Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis

Exclusion Criteria

• •Previous treatment with efalizumab.
• •Rheumatoid Factor positive without dactylitis or positive X-rays of the hands or feet, or with rheumatoid nodules.
• •History of joint replacement surgery within 60 days prior to the start of study drug dosing.
• •Joint replacement therapy planned within nine months subsequent to the start of study drug dosing.
• •Intra-articular cortisone injections within 28 days prior to the start of study drug dosing.
• •Pregnancy or lactation.
• •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 \< 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
• •Active bacterial, viral, fungal, mycobacterium tuberculosis or atypical mycobacterium infection.
• •Positive PPD test unless subject with positive PPD test completed a course of treatment for tuberculosis
• •History of any opportunistic infection.
• •History of a malignancy within the past five years. Subjects with a history of fully resolved, resected, basal or squamous cell carcinoma may be enrolled.
• •Received any vaccine within 28 days prior to the start of study drug dosing.
• •Chronic disorders apart from PsA affecting the joints, such as systemic lupus erythematosus, rheumatoid arthritis, gout, scleroderma or known reactive arthritis (e.g., Reiter's syndrome).
• •COPD, asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily.
• •Failed to respond or maintain response to Enbrel.
• •Received any DMARD other than methotrexate or sulfasalazine during the 28 days prior to the start of study drug dosing.
• •Approved biologic PsA therapy during the 28 days or seven half-lives of the drug prior to the start of study drug dosing, whichever is the greater length of time; Enbrel within 42 days prior to the start of study drug dosing.
• •Investigational drug and/or treatment during the 28 days or 7 half-lives of the drug prior to the start of study drug dosing, whichever is the greater length of time.
• •Any condition which, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to efalizumab.
• •Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function (AST or ALT ≥ 2.5
• •* ULN).
• •Serum creatinine level ≥ 1.5 mg/dL
• •Platelet count ≤ 125,000 cells/mm3
• •WBC count ≤ 3,500 cells/mm3
• •Total lymphocyte count ≤ 1000 cells/mm3
• •Seropositive for hepatitis B
• •Seropositive for hepatitis C antibody
• •Seropositive for HIV
• •Antinuclear antibodies titer ≥ 1:80
• •History of inflammatory bowel disease