Summary of TB cases across indications and trial periods

Slides:

Advertisements

Similar presentations

Monthly improvements in paid work productivity: ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) subpopulations (employed.

Advertisements

Monthly improvements in family, social and leisure activities to week 96 (last observation carried forward imputation). Assessed using the arthritis-specific.

Monthly improvements in paid work productivity: overall axial spondyloarthritis population (employed patients only; last observation carried forward imputation). Assessed.

Immunohistochemical (IHC) staining for CD68/CD21 and CD3/CD20 on synovial tissue (ST) of patients with inflammatory bowel disease (IBD) with onset of peripheral.

Multivariable model of abatacept retention by RF and anti-CCP status in biologic-naïve patients with or without radiographic erosion at baseline. Multivariable.

Immunohistochemical (IHC) staining for CD117 on synovial tissue (ST) of patients with inflammatory bowel disease (IBD) with onset of peripheral arthritis.

Main fields of interest.

Conversion to ACPA and RF seronegative status in patients with early RA treated with abatacept+MTX compared with MTX alone. Conversion to ACPA and RF seronegative.

Kaplan-Meier survival plots for survival without: (A) progression to RA according to the number of joints with significant synovitis defined by GS≥ grade.

ASAS 20/40 response rates, and mean change from baseline in BASDAI through week 156* of treatment. *For patients who discontinued, the end of treatment.

Baseline scores and corresponding changes to week 96 of the RAPID-axSpA trial for all CZP-treated patients included in the imaging substudy for: (A) SPARCC.

PPD status of CZP-treated patients with RA in the pooled RA safety database (N=4049) at baseline and TB incidence by INH treatment. †One patient who developed.

Patient disposition through 48 weeks in RA-BEYOND

ASAS 20/40 responses in anti-TNF-naïve and anti-TNF-IR subjects at weeks 52, 104 and 156. ASAS 20/40 responses in anti-TNF-naïve and anti-TNF-IR subjects.

Frequency of patients in flare at each time point over 3 months

Cumulative incidence of tuberculosis (TB) in certolizumab pegol (CZP)-treated patients with rheumatoid arthritis (RA) in the pooled RA safety database.

Schematic presentation of enrichment through linkages of clinical Rheumatology register data to other national data sources within each of the five Nordic.

The severity of fatigue over 8 years of disease in early rheumatoid arthritis patients. The severity of fatigue over 8 years of disease in early rheumatoid.

Pathogenesisof PsA and RA

Box plot of HAQ-DI scores at baseline, week 96 and week 144 categorised by baseline PsA duration. Box plot of HAQ-DI scores at baseline, week 96 and week.

(A) Reduction of circulating stromal cell-derived factor (SDF)-1 levels over time in patients with rheumatoid arthritis (RA) and ankylosing spondylitis.

Serum levels of (A), C reactive protein (CRP), (B), erythrocyte sedimentation rate (ESR) and (C), calprotectin of cohort 1 (SPACE) with patients with early.

Relationships between the baseline disease activity scores and scintigraphic sum scores for the patients with RA, pSpA and axSpA. Relationships between.

Different treatment strategies in rheumatoid arthritis in relation to radiographic progression (A) number of swollen joints (B) and fatigue severity over.

Fatigue severity across early patients with arthritis with different diagnoses at disease onset (A) and over 3 years of disease (B). Fatigue severity across.

Bold diamonds are the mean percentage of time with inactive disease during the first 12 months within the subgroup. Bold diamonds are the mean percentage.

Distribution of Tc99m-radiolabelled certolizumab pegol in hands, feet and SIJs 4–5 hours postinjection. Distribution of Tc99m-radiolabelled certolizumab.

Levels of participation in the Psoriatic Arthritis Impact of Disease (PsAID) development process. Levels of participation in the Psoriatic Arthritis Impact.

EULAR-defined characteristics describing arthralgia at risk for RA

SF-36 domain scores at baseline and 24 weeks compared with age-matched and gender-matched normative values in the (A) AMBITION and (B) ADACTA trial populations.

The association between alcohol consumption and the severity of MRI-detected inflammation in hand and foot joints of (A) patients with RA and (B) asymptomatic.

Difference in the risk of MACEs in patients treated with anti–IL17 agents compared with the placebo in RCTs. IL,interleukin; MACEs, major adverse cardiovascular.

Matrix risk model showing the probability of SRP in patients with moderate disease activity after 3 years of MTX treatment. Matrix risk model showing the.

Multivariate analysis for SRP after 3 years in patients with moderate disease activity despite MTX treatment. Multivariate analysis for SRP after 3 years.

Patient-reported adherence towards different IMID treatments in RA (A), PsA (B) or AS (C). Patient-reported adherence towards different IMID treatments.

Clinical response in patients with early and established RA at month 24. *p

Clinical expertise of GPs and rheumatologists in differentiating patients with arthralgia. Clinical expertise of GPs and rheumatologists in differentiating.

