Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus Study

Prior treatment

• Anaphylaxis to any human gamma globulin therapy
• History of recurrent infections requiring hospitalisation and intravenous (IV) antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks)
• Any severe case of herpes zoster (HZ) infection, including, but not limited to: (a) systemic HZ such as herpes encephalitis or ophthalmic herpes involving the retina at any time prior to signing the ICF; (b) recurrent cutaneous HZ defined as 2 or more episodes within 2 years prior to signing the ICF; (c) any HZ infection that has not completely resolved within 12 weeks prior to signing the ICF
• Any active cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
• Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to signing the ICF
• Any of the following infections: (a) clinically significant chronic infection (i.e., osteomyelitis, bronchiectasis, etc) within 8 weeks prior to signing the ICF (chronic nail infections are allowed); (b) any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF; (c) any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to signing the ICF
• Any live or attenuated vaccine within 8 weeks prior to signing the informed consent form (ICF). Administration of killed or subunit vaccines is acceptable
• Receiving other biological therapies or monoclonal antibodies
• Received rituximab or obinutuzumab within the past 24 weeks

Other illness

• Allergy and/or contraindication to anifrolumab or excipients
• Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection, confirmed by (a) HBsAg; or (b) HBcAb and HBV DNA detected above the lower limit of quantitation by reflex testing; or (c) HCV RNA
• Immunocompromised (known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus)
• History of active tuberculosis or latent tuberculosis in whom an adequate course of treatment could not be confirmed
• History of cancer (other than squamous or basal cell carcinoma of the skin/cervical cancer in situ treated with curative therapy more than 3 months prior to signing the ICF)

Lab values

• Received belimumab within the past 12 weeks
  • 18\. Received cyclophosphamide in the past 6 months 19. Cardiovascular event ≤3 months 20. Contra-indication to MRI or CT scanning 21. Contrast allergy or contrast-nephropathy 22. Active nephritis (\>1g protein/24hr or albumin to creatine ratio \>100) 23. Active central nervous system lupus 24. Active myocarditis 25. Chronic kidney disease (eGFR \<30 mL/min/1.73 m2) 26. Any condition that, in the opinion of the Investigator, would with impact patient safety, ability to complete imaging, or interfere with the interpretation of the study findings

Other

• Women of child-bearing potential not using adequate contraception
• Breastfeeding
• Already taking anifrolumab

• Male or female participants 18 to 70 years of age
• Able to give written, informed consent and to lie flat for scanning
• Fulfil American College of Rheumatology/European Alliance of Associations for Rheumatology 2019 classification criteria for SLE
• Current antinuclear antibody positive (ANA-ELISA ≥1.0, ANA Hep2 positivity)
• Have ≥4 points on the clinical SLEDAI-2K disease activity score
• Stable standard of care SLE therapies for ≥4 weeks
• Prednisolone dosage ≤7.5 mg (or equivalent) daily
• Up to date on required vaccinations (e.g., pneumonia, varicella zoster, and influenza \[inactivated/recombinant\]) prior to study entry