Peer-Reviewed Journal Articles

Published in Internationally Recognized Peer-Reviewed Journals

Clinical Trials (AMPEL has 50+ sites in the US and Canada)

Lupus Patients

Pfizer

M.D. Catalina, P. Bachali, N.S. Geraci, A.C. Grammer and P.E. Lipsky
Gene Expression Analysis Delineates the Potential Role of Multiple Interferons in Systemic Lupus Erythematosus
Nature Communications Biology 2:140, 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478921/

Lupus VALUE trial, AMPEL 2017-2021
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478921/

Astra Zenaca: Lupus background paper for Anifrolumab (2021 FDA-approval for Lupus)

R.W. Maul, M.D. Catalina, V. Kumar, P. Bachali, A.C. Grammer, S. Wang, W. Yang, S. Hasni, R. Ettinger, P.E. Lipsky and P.J. Gearhart
Transcriptome and IgH Repertoire Analyses Show that CD11chi B Cells Are a Distinct Population with Similarity to B Cells Arising in Autoimmunity and  Infection
Frontiers in Immunology 12:649458, 2021. doi.org/10.3389/fimmu.2021.649458.

Lilly

P. Bachali, A. Grammer and P. Lipsky.
Identification of subsets of systemic lupus erythematosus patients responsive to baricitinib targeting JAK1,2 by transcriptomic analysis at baseline.
Arthritis Rheumatol. 75: 9, 2023.

UCB/Biogen

I. Cutcuache, A.S. Powlesland, A. Skelton . . .P. Lipsky, A. Skowera and C. Stach.
Dapirolizumab pegol targeting CD40-ligand impacts important immunologic pathways in systemic lupus erythematosus: pharmacodynamic analysis of B cell and type I
Ann. Rheum. Dis 83:265, 2024.

BMS/Celgene

P. Bachali, Y. Hu, N. Delev, P. Schafer and P. Lipsky
Identification of subsets of SLE patients responsive to Iberdomide by transcriptomic analysis of baseline samples
Ann. Rheum. Dis. 10:4878, 2023.
http://dx.doi.org/10.1136/annrheumdis-2023-eular.4878

Lupus Iberdomide/CC220 Ph2 trial, AMPEL 2017-2018.
AMPEL is analyzing gene expression before & during treatment with DiD Iberdomide (2022-present)

P.E. Lipsky, R. van Vollenhoven, T. Doerner, V.P. Werth, J.T. Merrill, R. Furie, M. Petronijevic, B.V. Zamora, M. Majdan, F. Irazoque-Palazuelos, R. Terbrueggen, N. Delev, M. Weiswasser, S. Korish, M. Stern, S. Hersey, Y. Ye, A. Gaudy, Z. Liu, R. Gagnon, S. Tang and P.H. Schafer
The biological impact of Iberdomide in patients with active Systemic Lupus Erythematosus
Ann. Rheum. Dis. 10:1136, 2022. https://ard.bmj.com/content/early/2022/04/26/annrheumdis-2022-222212

Werth, J. Merrill, R. Furie, T. Dorner, R. van Vollenhoven, P. Lipsky, M. Weiswasser, S. Korish, P. Schafer, M. Stern, Z. Liu, S. Tang and N. Delev
Effect of Iberdomide on cutaneous manifestations in SLE: results of a 24-week, placebo-controlled, Phase 2 study
Ann.Rheum.Dis. 80: 76, 2021.  https://ard.bmj.com/content/80/Suppl_1/76

Lipsky, R. van Vollenhoven, T. Doerner, V. Werth, J. Merrill, R. Furie . . .and P. Schafer
Iberdomide decreases B cells and plasmacytoid DCs, increases regulatory T cells and IL2, and has enhanced clinical efficacy in active systemic lupus erythematosus patients with high aiolos or the IFN gene expression signature
Arthritis Rheumatol.2020; 72 (suppl 10).
https://www.investorvillage.com/smbd.asp?mb=4235&mn=4575&pt=msg&mid=21227365

Aker BioPharma

J. Salmon, D. Wallace, V. Rus, A. Cox, C. Dykas, B. Williams, Y. Ding, P.-A. Hals, L. Johnsen and P.E. Lipsky.
Correction of omega-3 fatty acid deficiency and improvement in disease activity in patients with systemic lupus erythematosus treated with krill oil concentrate: a multicentre, randomised, double-blind, placebo-controlled trial
Lupus Science & Medicine 11:e001201, 2024.

J.E. Salmon, D.J. Wallace, V. Rus and P. Lipsky
Correction of omega-3 fatty acid deficiency and improvement in disease activity in SLE patients treated in a concentrated extract of krill oil
Ann. Rheum. Dis. 82:1467, 2024.

