Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis

Exclusion Criteria

• •1. Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
• •2. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies or fusion proteins that contain an Ig Fc region
• •3. Clinically significant psoriasis flare during screening or at the time of enrollment that would necessitate immediate relief for that patient
• •4. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
• •5. History of opportunistic infections (e.g., systemic fungal infections, parasites)
• •6. Seropositivity for human immunodeficiency virus (HIV)
• •* Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded.
• •7. Pregnancy or lactation
• •8. WBC count \<4000/mL or \>14,000/mL
• •9. Patients with an history of clinically significant thrombocytopenia, bleeding disorder or a platelet count \<100,000/mL
• •10. Seropositivity for hepatitis B or C virus
• •* Patients will undergo testing during screening. Patients who are positive for hepatitis B antigen or hepatitis C antibody will be excluded.
• •11. Hepatic enzymes ³3 times the upper limit of normal
• •12. History of active tuberculosis (TB) or currently undergoing treatment for TB
• •* Chest X-ray within 3 months of Day 0 is required for all patients. Patients with a positive chest X-ray consistent with TB infection will be excluded.
• •13. Presence of malignancy within the past 5 years, including lymphoproliferative disorders
• •* Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled even if it is less than 5 years.
• •14. Previous treatment with efalizumab (anti-CD11a)
• •15. Diagnosis of hepatic cirrhosis, regardless of cause or severity
• •16. Serum creatinine ³2 times the upper limit of normal
• •17. Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
• •18. History of substance abuse (e.g. narcotics, alcohol) within the last 5 years
• •19. Any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug
• •Note: Restrictions and/or directions apply to the following treatments during specified time periods prior to initial study drug administration and during the study:
• •20. Systemic therapy for psoriasis within 28 days prior to Study Day 0
• •21. Systemic immunosuppressive drugs for other indications within 28 days prior to Study Day 0
• •22. Topical therapies for psoriasis within 14 days prior to Study Day 0
• •23. Live or killed virus or bacteria vaccines within 14 days prior to Study Day 0
• •24. Other vaccines or allergy desensitization within 14 days prior to study Day 0
• •25. Other experimental drugs or treatments within 28 days or five half lives, whichever is longer, prior to Day 0
• •26. Use of b Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant from Day -28 throughout the study)