Study schemas. Study schemas. Upper panel: single-ascending dose study. Subjects with mild, stable systemic lupus erythematosus (SLE) were randomised to.

Slides:



Advertisements
Similar presentations
Nat. Rev. Cardiol. doi: /nrcardio
Advertisements

Time between systemic lupus erythematosus (SLE) and haematological malignancy diagnoses. Time between systemic lupus erythematosus (SLE) and haematological.
Disease activity over time in autoantibody-positive patients treated with belimumab. Disease activity over time in autoantibody-positive patients treated.
Time course for laboratory parameters of a patient with systemic lupus erythematosus prior and during bortezomib therapy (arrow). Time course for laboratory.
Correlation between disease activity and phospho-H2AX levels at G0/G1, S and G2 cell-cycle phases in primary CD3+ T cells and monocytes from patients with.
Fig. 1. Serum HBsAg, HBcrAg, and HBeAg reduction in human patients treated with a single dose of ARC-520. Serum HBsAg, HBcrAg, and HBeAg reduction in human.
Daniel J. Lenihan et al. BTS 2016;1:
Anti-IL-17 Receptor Antibody AMG 827 Leads to Rapid Clinical Response in Subjects with Moderate to Severe Psoriasis: Results from a Phase I, Randomized,
Mean Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at the last.
Immunohistochemistry staining of interferon (IFN)-λ in renal tissue.
POPE-2 Trial design: Patients with moderate to large pericardial effusion after cardiac surgery were randomized to colchicine 2 mg loading dose, then 1.
(A) Phospho-H2AX levels are significantly increased in CD4+ T cells, CD8+ T cells and monocytes from SLE compared with those from healthy controls (p=2.16×10−4,
Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) comprised seven anchored Visual Analogue Scales (0–100 mm each) and can describe.
Fig. 7. NAC in breast cancer patients promotes TMEM assembly and increased MENAINV expression. NAC in breast cancer patients promotes TMEM assembly and.
Fig. 4. The effect of single-dose rozanolixizumab on the concentration of IgG subtypes in healthy subjects. The effect of single-dose rozanolixizumab on.
Fig. 4. Clearance of 12-mer-1 from a nonhuman primate model.
Leo F. Buckley et al. JCHF 2016;4:1-8
Serum osteopontin (OPN) levels in population-based controls and in cases with SLE. Serum levels of OPN, determined by ELISA, were significantly higher.
Correlations of EBV-specific T-cells and disease activity of SLE patients. Correlations of EBV-specific T-cells and disease activity of SLE patients. Correlation.
The pattern of alteration of HCQ, prednisolone and/or ISS drugs by physicians in a patient with a history of major organ involvement from their SLE (renal.
Representative ultrasound images of patients with SLE
No difference in T-cell response between SLE patients and healthy controls upon superantigen stimulation. No difference in T-cell response between SLE.
Mean (SD) AMG 557 serum concentration–time profiles following single-ascending dose (SAD) (A) and multiple-ascending dose (MAD) (B) administration AMG.
Receiver operating curve of soluble C3, C4, antibodies to double-stranded DNA (anti-dsDNA) compared with complement C4d levels on erythrocytes (EC4d) and.
Longitudinal changes in serum G3BP concentrations and SLEDAI in 15 patients with SLE. Each plot represents one patient. Longitudinal changes in serum G3BP.
Change in APOC3 level in response to treatment with APOC3 antisense oligonucleotide ISIS Phase 2, randomised, double-blind, placebo-controlled study.
Performance characteristics for multivariate assay SLE panel.
Positivity rate for antibodies to double-stranded DNA (anti-dsDNA), low complement, high complement C4 activation products (CBCAPS) and two-tiered methodology.
Correlation between frequency of Th17 cells and disease activity or amount of proteinuria in patients with systemic lupus erythematosus (SLE). Correlation.
Correlation between mean Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
Post-test probabilities of systemic lupus erythematosus (SLE) at different pretest probabilities for a positive and negative cell-bound complement activation.
Correlations between two measures of type I interferon activity and serum galectin-3-binding protein in the SLE-IFN-α (n=26) and HC-IFN-α (n=10) cohorts.
Effect of dose level on the anti-keyhole limpet haemocyanin (KLH) IgG response in the multiple-ascending dose (MAD) study. Effect of dose level on the.
Serum proteins dysregulated at baseline in patients enrolled in the MUSE study subsetted by IFNGS test status, Cutaneous Lupus Erythematosus Disease Area.
First-generation modular analysis of acutely ill systemic lupus erythematosus (SLE) (flare or infection) versus inactive SLE. The modules are numbered;
Attributed cause of end-stage renal disease (ESRD) among 251 patients with SLE in the Georgia Lupus Registry who progressed to ESRD (1979–2012), overall.
Change in urinary protein to creatinine ratio (uPCR) as a function of serum C4, C3, anti-C1q, EC4d, EC3d and ECR1. Change in urinary protein to creatinine.
