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/
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.
BMS/Celgene
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
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 Efficacay 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://ard.bmj.com/content/early/2022/04/26/annrheumdis-2022-222212.abstract
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
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 Mouse
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; 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, Differential reliance on glucose oxidation by activated autoreactive B cells provides a unique target of therapeutic intervention
Preprint, https://www.biorxiv.org/content/10.1101/2022.02.01.475510v1.full. Cell iScience, in press.
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
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.
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.