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Authors
Gupta, Sneha V.
Fanget, Marie C.
MacLauchlin, Christopher
Clausen, Valerie A.
Li, Jing
Cloutier, Daniel
Shen, Ling
Robbie, Gabriel J.
Mogalian, Erik
-
Clinical Trials BETA
Clinical trials referenced in this document:
nct03672188 at ClinicalTrials.govnct00657007 at ClinicalTrials.govDocuments that mention this clinical trial
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
nct00071487 at ClinicalTrials.govDocuments that mention this clinical trial
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
nct01345253 at ClinicalTrials.govDocuments that mention this clinical trial
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
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
Belimumab prevention against organ damage over 8 years and safety up to 13 years: three pooled open-label, long-term extension SLE studies
https://doi.org/10.1136/lupus-2026-002199
OP0232 Sustained safety and efficacy over 10 years with belimumab (BEL) plus standard systemic lupus erythematosus (SLE) therapy (SOC) in patients with SLE
https://doi.org/10.1136/annrheumdis-2017-eular.6430
POS0185 BELIMUMAB DISRUPTS MEMORY B-CELL TRAFFICKING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2022-eular.1820
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
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
nct01516450 at ClinicalTrials.govDocuments that mention this clinical trial
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
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
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
Belimumab induces early and sustained resolution of lupus thrombocytopenia
https://doi.org/10.1136/lupus-2026-002010
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
106 Effects of belimumab on corticosteroid use in a pivotal phase iii, randomised, placebo controlled study in subjects with systemic lupus erythematosus in north east asia
https://doi.org/10.1136/lupus-2017-000215.106
AB1079 BELIMUMAB VERSUS PLACEBO IMPROVES DISEASE ACTIVITY AND REDUCES CUMULATIVE GLUCOCORTICOID DOSE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS WHO WERE TREATMENT RESPONDERS: RESULTS OF A LARGE INTEGRATED ANALYSIS
https://doi.org/10.1136/annrheumdis-2024-eular.1843
Outcomes of patients with systemic lupus erythematosus treated with belimumab: a post hoc efficacy analysis of five phase III clinical trials by British Isles Lupus Assessment Group-based Combined Lupus Assessment criteria
https://doi.org/10.1136/rmdopen-2025-005444
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
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
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
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
Belimumab outperforms placebo for attainment of modified DORIS remission and LLDAS without the glucocorticoid component: a post hoc analysis of five phase III SLE trials
https://doi.org/10.1136/rmdopen-2025-006624
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
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
Phase 3, long-term, open-label extension period of safety and efficacy of belimumab in patients with systemic lupus erythematosus in China, for up to 6 years
https://doi.org/10.1136/rmdopen-2021-001669
Real-world effectiveness of belimumab in patients with lupus in China: RELIABLE observational cohort study protocol
https://doi.org/10.1136/lupus-2024-001144
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
POS0547 BELIMUMAB EFFICACY IN MUCOCUTANEOUS SYSTEMIC LUPUS ERYTHEMATOSUS: A LARGE POST-HOC ANALYSIS INTEGRATING DATA FROM FIVE PHASE III RANDOMISED CONTROLLED TRIALS
https://doi.org/10.1136/annrheumdis-2024-eular.4849
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
Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials
https://doi.org/10.1007/s00296-024-05667-5
Belimumab in systemic lupus erythematosus
https://doi.org/10.1136/rmdopen-2014-000011
nct00410384 at ClinicalTrials.govDocuments that mention this clinical trial
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
nct00424476 at ClinicalTrials.govDocuments that mention this clinical trial
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
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
Belimumab induces early and sustained resolution of lupus thrombocytopenia
https://doi.org/10.1136/lupus-2026-002010
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
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
Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) enables accurate and user-friendly definitions of clinical remission and categories of disease activity
https://doi.org/10.1136/annrheumdis-2021-220363
Belimumab prevention against organ damage over 8 years and safety up to 13 years: three pooled open-label, long-term extension SLE studies
https://doi.org/10.1136/lupus-2026-002199
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
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
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
AB1079 BELIMUMAB VERSUS PLACEBO IMPROVES DISEASE ACTIVITY AND REDUCES CUMULATIVE GLUCOCORTICOID DOSE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS WHO WERE TREATMENT RESPONDERS: RESULTS OF A LARGE INTEGRATED ANALYSIS
https://doi.org/10.1136/annrheumdis-2024-eular.1843
Outcomes of patients with systemic lupus erythematosus treated with belimumab: a post hoc efficacy analysis of five phase III clinical trials by British Isles Lupus Assessment Group-based Combined Lupus Assessment criteria
https://doi.org/10.1136/rmdopen-2025-005444
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
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
Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
https://doi.org/10.1136/annrheumdis-2018-214880
Can disease activity and treatment responses be captured by a core set of domains in SLE clinical trials? An analysis of phase III belimumab trial data
https://doi.org/10.1136/lupus-2025-001928
Poor health-related quality of life despite Lupus Low Disease Activity State or Definitions of Remission in systemic lupus erythematosus (SLE) remission in patients with SLE: results from a clinical trial setting
https://doi.org/10.1136/rmdopen-2025-006061
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
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
OP0297 THE SLE-DAS ENABLES ACCURATE AND USER-FRIENDLY DEFINITIONS OF REMISSION AND CATEGORIES OF LUPUS DISEASE ACTIVITY: DERIVATION AND VALIDATION STUDY IN 1190 SLE PATIENTS
https://doi.org/10.1136/annrheumdis-2021-eular.1677
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
