David A. Roth
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View article: Phase III/IV, Randomized, Fifty‐Two–Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus
Phase III/IV, Randomized, Fifty‐Two–Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus Open
OBJECTIVE: Enrollment of patients of Black African ancestry with systemic lupus erythematosus (SLE) in phase II and phase III of the belimumab trials was not reflective of the racial distribution observed in the lupus population. This stud…
View article: Pivotal results of SELECT-MDS-1 phase 3 study of tamibarotene with azacitidine in newly diagnosed higher-risk MDS
Pivotal results of SELECT-MDS-1 phase 3 study of tamibarotene with azacitidine in newly diagnosed higher-risk MDS Open
Higher-risk myelodysplastic syndrome (HR-MDS) with RARA gene overexpression is a subset of patients (pts) with an actionable target for tamibarotene, an oral and a selective retinoic acid receptor-α (RAR-α) agonist. Tamibarotene with azaci…
View article: A pharmacokinetic and safety study of oral arsenic trioxide in patients with acute promyelocytic leukemia
A pharmacokinetic and safety study of oral arsenic trioxide in patients with acute promyelocytic leukemia Open
SY-2101 is a novel oral formulation of arsenic trioxide (ATO). Although IV ATO in combination with all trans retinoic acid is highly efficacious in treating acute promyelocytic leukemia (APL), there remains a significant unmet need due to …
View article: Trametinib Sensitivity is Defined by a Myeloid Differentiation Profile in Acute Myeloid Leukemia
Trametinib Sensitivity is Defined by a Myeloid Differentiation Profile in Acute Myeloid Leukemia Open
Our study identifies additional molecular markers that can be used with molecular features including RAS status to identify patients with AML that may benefit from trametinib treatment.
View article: Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study
Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study Open
View article: Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus
Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus Open
Objectives Autoreactive memory B cells (MBCs) contribute to chronic and progressive courses in autoimmune diseases like SLE. The efficacy of belimumab (BEL), the first approved biologic treatment for SLE and LN, is generally attributed to …
View article: Use of tamibarotene, a potent and selective RARα agonist, in combination with azacitidine in patients with relapsed and refractory AML with <i>RARA</i> gene overexpression
Use of tamibarotene, a potent and selective RARα agonist, in combination with azacitidine in patients with relapsed and refractory AML with <i>RARA</i> gene overexpression Open
Tamibarotene-based therapy is a novel targeted approach for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML) with retinoic acid receptor alpha (RARA) gene overexpression. Approximately, 50% of higher-risk myel…
View article: PB1773: AML AND MDS WITH RARA OVEREXPRESSION: MOLECULAR AND CLINICAL FEATURES OF PATIENTS ENROLLED IN A PHASE 2 TRIAL EVALUATING TAMIBAROTENE-BASED THERAPY
PB1773: AML AND MDS WITH RARA OVEREXPRESSION: MOLECULAR AND CLINICAL FEATURES OF PATIENTS ENROLLED IN A PHASE 2 TRIAL EVALUATING TAMIBAROTENE-BASED THERAPY Open
Topic: 3. Acute myeloid leukemia - Biology & Translational Research Background: A novel genomically defined subset of non-APL AML and MDS patients with RARA gene overexpression was identified with an actionable target for tamibarotene (for…
View article: Safety and efficacy of belimumab in older adults with SLE: results of an integrated analysis of clinical trial data
Safety and efficacy of belimumab in older adults with SLE: results of an integrated analysis of clinical trial data Open
Objective Assess the safety and efficacy of belimumab in older adults with SLE. Methods This post hoc integrated analysis (GSK Study 116559) included safety data from six randomised, placebo-controlled belimumab trials (BLISS-76, BLISS-52,…
View article: A randomized, phase II study of sequential belimumab and rituximab in primary Sjögren’s syndrome
A randomized, phase II study of sequential belimumab and rituximab in primary Sjögren’s syndrome Open
