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Article ; Online: B cell-targeted therapies in systemic lupus erythematosus.

Arbitman, Leah / Furie, Richard / Vashistha, Himanshu

2022 Volume 132, Page(s) 102873

Abstract: ... development targets exist, there has been much attention focused on B cells. Strategies have included direct B ... cell killing, modulation of B cell function, inhibition of molecules essential to B cell growth and ... clinical trials evaluating experimental agents that target B cells or plasma cells. ...

Abstract	Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of unknown etiology that primarily affects women of childbearing age. There is no disease more heterogeneous than SLE as patients experience a myriad of manifestations and unpredictable periods of heightened disease activity. This heterogeneity not only makes it difficult for treatment decisions and prognostication, but has made drug development quite challenging. Despite these challenges, belimumab, voclosporin, and anifromulab, approved by the United States Food and Drug Administration (FDA) to treat SLE or lupus nephritis (LN), enhanced our armamentarium of traditional therapies, such as hydroxychloroquine, corticosteroids, and immunosuppressives. However, there remains a dire need to develop therapies that offer greater efficacy and safety. Patients with SLE produce excessive amounts of autoantibodies and cytokines that result in inflammation and organ damage. While a considerable number of potential drug development targets exist, there has been much attention focused on B cells. Strategies have included direct B cell killing, modulation of B cell function, inhibition of molecules essential to B cell growth and survival, and acceleration of autoantibody clearance, to name just a few. In this article, we review SLE clinical trials evaluating experimental agents that target B cells or plasma cells.
MeSH term(s)	Humans ; Female ; United States ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Nephritis ; B-Lymphocytes ; Hydroxychloroquine ; Autoantibodies
Chemical Substances	Hydroxychloroquine (4QWG6N8QKH) ; Autoantibodies
Language	English
Publishing date	2022-08-11
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	639452-8
ISSN	1095-9157 ; 0896-8411
ISSN (online)	1095-9157
ISSN	0896-8411
DOI	10.1016/j.jaut.2022.102873
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Article ; Online: B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial.

Furie, Richard A / Aroca, Gustavo / Cascino, Matthew D / Garg, Jay P / Rovin, Brad H / Alvarez, Analia / Fragoso-Loyo, Hilda / Zuta-Santillan, Elizabeth / Schindler, Thomas / Brunetta, Paul / Looney, Cary M / Hassan, Imran / Malvar, Ana

Annals of the rheumatic diseases

2021 Volume 81, Issue 1, Page(s) 100–107

Abstract: ... CD20 monoclonal antibody that induces potent B-cell depletion, with placebo for the treatment of LN ...

