# Presentation: 719524

- Mark Lebwohl, MD
*Chairman, Department of Dermatology**Mount Sinai School of Medicine*
*New York, NY*

**Raptiva****TM**** (efalizumab)****Plaque Psoriasis: The Unmet Need**

## Psoriasis

## Psoriasis

## Psoriasis

## Psoriasis: Unmet Medical Need

- 41⁄2 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

- Rapp SR, et al. *J Am Acad Dermatol.* 1999;41:401-407.

- Physical Component Summary Score
- (n = 317)

- 50

- 45

- 40

- 35

- 30

- 25

- 20

- 15

- 10

- 5

- 0

- SF-36 Score

- 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**

## Impact of Psoriasis vs. Other Diseases on Patient-reported Mental Outcomes

- Mental Component Summary Score
- (n = 317)

- 60

- 40

- 30

- 20

- 10

- 0

- SF-36 Score

- 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.

## Patients Dissatisfied with Current Psoriasis Therapy

- Krueger G, et al. *Arch Dermatol*. 2001;137:280-284.

- 78%

- 32%

- Percentage of respondents

- Treatment notaggressive enough

- Frustrated withtreatment

## 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
- 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

-  50% Reduction in PASI

-  75% Reductionin 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**

## Example: PASI-50 After 12 Weeks of Treatment

**Example: PASI-50 After 12 Weeks of Treatment**

- Day 84:  PASI 6.8(62% improvement)

- Day 0:  PASI 18.0

- 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