Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.

The SLEDAI-2K stands for Systemic Lupus Erythematosus Disease Activity Index -2000. It measures disease activity in the 28 days prior to and at the time point of the assessment. It is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies (anti-dsDNA positive or negative) and low complement, as well as some renal and hematologic parameters. The total score ranges between 0 and 105, with higher scores representing increased disease activity. In practice it is expected that SLEDAI scores will be skewed towards 0, with scores higher than 20 being rare.

The PGA is a single-item visual analogue scale that describes the physician assessment of a patient's disease and its impact on daily functioning at the time of assessment. The scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3 (severe disease and limitation of normal activities).

0 - none

• - mild
• - moderate
• - severe

Remission: defined as clinical SLEDAI = 0, and PGA < 0.5. The patients may be on antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives, including biologics

LLDAS assessment requires all of the following criteria to be met:

• SLEDAI-2K score ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, or fever),
• No new SLEDAI-2K assessed disease activity compared with the previous visit,
• PGA score ≤ 1,
• Prednisone or equivalent dosage ≤ 7.5 mg/day, and
• No non-standard immunosuppressant dosing, with antimalarials allowed.

Worsening of symptoms, referred to as flares, will be defined based on the the Revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index Flare Index (rSFI). Flares will be categorized into mild/moderate and severe flares as per the rSFI definitions.

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) consists of 2 scores; the first summarizes the activity of the disease and the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hypertrophy of skin and mucous membranes, acute hair loss, and nonscarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia.

Study participants are asked whether dyspigmentation due to cutaneous lupus erythematosus lesions usually remains visible for more than 12 months, which is taken to be permanent. If the dyspigmentation lasts longer than 12 months after the active lesion has resolved, then the score is doubled. The scores are calculated by simple addition and range from 0-70 for activity and 0-56 for damage, with higher scores indicating worse disease activity/damage.

• Pre- Anifrolumab treatment/ OCS usage before anifrolumab initiation
• Treatment concomitant with Anifrolumab / OCS usage concomitant with Anifrolumab
• Post-Anifrolumab treatment/ OCS usage after anifrolumab end/discontinuation.

Adherence is the actual number of infusions received out of the expected number of infusions during a specified duration

Persistence is the time on treatment as per indicated treatment interval

• Demographics (age, gender, ethnicity)
• Patients medical history

• Family history of autoimmune diseases
• Baseline comorbid conditions
• SLE treatment history
• Lifestyle (smoking history, alcohol consumption history)

Charlson Comorbidity Index (CCI) predicts the mortality for a patient who may have a range of concurrent conditions, includes 17 chronic diseases in estimating the CCI. The CCI predicts 10- year mortality risk from chronic comorbidities.

Whole blood tests

Biochemical

Serological

Urine test