BACKGROUNDPrimary Sjögren's syndrome (pSS) is characterized by B cell hyperactivity and elevated B-lymphocyte stimulator (BLyS). Anti-BLyS treatment (e.g., belimumab) increases peripheral memory B cells; decreases naive, activated, and pla…
View article: Targeting <i>RARA</i> overexpression with tamibarotene, a potent and selective RARα agonist, is a novel approach in AML
Targeting <i>RARA</i> overexpression with tamibarotene, a potent and selective RARα agonist, is a novel approach in AML Open
A superenhancer at the retinoic acid receptor alpha (RARA) gene is associated with RARA mRNA overexpression in ∼30% of non-acute promyelocytic leukemia acute myeloid leukemia (AML) and in ∼50% of myelodysplastic syndromes (MDS). RARA overe…
View article: 1104 Effects of Belimumab (BEL) on Renal Outcomes in Patients (pts) With Relapsed and Newly Diagnosed Active Lupus Nephritis (LN)
1104 Effects of Belimumab (BEL) on Renal Outcomes in Patients (pts) With Relapsed and Newly Diagnosed Active Lupus Nephritis (LN) Open
Background Despite standard therapy (ST) for LN, only 20–40% of pts achieve Complete Renal Response (CRR) at 0.5–1 year and 20–25% relapse in 3–5 years. Achieving CRR is often more difficult in relapsed patients than in de novo pati…
View article: Safety and Efficacy of Belimumab in Patients with Lupus Nephritis
Safety and Efficacy of Belimumab in Patients with Lupus Nephritis Open
Background and objectives In the BLISS-LN study, belimumab improved kidney outcomes in adult patients with active lupus nephritis. This 28-week open-label extension of BLISS-LN assessed belimumab’s safety and efficacy. Design, setting, par…
View article: Efficacy of belimumab in patients with systemic lupus erythematosus from North East Asia: Results of exploratory subgroup analyses
Efficacy of belimumab in patients with systemic lupus erythematosus from North East Asia: Results of exploratory subgroup analyses Open
Objectives To assess belimumab efficacy in patients from North East Asia (NEA) with systemic lupus erythematosus (SLE) in baseline demographic/disease characteristic subgroups. Methods This analysis of patient subgroups from BLISS-NEA (GSK…
View article: Safety of belimumab in adult patients with systemic lupus erythematosus: Results of a large integrated analysis of controlled clinical trial data
Safety of belimumab in adult patients with systemic lupus erythematosus: Results of a large integrated analysis of controlled clinical trial data Open
Objectives Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that affects multiple organ systems. Belimumab, a targeted human monoclonal antibody, binds to and inhibits soluble B-lymphocyte stimulator. The safety and effi…
View article: Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports
Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports Open
View article: Efficacy and Safety of Belimumab in Patients With Lupus Nephritis: Subgroup Analyses of a Phase 3 Randomized Trial in the East Asian Population
Efficacy and Safety of Belimumab in Patients With Lupus Nephritis: Subgroup Analyses of a Phase 3 Randomized Trial in the East Asian Population Open
View article: Renal response at 2 years post biopsy to predict long-term renal survival in lupus nephritis: a retrospective analysis of the Hopkins Lupus Cohort
Renal response at 2 years post biopsy to predict long-term renal survival in lupus nephritis: a retrospective analysis of the Hopkins Lupus Cohort Open
Objective This retrospective analysis evaluated the prognostic value of renal response status 2 years after biopsy-proven lupus nephritis (LN) for the prediction of long-term renal outcomes. Methods Eligible patients with SLE as per Americ…
View article: <scp>EMBRACE</scp>: One Small Story in Lupus—One Giant Challenge in Clinical Trials
<span>EMBRACE</span>: One Small Story in Lupus—One Giant Challenge in Clinical Trials Open
Clinical trials of novel therapeutics in the United States have not been adequately representative of diverse populations, particularly racial and ethnic minorities. The challenges and consequences of underrepresentation in clinical trial …
