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Authors
Nikolopoulos, Dionysis https://orcid.org/0000-0002-9894-6966
Cetrez, Nursen https://orcid.org/0000-0001-9874-841X
Lindblom, Julius https://orcid.org/0000-0003-1582-9471
Parodis, Ioannis https://orcid.org/0000-0002-4875-5395
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Clinical Trials BETA
Clinical trials referenced in this document:
nct00424476 at ClinicalTrials.govnct00410384 at ClinicalTrials.govDocuments that mention this clinical trial
Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies
https://doi.org/10.1080/14712598.2019.1561856
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
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
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
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
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
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
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
FRI0205 ANTIMALARIAL AGENTS IMPROVE PHYSICAL FUNCTIONING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2019-eular.6430
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
Belimumab in systemic lupus erythematosus
https://doi.org/10.1136/rmdopen-2014-000011
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
How to use the Lupus Low Disease Activity State (LLDAS) in clinical trials
https://doi.org/10.1136/annrheumdis-2019-215650
Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
https://doi.org/10.1136/annrheumdis-2018-214880
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
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
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
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
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
Clinical trial data sharing: here’s the challenge
https://doi.org/10.1136/bmjopen-2019-032334
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
nct01484496 at ClinicalTrials.govDocuments that mention this clinical trial
POS0185 BELIMUMAB DISRUPTS MEMORY B-CELL TRAFFICKING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2022-eular.1820
Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies
https://doi.org/10.1080/14712598.2019.1561856
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
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
https://doi.org/10.1007/s40268-021-00363-2
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
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
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
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
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
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
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
FRI0205 ANTIMALARIAL AGENTS IMPROVE PHYSICAL FUNCTIONING IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
https://doi.org/10.1136/annrheumdis-2019-eular.6430
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
Belimumab in systemic lupus erythematosus
https://doi.org/10.1136/rmdopen-2014-000011
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
How to use the Lupus Low Disease Activity State (LLDAS) in clinical trials
https://doi.org/10.1136/annrheumdis-2019-215650
Established organ damage reduces belimumab efficacy in systemic lupus erythematosus
https://doi.org/10.1136/annrheumdis-2018-214880
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
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
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
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
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
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
Clinical trial data sharing: here’s the challenge
https://doi.org/10.1136/bmjopen-2019-032334
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
nct01345253 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
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
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
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
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
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
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
Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus
https://doi.org/10.1136/lupus-2020-000438
Clinical response beyond the Systemic Lupus Erythematosus Responder Index: post-hoc analysis of the BLISS-SC study
https://doi.org/10.1136/lupus-2018-000288
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
SAT0231 Safety of subcutaneous belimumab in patients with systemic lupus erythematosus: a 6-month open-label extension study
https://doi.org/10.1136/annrheumdis-2017-eular.5235
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
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
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
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
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
Belimumab in systemic lupus erythematosus
https://doi.org/10.1136/rmdopen-2014-000011
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
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
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
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
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
nct01632241 at ClinicalTrials.govDocuments 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
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
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
Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection
https://doi.org/10.1007/s40268-021-00369-w
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
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
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
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
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https://doi.org/10.1136/rmdopen-2014-000011
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https://doi.org/10.1136/rmdopen-2021-001747
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https://doi.org/10.1007/s00296-024-05667-5
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Funding
Funding for this research was provided by:
Ulla och Gustaf af Ugglas Stiftelse (2023-025029)
Reumatikerförbundet (2024 R-995557)
Karolinska Institutet
Svenska Läkaresällskapet (SLS-974449)
Stiftelsen Professor Nanna Svartz Fond (2021-00436)
Nyckelfonden (OLL-974804)
Stiftelsen Konung Gustaf V:s 80-årsfond (FAI-2023-1006)
Stiftelsen Konung Gustaf V:s 80-årsfond (FAI-2020-0741)
Karolinska Institute
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Article History
Received: 21 May 2024
Accepted: 20 July 2024
First Online: 8 August 2024
Declarations
:
: IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia, Bristol-Myers Squibb, Elli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Otsuka, and Roche. The other authors declare that they have no conflicts of interest related to this work. The funders had no role in the design of the study, the analyses or interpretation of data, or the writing of the manuscript.
: The study adhered to the ethical principles outlined in the Declaration of Helsinki. Prior to their enrolment, written informed consent was obtained from all participants involved in the study. The study protocols for BLISS-52, BLISS-76, BLISS-SC, BLISS-NEA and EMBRACE were approved by regional ethics review boards for all participating centres, and the protocol for the present study was approved by the Swedish Ethical Review Authority under the reference number 2019–05498.
: The trials of belimumab, including BLISS-52, BLISS-76, BLISS-SC, BLISS-NEA, and EMBRACE, were registered on ClinicalTrials.gov with the following identifiers: NCT00424476, NCT00410384, NCT01484496, NCT01345253, and NCT01632241, respectively.