Lupus Krill Oil Trial, AMPEL 2018-2021.
AMPEL is analyzing gene expression before & during treatment with Krill Oil (2022-present)

 

Janssen: Lupus Stelara/Ustekinumab (Ph2, not involved in Ph3)

Confirmation of AMPEL’s scoring system to predict drugs for Lupus

AMPEL is analyzing changes in gene expression before & during treatment with Ustekinumab (2022-present)

R.F. van Vollenhoven, B.H. Hahn, G.C. Tsokos, P. Lipsky, R.M. Gordon, K. Fei, H. Lo, M. Chevrier, S. Rose, P. Berry, Z. Yao, C.S. Karyekar, Q. Zuraw
Efficacy and Safety of Ustekinumab in Patients With Active Systemic Lupus Erythematosus: Results of a Phase II Open-label Extension Study.” J. Rheumatology 49(4): 380-387, 2022.
https://www.jrheum.org/content/early/2022/01/25/jrheum.210805

R.F. van Vollenhoven, B.H. Hahn, G.C. Tsokos, P.E. Lipsky, K. Fei, R.M. Gordon, I. Gregen, K.M. Lo, M. Chevrier and S. Rose
Maintenance of Efficacy and Safety of Ustekinumab Through One Year in a Phase II Multicenter, Prospective, Randomized, Double-Blind Placebo-Controlled Crossover Trial of Patients with Active SLE
Arthritis Rheum. 72:761, 2020.
https://acrjournals.onlinelibrary.wiley.com/doi/epdf/10.1002/art.41179

R.F. van Vollenhoven, B.H. Hahn, G.C. Tsokos, C.L. Wagner, P.E. Lipsky, Z. Touma, V.P. Werth, R.M Gordon, B. Zhou, B. Hsu, M. Chevrier, M. Triebel, J.L. Jordan and S. Rose
Efficacy and safety of ustekinumab, an IL-12 and IL-23 inhibitor, in patients with active systemic lupus erythematosus: results of a multicentre, double-blind, phase 2, randomised, controlled study. Lancet 392:1330, 2018.
https://www.sciencedirect.com/science/article/abs/pii/S0140673618321676#!

Alliance for Lupus Research Consortium of Rheumatologists & Companies

Rescue “failed” trials using AMPEL’s predictive machine learning approach

Development/validation of evidence-based Lupus Multivariable Outcome Score for clinical trials

Abrahamowicz, M.I. Abrahamowicz and P.E. Lipsky
External Validation of the Lupus Multivariable Outcome Score (LuMOS®) for Systemic Lupus Erythematosus Trials
Open Rhematology 8:1-8, 2022.
https://onlinelibrary.wiley.com/doi/epdf/10.1002/acr2.11451

Abrahamowicz, J.M. Sedalia, R. Goldman-Ramsey, L.S. Simon, V. Strand and P.E. Lipsky
Development of a novel evidence-based LuMOS for clinical trials
Arthritis and Rheumatism 70:1450, 2018
https://www.ncbi.nlm.nih.gov/pubmed/29648686

Abrahamowicz and P.E. Lipsky
Validation of a LuMOS® as an outcome measure for SLE trials
Lupus Science & Medicine 8:1136, 2021.
https://lupus.bmj.com/content/8/Suppl_2/A44.2.abstract

CAR-T Cells

Peter E Lipsky, Andrea R Daamen
Potential and pitfalls of repurposing the CAR-T cell regimen for the treatment of autoimmune disease
Ann. Rheum. Dis. 83:, 696, 2024.
https://ard.bmj.com/content/83/6/696

NIH: Lupus Stem Cell Transplantation (autologous)

Sencer Goklemez, S. Hasni, F.T. Hakim . .. G.G. Illei, P.E. Lipsky and S.Z. Pavletic
Long-term follow-up after lymphodepleting autologous haematopoietic cell transplantation for treatment-resistant SLE
Rheumatology 61:3317-3328, 2022.
https://doi.org/10.1093/rheumatology/keab877 | https://clinicaltrials.gov/ct2/show/NCT00076752

Lupus Pre-Clinical Mice

Hospital for Special Surgery, NYC

T.M. Li, V. Zyulina, E.S. Seltzer, M. Dacic, Y. Chinenov, A. Daamen. . .P.E. Lipsky and T. Lu,
Interferon-rich skin environment regulates Langerhans cell ADAM17 to promote photosensitivity in Lupus
eLife 13:e85914, 2024.
https://doi.org/10.7554/eLife.85914

University of Virginia

A.R. Daamen, H.W. Wang, P. Bachali, N. Shen, K.M. Kingsmore, R.D. Robl, A.C. Grammer, S.M. Fu, and P.E. Lipsky
Molecular mechanisms governing the progression of nephritis in lupus-prone mice and human lupus patients
Frontiers in Immunology 14:1147526, 2023.
doi: 10.3389/fimmu.2023.1147526
Preprint https://lupus.bmj.com/content/9/Suppl_3/A78

Wang, N. Geraci, P. Bachali, B. Kegerreis, M. Catalina, E. Hubbard, S.S. Sung, F. Gaskin, A. Grammer, P. Lipsky and S.M. Fu
Glomerular and Tubular Transcriptional Profiles Reveal Gene Clusters Specific for Different Stages of Glomerulonephritis in NZM2328 Mice
Arthritis Rheumatol. 70:10, 2018

Jackson Labs/Tufts University

J.J. Wilson, J. Wei, A.R. Daamen, C.L. Mayberry, A.C. Grammer, P.E. Lipsky, D.C. Roopenian and C-H. Chang,
Unveiling metabolic vulnerabilities in lupus B cells: targeting BCMA and glucose dependency for therapeutic strategies
Lupus Sci & Med 11:1136, 2023
 https://lupus.bmj.com/content/11/Suppl_2/A103.citation-tools.

