1 C-UMN- Mark Lebwohl, MD Chairman, Department of Dermatology Mount Sinai School of Medicine New York, NY Raptiva ™ (efalizumab) Plaque Psoriasis: The Unmet Need
1C-UMN-
Mark Lebwohl, MD
Chairman, Department of DermatologyMount Sinai School of Medicine
New York, NY
Raptiva™ (efalizumab)Plaque Psoriasis: The Unmet Need
2C-UMN-
Psoriasis
3C-UMN-
Psoriasis
4C-UMN-
Psoriasis
5C-UMN-
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
6C-UMN-
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.
7C-UMN-
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
8C-UMN-
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.
9C-UMN-
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
10C-UMN-
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
11C-UMN-
Rotational Therapy
• All widely used therapies have shortcomings
• Major concerns with toxicities have resulted in “rotational therapy” as a management approach
12C-UMN-
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
13C-UMN-
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
14C-UMN-
Example: PASI-50 After 12 Weeks of Treatment
Day 84: PASI 6.8(62% improvement)
Day 0: PASI 18.0
Study 2390, #35006
15C-UMN-
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