Abstract	Objective: Randomised trials of type I anti-CD20 antibodies rituximab and ocrelizumab failed to show benefit in proliferative lupus nephritis (LN). We compared obinutuzumab, a humanised type II anti-CD20 monoclonal antibody that induces potent B-cell depletion, with placebo for the treatment of LN in combination with standard therapies. Methods: Patients with LN receiving mycophenolate and corticosteroids were randomised to obinutuzumab 1000 mg or placebo on day 1 and weeks 2, 24 and 26, and followed through week 104. The primary endpoint was complete renal response (CRR) at week 52. Exploratory analyses through week 104 were conducted. The prespecified alpha level was 0.2. Results: A total of 125 patients were randomised and received blinded infusions. Achievement of CRR was greater with obinutuzumab at week 52 (primary endpoint, 22 (35%) vs 14 (23%) with placebo; percentage difference, 12% (95% CI -3.4% to 28%), p=0.115) and at week 104 (26 (41%) vs 14 (23%); percentage difference, 19% (95% CI 2.7% to 35%), p=0.026). Improvements in other renal response measures, serologies, estimated glomerular filtration rate and proteinuria were greater with obinutuzumab. Obinutuzumab was not associated with increases in serious adverse events, serious infections or deaths. Non-serious infusion-related reactions occurred more frequently with obinutuzumab. Conclusions: Improved renal responses through week 104 were observed in patients with LN who received obinutuzumab plus standard therapies compared with standard therapies alone. Obinutuzumab was well tolerated and no new safety signals were identified. Trial registration number: NCT02550652.
MeSH term(s)	Adrenal Cortex Hormones/therapeutic use ; Adult ; Antibodies, Monoclonal, Humanized/pharmacology ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Agents, Immunological/pharmacology ; Antineoplastic Agents, Immunological/therapeutic use ; B-Lymphocytes/drug effects ; Double-Blind Method ; Drug Therapy, Combination ; Enzyme Inhibitors/therapeutic use ; Female ; Glomerular Filtration Rate ; Humans ; Lupus Nephritis/drug therapy ; Lupus Nephritis/physiopathology ; Male ; Mycophenolic Acid/therapeutic use ; Placebos/therapeutic use ; Treatment Outcome ; Young Adult
Chemical Substances	Adrenal Cortex Hormones ; Antibodies, Monoclonal, Humanized ; Antineoplastic Agents, Immunological ; Enzyme Inhibitors ; Placebos ; Mycophenolic Acid (HU9DX48N0T) ; obinutuzumab (O43472U9X8)
Language	English
Publishing date	2021-10-06
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	7090-7
ISSN	1468-2060 ; 0003-4967
ISSN (online)	1468-2060
ISSN	0003-4967
DOI	10.1136/annrheumdis-2021-220920
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Article ; Online: Belimumab promotes negative selection of activated autoreactive B cells in systemic lupus erythematosus patients.

Huang, Weiqing / Quach, Tam D / Dascalu, Cosmin / Liu, Zheng / Leung, Tungming / Byrne-Steele, Miranda / Pan, Wenjing / Yang, Qunying / Han, Jian / Lesser, Martin / Rothstein, Thomas L / Furie, Richard / Mackay, Meggan / Aranow, Cynthia / Davidson, Anne

JCI insight

2018 Volume 3, Issue 17

Abstract: ... in patients with high-titer anti-dsDNA antibodies. We asked whether the profound B cell loss in belimumab ... patients who were studied before and after drug initiation. VH genes of sort-purified mature B cells and ... plasmablasts were subjected to next-generation sequencing. We found that B cell-activating factor (BAFF ...

Abstract	Belimumab has therapeutic benefit in active systemic lupus erythematosus (SLE), especially in patients with high-titer anti-dsDNA antibodies. We asked whether the profound B cell loss in belimumab-treated SLE patients is accompanied by shifts in the immunoglobulin repertoire. We enrolled 15 patients who had been continuously treated with belimumab for more than 7 years, 17 matched controls, and 5 patients who were studied before and after drug initiation. VH genes of sort-purified mature B cells and plasmablasts were subjected to next-generation sequencing. We found that B cell-activating factor (BAFF) regulates the transitional B cell checkpoint, with conservation of transitional 1 (T1) cells and approximately 90% loss of T3 and naive B cells after chronic belimumab treatment. Class-switched memory B cells, B1 B cells, and plasmablasts were also substantially depleted. Next-generation sequencing revealed no redistribution of VH, DH, or JH family usage and no effect of belimumab on representation of the autoreactive VH4-34 gene or CDR3 composition in unmutated IgM sequences, suggesting a minimal effect on selection of the naive B cell repertoire. Interestingly, a significantly greater loss of VH4-34 was observed among mutated IgM and plasmablast sequences in chronic belimumab-treated subjects than in controls, suggesting that belimumab promotes negative selection of activated autoreactive B cells.
MeSH term(s)	Adult ; Antibodies, Monoclonal, Humanized/pharmacology ; B-Cell Activating Factor ; B-Cell Activation Factor Receptor ; B-Lymphocytes/drug effects ; Female ; Humans ; Immunoglobulin M ; Lupus Erythematosus, Systemic/immunology ; Lymphocyte Activation/drug effects ; Male ; Middle Aged ; Phenotype
Chemical Substances	Antibodies, Monoclonal, Humanized ; B-Cell Activating Factor ; B-Cell Activation Factor Receptor ; Immunoglobulin M ; TNFSF13B protein, human ; belimumab (73B0K5S26A)
Language	English
Publishing date	2018-09-06
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ISSN	2379-3708
ISSN (online)	2379-3708
DOI	10.1172/jci.insight.122525
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Article: B cells from African American lupus patients exhibit an activated phenotype.

