Gupta, Sneha V.
Fanget, Marie C.
MacLauchlin, Christopher
Clausen, Valerie A.
Li, Jing
Cloutier, Daniel
Shen, Ling
Robbie, Gabriel J.
Mogalian, Erik
Clinical trials referenced in this document:
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Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
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Safety and efficacy of belimumab in older adults with SLE: results of an integrated analysis of clinical trial data
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Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/rmdopen-2021-001747
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
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Belimumab versus anifrolumab in adults with systemic lupus erythematosus: an indirect comparison of clinical response at 52 weeks
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Safety and efficacy of belimumab in older adults with SLE: results of an integrated analysis of clinical trial data
https://doi.org/10.1136/lupus-2022-000830
Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/rmdopen-2021-001747
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
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POS1467 PREDICTORS OF NEUROPSYCHIATRIC FLARES IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS FROM FIVE PHASE III CLINICAL TRIALS OF BELIMUMAB
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Long-term open-label continuation study of the safety and efficacy of belimumab for up to 7 years in patients with systemic lupus erythematosus from Japan and South Korea
https://doi.org/10.1136/rmdopen-2021-001629
A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea
https://doi.org/10.1136/annrheumdis-2017-211631
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
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OP0052 PREDICTORS OF RENAL FLARES IN SYSTEMIC LUPUS ERYTHEMATOSUS: A POST-HOC ANALYSIS OF FOUR PHASE III CLINICAL TRIALS OF BELIMUMAB
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POS1156 PREDICTORS OF DE NOVO RENAL FLARES IN SYSTEMIC LUPUS ERYTHEMATOSUS – TIME TO REVISIT BELIMUMAB DOSE FOR EXTRA-RENAL DISEASE? RESULTS FROM FIVE PHASE III CLINICAL TRIALS OF BELIMUMAB
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Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports
https://doi.org/10.1136/ard-2022-222505
LSO-030 Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab
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Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
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LSO-028 Predictors of de novo renal flares in systemic lupus erythematosus – time to revisit belimumab dose for extra-renal disease? Results from five phase III clinical trials of belimumab
https://doi.org/10.1136/lupus-2023-kcr.69
FRI0205 ANTIMALARIAL AGENTS IMPROVE PHYSICAL FUNCTIONING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
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P128 Efficacy of intravenous belimumab in children with systemic lupus erythematosus with markers of high disease activity: across-trial comparison with adult belimumab studies
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Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies
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A Retrospective Administrative Claims Database Evaluation of the Utilization of Belimumab in US Managed Care Settings
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Belimumab versus anifrolumab in adults with systemic lupus erythematosus: an indirect comparison of clinical response at 52 weeks
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Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus
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PO.7.149 Associations between abnormal bmi and patient-reported health-related quality of life before and after therapeutic intervention in patients with systemic lupus erythematosus
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Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/rmdopen-2021-001747
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https://doi.org/10.1007/s40268-021-00369-w
POS1467 PREDICTORS OF NEUROPSYCHIATRIC FLARES IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS FROM FIVE PHASE III CLINICAL TRIALS OF BELIMUMAB
https://doi.org/10.1136/annrheumdis-2023-eular.5428
Clinical trial data sharing: here’s the challenge
https://doi.org/10.1136/bmjopen-2019-032334
Effect of belimumab treatment on antiphospholipid antibody levels: post-hoc analysis based on two randomised placebo-controlled trials in systemic lupus erythematosus
https://doi.org/10.1136/annrheumdis-2019-216367
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https://doi.org/10.1136/annrheumdis-2019-215650
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
OP0052 PREDICTORS OF RENAL FLARES IN SYSTEMIC LUPUS ERYTHEMATOSUS: A POST-HOC ANALYSIS OF FOUR PHASE III CLINICAL TRIALS OF BELIMUMAB
https://doi.org/10.1136/annrheumdis-2023-eular.6142
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148 Antimalarial agents and other immunosuppressants influence BAFF levels in opposite directions in patients with systemic lupus erythematosus
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https://doi.org/10.1136/annrheumdis-2022-eular.2769
Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
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Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports
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LSO-068 Association between organ-specific safety of estrogens in lupus erythematosus national assessment-systemic lupus erythematosus (SLE) disease activity index (SELENA-SLEDAI) response to belimumab and SF-36v2 and FACIT-fatigue scores in patients with SLE
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LSO-030 Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab
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Documents that mention this clinical trial
LSO-028 Predictors of de novo renal flares in systemic lupus erythematosus – time to revisit belimumab dose for extra-renal disease? Results from five phase III clinical trials of belimumab
https://doi.org/10.1136/lupus-2023-kcr.69
FRI0205 ANTIMALARIAL AGENTS IMPROVE PHYSICAL FUNCTIONING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2019-eular.6430
P128 Efficacy of intravenous belimumab in children with systemic lupus erythematosus with markers of high disease activity: across-trial comparison with adult belimumab studies
https://doi.org/10.1136/lupus-2020-eurolupus.172
Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme
https://doi.org/10.1136/lupus-2020-000459
Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies
https://doi.org/10.1080/14712598.2019.1561856
Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial
https://doi.org/10.1016/s0140-6736(10)61354-2
A Retrospective Administrative Claims Database Evaluation of the Utilization of Belimumab in US Managed Care Settings
https://doi.org/10.1016/j.clinthera.2015.10.008
MOONLIGHT study: the design of a comparative study of the effectiveness of belimumab in patients with a history of lupus nephritis from the post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide reGistry (LUNA) coHorT
https://doi.org/10.1136/lupus-2022-000746
Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study
https://doi.org/10.1136/lupus-2020-000412
PO.7.146 Sensitivity analysis of EQ-5D-3L index scores in relation to discriminative and known-groups validity in systemic lupus erythematosus
https://doi.org/10.1136/lupus-2022-elm2022.166
POS0101 ADVERSE HEALTH-RELATED QUALITY OF LIFE OUTCOME DESPITE ADEQUATE CLINICAL RESPONSE TO TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2021-eular.1472
FRI0168 ASSOCIATION OF OVERWEIGHT/OBESITY WITH IMPAIRED HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2020-eular.4016
POS0119 SLE-DAS REMISSION AND LOW DISEASE ACTIVITY STATES ARE ASSOCIATED WITH IMPROVED HEALTH-RELATED QUALITY OF LIFE AND FATIGUE: POST-HOC ANALYSIS OF THE BLISS-52 AND BLISS-76 PHASE III TRIALS.
https://doi.org/10.1136/annrheumdis-2022-eular.3634
FRI0175 PREDICTORS OF LOW DISEASE ACTIVITY AND CLINICAL REMISSION FOLLOWING BELIMUMAB TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2019-eular.6376
Belimumab versus anifrolumab in adults with systemic lupus erythematosus: an indirect comparison of clinical response at 52 weeks
https://doi.org/10.1136/lupus-2023-000907
Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis
https://doi.org/10.1136/annrheumdis-2018-214043
FRI0198 ANTIMALARIAL AGENTS DIMINISH WHILE METHOTREXATE, AZATHIOPRINE AND MYCOPHENOLIC ACID INCREASE BAFF LEVELS IN SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2019-eular.6414
Lupus Low Disease Activity State (LLDAS) discriminates responders in the BLISS-52 and BLISS-76 phase III trials of belimumab in systemic lupus erythematosus
https://doi.org/10.1136/annrheumdis-2018-214427
Safety and efficacy of belimumab in older adults with SLE: results of an integrated analysis of clinical trial data
https://doi.org/10.1136/lupus-2022-000830
PO.7.149 Associations between abnormal bmi and patient-reported health-related quality of life before and after therapeutic intervention in patients with systemic lupus erythematosus
https://doi.org/10.1136/lupus-2022-elm2022.169
Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
https://doi.org/10.1136/rmdopen-2021-001747
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
POS1467 PREDICTORS OF NEUROPSYCHIATRIC FLARES IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS FROM FIVE PHASE III CLINICAL TRIALS OF BELIMUMAB
https://doi.org/10.1136/annrheumdis-2023-eular.5428
How to use the Lupus Low Disease Activity State (LLDAS) in clinical trials
https://doi.org/10.1136/annrheumdis-2019-215650
Effect of belimumab treatment on antiphospholipid antibody levels: post-hoc analysis based on two randomised placebo-controlled trials in systemic lupus erythematosus
https://doi.org/10.1136/annrheumdis-2019-216367
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
Clinical trial data sharing: here’s the challenge
https://doi.org/10.1136/bmjopen-2019-032334
148 Antimalarial agents and other immunosuppressants influence BAFF levels in opposite directions in patients with systemic lupus erythematosus
https://doi.org/10.1136/lupus-2019-lsm.148
OP0147 THE SLE-DAS REMISSION AND LOW DISEASE ACTIVITY STATES DISCRIMINATE DRUG FROM PLACEBO AND BETTER HEALTH-RELATED QUALITY OF LIFE: POST-HOC ANALYSIS OF THE BLISS-52 AND BLISS-76 PHASE III TRIALS.
