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Table 1. Measurements Used to Determine Response to Psoriasis Therapies

Measurement Tool

 Definition

 

Psoriasis Area and Severity Index (PASI)

 

Measures 4 body areas (head, trunk, upper extremities, lower extremities) for the extent and severity of psoriasis.  PASI score denotes percent improvement from baseline (eg, PASI 75).

·  Evaluate

· Score is weighted by

-Scale

-    Severity

-Erythema

-    Body surface area (BSA) affected

-    Induration

 

 

Target Lesion Assessment

 

Measures an identified lesion at baseline and then at designated time points throughout the trial period for:

·  Plaque elevation (0 = none to 4 = very severe)

·  Scaling (0 = none to 4 = very severe)

·  Erythema (0 = none to 4 = very severe)

·  Global assessment (0 = none to 4 = very severe psoriasis)

 

BSA

 

Measurement of the percentage of BSA involved; ranges from mild (less than 2% BSA), to moderate (2%-10% BSA), to severe (greater than 10% BSA)

Physician’s Global Assessment (PGA)

A 6-category scale ranging from very severe to clear indicating physician’s overall assessment of the psoriasis severity at one time point, focusing on plaque, scaling, and erythma.

 

Health Assessment Questionnaire (HAQ)

 

A validated self-administrated questionnaire, which can also be given face-to-face in a clinical setting or in a telephone interview format by trained outcome assessors.  The Disability Index, part of the HAQ, includes 8 categories of assessment relative to the patient’s ability to perform activities.

·  Dressing and grooming

·  Hygiene

·  Arising

·  Reach

·  Eating

·  Grip

·  Walking

·  Common daily activities

Dermatology Life Quality Index (DLQI)

10-item dermatology-specific questionnaire; scores range from 0-30, with higher scores indicating worse quality of life.  Address:

·  Daily activities

·  Leisure

·  Treatment-related distress

·  Work or school

·  Personal relationships

·  Symptoms

·  Feelings

 

 

Table 2. Dosing and Administration of Biologic Agents for Psoriasis

Type

Agent

Brand Name

Manufacturer

Mode of Administration

 

T-cell depletory

 

Alefacept

 

Amevive®

 

Biogen

 

· IM injection in physician’s office or treatment facility

· Administer once per week for 12 weeks with a

12-week observation period

· Additional 12-week courses as needed

 

T-cell modulator

 

Efalizumab

 

Raptiva™

 

Genentech

 

· SC self-injection

· Administer once per week

 

Anti-TNF monoclonal antibody

 

Adalimumab

 

 

 

 

Infliximab

 

Humira®

 

 

 

 

Remicade®

 

Abbott

 

 

 

 

Centocor

 

· SC self-injection

· 40 mg every other week or 40 mg once weekly

 

· IV infusion in physician’s office or treatment facility

· 3 infusions of 3 mg-10 mg/kg over 6 weeks; then every 8 weeks or as needed

 

Soluble TNF receptor protein

 

Etanercept

 

Enbrel®

 

Amgen/Wyeth

 

· SC self-injection

· 50 mg twice weekly (administered 3 to 4 days apart) for 3 months followed by a reduction to a maintenance dose of 50 mg per week

 

Table 3. Efficacy of Biologic Agents

 

 

Agent

Percentage of Patients Achieving Primary Endpoint (PASI 75 After 12 Weeks of Treatment)

Percentage of Patients Achieving PASI 75 at

Week 24

 

Alefacept

     15 mg IM

 

 

21

 

 

N/A

 

Efalizumab

     1 mg/kg SC

 

 

27

 

 

44

 

Infliximab*

     3 mg/kg IV

     5 mg/kg IV

 

 

72

88

 

 

N/A

N/A

 

Etanercept

     25 mg twice weekly SC

     50 mg twice weekly SC

 

 

34

49

 

 

44

59

 

Table 4. Safety and Toxicity Associated with Biologic Agents

Biologic Agent

Safety Concerns

Alefacept

· Monitoring required for T-cell depletion

· Lymphocyte depression

 

 

Efalizumab

· Worsening of psoriasis/rebound can occur during/after discontinuation of treatment

· Thrombocytopenia reported in clinical trials; assessment of platelet counts recommended during treatment once a month for the first 3 months of therapy and quarterly thereafter

 

Infliximab

 

· Serious infusion reactions

· HACA formation

· Rare cases of CNS disorders and hematological abnormalities

· Opportunistic infections

· Tuberculin test required

 

Etanercept

 

· Injection-site reactions

· Rare cases of CNS disorders and hematological abnormalities

 

Table 5. Overview of Biologic Agents

 

T-Cell

Depletor/Modulator

Anti-TNF Monoclonal Antibody

Soluble TNF Receptor

 

 

Alefacept

  Efalizumab

 

Inflizimab

 

Etanercept

 

Administration

 

IM

 SC

 

IV infusion

 

SC

 

Speed of onset

 

+

 + + +

 

+ + + +

 

+ + +

 

Durability

 

+ + +

(in responders)

+

 

+ + + +

 

+ +

 

Efficacy

 

+

  + +

 

+ + + +

 

25 mg twice weekly: + +

50 mg twice weekly: + + +

 

Safety

 

+ + +

    + + +

 

+

 

+ + + +

 

Pediatric use

 

No

   No

 

Unknown

 

Yes (JRA)

 

Pregnancy category

 

B

   C

 

B

 

B

 

Monitoring

 

Weekly CD4

  Recom-

  mended

  for platelets

 

PPD

 

None

 

FDA status for psoriasis

 

Approved

Approved

 

Phase 3

 

Approved

 

Features

 

Potential for durable response in those patients that respond

Fast

Convenient

 

Fast

 

Fast (50 mg twice weekly)

Convenient

 

Issues

 

Reimbursement cost of failure

Rebound

 

 

Infection

Dose creep-the need to use increasing doses or shortened dosing intervals to maintain response

Infusion reactions

Rare case of congestive heart failure and multiple sclerosis

 

Rare case of congestive heart failure and multiple sclerosis

 

Efficacy in psoriatic arthritis

 

Unknown

No

 

Maybe

 

Yes

 

FDA Status for psoriatic arthritis

 

In trials

Not approved

 

In trials

 

Approved (2002)

 

+ = Poor, + + = Fair, + + + = Good, + + + + = Excellent

 

 

 

 

All information extracted from a publication by Craig Leonardi, M.D.

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