Paul T. Manser

Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy

Jürgen Floege, Richard A. Lafayette, Jonathan Barratt, Brian S. Schwartz et autres

INTRODUCTION: Felzartamab is a fully human anti-CD38 monoclonal antibody under investigation for treatment of IgA nephropathy (IgAN). IGNAZ (NCT05065970) is a randomized, double blind, placebo-controlled Phase 2a study that assessed the efficacy and safety of felzartamab in 54 patients with biopsy-confirmed IgAN …

de, us, gb, ca (code pays fourni par la source)

WCN25-318 FELZARTAMAB DURABLY REDUCES DISEASE RELEVANT BIOMARKERS THROUGH TARGETING OF CD38+ PLASMA CELLS AND PLASMABLASTS, THE UPSTREAM DRIVERS OF IgA NEPHROPATHY (IgAN)

Lisa Kivman, Tabea Kräft, Julia Rauser, Rainer Boxhammer et autres

Results:We enrolled 84 patients, 30 (36%) males and 54 (64%) females.Median age at AAV onset was 49.5 (35; 57) years.Seventy-four (88%) patients were ANCA-positive.Seventeen (20%) patients were diagnosed with renal-limited AAV.Median Birmingham vasculitis activity score (BVAS v.3) at biopsy was 14.5 (12; …

us, de, gb (code pays fourni par la source)

WCN25-844 FELZARTAMAB FOR IgA NEPHROPATHY: FINAL RESULTS OF THE IGNAZ STUDY

Uptal D. Patel, Jürgen Flöge, Jonathan Barratt, Richard A. Lafayette et autres

Methods: Serum and whole blood were collected pre/post-felza treatment in patients with aPLA2R+ PMN.Biomarker analyses were performed for aPLA2R (ELISA), total IgG (turbidimetry), anti-Tetanus Toxoid (TT) (ELISA), and B cell populations (flow cytometry).Results: Felza reduced aPLA2R comparably in patients with baseline levels …

us, de, gb, ca (code pays fourni par la source)

Cross-sectional and prognostic associations of baseline [ 18 F]GTP1 tau PET signal and white matter lesion volumes for cognitive and functional decline in prodromal-to-mild Alzheimer's disease

Nancy E. Ruiz‐Uribe, Paul T. Manser, Brandon D. Butcher, Yihao Li et autres

BACKGROUND: In Alzheimer's disease (AD), tau and white matter lesion pathology are associated with clinical severity and subsequent decline, but their relative relationships with clinical assessments remain uncertain. OBJECTIVE: F]GTP1 tau positron emission tomography (PET) standardized uptake value ratio (SUVRs) and T1 …

us (code pays fourni par la source)

Felzartamab for IgA Nephropathy: Final Results of the IGNAZ Study

Jonathan Barratt, Jürgen Floege, Richard A. Lafayette, Brian M. Schwartz et autres

Background: Felzartamab is a monoclonal antibody that binds to CD38 on plasma cells–the likely source of pathogenic Gd-IgA1 and autoantibodies in IgA nephropathy (IgAN). The randomized, double-blind, placebo-controlled phase 2a IGNAZ study assessed the efficacy and safety of felzartamab vs placebo (PBO) …

gb, de, us, ca (code pays fourni par la source)

Felzartamab Durably Reduces Disease-Relevant Biomarkers through Targeting of CD38+ Plasma Cells and Plasmablasts, the Upstream Drivers of IgAN

Jonathan Barratt, Millie Shah, Lisa Kivman, Tabea Kräft et autres

Background: IgAN is driven by antibody secreting cell (ASC) production of galactose-deficient IgA1 (Gd-IgA1) and anti-Gd-IgA1 autoantibodies resulting in immune complex deposition-induced kidney damage. Felzartamab (felza) is a fully human anti-CD38 mAb that directly depletes CD38+ ASCs, the upstream cellular mediators of …

gb, de, us (code pays fourni par la source)

Phase 1b/2a Study Assessing the Safety and Efficacy of Felzartamab in Anti-Phospholipase A2 Receptor Autoantibody–Positive Primary Membranous Nephropathy

Brad H. Rovin, Pierre Marie Ronco, Jack F.M. Wetzels, Sharon G. Adler et autres

Introduction: Primary membranous nephropathy (PMN) is most often caused by autoantibodies to phospholipase A2 receptor (PLA2R). M-PLACE (NCT04145440) is an open-label, phase 1b/2a study that assessed the safety and efficacy of the fully human anti-CD38 monoclonal antibody felzartamab in high-risk anti-PLA2R+ PMN. …

us, fr, nl, kr, de, be (code pays fourni par la source)

Evaluation of partial volume correction and analysis of longitudinal [18F]GTP1 tau PET imaging in Alzheimer's disease using linear mixed-effects models

Sandra Sanabria Bohórquez, Suzanne L. Baker, Paul T. Manser, Matteo Tonietto et autres

Purpose: F]GTP1 tau positron-emission tomography (PET) in Alzheimer's disease and the suitability of describing the tau pathology burden temporal trajectories using linear mixed-effects models (LMEM). Methods: We applied van Cittert iterative deconvolution (VC), 2-compartment, and 3-compartment, and the geometric transfer matrix plus …

us, ch (code pays fourni par la source)

Felzartamab (anti-CD38) in patients with IgA Nephropathy-interim results from the IGNAZ study

Jürgen Flöge, Richard Lafayette, Anjali Thakur, Sean Barbour et autres

Results of Single-Arm, Phase 1b Study of Anti-C1q Treatment (ANX009) Show that the Classical Pathway Is a Key Driver of Complement Activation and Consumption in Patients with Active Lupus Nephritis

Min Bao, Juan Javier Lichauco, Hsiang Chen, Harold Gomez et autres

Background: Lupus nephritis (LN) is an autoantibody-mediated disease involving glomerular deposition of immune complexes containing pathogenic anti-C1q antibodies, leading to C1q binding and activation of the classical complement pathway. ANX009 is a subcutaneously administered antigen-binding fragment of a humanized antibody that inhibits …

us, ph, tw (code pays fourni par la source)

Modeling Alzheimer's disease progression utilizing clinical trial and ADNI data to predict longitudinal trajectory of CDR‐SB

Samira Jamalian, Michael J. Dolton, Pascal Chanu, Vidya Ramakrishnan et autres

There is strong interest in developing predictive models to better understand individual heterogeneity and disease progression in Alzheimer's disease (AD). We have built upon previous longitudinal AD progression models, using a nonlinear, mixed-effect modeling approach to predict Clinical Dementia Rating Scale - …

fr, us (code pays fourni par la source)

Cross‐sectional and longitudinal assessments of function in prodromal‐to‐mild Alzheimer's disease: A comparison of the ADCS‐ADL and A‐IADL‐Q scales

Edmond Teng, Yihao Li, Paul T. Manser, Karen Pickthorn et autres

Abstract Introduction Prior observational work in a heterogeneous cohort of participants with mild cognitive impairment suggests the Amsterdam Instrumental Activities of Daily Living Questionnaire (A‐IADL‐Q) may have greater sensitivity for functional decline than the more established Alzheimer's Disease Cooperative Study–Activities of Daily …

nl (code pays fourni par la source)