https://doi.org/10.1136/annrheumdis-2022-eular.2769
Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
https://doi.org/10.1136/annrheumdis-2018-214880
OP0052 PREDICTORS OF RENAL FLARES IN SYSTEMIC LUPUS ERYTHEMATOSUS: A POST-HOC ANALYSIS OF FOUR PHASE III CLINICAL TRIALS OF BELIMUMAB
https://doi.org/10.1136/annrheumdis-2023-eular.6142
POS1156 PREDICTORS OF DE NOVO RENAL FLARES IN SYSTEMIC LUPUS ERYTHEMATOSUS – TIME TO REVISIT BELIMUMAB DOSE FOR EXTRA-RENAL DISEASE? RESULTS FROM FIVE PHASE III CLINICAL TRIALS OF BELIMUMAB
https://doi.org/10.1136/annrheumdis-2023-eular.6006
LSO-030 Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab
https://doi.org/10.1136/lupus-2023-kcr.71
LSO-068 Association between organ-specific safety of estrogens in lupus erythematosus national assessment-systemic lupus erythematosus (SLE) disease activity index (SELENA-SLEDAI) response to belimumab and SF-36v2 and FACIT-fatigue scores in patients with SLE
https://doi.org/10.1136/lupus-2023-kcr.109
Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports
https://doi.org/10.1136/ard-2022-222505
Documents that mention this clinical trial
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
Documents that mention this clinical trial
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
Article History
Accepted: 6 October 2021
First Online: 6 November 2021
Declarations
:
: This work was supported by Vir Biotechnology, Inc. and Alnylam Pharmaceuticals, Inc., who contributed to the study design, research, and interpretation of data and the writing, review, and approval of the manuscript for publication.
: Sneha V. Gupta, Marie C. Fanget, Daniel Cloutier, Ling Shen, and Erik Mogalian are or were employees of Vir Biotechnology, Inc. and may hold Vir stocks or options. Christopher MacLauchlin, Valerie A. Clausen, Jing Li, and Gabriel J. Robbie are or were employees of Alnylam Pharmaceuticals, Inc. and may hold Alnylam stocks or options.
: This study was conducted according to the International Conference on Harmonization for Good Clinical Practice, the Declaration of Helsinki, and all applicable federal and local regulations. The study was approved by central and local institutional review boards.
: Written informed consent was obtained from each subject before any study-related procedures were performed.
: The authors, jointly and severally, give the publisher the permission to publish the work. Subjects signed informed consent regarding publishing their data.
: The authors declare that the data supporting the findings of this study are available within the article and its supplementary information files.
: Not applicable.
: Data collection and analysis were performed by Sneha V. Gupta, Marie C. Fanget, Christopher MacLauchlin, Valerie A. Clausen, Jing Li, and Erik Mogalian. Sneha V. Gupta, Marie C. Fanget, Christopher MacLauchlin, Valerie A. Clausen, Jing Li, Daniel Cloutier, Ling Shen, Gabriel J. Robbie, and Erik Mogalian contributed to the study conceptualization and design, interpretation of results, and writing and reviewing of the manuscript.