Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Exclusion Criteria

• •7. Active severe or unstable neuropsychiatric SLE
• •8. Active severe SLE-driven renal disease
• •9. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
• •10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
• •11. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
• •12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
• •13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
• •14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
• •15. History of cancer, apart from:
• •1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
• •2. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).