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C-UMN- Mark Lebwohl, MD Chairman, Department of Dermatology

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C-UMN- Mark Lebwohl, MD Chairman, Department of Dermatology

  1. 1. 1C-UMN- Mark Lebwohl, MD Chairman, Department of Dermatology Mount Sinai School of Medicine New York, NY Raptiva™ (efalizumab) Plaque Psoriasis: The Unmet Need
  2. 2. 2C-UMN- Psoriasis
  3. 3. 3C-UMN- Psoriasis
  4. 4. 4C-UMN- Psoriasis
  5. 5. 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
  6. 6. 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.
  7. 7. 7C-UMN- Lower scores reflect worse patient-reported outcomes Rapp SR, et al. J Am Acad Dermatol. 1999;41:401-407. Physical Component Summary Score (n = 317) 50454035302520151050 SF-36Score 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
  8. 8. 8C-UMN- Mental Component Summary Score (n = 317) 60403020100 SF-36Score 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 outcomes Rapp SR, et al. J Am Acad Dermatol. 1999;41:401-407.
  9. 9. 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 not aggressive enough Frustrated with treatment
  10. 10. 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
  11. 11. 11C-UMN- Rotational Therapy • All widely used therapies have shortcomings • Major concerns with toxicities have resulted in “rotational therapy” as a management approach
  12. 12. 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
  13. 13. 13C-UMN- 65 26 9 0 20 40 60 80 ≥ 50% Reduction in PASI ≥ 75% Reduction in PASI Proportion responding(%) ≥ 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
  14. 14. 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
  15. 15. 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

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