Clinical trial data sharing: here’s the challenge
https://doi.org/10.1136/bmjopen-2019-032334
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
SF-36v2 and FACIT-Fatigue quality of life improvements with organ-specific SELENA-SLEDAI response and belimumab treatment in patients with systemic lupus erythematosus
https://doi.org/10.1136/lupus-2023-001118
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
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
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
POS0185 BELIMUMAB DISRUPTS MEMORY B-CELL TRAFFICKING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2022-eular.1820
PO.5.104 Evaluation of traditional laboratory markers as predictors of renal flares: a post-hoc analysis of four phase iii clinical trials of SLE
https://doi.org/10.1136/lupus-2022-elm2022.128
Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies
https://doi.org/10.1080/14712598.2019.1561856
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
Belimumab outperforms placebo for attainment of modified DORIS remission and LLDAS without the glucocorticoid component: a post hoc analysis of five phase III SLE trials
https://doi.org/10.1136/rmdopen-2025-006624
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
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
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
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
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
POS0762 CAN THE SLE-DAS SUBSTITUTE BILAG TO MEASURE LUPUS DISEASE ACTIVITY IN CLINICAL TRIALS? POST-HOC ANALYSIS OF THE BLISS-76 TRIAL
https://doi.org/10.1136/annrheumdis-2021-eular.3162
Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials
https://doi.org/10.1136/lupus-2014-000031
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
How to use the Lupus Low Disease Activity State (LLDAS) in clinical trials
https://doi.org/10.1136/annrheumdis-2019-215650
Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE
https://doi.org/10.1136/lupus-2021-000499
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
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
FRI0205 ANTIMALARIAL AGENTS IMPROVE PHYSICAL FUNCTIONING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2019-eular.6430
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
POS0547 BELIMUMAB EFFICACY IN MUCOCUTANEOUS SYSTEMIC LUPUS ERYTHEMATOSUS: A LARGE POST-HOC ANALYSIS INTEGRATING DATA FROM FIVE PHASE III RANDOMISED CONTROLLED TRIALS
https://doi.org/10.1136/annrheumdis-2024-eular.4849
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
Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials
https://doi.org/10.1007/s00296-024-05667-5
Belimumab in systemic lupus erythematosus
https://doi.org/10.1136/rmdopen-2014-000011
nct02880852 at ClinicalTrials.govDocuments that mention this clinical trial
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
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
Belimumab induces early and sustained resolution of lupus thrombocytopenia
https://doi.org/10.1136/lupus-2026-002010
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
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
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
Belimumab prevention against organ damage over 8 years and safety up to 13 years: three pooled open-label, long-term extension SLE studies
https://doi.org/10.1136/lupus-2026-002199
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
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
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
AB1079 BELIMUMAB VERSUS PLACEBO IMPROVES DISEASE ACTIVITY AND REDUCES CUMULATIVE GLUCOCORTICOID DOSE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS WHO WERE TREATMENT RESPONDERS: RESULTS OF A LARGE INTEGRATED ANALYSIS
https://doi.org/10.1136/annrheumdis-2024-eular.1843
Outcomes of patients with systemic lupus erythematosus treated with belimumab: a post hoc efficacy analysis of five phase III clinical trials by British Isles Lupus Assessment Group-based Combined Lupus Assessment criteria
https://doi.org/10.1136/rmdopen-2025-005444
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
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
Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
https://doi.org/10.1136/annrheumdis-2018-214880
Poor health-related quality of life despite Lupus Low Disease Activity State or Definitions of Remission in systemic lupus erythematosus (SLE) remission in patients with SLE: results from a clinical trial setting
https://doi.org/10.1136/rmdopen-2025-006061
Can disease activity and treatment responses be captured by a core set of domains in SLE clinical trials? An analysis of phase III belimumab trial data
https://doi.org/10.1136/lupus-2025-001928
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
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
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
Clinical trial data sharing: here’s the challenge
https://doi.org/10.1136/bmjopen-2019-032334
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
SF-36v2 and FACIT-Fatigue quality of life improvements with organ-specific SELENA-SLEDAI response and belimumab treatment in patients with systemic lupus erythematosus
https://doi.org/10.1136/lupus-2023-001118
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
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
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
Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies
https://doi.org/10.1080/14712598.2019.1561856
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
Belimumab outperforms placebo for attainment of modified DORIS remission and LLDAS without the glucocorticoid component: a post hoc analysis of five phase III SLE trials
https://doi.org/10.1136/rmdopen-2025-006624
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
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
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
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
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
Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials
https://doi.org/10.1136/lupus-2014-000031
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
How to use the Lupus Low Disease Activity State (LLDAS) in clinical trials
https://doi.org/10.1136/annrheumdis-2019-215650
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
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
Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial
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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.