Menard, Laurence C / Habte, Sium / Gonsiorek, Waldemar / Lee, Deborah / Banas, Dana / Holloway, Deborah A / Manjarrez-Orduno, Nataly / Cunningham, Mark / Stetsko, Dawn / Casano, Francesca / Kansal, Selena / Davis, Patricia M / Carman, Julie / Zhang, Clarence K / Abidi, Ferva / Furie, Richard / Nadler, Steven G / Suchard, Suzanne J

JCI insight

2016 Volume 1, Issue 9, Page(s) e87310

Abstract: ... differences between African American and European American patients, we analyzed the frequencies of B cell ... subsets and the expression of B cell activation markers from a total of 68 SLE patients and 69 normal ... healthy volunteers. We found that B cells expressing the activation markers CD86, CD80, PD1, and CD40L ...

Abstract	Systemic lupus erythematosus (SLE) is a complex systemic autoimmune disease driven by both innate and adaptive immune cells. African Americans tend to present with more severe disease at an earlier age compared with patients of European ancestry. In order to better understand the immunological differences between African American and European American patients, we analyzed the frequencies of B cell subsets and the expression of B cell activation markers from a total of 68 SLE patients and 69 normal healthy volunteers. We found that B cells expressing the activation markers CD86, CD80, PD1, and CD40L, as well as CD19
MeSH term(s)	African Americans ; Antigens, Surface/analysis ; B-Lymphocytes/cytology ; B7-2 Antigen/analysis ; CD40 Antigens/analysis ; CD40 Ligand/analysis ; Humans ; Lupus Erythematosus, Systemic/ethnology ; Phenotype
Chemical Substances	Antigens, Surface ; B7-2 Antigen ; CD40 Antigens ; CD40 Ligand (147205-72-9)
Language	English
Publishing date	2016-06-16
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2379-3708
ISSN	2379-3708
DOI	10.1172/jci.insight.87310
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Article ; Online: The development of litifilimab (BIIB 059) for cutaneous and systemic lupus erythematosus.

Cho, Young Min / Furie, Richard

Immunotherapy

2023 Volume 16, Issue 1, Page(s) 15–20

Abstract: ... A and B achieved primary end points in SLE and CLE patients, confirming the importance of pDCs and IFN ...

Abstract	This review describes the litifilimab (BIIB 059) development program to date for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Plasmacytoid dendritic cells (pDCs), major producers of type I interferons (IFN-I), play a key role in SLE pathogenesis. Litifilimab, a humanized monoclonal antibody, binds to BDCA2, a protein uniquely expressed on pDCs. The consequence of BDCA2 ligation is the inhibition of IFN-I as well as IFN-III, cytokine and chemokine production. Phase I and II LILAC trial parts A and B achieved primary end points in SLE and CLE patients, confirming the importance of pDCs and IFN-I in SLE and CLE. Litifilimab is currently being evaluated in phase III trials in both SLE and CLE.
MeSH term(s)	Humans ; Skin/pathology ; Lupus Erythematosus, Systemic ; Lupus Erythematosus, Cutaneous/metabolism ; Lupus Erythematosus, Cutaneous/pathology ; Dendritic Cells ; Antibodies ; Interferon Type I
Chemical Substances	Antibodies ; Interferon Type I
Language	English
Publishing date	2023-10-25
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2495964-9
ISSN	1750-7448 ; 1750-743X
ISSN (online)	1750-7448
ISSN	1750-743X
DOI	10.2217/imt-2023-0086
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Article ; Online: B-type natriuretic peptides help in cardioembolic stroke diagnosis: pooled data meta-analysis.

