Table 1

Summary of objectives and related endpoints in ASTER

ObjectiveEndpoints and definitions
Primary

  1. Disease activity assessed by the PGA and SLEDAI-2K.

  2. Proportion of patients attaining the composite endpoint of LLDAS.*

Secondary

  1. Clinical SLE flares assessment per rSFI.

  2. Proportion of patients with irreversible organ damage per SDI.

  3. SLE treatment patterns prior to, concomitant with and after anifrolumab, including use of antimalarials, immunosuppressants, biologics, NSAIDS and/or corticosteroids; and adherence, persistence and discontinuation of anifrolumab.

  4. Changes in patient-reported HRQoL, symptoms and impairments on the basis of FACIT-Fatigue, Lupus QoL, PtGA, EQ-5D-5L, WPAI:Lupus and pain NRS.

  5. Number of outpatient hospital and emergency room visits and procedures; hospital admissions and inpatient hospital procedures (including reason and duration of stay, stratified by ICU vs non-ICU admission); rheumatologist visits and procedures (including SLE-related laboratory tests); and dialysis appointments.

Exploratory

  1. Extent of skin manifestations over time per CLASI in a subset of participating sites.

  2. Changes in patient-reported medication use, pain, fatigue and sleep quality during the first year after anifrolumab initiation.

  3. Potential differences in patient characteristics by calendar year of anifrolumab initiation.

  4. Prevalence and/or incidence of anaphylaxis following anifrolumab treatment, herpes zoster (and vaccination), serious infections, COVID-19 infection (and vaccination), MACE, malignancies and pregnancy.

  5. Proportion and characteristics of patients who reach DORIS remission.†

  • *Defined as: SLEDAI-2K≤4 with no activity in major organ systems and no hemolytic anaemia or gastrointestinal activity; no new lupus disease activity since the previous assessment; PGA≤1; current prednisone-equivalent dose≤7.5 mg/day; and standard maintenance dose of immunosuppressive drugs and biologics (if any) being well tolerated.

  • †Defined as: Clinical SLEDAI=0, Physician Global Assessment<0.5 (0–3), patients may be on antimalarials, low-dose glucocorticoids (prednisolone≤5 mg/day) and/or stable immunosuppressives, including biologics.3

  • ASTER, Anifrolumab Study for Treatment Effectiveness in the Real World; CLASI, Cutaneous Lupus Disease Area and Severity Index; DORIS, Definition of Remission in Systemic Lupus Erythematosus; EQ-5D-5L, EuroQol 5-Dimension Health Questionnaire 5 Level; FACIT, Functional Assessment of Chronic Illness Therapy; HRQoL, health-related quality of life; ICU, intensive care unit; LLDAS, lupus low disease activity state; MACE, major adverse cardiovascular events; NRS, Numerical Rating Scale; NSAIDS, non-steroidal anti-inflammatory drugs; PGA, Physician Global Assessment; PtGA, Patient Global Assessment; rSFI, revised SELENA-SLEDAI flare index on the basis of SLEDAI-2K assessment; SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology SLE Damage Index; SELENA, Safety of Estrogens in Lupus National Assessment; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; WPAI, Work Productivity and Activity Impairment.