A Study of Guselkumab in Participants With Active Lupus Nephritis

Percentage of participants who achieved CRR at Week 24 were reported. CRR was defined as UPCR less than (<) 0.5 milligrams per milligrams (mg/mg), estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) or no confirmed decrease >=20% from baseline and prednisone dose less than or equal to (<=) 10 milligrams per day (mg/d). Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure (OM) time point (Week 24) or initiation of prohibited medications at any time prior to the endpoint time point (Week 24).

Percentage of participants who achieved CRR at Week 52 were reported. CRR was defined as UPCR less than (<) 0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease >=20% from baseline and prednisone dose <= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52).

Percentage of participants achieving a sustained reduction in steroid dose less than or equal to (<=) 10 mg/day of prednisone or equivalent from week 16 through Week 24were reported.

Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 52 were reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease.

Percentage of participants with UPCR <0.5 mg/mg at Week 24 were reported.

Percentage of participants with UPCR less than 0.75 mg/mg at Week 24 were reported.

Percentage of participants who achieved CRR through Week 24 was reported. CRR was defined as UPCR<0.5 mg/mg, eGFR >= 60 mL/min/1.73m^2 or no confirmed decrease>=20% from baseline and prednisone dose <= 10 mg/d. Participant was considered as achieved CRR who did not discontinue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to lupus nephritis (LN) or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 24) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 24).

Percentage of participants with TF through Week 52 was reported. TF was defined as time to the first occurrence of TF from baseline. Participant was considered to have treatment failure, who did not continue study intervention for any reason excluding COVID-19 related discontinuations or met the medication intercurrent event (exceeded baseline glucocorticoid dose, increase above 10 mg/d prednisone equivalent after Week 12, use of new or increased dose of concomitant medication related to LN or other immunosuppressive agents, within 8 weeks prior to the outcome measure time point (Week 52) or initiation of prohibited medications at any time prior to the outcome measure time point (Week 52).

Number of participants with AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.

Number of Participants with SAEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important.

Number of participants with related AEs were reported. An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product did not necessarily have a causal relationship with the treatment. Therefore, it could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Related AE was defined as the AE assessed by the investigator related to study agent.

Number of participants with AEs leading to discontinuation of study intervention were reported.

Number of participants with infections as assessed by the investigator were reported.

Number of participants with serious infections as assessed by the investigator were reported.

Number of participants with infections requiring oral or parenteral antimicrobial treatment planned to be were reported.

Number of participants with AEs temporally (a reaction that occurred during or within 1 hour after infusion) associated with an infusion were reported. AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.

Number of participants with injection-site reactions as assessed by the investigator were reported. An injection-site reaction is any adverse reaction at a SC study intervention injection-site.

Change from baseline in clinical laboratory parameter: activated partial thromboplastin time was reported.

Change from baseline in clinical laboratory parameter: basophils was reported.

Change from baseline in clinical laboratory parameter: eosinophils was reported.

Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular hemoglobin was reported.

Change from baseline in clinical laboratory parameter: erythrocytes mean corpuscular volume was reported.

Change from baseline in clinical laboratory parameter: erythrocytes was reported.

Change from baseline in clinical Laboratory parameter: hematocrit was reported.

Change from baseline in clinical laboratory parameter: hemoglobin was reported.

Change from baseline in clinical laboratory parameter: leukocytes was reported.

Change from baseline in clinical laboratory parameter: lymphocytes was reported.

Change from baseline in clinical laboratory parameter: monocytes was reported.

Change from baseline in clinical laboratory parameter: segmented neutrophils was reported.

Change from baseline in clinical laboratory parameter: platelets was reported.

Change from baseline in clinical laboratory parameter: prothrombin international normalized ratio was reported.

Change from baseline in clinical laboratory parameter: prothrombin time was reported.

Change from baseline in clinical laboratory hematology parameter:reticulocytes/erythrocytes was reported.

Change from baseline in clinical laboratory parameter: alanine aminotransferase was reported.

Change from baseline in clinical laboratory parameter: albumin was reported.

Change from baseline in clinical laboratory parameter: alkaline phosphatase was reported.

Change from baseline in clinical laboratory parameter: aspartate aminotransferase was reported.

Change from baseline in clinical laboratory parameter: bicarbonate was reported.

Change from baseline in clinical laboratory parameter: bilirubin was reported.

Change from baseline in clinical laboratory parameter: calcium was reported.

Change from baseline in clinical laboratory parameter: chloride was reported.

Change from baseline in clinical laboratory parameter: cholesterol was reported.

Change from baseline in clinical laboratory parameter: creatine kinase was reported.

Change from baseline in clinical laboratory parameter: creatinine was reported.

Change from baseline in clinical laboratory parameter: protein was reported.

Change from baseline in clinical laboratory parameter: phosphate was reported.

Change from baseline in clinical laboratory parameter: sodium was reported.

Change from baseline in clinical laboratory parameter: potassium was reported.

Change from baseline in clinical laboratory parameter: urea nitrogen was reported.

Change from baseline in clinical laboratory parameter: GFR from Creatinine Adjusted for BSA was reported.

Change from baseline in clinical laboratory parameter: gamma glutamyl transferase and lactate dehydrogenase were reported.

Change from baseline in clinical laboratory parameter: glucose and magnesium were reported.

Change from baseline in clinical laboratory parameter: protein was reported.

Change from baseline in chemistry parameter: protein/creatinine was reported.

Change from baseline in clinical laboratory parameter: urate was reported.

Change from baseline in clinical laboratory parameter: urine protein was reported.

Number of participants with maximum US NCI-CTCAE toxicity grade (Grade 4) in clinical laboratory parameters: hematology and chemistry were reported. Toxicity were graded as Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death.

Percentage of participants with abnormal vital signs: Systolic and Diastolic blood pressure were reported.

Serum Concentration of guselkumab were reported.

Treatment-boosted ADA positive participants: participants who were positive at baseline and whose titers increased 2-fold at any time after treatment. Titer values were categorized as<=1:10, 10 to 100, 100 to 1000, >1000.