Llombart, Víctor / Antolin-Fontes, Albert / Bustamante, Alejandro / Giralt, Dolors / Rost, Natalia S / Furie, Karen / Shibazaki, Kensaku / Biteker, Murat / Castillo, José / Rodríguez-Yáñez, Manuel / Fonseca, Ana Catarina / Watanabe, Tetsu / Purroy, Francisco / Zhixin, Wu / Etgen, Thorleif / Hosomi, Naohisa / Jafarian Kerman, Scott Reza / Sharma, Jagdish C / Knauer, Carolin /

Santamarina, Estevo / Giannakoulas, George / García-Berrocoso, Teresa / Montaner, Joan

Stroke

2015 Volume 46, Issue 5, Page(s) 1187–1195

Abstract: ... secondary prevention treatment. Increased blood levels of natriuretic peptides (B-type natriuretic peptide/N-terminal ...

Abstract	Background and purpose: Determining the underlying cause of stroke is important to optimize secondary prevention treatment. Increased blood levels of natriuretic peptides (B-type natriuretic peptide/N-terminal pro-BNP [BNP/NT-proBNP]) have been repeatedly associated with cardioembolic stroke. Here, we evaluate their clinical value as pathogenic biomarkers for stroke through a literature systematic review and individual participants' data meta-analysis. Methods: We searched publications in PubMed database until November 2013 that compared BNP and NT-proBNP circulating levels among stroke causes. Standardized individual participants' data were collected to estimate predictive values of BNP/NT-proBNP for cardioembolic stroke. Dichotomized BNP/NT-proBNP levels were included in logistic regression models together with clinical variables to assess the sensitivity and specificity to identify cardioembolic strokes and the additional value of biomarkers using area under the curve and integrated discrimination improvement index. Results: From 23 selected articles, we collected information of 2834 patients with a defined cause. BNP/NT-proBNP levels were significantly elevated in cardioembolic stroke until 72 hours from symptoms onset. Predictive models showed a sensitivity >90% and specificity >80% when BNP/NT-proBNP were added considering the lowest and the highest quartile, respectively. Both peptides also increased significantly the area under the curve and integrated discrimination improvement index compared with clinical models. Sensitivity, specificity, and precision of the models were validated in 197 patients with initially undetermined stroke with final pathogenic diagnosis after ancillary follow-up. Conclusions: Natriuretic peptides are strongly increased in cardioembolic strokes. Future multicentre prospective studies comparing BNP and NT-proBNP might aid in finding the optimal biomarker, the best time point, and the optimal cutoff points for cardioembolic stroke identification.
MeSH term(s)	Aged ; Aged, 80 and over ; Electrocardiography ; Embolism/complications ; Embolism/diagnosis ; Female ; Humans ; Male ; Middle Aged ; Natriuretic Peptide, Brain/blood ; Predictive Value of Tests ; Stroke/diagnosis ; Stroke/etiology
Chemical Substances	Natriuretic Peptide, Brain (114471-18-0)
Language	English
Publishing date	2015-05
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	80381-9
ISSN	1524-4628 ; 0039-2499 ; 0749-7954
ISSN (online)	1524-4628
ISSN	0039-2499 ; 0749-7954
DOI	10.1161/STROKEAHA.114.008311
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Article ; Online: Creating a More Welcoming Home for Your Work at The American Journal of Pathology.