View article: POS0193 EVALUATION OF CRESS IN THE PHASE 2 RANDOMISED PLACEBO-CONTROLLED STUDY OF SEQUENTIAL BELIMUMAB/RITUXIMAB ADMINISTRATION IN PATIENTS WITH PRIMARY SJÖGREN'S SYNDROME
POS0193 EVALUATION OF CRESS IN THE PHASE 2 RANDOMISED PLACEBO-CONTROLLED STUDY OF SEQUENTIAL BELIMUMAB/RITUXIMAB ADMINISTRATION IN PATIENTS WITH PRIMARY SJÖGREN'S SYNDROME Open
View article: POS0712 YEAR-4 OBSERVATIONAL FOLLOW-UP OF BELIMUMAB SAFETY (MORTALITY AND MALIGNANCIES) IN PATIENTS WITH SLE WHO COMPLETED A PHASE 4, 52-WEEK, RANDOMISED, DOUBLE-BLIND PLACEBO-CONTROLLED SAFETY STUDY
POS0712 YEAR-4 OBSERVATIONAL FOLLOW-UP OF BELIMUMAB SAFETY (MORTALITY AND MALIGNANCIES) IN PATIENTS WITH SLE WHO COMPLETED A PHASE 4, 52-WEEK, RANDOMISED, DOUBLE-BLIND PLACEBO-CONTROLLED SAFETY STUDY Open
View article: OP0281 PHARMACODYNAMIC EFFECT OF SEQUENTIAL BELIMUMAB (BEL) AND RITUXIMAB (RTX) THERAPY IN PATIENTS (PTS) WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): THE PHASE 3, RANDOMISED, PLACEBO-CONTROLLED BLISS-BELIEVE STUDY
OP0281 PHARMACODYNAMIC EFFECT OF SEQUENTIAL BELIMUMAB (BEL) AND RITUXIMAB (RTX) THERAPY IN PATIENTS (PTS) WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): THE PHASE 3, RANDOMISED, PLACEBO-CONTROLLED BLISS-BELIEVE STUDY Open
View article: Impact of Belimumab on Organ Damage in Systemic Lupus Erythematosus
Impact of Belimumab on Organ Damage in Systemic Lupus Erythematosus Open
Organ damage is a key determinant of poor long‐term prognosis and early death in patients with systemic lupus erythematosus (SLE). Prevention of damage is a key treatment goal of the 2019 update of the European Alliance of Associations for…
View article: 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
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 Open
Objectives To evaluate the long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus (SLE) in China. Methods In this phase 3, open-label extension period, eligible completers of study BEL113750 ( NCT01345253 …
View article: The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomised 52-week study
The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomised 52-week study Open
View article: Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE
Reductions in circulating B cell subsets and immunoglobulin G levels with long-term belimumab treatment in patients with SLE Open
Objective To examine the long-term changes in circulating B cell subsets and IgG levels at 5+ years of continuous belimumab treatment and their correlations with efficacy and safety measures. Methods This was a post hoc analysis of a conti…
View article: 506 Belimumab (BEL) improves renal outcomes in active Lupus Nephritis (LN): a phase 3 randomized, Placebo (PBO)-controlled trial
506 Belimumab (BEL) improves renal outcomes in active Lupus Nephritis (LN): a phase 3 randomized, Placebo (PBO)-controlled trial Open
Background BEL is approved for patients (pts) with systemic lupus erythematosus (SLE). We evaluated intravenous (IV) BEL in active LN. Methods This 104-week trial (GSK Study BEL114054; NCT01639339) randomized adults with active LN (class I…
View article: A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis
A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis Open
We performed a post hoc analysis of the Belimumab International Study in Lupus Nephritis (BLISS-LN), a Phase 3, multinational, double-blind, 104-week trial, in which 448 patients with lupus nephritis were randomized to receive intravenous …
View article: Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison
Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison Open
Objective To assess the efficacy and safety of belimumab in paediatric versus adult patients with systemic lupus erythematosus (SLE). Methods We performed across-study comparisons of patients with active SLE who received belimumab or place…
View article: 10 Years of belimumab experience: What have we learnt?
10 Years of belimumab experience: What have we learnt? Open
Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease affecting both adults and children. Belimumab is the only biologic approved for SLE, and the first in a class of drugs known as B-lymphocyte stimulator-specifi…