Transcript Raptiva (efalizumab) Plaque Psoriasis: The Unmet Need Mark Lebwohl, MD

C-UMN- 1
Raptiva™ (efalizumab)
Plaque Psoriasis: The Unmet Need
Mark Lebwohl, MD
Chairman, Department of Dermatology
Mount Sinai School of Medicine
New York, NY
C-UMN- 2
Psoriasis
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Psoriasis
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Psoriasis
C-UMN- 5
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.
C-UMN- 7
Impact of Psoriasis vs. Other Diseases
on Patient-reported Physical Outcomes
35
Congestive Heart Failure
41
SF-36 Score
Psoriasis
42
Diabetes
Myocardial Infarction
43
Arthritis
43
44
Hypertension
Depression
45
Cancer
45
0
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;41:401-407.
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Impact of Psoriasis vs. Other Diseases
on Patient-reported Mental Outcomes
35
Depression
46
SF-36 Score
Psoriasis
Arthritis
49
Cancer
49
50
Congestive Heart Failure
Diabetes
52
Hypertension
52
Myocardial Infarction
52
0
10
20
30
40
50
Mental Component Summary Score
(n = 317)
Lower scores reflect worse patient-reported outcomes
Rapp SR, et al. J Am Acad Dermatol. 1999;41:401-407.
60
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Patients Dissatisfied with
Current Psoriasis Therapy
Frustrated with
treatment
78%
Treatment not
aggressive enough
32%
0
10 20 30 40 50 60 70 80 90
Percentage of respondents
Krueger G, et al. Arch Dermatol. 2001;137:280-284.
100
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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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Efficacy of Methotrexate Treatment
(15–30 mg/wk): PASI Response at Week 24
Proportion
responding (%)
80
n = 23
65
60
40
26
20
9
0
 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
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Example: PASI-50 After 12 Weeks of Treatment
Day 0: PASI 18.0
Study 2390, #35006
Day 84: PASI 6.8
(62% improvement)
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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