Trial Outcomes & Findings for The Evaluation of Belimumab in Myasthenia Gravis (MG) (NCT NCT01480596)

Last Updated: 2017-02-09

Results Overview

The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means were presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline QMG Score, Treatment by Visit, and Baseline QMG Score by Visit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2017-02-09

Participant Flow

Participants (par.) with myasthenia gravis (MG) and who were acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive, on current standard of care therapy and continued to exhibit signs of MG were eligible for participation in the study.

The study was conducted in 3 phases: a 4 week screening period, a 24 week Treatment (trt) Period, and a 12 week Follow-up period. A total of 40 par. were enrolled, however 1 par. withdrew due to MG exacerbation on Day 7 prior to the first efficacy assessment; therefore, 39 par. comprise the Intent-to-Treat (ITT) Population.

Participant milestones

Participant milestones
Measure	Placebo IV Participants received 250 milliliter (ml) of a normal saline placebo administered as intravenous (IV) infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV Participants received 10 milligrams per kilogram (mg/kg) of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Study STARTED	22	18
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo IV Participants received 250 milliliter (ml) of a normal saline placebo administered as intravenous (IV) infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV Participants received 10 milligrams per kilogram (mg/kg) of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Overall Study Adverse Event	3	0
Overall Study MG exacerbation or change in medication	2	2

Baseline Characteristics

The Evaluation of Belimumab in Myasthenia Gravis (MG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Total n=39 Participants Total of all reporting groups
Age, Continuous	59.0 Years STANDARD_DEVIATION 13.88 • n=5 Participants	52.7 Years STANDARD_DEVIATION 17.32 • n=7 Participants	56.1 Years STANDARD_DEVIATION 15.67 • n=5 Participants
Gender Female	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Gender Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Intent-to-Treat (ITT) Population includes participants in the Safety Population who has provided any post treatment efficacy assessment.

Outcome measures

Outcome measures
Measure	Placebo IV n=17 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=17 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at Week 24	-2.37 Units on a scale Standard Error 1.099	-4.21 Units on a scale Standard Error 1.143

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: ITT Population.

The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (less than or equal to \[\<=\] median, greater than \[ \>\] median). Exact odds ratio, double the exact one-sided p-value and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Number of Participants With Improvement by Greater Than or Equal to (>=) 3 Points From Baseline Through to Week 24 in the QMG Score	6 Number of participants	11 Number of participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: ITT Population.

The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (\<=median, \> median). Exact odds ratio, double the exact one-sided p-value and exact confidence interval were presented. Participants with missing data were assumed to have a worsening response.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Number of Participants Worsening by >=3 Points in QMG Score From Baseline Through to Week 24	4 Number of participants	2 Number of participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: ITT Population.

A sustained response during the treatment phase is when a participant improves by \>=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Odds ratios are calculated by Cochran-Mantel-Haenszel method stratified by the observed median baseline score (\<= median, \> median). Wald confidence intervals and p-values were presented.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Number of Participants With a Sustained Response in the QMG Score	5 Number of participants	8 Number of participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since \<50% of subjects met the criteria (i.e. had the event in question).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 28, Week 32 and Week 36

Population: ITT Population.

The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. Total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (mild) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at baseline (BL) is the average of the screening and Week 0 BL scores. Change from BL was calculated by subtracting the BL value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative trt difference indicates benefit relative to placebo. Analysis method was Mixed-Model Repeated Measures adjusted for Trt, Visit, BL QMG Score, Trt by Visit and BL QMG Score by Visit. Only follow-up visits are presented but the analysis also includes all trt phase visits. Only those par. available at indicated time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36 Week 28, n=16, 14	-3.33 Units on a scale Standard Error 0.839	-5.03 Units on a scale Standard Error 0.889
Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36 Week 32, n=15, 16	-2.82 Units on a scale Standard Error 0.880	-4.12 Units on a scale Standard Error 0.904
Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36 Week 36, n=17, 14	-2.44 Units on a scale Standard Error 0.872	-4.73 Units on a scale Standard Error 0.921

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: ITT Population.

