BENLYSTA® Special Drug Use Investigation

NCT03370263 | Completed Results

• 1 other identifier: 207735
• Study Type: observational
• Target: 1,514
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta") in daily clinical practice. The aim of conducting this drug use investigation (DUI) in all subjects until data are accumulated from a certain number of subjects after Benlysta being marketed, data will be collected on safety and effectiveness of Benlysta in an early stage and thereby to take the necessary measures for proper use of Benlysta. Approximately 600 subjects will be enrolled in to this study. The observation period per subject will be 52 weeks from the start of Benlysta administration. BENLYSTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Conditions

Systemic Lupus Erythematosus

Keywords

Benlysta, systemic lupus erythematosus, safety, efficacy

Outcome Measures

Primary Outcomes (31)

• Number of Participants With Adverse Drug Reactions (ADRs)

  ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.

  From the start of the study intervention (Day 1) up to maximum of 3 years

• Number of Participants With Serious ADR of Events Defined as a Priority Study Matter

  ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Following serious ADRs were considered as priority study matter: 1. Serious hypersensitivity, 2. Serious infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, and opportunistic infection), 3. Reactivation of hepatitis B virus, 4. Progressive multifocal leukoencephalopathy, 5. Interstitial pneumonitis, 6. Malignant tumor, 7. Depression and events related to suicide/self-injury.

  From the start of the study intervention (Day 1) up to maximum of 3 years

• Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24

  The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 24

• Change From Baseline in SELENA SLEDAI Score at Week 52

  The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 52

• Change From Baseline in Lupus Impact Tracker Score at Week 24

  Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.

  Baseline (Day 0) and Week 24

• Change From Baseline in Lupus Impact Tracker Score at Week 52

  Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.

  Baseline (Day 0) and Week 52

• Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24

  The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 24

• Change From Baseline in PGA Score at Week 52

  The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 52

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 4

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 4

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 8

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 8

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 12

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 12

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 16

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 16

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 20

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 20

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 24

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 24

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 28

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 28

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 32

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 32

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 36

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 36

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 40

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 40

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 44

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 44

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 48

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 48

• Percent Change From Baseline in Mean Daily Steroid Dose at Week 52

  Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.

  Baseline (Day 0) and Week 52

• Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24

  LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (\<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score \<=1 (33 millimeter); (4) corticosteroid dose \<=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.

  At Week 24

• Number of Participants Who Achieved LLDAS Response Criteria at Week 52

  LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (\<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score \<=1 (33 millimeter); (4) corticosteroid dose \<=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.

  At Week 52

• Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24

  Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 24

• Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52

  Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 52

• Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 24

  Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 24

• Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 52

  Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 52

• Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24

  Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 24

• Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52

  Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 52

• Change From Baseline in Urine Protein/Creatinine Ratio at Week 24

  Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 24

• Change From Baseline in Urine Protein/Creatinine Ratio at Week 52

  Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

  Baseline (Day 0) and Week 52

Study Arms (4)

Benlysta intravenous (IV)

Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.

Drug: Benlysta

Benlysta subcutaneous (SC)

Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.

Drug: Benlysta

Benlysta switched from IV to SC or SC to IV

Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV during the study.

Drug: Benlysta

Benlysta IV or SC (Initial route of administration unknown)

Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.

Drug: Benlysta

Interventions

Benlysta DRUG

Benlysta was administered

Benlysta IV or SC (Initial route of administration unknown); Benlysta intravenous (IV); Benlysta subcutaneous (SC); Benlysta switched from IV to SC or SC to IV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include all subjects to whom Benlysta is administered. In addition, among subjects who start administration after launch, those to whom Benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well.

You may qualify if:

• The study will include all subjects to whom Benlysta is administered. In addition, among subjects who start administration after launch, those to whom Benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well.

You may not qualify if:

• N/A

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hiroshima, 730-0001, Japan

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Data have not been disclosed for the Lupus Impact Tracker (LIT) score outcome measures because the data cannot be reported externally at this time due to pending validation and copyright authorization by the copyright holder, although LIT assessments were collected at Baseline and Weeks 24 and 52. The data for pre-specified LIT outcome measures are anticipated to be disclosed by November 2027.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 12, 2017
• Study Start: January 15, 2018
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: May 18, 2026
• Results First Posted: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)