical trials.

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Financial Support

• Financial support was provided by Novartis

Pharmaceuticals Corporation, East Hanover, NJ and Kantar Health, New York City, NY.

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References

1.

Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Invest Dermatol Symp Proc .2004; 9:136-139.

2.

Folwer Fj, Duh MS, Rovba L, Buteau S, Pinheiro L, Lobo F, Sung J, Doyle JJ, Swenesen A, Mallett DA, Kosicki G. The impact of psoriasis on health care costs and patient work loss. J Am Acad Dermatol. 2008; 59(5):772-780.

3.

Gelfand JM, Gladman DD, Mease PJ, Smith N, Margolis DJ, Nijsten T, Stern RS, Feldman SR, Rolstad T. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005; 53(4):573.

4.

Horn EJ, Fox KM, Patel V, Chiou CF, Dann F, Lebwohl M. Association of patient reported psoriasis severity with income and employment. J Am Acad Dermatol. 2007; 57(6):963-971.

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