Essex, Emily H / Furie, Martha B

The American journal of pathology

2022 Volume 193, Issue 1, Page(s) 2–3

MeSH term(s)	United States ; Pathology
Language	English
Publishing date	2022-12-12
Publishing country	United States
Document type	Editorial
ZDB-ID	2943-9
ISSN	1525-2191 ; 0002-9440
ISSN (online)	1525-2191
ISSN	0002-9440
DOI	10.1016/j.ajpath.2022.10.005
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Article ; Online: A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study.

Furie, R A / Leon, G / Thomas, M / Petri, M A / Chu, A D / Hislop, C / Martin, R S / Scheinberg, M A

Annals of the rheumatic diseases

2015 Volume 74, Issue 9, Page(s) 1667–1675

Abstract: Objective: To evaluate the efficacy and safety of subcutaneous blisibimod, an inhibitor of B cell ... complement C3 and C4, and reductions in B cells were observed with blisibimod.No imbalances in serious ...

Abstract	Objective: To evaluate the efficacy and safety of subcutaneous blisibimod, an inhibitor of B cell activating factor, in patients with systemic lupus erythematosus (SLE) in a dose-ranging Phase 2b clinical trial. Methods: 547 patients with SLE with anti-double stranded DNA or antinuclear antibodies and Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score ≥6 at baseline were randomised to receive placebo or blisibimod at one of 3 dose levels. The primary end point, measured at Week 24, was the SLE Responder Index-5 (SRI-5, meeting established SRI criteria but with ≥5 point improvement in SELENA-SLEDAI). Results: Although SRI-5 response rates were not significantly improved in the pooled blisibimod groups compared with placebo, they were higher in subjects randomised to the highest dose of blisibimod (200 mg once-weekly (QW)) compared with pooled placebo, from Week 16 to Week 24, reaching statistical significance at Week 20 (p=0.02). SRI response rates compared with placebo were higher still in subjects who attained SELENA-SLEDAI improvements of ≥8, and in a subgroup of patients with severe disease (SELENA-SLEDAI ≥10 and receiving corticosteroids at baseline). In subjects with protein:creatine ratios of 1-6 at baseline, significant reductions in proteinuria were observed with blisibimod. Significant (p<0.01) changes in anti-double stranded DNA antibodies, complement C3 and C4, and reductions in B cells were observed with blisibimod.No imbalances in serious adverse events or infections (4/280 and 3/266), deaths (4/280 and 3/266) and malignancies (2/280 and 2/266) were reported for blisibimod compared with placebo. Conclusions: This study successfully identified a safe, effective and convenient dose, study population and end point for evaluation of blisibimod effect in Phase 3. Trial registration number: NCT01162681.
MeSH term(s)	Adrenal Cortex Hormones/therapeutic use ; Adult ; Antibodies, Antinuclear/immunology ; Antimalarials/therapeutic use ; Complement C3/immunology ; Complement C4/immunology ; Double-Blind Method ; Female ; Humans ; Immunologic Factors/administration & dosage ; Immunologic Factors/therapeutic use ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Erythematosus, Systemic/immunology ; Male ; Recombinant Fusion Proteins/administration & dosage ; Recombinant Fusion Proteins/therapeutic use ; Severity of Illness Index ; Treatment Outcome
Chemical Substances	AMG623 peptibody ; Adrenal Cortex Hormones ; Antibodies, Antinuclear ; Antimalarials ; Complement C3 ; Complement C4 ; Immunologic Factors ; Recombinant Fusion Proteins
Language	English
Publishing date	2015-09
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	7090-7
ISSN	1468-2060 ; 0003-4967
ISSN (online)	1468-2060
ISSN	0003-4967
DOI	10.1136/annrheumdis-2013-205144
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Article: Effect of long-term belimumab treatment on B cells in systemic lupus erythematosus: extension of a phase II, double-blind, placebo-controlled, dose-ranging study.

