c-umn- mark lebwohl, md chairman, department of dermatology

1C-UMN-

Mark Lebwohl, MD

Chairman, Department of DermatologyMount Sinai School of Medicine

New York, NY

Raptiva™ (efalizumab)Plaque Psoriasis: The Unmet Need

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Psoriasis

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Psoriasis

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Psoriasis

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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 500-600,000 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;14:485-96., NPF 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.

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Lower scores reflect worse patient-reported outcomesRapp SR, et al. J Am Acad Dermatol. 1999;41:401-407.

Physical Component Summary Score(n = 317)

50454035302520151050

SF

-36

Sco

re

Psoriasis 41

Hypertension 44

Myocardial Infarction

Congestive Heart Failure 35

Diabetes 42

Depression 45

Arthritis 43

Cancer 45

43

Impact of Psoriasis vs. Other Diseases on Patient-reported Physical Outcomes

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Mental Component Summary Score(n = 317)

60403020100

SF

-36

Sco

re

50

Hypertension 52

Depression 35

Congestive Heart Failure 50

Psoriasis 46

Myocardial Infarction 52

Arthritis 49

Diabetes 52

Cancer 49

Impact of Psoriasis vs. Other Diseases on Patient-reported Mental Outcomes

Lower scores reflect worse patient-reported outcomesRapp SR, et al. J Am Acad Dermatol. 1999;41:401-407.

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Patients Dissatisfied with Current Psoriasis Therapy

Krueger G, et al. Arch Dermatol. 2001;137:280-284.

78%

32%

0 10 20 30 40 50 60 70 80 90 100

Percentage of respondents

Treatment notaggressive enough

Frustrated withtreatment

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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

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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

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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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65

26

9

0

20

40

60

80

≥ 50% Reduction

in PASI

≥ 75% Reduction

in PASI

Pro

port

ion

re

spo

ndin

g (%

)

≥ 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

n = 23

Efficacy of Methotrexate Treatment (15–30 mg/wk): PASI Response at Week 24

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Example: PASI-50 After 12 Weeks of Treatment

Day 84: PASI 6.8(62% improvement)

Day 0: PASI 18.0

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