J.J. Wilson, J. Wei, A.R. Daamen; J.D. Sears, E. Bechtel, C.L. Mayberry, G.A. Stafford, L. Bechtold, A.C. Grammer. P.E. Lipsky, D.C. Roopenian and C.-H. Chang, Glucose oxidation-dependent survival of activated B cells provides a novel therapeutic target for lupus treatment
iScience 26:107487, 2023
 https://www.cell.com/iscience/fulltext/S2589-0042(23)01564-X.

A.R. Daamen, C. Chang, D.C. Roopenian, A.C. Grammer and P.E. Lipsky
Transcriptomic analysis reveals a critical regulatory role for CD8 T cells in a mouse model of SLE
Lupus Science & Medicine 8: 1136, 2021.
https://lupus.bmj.com/content/8/Suppl_2/A6.2.abstract

Virginia Tech University

R.M. Alajoleen, A. Daamen, P.R. Timilesena, P.E. Lipsky and X.M. Luo
Single-cell RNA sequencing analysis reveals disease stage-dependent transcriptomic profiles of regulatory B cell in Systemic Lupus Erythematosus
J. Immunol. 210: 15505, 2024.
https://journals.aai.org/jimmunol/article/210/1_Supplement/155.05/264956

P. Rai, J.M. Marano, L. Kang, S. Coutermarsh-Ott, A. Daamen, P.E. Lipsky and J. Weger-Lucarelli
Obesity fosters severe disease outcomes in a mouse model of cornovirus infection associated with transcriptomic abnormalities
J. Med. Virol. 96: e29587, 2024
https://onlinelibrary.wiley.com/doi/10.1002/jmv.29587

A.R. Daamen, R.M. Alajoleen, A.C. Grammer, X.M. Luo and P.E. Lipsky
Single-cell RNA sequencing analysis reveals the heterogeneity of IL-10 producing regulatory B cells in lupus-prone mice
Frontiers Immunol. 14: 1282770, 2023
https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1282770/full

D.N. Oakland, M. Appiah, J. Zhu, P. Lipsky and X.M. Luo
Bacterial DNA mediated protection from Systemic Lupus Erythematosus
J. Immunol. 210: 7716, 2023.
https://journals.aai.org/jimmunol/article/210/1_Supplement/77.16/264863

Abdelhamid, R. Alajoleen, K.M. Kingsmore, X. Cabana-Puig, R. Lu, J. Zhu, J.C. Testerman, Y. Li, A.C. Ross, T. E. Cecere, C.M. Reilly, A.C. Grammer, P.E. Lipsky and X.M. Luo
Hypovitaminosis A Drives the Progression of Tubulointerstitial Lupus Nephritis through Potentiating Predisease Cellular Autoreactivity
Immunohorizons 7:17, 2023.

M. Appiah, D.N. Oakland, J. Zhu, X. Cabana-Puig, R. Lu, R. Alajoleen, C. Armstrong, D. Xu, C.M. Reilly, A.C. Grammer, M.J. Shlomchik, P.E. Lipsky and X.M. Luo
Bacterial DNA induces regulatory B cells and attenuates lupus through a B cell-extrinsic, TLR9-dependent mechanism
Lupus Science and Medicine 9:1303, 2022.

Mu, B.K. Swartwout, X.C. Puig, J. Grieco, T.E. Cecere, H. Wang, C. Puglisi, C.M. Reilly, A.C. Grammer, P.E. Lipsky*, X.M. Luo* (*co-corresponding authors)
Gut microbiota and bacterial DNA suppress autoimmunity by stimulating regulatory B cells in a murine model of lupus
Frontiers in Immunology 11:593353, 2020.

Ren*, M. Catalina*, K. Eden, X. Liao, K. Read, X. Luo, R. McMillan, M. Hulver, M. Jarpe, P. Bachali, A. Grammer, P. Lipsky and C. Reilly (*co-first authors)
Selective HDAC6 inhibition normalizes B cell activation and germinal center formation in SLE
Frontiers in Immunology 10:2512, 2019.
https://www.frontiersin.org/articles/10.3389/fimmu.2019.02512

Ren, E. Panther, X. Liao, A.C. Grammer, P.E. Lipsky and C.M. Reilly
The impact of protein acetylation/deacetylation on systemic lupus erythematosus
Int. J. Molec. Sci. 19: E4007, 2018.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6321219/

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