Jacobi, Annett M / Huang, Weiqing / Wang, Tao / Freimuth, William / Sanz, Inaki / Furie, Richard / Mackay, Meggan / Aranow, Cynthia / Diamond, Betty / Davidson, Anne

Arthritis and rheumatism

2009 Volume 62, Issue 1, Page(s) 201–210

Abstract: ... 84, 168, 365, and 532 and after day 730. The total number of B cells started to decrease ... from baseline between days 84 and 168. This was due to a decrease in naive and transitional B cells. CD27+IgD+ ... memory B cells and plasmablasts decreased only after 532 days, whereas CD27+IgD- memory B cells were not ...

Abstract	Objective: To understand the effects of long-term BLyS inhibition in human systemic lupus erythematosus (SLE). Methods: Seventeen patients with SLE who were enrolled in a clinical trial of belimumab, a BLyS-specific inhibitor, plus standard of care therapy were studied. Phenotypic analysis of lymphocytes was performed using flow cytometry. Circulating antibody-secreting cells were enumerated using enzyme-linked immunospot assay. Serum was analyzed by enzyme-linked immunosorbent assay using an antibody that recognizes products of the V(H)4-34 gene. Lymphocyte counts, Ig levels, and anti-double-stranded DNA antibody levels were available as part of the clinical trial analyses. Results: Samples were collected on days 0, 84, 168, 365, and 532 and after day 730. The total number of B cells started to decrease from baseline between days 84 and 168. This was due to a decrease in naive and transitional B cells. CD27+IgD+ memory B cells and plasmablasts decreased only after 532 days, whereas CD27+IgD- memory B cells were not affected, and there were no changes in T cells. Serum IgM levels began to decline between days 84 and 168, but there were no changes in serum levels of IgG, IgG anti-DNA antibodies, or V(H)4-34 antibodies during the study. SLE patients had more IgM-, IgG-, and autoantibody-producing B cells than did normal controls on day 0. There was only a modest decrease in the frequency of total IgM-producing, but not IgG-producing, cells on days 365 and 532, consistent with the phenotypic and serologic data. Conclusion: Our data confirm the dependence of newly formed B cells on BLyS for survival in humans. In contrast, memory B cells and plasma cells are less susceptible to selective BLyS inhibition.
MeSH term(s)	Adult ; Aged ; Antibodies, Antinuclear/blood ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; B-Cell Activating Factor/antagonists & inhibitors ; B-Cell Activating Factor/immunology ; B-Lymphocytes/drug effects ; B-Lymphocytes/immunology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Enzyme-Linked Immunosorbent Assay ; Female ; Flow Cytometry ; Humans ; Immunoglobulin M/blood ; Immunologic Memory/drug effects ; Immunologic Memory/immunology ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/therapeutic use ; Lupus Erythematosus, Systemic/blood ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Erythematosus, Systemic/immunology ; Male ; Middle Aged ; Pilot Projects ; Plasma Cells/drug effects
Chemical Substances	Antibodies, Antinuclear ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; B-Cell Activating Factor ; Immunoglobulin M ; Immunosuppressive Agents ; belimumab (73B0K5S26A)
Language	English
Publishing date	2009-12-29
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	127294-9
ISSN	1529-0131 ; 0004-3591 ; 2326-5191
ISSN (online)	1529-0131
ISSN	0004-3591 ; 2326-5191
DOI	10.1002/art.27189
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Article ; Online: A New Scope and a New Editorial Team for The American Journal of Pathology.

Furie, Martha B

The American journal of pathology

2017

Abstract: This Editorial describes new enhanced scope of The American Journal of Pathology and introduces its new editorial team. ...

Abstract	This Editorial describes new enhanced scope of The American Journal of Pathology and introduces its new editorial team.
Language	English
Publishing date	2017-11-10
Publishing country	United States
Document type	Editorial
ZDB-ID	2943-9
ISSN	1525-2191 ; 0002-9440
ISSN (online)	1525-2191
ISSN	0002-9440
DOI	10.1016/j.ajpath.2017.10.008
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