The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit.

Outcome measures

Outcome measures
Measure	Placebo IV n=17 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=17 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Mean Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Through to Week 24	-3.86 Units on a scale Standard Error 1.037	-3.81 Units on a scale Standard Error 1.064

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: ITT Population.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Number of Participants With Improvement by >=3 Points From Baseline Through to Week 24 in the MGC Score	10 Number of participants	9 Number of participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: ITT Population.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Number of Participants Worsening by >=3 Points From Baseline Through to Week 24 in the MGC Score	5 Number of participants	2 Number of participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: ITT Population.

AA sustained response during the treatment phase is when a participant improves by \>=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Odds ratios are calculated by Cochran-Mantel-Haenszel method without adjusting for any strata. Wald confidence intervals and p-values were presented.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Number of Participants With a Sustained Response in the MGC Score	4 Number of participants	7 Number of participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since \<50% of subjects met the criteria (i.e. had the event in question).

A sustained response during the treatment phase is when a participant improves by \>=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants' last available assessment prior to initiation of study intravenous (IV) infusion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 28, Week 32 and Week 36

Population: ITT Population.

The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36 Week 28, n=16, 14	-4.63 Units on a scale Standard Error 0.856	-5.64 Units on a scale Standard Error 0.905
Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36 Week 32, n=15, 16	-5.46 Units on a scale Standard Error 0.975	-5.44 Units on a scale Standard Error 0.948
Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36 Week 36, n=17, 14	-4.77 Units on a scale Standard Error 0.970	-5.04 Units on a scale Standard Error 1.052

SECONDARY outcome

Timeframe: Week 24 and Week 36

Population: The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.

Myasthenia Foundation of America-post intervention status assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24 and Week 36

Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12 through Week 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12 through Week 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24 and Week 36

Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being unchanged, improved or worsened.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Population: ITT Population.

The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores ranges from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 12 and Week 24 Week 12, n=19, 18	-1.33 Units on a scale Standard Error 0.489	-1.83 Units on a scale Standard Error 0.511
Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 12 and Week 24 Week 24, n=17, 17	-2.01 Units on a scale Standard Error 0.589	-2.32 Units on a scale Standard Error 0.603

SECONDARY outcome

Timeframe: Baseline, Week 28, Week 32 and Week 36

Population: ITT Population.

The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores range from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.

Outcome measures

Outcome measures
Measure	Placebo IV n=21 Participants Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 Participants Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36 Week 28, n=16, 14	-1.21 Units on a scale Standard Error 0.522	-2.96 Units on a scale Standard Error 0.546
Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36 Week 32, n=15, 16	-1.52 Units on a scale Standard Error 0.632	-1.80 Units on a scale Standard Error 0.619
Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36 Week 36, n=17, 14	-1.51 Units on a scale Standard Error 0.621	-1.78 Units on a scale Standard Error 0.663

Adverse Events

Placebo IV

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Belimumab 10 mg/kg IV

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo IV n=22 participants at risk Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.	Belimumab 10 mg/kg IV n=18 participants at risk Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
Hepatobiliary disorders Cholelithiasis	4.5% 1/22 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.	0.00% 0/18 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.
Infections and infestations Sepsis	4.5% 1/22 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.	0.00% 0/18 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.
Nervous system disorders Myasthenia gravis	4.5% 1/22 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.	0.00% 0/18 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.
Renal and urinary disorders Nephrolithiasis	4.5% 1/22 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.	0.00% 0/18 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.
Vascular disorders Aortic dissection rupture	4.5% 1/22 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.	0.00% 0/18 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from the date first infusion of investigational product up to the Week 24 visit. AEs and SAEs are reported for the safety population which is comprised of participants who had at least one infusion of study agent.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER