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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. Psoriasis. Psoriasis. Psoriasis. Psoriasis: Unmet Medical Need.
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Raptiva™ (efalizumab)Plaque Psoriasis: The Unmet Need Mark Lebwohl, MD Chairman, Department of DermatologyMount Sinai School of Medicine New York, NY
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
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.
Impact of Psoriasis vs. Other Diseases on Patient-reported Physical Outcomes 35 Congestive Heart Failure 41 Psoriasis 42 Diabetes 43 Myocardial Infarction SF-36 Score 43 Arthritis 44 Hypertension 45 Depression 45 Cancer 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.
Impact of Psoriasis vs. Other Diseases on Patient-reported Mental Outcomes 35 Depression 46 Psoriasis 49 Arthritis Cancer 49 SF-36 Score 50 Congestive Heart Failure 52 Diabetes 52 Hypertension 52 Myocardial Infarction 0 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;41:401-407.
0 10 20 30 40 50 60 70 80 90 100 Patients Dissatisfied with Current Psoriasis Therapy Frustrated withtreatment 78% Treatment notaggressive enough 32% Percentage of respondents Krueger G, et al. Arch Dermatol. 2001;137:280-284.
Rotational Therapy • All widely used therapies have shortcomings • Major concerns with toxicities have resulted in “rotational therapy” as a management approach
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
Efficacy of Methotrexate Treatment (15–30 mg/wk): PASI Response at Week 24 n = 23 Proportion responding (%) 50% Reduction in PASI 90% Reduction in PASI 75% Reductionin PASI Callis et al. Presented at: 63rd Annual Meeting of the Society for Investigative Dermatology; May 15-18, 2002, Los Angeles, CA
Example: PASI-50 After 12 Weeks of Treatment Day 0: PASI 18.0 Day 84: PASI 6.8(62% improvement) Study 2390, #35006
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