Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Prior treatment

• 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.
• History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
• Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),

Other illness

• Active severe SLE-driven renal disease
• At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
• Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
• History of cancer, apart from:
  • Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
  • Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

Lab values

• 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.

Other

• Active severe or unstable neuropsychiatric SLE

• Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
• To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
• BILAG2004 with at least 1 of the following:
  • BILAG2004 level A disease in ≥ 1 organ system
  • BILAG2004 level B disease in ≥ 2 organ systems
• Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
• Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
• Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.