 - Severe comorbidities including: History of cancer other than resected cutaneous basal and squamous cell carcinoma, and in situ cervical cancer within 5 years of screening visit. Documentation of disease-free state since treatment required; Diagnosis of Class III or IV congestive heart failure CHF or myocardial infarction MI within 12 months of screening; Unstable or stable angina pectoris; Uncontrolled hypertension defined as systolic blood pressure measurement of greater than 180 mm Hg or a diastolic blood pressure of greater than 110 mm Hg; Oxygen-dependent pulmonary disease; Known HIV-positive status or other immunodeficiency syndromes; Chronic hepatitis B HbsAg or C HCV; Systemic lupus erythematosus SLE; CNS demyelinating events suggestive of multiple sclerosis; Presence of active infection or any underlying diseases that could predispose subjects to infection e.g., history of recurrent infections, non-healing leg ulcers, advanced or poorly controlled diabetes; Active or prior history of tuberculosis or known exposure. 