1. Raptiva™ (efalizumab) Plaque Psoriasis: The Unmet Need
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Raptiva™ (efalizumab) Plaque Psoriasis: The Unmet Need
Mark Lebwohl, MD
Chairman, Department of Dermatology Mount Sinai School of Medicine
New York, NY

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Psoriasis

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Psoriasis

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Psoriasis

5. Psoriasis: Unmet Medical Need
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Psoriasis: Unmet Medical Need
4½ million Americans have psoriasis with at least 10% of those patients having moderate-to-severe disease
About ,000 of these patients are candidates for systemic therapy
People with moderate-to-severe disease reported a larger, negative impact on QOL
Majority of patients with moderate-to-severe psoriasis are not using the most aggressive treatments for their disease
Koo JY. Dermatol Clinics 1996;14: , NPF Survey

6. Short Form 36 (SF-36) Health Survey
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Short Form 36 (SF-36) Health Survey
Health status measurement tool that can compare different disease states
8 domains
Assesses impact of disease and treatment on functional status and well-being
Physical Component Summary
Mental Component Summary
Ware JE, et al. SF-36® Health Survey Manual and Interpretation Guide. The Health Institute;1993.

7. Physical Component Summary Score
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Impact of Psoriasis vs. Other Diseases on Patient-reported Physical Outcomes
Congestive Heart Failure 35
Psoriasis 41
Diabetes 42
Myocardial Infarction 43
SF-36 Score
Arthritis 43
Hypertension 44
Depression 45
Cancer 45 5 10 15 20 25 30 35 40 45 50
Physical Component Summary Score
(n = 317)
Lower scores reflect worse patient-reported outcomes
Rapp SR, et al. J Am Acad Dermatol. 1999;41:

8. Mental Component Summary Score.
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Impact of Psoriasis vs. Other Diseases on Patient-reported Mental Outcomes
Depression 35
Psoriasis 46
Arthritis 49
Cancer 49
SF-36 Score
Congestive Heart Failure 50
Diabetes 52
Hypertension 52
Myocardial Infarction 52 10 20 30 40 50 60
Mental Component Summary Score
(n = 317)
Lower scores reflect worse patient-reported outcomes
Rapp SR, et al. J Am Acad Dermatol. 1999;41:

9. Patients Dissatisfied with Current Psoriasis Therapy
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Patients Dissatisfied with Current Psoriasis Therapy
Frustrated with treatment
78%
Treatment not aggressive enough
32% 10 20 30 40 50 60 70 80 90
100
Percentage of respondents
Krueger G, et al. Arch Dermatol. 2001;137:

10. Drawbacks of Current Psoriasis Therapies
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Drawbacks of Current Psoriasis Therapies
UVB
Frequent visits
PUVA
Frequent visits, skin carcinoma, melanoma
Acitretin
Teratogenic, inadequate as monotherapy
Methotrexate
Bone marrow toxicity, hepatotoxicity
Cyclosporine
Nephrotoxicity
Alefacept
Weekly office visits, slow onset

11. Rotational Therapy All widely used therapies have shortcomings
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Rotational Therapy
All widely used therapies have shortcomings
Major concerns with toxicities have resulted in “rotational therapy” as a management approach

12. Concerns from a Practitioner
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Concerns from a Practitioner
Concerns
Safety of the current treatments for moderate-to-severe plaque psoriasis
Needs
Need for safe, convenient and effective treatment option that reduces psoriasis
Need for a therapy safe enough to give over the long term
Need for rapid acting therapy

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Efficacy of Methotrexate Treatment (15–30 mg/wk): PASI Response at Week 24
n = 23
responding (%)
Proportion
 50% Reduction in PASI
 75% Reduction in PASI
 90% Reduction in PASI
Callis et al. Presented at: 63rd Annual Meeting of the Society for Investigative Dermatology; May 15-18, 2002, Los Angeles, CA

14. Example: PASI-50 After 12 Weeks of Treatment
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Example: PASI-50 After 12 Weeks of Treatment
Day 0: PASI 18.0
Day 84: PASI 6.8 (62% improvement)
Study 2390, #35006

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Summary
Psoriasis is a chronic life-long disease that causes significant disability
Current treatments have limitations
Need a safe and effective therapy for long-term use