Raptiva™ (efalizumab) Plaque Psoriasis: The Unmet Need

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Presentation transcript:

Raptiva™ (efalizumab) Plaque Psoriasis: The Unmet Need 4/13/2017 4:00 PM Raptiva™ (efalizumab) Plaque Psoriasis: The Unmet Need Mark Lebwohl, MD Chairman, Department of Dermatology Mount Sinai School of Medicine New York, NY

4/13/2017 4:00 PM Psoriasis

4/13/2017 4:00 PM Psoriasis

4/13/2017 4:00 PM Psoriasis

Psoriasis: Unmet Medical Need 4/13/2017 4:00 PM 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 4/13/2017 4:00 PM 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.

Physical Component Summary Score 4/13/2017 4:00 PM Impact of Psoriasis vs. Other Diseases on Patient-reported Physical Outcomes Congestive Heart Failure 35 Psoriasis 41 Diabetes 42 Myocardial Infarction 43 SF-36 Score Arthritis 43 Hypertension 44 Depression 45 Cancer 45 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.

Mental Component Summary Score . 4/13/2017 4:00 PM Impact of Psoriasis vs. Other Diseases on Patient-reported Mental Outcomes Depression 35 Psoriasis 46 Arthritis 49 Cancer 49 SF-36 Score Congestive Heart Failure 50 Diabetes 52 Hypertension 52 Myocardial Infarction 52 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.

Patients Dissatisfied with Current Psoriasis Therapy 4/13/2017 4:00 PM Patients Dissatisfied with Current Psoriasis Therapy Frustrated with treatment 78% Treatment not aggressive enough 32% 10 20 30 40 50 60 70 80 90 100 Percentage of respondents Krueger G, et al. Arch Dermatol. 2001;137:280-284.

Drawbacks of Current Psoriasis Therapies 4/13/2017 4:00 PM 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

Rotational Therapy All widely used therapies have shortcomings 4/13/2017 4:00 PM 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 4/13/2017 4:00 PM 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

4/13/2017 4:00 PM Efficacy of Methotrexate Treatment (15–30 mg/wk): PASI Response at Week 24 n = 23 responding (%) Proportion  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

Example: PASI-50 After 12 Weeks of Treatment 4/13/2017 4:00 PM Example: PASI-50 After 12 Weeks of Treatment Day 0: PASI 18.0 Day 84: PASI 6.8 (62% improvement) Study 2390, #35006

4/13/2017 4:00 PM 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