Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission)

To assess disease activity at month 24 by evaluating the attainment of DORIS remission following initiation of anifrolumab SC treatment

At month 24

Proportion and number of patients in DORIS remission

To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC

During routine visits up to 24 months

Proportion and number of patients who ever achieved DORIS remission

To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC

During routine visits up to 24 months

Time (in months) to first DORIS remission among patients achieving DORIS criteria

To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC

Baseline up to 24 months

Time (in months) spent in DORIS remission among patients achieving DORIS criteria

To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC

Up to 24 months

Time (in months) spent in sustained DORIS remission if in remission for at least 2 consecutive routine visits among patients achieving DORIS criteria

To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC

Up to 24 months

Proportion and number of patients attaining sustained DORIS remission among patients achieving DORIS criteria

To describe the course of DORIS remission in patients initiating treatment with anifrolumab SC

At month 6 and month 12

Proportion and number of patients who fulfill criteria of lupus low disease activity state (LLDAS)

To describe the course of LLDAS in patients initiating treatment with anifrolumab SC

At month 24

Proportion and number of patients ever achieving LLDAS criteria

To describe the course of LLDAS in patients initiating treatment with anifrolumab SC

During routine visits up to 24 months

Time (in months) to first achieving LLDAS criteria among patients achieving LLDAS criteria

To describe the course of LLDAS in patients initiating treatment with anifrolumab SC

Up to 24 months

Time (in months) spent in LLDAS among patients achieving LLDAS criteria

To describe the course of LLDAS in patients initiating treatment with anifrolumab SC

Up to 24 months

Time (in months) spent in sustained LLDAS if in LLDAS for at least 2 consecutive routine visits among patients achieving LLDAS criteria

To describe the course of LLDAS in patients initiating treatment with anifrolumab SC

Up to 24 months

Proportion and number of patients attaining sustained LLDAS

To describe the course of LLDAS in patients initiating treatment with anifrolumab SC

At month 6 and month 12

Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k)

To describe the course of disease activity as captured by SLEDAI-2K in patients initiating treatment with anifrolumab SC. The SLEDAI-2K 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 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.

From Baseline to every routine visit up to 24 months during routine visits

Change in Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS)

To describe the course of disease activity as captured by SLE-DAS in patients initiating treatment with anifrolumab SC. The Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) is a validated and reliable composite index that includes 17 clinical and laboratory variables capturing a broad spectrum of SLE manifestations across multiple organ systems. The SLE-DAS will use a 30-day reference window, yielding a continuous score, with higher values indicating greater disease activity.

From Baseline to every routine visit up to 24 months during routine visits

Change in Physician Global Assessment (PhGA) analog scale (0-3)

To describe the course of disease activity as captured by PhGA in patients initiating treatment with anifrolumab SC. PhGA 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).

From Baseline to every routine visit up to 24 months during routine visits

Change in Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI) score

To describe organ involvement captured by SLICC damage index (SDI) in patients initiating treatment with anifrolumab SC. The Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index will be used to measure irreversible, accumulated organ damage from either the disease process or disease treatment, which has been present for at least 6 months, in 12 organ systems.

Baseline up to month 24

SLE treatment patterns prior to, concomitant with and after anifrolumab

To characterize SLE medication patterns in patients initiating treatment with anifrolumab SC

From Baseline (1 year pre-anifrolumab) up to 24 months

Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)

To describe the course of patient-reported fatigue. The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses patient-reported fatigue and its impact upon daily activities and function over the past 7 days. Patients will be asked to answer each question using a 5-point verbal rating scale, with total scores ranging from 0 (most fatigued) to 52 (least fatigued).

Baseline up to 24 months

Patient Global Assessment (PtGA)

To describe the course of overall patient-reported quality of life. The PtGA is a single-item question that takes into account all the ways in which illness and health conditions may affect the patient at this time. The patient should consider the previous week when answering this question. Responses range from 0 (Very Well) to 100 (Very Poorly) on a visual analogue scale (VAS)

Baseline up to 24 months

Lupus Quality of Life (LupusQoL)

To describe the course of patient-reported SLE-specific quality of life. The LupusQoL is a validated SLE-specific HRQoL (health-related quality of life) instrument consisting of 34 items across 8 domains (Physical health, Emotional health, Body image, Pain, Planning, Fatigue, Intimate relationships, and Burden to others). The LupusQoL has a 5-point verbal rating scale, and uses a 4-week recall period. The mean raw domain score is transformed to scores ranging from 25 (worst HRQoL) to 125 (best HRQoL) by dividing by 4 and then multiplying by 100.

Baseline up to 24 months

SLE Flares assessment by modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI)

To describe frequency and intensity of flares within the observational period. The frequency and intensity of flares will be documented using the modified revised SELENA-SLEDAI Flare Index (rSFI), which detects flares and classifies severity based on changes in SLEDAI-2K. Flare will be defined as any one criterion present either the Mild/Moderate Flare or Severe Flare categories. Flares experienced by the patients since enrolment will be collected at subsequent routine visit by the physician.

Baseline up to 24 months