Real World Effectiveness of belimumab in Systemic Lupus Erythematosus (SLE) in China (Reliable Study)
Trial overview
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) after initiation of belimumab treatment for SLE
Timeframe: At 12 months
Proportion of participants achieving LLDAS after initiation of belimumab treatment for SLE
Timeframe: At 24 months
Proportion of participants achieving LLDAS after initiation of belimumab treatment for SLE
Timeframe: 3 months, 6 months, 9 months and 18 months
Proportion of participants with SLE Disease Activity Index (SLEDAI)-2K lesser than or equal to (≤)4
Timeframe: Up to 24 months
Proportion of participants with no new lupus disease activity compared with the previous assessment
Timeframe: Up to 24 months
Proportion of participants with Physician global assessment (scale 0–3) ≤1
Timeframe: Up to 24 months
Proportion of participants with current prednisolone (or equivalent) dose ≤7.5 milligram (mg) daily
Timeframe: Up to 24 months
Proportion of participants with well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents
Timeframe: Up to 24 months
Mean value of each domain for LLDAS
Timeframe: Up to 24 months
Time to achieve LLDAS after initiation of belimumab treatment (Time-to event)
Timeframe: Up to 24 months
Duration from the time LLDAS achievement is firstly recorded till the last time that LLDAS is remained, without LLDAS failure in between (Not time-to-event)
Timeframe: Up to 24 months
Duration from the time LLDAS achievement is firstly recorded till the last time that LLDAS is remained, across 2 years (Not time-to-event)
Timeframe: Up to 24 months
Proportion of participants achieving 4 points reduction in SLEDAI-2K after belimumab initiation
Timeframe: Up to 24 months
Mean SLICC/ACR Damage Index (SDI) Score after belimumab initiation
Timeframe: At 12 months and 24 months
Change from baseline in SDI Score after belimumab initiation
Timeframe: At 12 months and 24 months
Mean value of each domain in SDI
Timeframe: Up to 24 months
Proportion of participants achieving remission after belimumab initiation
Timeframe: At 12 months, 18 months and 24 months
Time to achieve remission - duration from belimumab initiation till the time that remission is firstly achieved (Time-to event)
Timeframe: Up to 24 months
Time on remission - duration from the time remission achievement is firstly recorded till the last time that remission is remained, without remission failure in between (Not time-to-event)
Timeframe: Up to 24 months
Mean value of each domain in DORIS remission
Timeframe: Up to 24 months
Mean FACIT-Fatigue after belimumab initiation
Timeframe: Up to 24 months
Change from baseline in FACIT-Fatigue after belimumab initiation
Timeframe: Up to 24 months
Mean Work Productivity and Activity Impairment (WPAI) status after belimumab initiation
Timeframe: Up to 24 months
Change from baseline in WPAI status after belimumab initiation
Timeframe: Up to 24 months
Mean flare number since index date after belimumab initiation
Timeframe: Up to 24 months
Flare rate (Flare number per participant per year) after belimumab initiation
Timeframe: Up to 24 months
Change from baseline after belimumab initiation in flare rate
Timeframe: Up to 24 months
Duration of belimumab infusion
Timeframe: Up to 24 months
Time to initial discontinuation (time-to-event)
Timeframe: Up to 24 months
Time interval between belimumab treatments, stratified by the first 3 doses versus following doses
Timeframe: Up to 24 months
Mean belimumab doses for each infusion
Timeframe: Up to 24 months
Number of participants with concomitant therapies during belimumab treatment
Timeframe: Up to 24 months
Type of concomitant therapies during belimumab treatment
Timeframe: Up to 24 months
Number of participants with combinations of concomitant therapies
Timeframe: Up to 24 months
Number of participants with receiving concomitant steroids, specified by oral or non-oral
Timeframe: Up to 24 months
Number of participants with concomitant steroid dose (greater than [>]7.5 vs ≤7.5 mg per day prednisone equivalent)
Timeframe: Up to 24 months
Mean steroid dose during belimumab treatment
Timeframe: Up to 24 months
Cumulative steroid dose over the 2 years
Timeframe: Up to 24 months
Reason for belimumab initial discontinuation
Timeframe: Up to 24 months
Proportion of participants with subsequent SLE treatments
Timeframe: Up to 24 months
Proportion of participants who re-initiate belimumab
Timeframe: Up to 24 months
Days since last belimumab treatment/prescription to the initiation of the subsequent SLE treatment or the re-start of belimumab
Timeframe: Up to 24 months
Number and type of subsequent SLE treatments
Timeframe: Up to 24 months
Duration of subsequent SLE treatments
Timeframe: Up to 24 months
Doses and frequency of subsequent SLE treatments
Timeframe: Up to 24 months
Proportion of participants without subsequent SLE treatments
Timeframe: Up to 24 months
Duration of no SLE treatments
Timeframe: Up to 24 months
All-cause and SLE related Healthcare Resource Utilization (HCRU)
Timeframe: Up to 24 months
Proportion of participants with at least one outpatient visit during the study follow-up, even after belimumab discontinuation
Timeframe: Up to 24 months
Proportion of participants with least one emergency room visit
Timeframe: Up to 24 months
Proportion of participants with at least one hospitalization
Timeframe: Up to 24 months
Number of medical visits per participant per year
Timeframe: Up to 24 months
Number of hospitalizations per participant per year
Timeframe: Up to 24 months
Number of outpatients visit per participant per year
Timeframe: Up to 24 months
Number of emergency room visit per participant per year
Timeframe: Up to 24 months
Length of stay (LOS) per hospitalization
Timeframe: Up to 24 months
Participation criteria
- Participants should meet ALL below inclusion criteria at index date -
- 1. Adults aged greater than or equal to (≥)18 years at (planned) first belimumab infusion
- Participants who meet any of these exclusion criteria should be excluded –
- 1. Participants enrolled in any other medicinal SLE interventional clinical trial at the time of study entry
- Participants should meet ALL below inclusion criteria at index date
- 1. Adults aged greater than or equal to (≥)18 years at (planned) first belimumab infusion 2. Documented diagnosis of SLE based on the physician’s judgement 3. New users of belimumab 4. Had at least one available assessment of each the following 5 components of LLDAS during the 3 months preceding belimumab initiation: (1) SLEDAI-2K, (2) new lupus disease activity compared with the previous assessment (yes/no), (3) PGA lesser than or equal to (≤)1, (4) prednisolone or equivalent dose <=7.5mg daily (yes/no), and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents (yes/no) 5. Participants with Informed Consent From (ICF) for this study
- Participant with severe central nervous system manifestations (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or central nervous system [CNS] vasculitis) requiring therapeutic intervention any time prior to study entry.
Participants who meet any of these exclusion criteria should be excluded – 1. Participants enrolled in any other medicinal SLE interventional clinical trial at the time of study entry
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.