BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation

Change from Baseline in Physician's Global Assessment (PGA) score

时间窗: Baseline and up to 52 weeks

The PGA is a 0 to 30 centimeters (cm) visual analogue scale (VAS). The investigator will assess the subject's global disease activity, and draw a vertical line between 0 (none) and 3 (severe) where 0 is none (no disease activity), 1 is mild, 2 is moderate and 3 is severe (worst lupus disease imaginable).

Number of subjects with abnormal change in laboratory parameters

时间窗: Baseline and up to 52 weeks

Information will be collected for number of subjects with abnormal changes in laboratory parameters.

Change from Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI)

时间窗: Baseline and up to 52 weeks

The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated index for assessing Systemic Lupus Erythematosus (SLE) disease activity. It is a weighted index in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed, if present at the time of the visit or in the preceding 10 days. Modified version of SLEDAI is Safety of Estrogen in Lupus National Assessment (SELENA) SLEDAI where the maximum theoretical score for the SELENA SLEDAI was 105 with 0 indicating inactive disease.

Change from Baseline in Lupus Impact Tracker score

时间窗: Baseline and up to 52 weeks

The investigator will interview subjects about their conditions in the previous one month using Lupus Impact Tracker, the impact on daily living will be assessed using a 5-point scale of 0 (none of the time) to 4 (all of the time).

Number of subjects with adverse events (AE) and serious adverse events (SAE)

时间窗: Up to 52 weeks

AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.

Number of subjects with adverse drug reactions (ADR) of events defined as a priority study matter

时间窗: Up to 52 weeks

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and is suspected to be related to the drug. Following will be considered as priority study matter: Serious hypersensitivity, Serious infections (including tuberculosis \[TB\], pneumonia, pneumocystis pneumonia \[PCP\], sepsis, and opportunistic infection \[OI\]), Reactivation of hepatitis B (HB) virus, Progressive multifocal leukoencephalopathy (PML), Interstitial pneumonitis (IP), Malignant tumor (MT), Depression and events related to suicide/self-injury.