Trial · NCT01729455

Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry

NCT01729455, Completed, GlaxoSmithKline; results first posted 2026-03-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry. Trials, record NCT01729455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01729455

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
NCT number: NCT01729455
Status: Completed
Enrollment: 3,138 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Systemic Lupus Erythematosus
Interventions: Benlysta, Standard of Care (SoC) Therapy
First posted: 2012-11-20
Last updated: 2026-03-20
Results first posted: 2026-03-20
Limitations and caveats: EOS forms were missing for 13 participants from the Eligible Population. However, as these participants contributed data to all analyses presented, they were included under 'Completed' participants.

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Up to 63 Months	An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs included mortality, malignancies (excluding non-melanoma skin cancers \[NMSC\]), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events. Initial exposure ITT strategy assigned exposure status of participants based on SLE medication (Benlysta or Non-Benlysta) at enrollment (Day 0). This exposure strategy analyzed all accrued AESI data during the whole follow-up period irrespective of treatment switching from Benlysta to Non-Benlysta or vice-versa.
Primary	Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy	Up to 12 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events divided by (/) Total participant-years at risk of event expressed per 100 participant-years.
Primary	Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy	Up to 24 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years.
Primary	Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy	Up to 36 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years.
Primary	Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy	Up to 48 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years.
Primary	Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy	Up to 63 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years.
Primary	Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy	Up to 12 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.
Primary	Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy	Up to 24 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.
Primary	Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy	Up to 36 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.
Primary	Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy	Up to 48 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Up to 63 Months	Evaluable Population included participants in the Eligible Population with a collection of enrollment data and at least one post-baseline assessment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy	Up to 12 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy	Up to 24 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy	Up to 36 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy	Up to 48 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy	Up to 63 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy	Up to 12 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy	Up to 24 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy	Up to 36 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy	Up to 48 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group144

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Benlysta	Mortality	48	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Non-Benlysta	Mortality	29	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Benlysta	Malignancies (excluding NMSC)	44	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Non-Benlysta	Malignancies (excluding NMSC)	24	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Benlysta	Serious infections	167	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Non-Benlysta	Serious infections	65	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Benlysta	Opportunistic infections	38	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Non-Benlysta	Opportunistic infections	21	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Benlysta	Other infections of special interest	44	Participants
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Non-Benlysta	Other infections of special interest	19	Participants

1 to 10 of 144Source ClinicalTrials.gov

See all 144 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Benlysta	2,030
Overall Study	STARTED	Non-Benlysta	937
Overall Study	Evaluable Population	Benlysta	1,924
Overall Study	Evaluable Population	Non-Benlysta	881
Overall Study	Participants With Missing End-of-Study (EOS) Forms	Benlysta	10
Overall Study	Participants With Missing End-of-Study (EOS) Forms	Non-Benlysta	3
Overall Study	COMPLETED	Benlysta	1,023
Overall Study	COMPLETED	Non-Benlysta	485
Overall Study	NOT COMPLETED	Benlysta	1,007
Overall Study	NOT COMPLETED	Non-Benlysta	452

Source ClinicalTrials.gov

Adverse events470

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hepatic lesion	Hepatobiliary disorders	Benlysta	1	1,924
other	Hepatic lesion	Hepatobiliary disorders	Non-Benlysta	0	881
other	Cytomegalovirus colitis	Infections and infestations	Benlysta	1	1,924
other	Cytomegalovirus colitis	Infections and infestations	Non-Benlysta	0	881
other	Cytomegalovirus viraemia	Infections and infestations	Benlysta	2	1,924
other	Cytomegalovirus viraemia	Infections and infestations	Non-Benlysta	0	881
other	Gastroenteritis Escherichia coli	Infections and infestations	Benlysta	0	1,924
other	Gastroenteritis Escherichia coli	Infections and infestations	Non-Benlysta	1	881
other	Herpes zoster	Infections and infestations	Benlysta	42	1,924
other	Herpes zoster	Infections and infestations	Non-Benlysta	23	881

1 to 10 of 470Source ClinicalTrials.gov

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Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Benlysta	48	1,924
Total, all-cause mortality	Non-Benlysta	29	881
Total, other adverse events	Benlysta	81	1,924
Total, other adverse events	Non-Benlysta	32	881
Total, serious adverse events	Benlysta	248	1,924
Total, serious adverse events	Non-Benlysta	108	881

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Benlysta vs Non-Benlysta: deaths from any cause	Trial comparisons
Benlysta vs Non-Benlysta: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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