Comparison of the effects of growing podocytes in plasma from patients with lupus nephritis (LN), rheumatoid arthritis or non-renal lupus. Comparison of.
Hierarchical clustering of non-classical monocytes from patients and controls, with tracks indicating individuals, IFN score, SLEDAI score and prednisone.
Distribution of the RAMRIS component scores sorted by pain score.
Association of MRI findings and serum autoantibodies in diffuse neuropsychiatric systemic lupus erythematosus. Association of MRI findings and serum autoantibodies.
Colonization in tumor models and different modes of administration
Presence of inpatient diagnostic codes for attributed cause of end-stage renal disease (ESRD) among 46 patients with systemic lupus erythematosus (SLE)
Estimated glucose delta values (mmol/L) after glucagon injection (5 µg/kg) in octreotide-treated rats. Estimated glucose delta values (mmol/L) after glucagon.
SLE deconvolution patient clusters and representative immune cell types (A), and distribution of patients by SLE deconvolution cluster and treatment group—all.
Multivariate assay panel for systemic lupus erythematosus (SLE) diagnosis. Multivariate assay panel for systemic lupus erythematosus (SLE) diagnosis. Two-tier.
Least squares (LS) mean (SE) changes from baseline in (A) Cutaneous Lupus Erythematosus Disease Area and Severity Index activity scores and (B) Tender.
Summary of evidence search and selection.
A proposed algorithm for the handling of glucocorticoid (GC) therapy in patients with active or flaring SLE. Mild: presence of only BILAG C or ≤1 BILAG.
Antibody levels to Ro52, Ro60, p200 and La antigens in control and congenital heart block (CHB) cohort were measured as bound units (BU). Antibody levels.
Proportion of patients consulting their general practitioner for symptoms within each British Isles Lupus Activity Group (BILAG) domain in the 5 years.
Presence of autoreactive anti-HLA antibodies among SLE and RA subjects
Impact of skin damage on health-related quality of life.
Fig. 7 BMS reduces the elevated expression of type I IFN–regulated genes both ex vivo in blood from patients with lupus and in a phase 1 study of.
Serum anti-neuronal antibodies (anti-N) in patients with positive serum anti-GRP78. Serum anti-neuronal antibodies (anti-N) in patients with positive serum.
Mean fluorescence intensity (MFI) of SIGLEC1 expression before and after introduction of prednisolone or hydroxychloroquine. Mean fluorescence intensity.
Enrollment, outcomes, and pharmacokinetics.
Postulated impact of SLE on endothelial nitric oxide (NO) synthase activity and endothelial nitric oxide synthase (eNOS) uncoupling. Postulated impact.
Mean change from baseline over time in BILAG score,
Fig. 2 PK dosing results. PK dosing results. (A) Plasma concentration of hPTH(1–34) versus time after release of 40-μg dose from implanted microchip device.
Overall gene expression in monocyte subsets in patients and controls.
(A) Mean urine protein/creatinine ratio (UPCR) and SEM in participants from the combined Lupus Nephritis Assessment of Rituximab (LUNAR) and A Study to.
IFN-γ-producing T-cells in SLE patients and healthy controls upon EBV antigen stimulation. IFN-γ-producing T-cells in SLE patients and healthy controls.
Activated T-cells in SLE patients and healthy controls upon EBV antigen stimulation. Activated T-cells in SLE patients and healthy controls upon EBV antigen.
Mean serum concentration time profiles of anifrolumab following subcutaneous and intravenous administration of anifrolumab.a aData below the limits of.
Networks of treatment comparisons for primary outcomes of SLE agents in patients with SLE. The size of the nodes (blue circles) corresponds to the number.
Median percentage change in complement components 3 and 4 over time by SLE deconvolution cluster—all randomised and treated patients.* *Data from five.
Measures of endothelial activation/dysfunction are associated with QRISK3. Measures of endothelial activation/dysfunction are associated with QRISK3. Increased.
Overall and recurrence-free survival.
Fig. 3 Evaluation of PTMAO immunogenicity.
Presentation transcript:

Study schemas. Study schemas. Upper panel: single-ascending dose study. Subjects with mild, stable systemic lupus erythematosus (SLE) were randomised to receive placebo or AMG 557 at 1.8, 6, 18, 60, 140 and 210 mg subcutaneously (SC) or 18 mg intravenously (IV) in seven sequential rising-dose cohorts. Subjects were immunised with both a prime and boost consisting of a 1 mg intradermal injection of keyhole limpet haemocyanin (KLH) on days 2 and 29 (for 60 mg SC cohort), days 8 and 36 (for 140 and 210 mg SC cohorts), and days 15 and 43. Lower panel: multiple-ascending dose study. Subjects with mild, stable SLE were randomised to receive placebo or AMG 557 at 6, 18, 30, 45, 70, 140  or 210 mg subcutaneously in seven sequential rising-dose cohorts. Subjects were administered AMG 557 or placebo on days 1, 15, 29, 43, 57, 71 and 85. Subjects were immunised with KLH on days 57 and 85. EOS, end of study. B A Sullivan et al. Lupus Sci Med 2016;3:e000146 ©2016 by Lupus Foundation of America