Relative impact of the different levels of education on the physical and mental components of SF-12 across the different chronic disorders. Relative impact.

Difference in the risk of MACEs in patients treated with anti-IL23 agents compared with the placebo in RCTs. IL, interleukin; MACEs, major adverse cardiovascular.

ACR20/50/70 response rates at week 24 (TP1 per-protocol set).

Malignancy-related events over time for all-bari-RA analysis set (IR).

Serum sRANKL and OPG levels in healthy donors and patients with RA at baseline and after MTX and low-dose prednisolone treatment. Serum sRANKL and OPG.

Monthly improvements in home productivity: ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) subpopulations (last observation.

Frequency of methotrexate (MTX) doses at 24 months (plot) and summary of MTX doses across the MTX dosing categories (low, medium, high) based on data at.

Ultrasonographic characteristics and synovitis pattern of patients with inflammatory bowel disease (IBD) with onset of peripheral arthritis under tumour.

Patient disposition after 2 years of treatment.

Efficacy as first, second and third bDMARD in patients with axial spondyloarthritis. ASAS, Assessment of Spondylo Arthritis international Society; BASDAI,

Study design. *Randomisation stratified by corticosteroid use at baseline. Study design. *Randomisation stratified by corticosteroid use at baseline. DAS28-CRP,

Difference in the risk of MACEs in patients treated with anti-TNF agents compared with the placebo in RCTs. MACEs, major adverse cardiovascular events;

Satisfaction with control of RA

SIR data for all CZP-treated patients (RCT+OLE) for each malignancy type, standardised to the general population by age and gender (GLOBOCAN and SEER).

Design for the long-term extension study RA-BEYOND from randomisation in the originating studies. Design for the long-term extension study RA-BEYOND from.

Cardiovascular disease risk assessment capture rates in the NOCAR project, evaluated across diagnosis groups and participating centre. Cardiovascular disease.

Sera metabolite profiles of patients with RA discriminate rituximab responders and non-responders. Sera metabolite profiles of patients with RA discriminate.

Patient-level radiographic progression of structural joint damage at year 1 and year 2 by original randomisation. Patient-level radiographic progression.

(A) Mean NMR spectra of patient sera show differences in metabolite intensities between responders and non-responders before (a) and 6 months after (b)

Joint pain location and severity.

Nail photographs and MRI scans of a patient with psoriatic arthritis.

Forest plot showing the results of the meta-analysis on the effect of strength exercise on M.quadriceps femoris in people with rheumatoid arthritis and.

Forest plot showing the results of the meta-analysis on the effect of aerobic exercise on measured on VO2max in people with rheumatoid arthritis, spondyloarthritis.

Graphical representation of the content of the Social Role Participation Questionnaire (SRPQ), which assesses several dimensions of role participation.

ACPA and RF titres in patients with early RA treated with abatacept+MTX compared with MTX alone. ACPA and RF titres in patients with early RA treated with.

ACR20, ACR20 and ACR70 response rates (proportions of patients meeting ACR 20, 50% or 70% improvement criteria) in patients with rheumatoid arthritis randomised.

Multivariate Cox proportional hazards model of time to first serious infectious events. Multivariate Cox proportional hazards model of time to first serious.

MRI remission in the imaging set of patients from the RAPID-axSpA trial. MRI remission in the imaging set of patients from the RAPID-axSpA trial. Remission.

NRDC and TNF-α increase in synovial fluid from patients with RA

Changes in non-classical (CD11b+CD14+CD163−CD16+) and classical (CD11b+CD14+CD163+CD16−) monocytes over time in patients with rheumatoid arthritis (RA)

Incidence rates over time of SAEs, malignancies and TB pre-2007 and post-2007 for RCT PBO and CZP-treated patients (all doses) in the combined RCT and.

Kaplan-Meier failure curves with development of RA stratified by depression exposure. Kaplan-Meier failure curves with development of RA stratified by.

Distribution of points (%) across the ESSDAI domains in patients with neurological involvement and in those with non-neurological systemic involvement.

Presentation transcript:

Summary of TB cases across indications and trial periods Summary of TB cases across indications and trial periods. †A total of 42 TB cases were reported in rheumatoid arthritis (RA) trials initiated or completed prior to protocol amendment; 20 cases in original RA trials (completed prior to protocol amendment) and 22 in intermediate RA trials (initiated before but completed after the introduction of more stringent PPD screening criteria in 2007). *Of the 22 TB cases in patients with RA from intermediate RA trials (RAPID1 and RAPID2), 9 cases were reported after protocol amendment. Summary of TB cases across indications and trial periods. †A total of 42 TB cases were reported in rheumatoid arthritis (RA) trials initiated or completed prior to protocol amendment; 20 cases in original RA trials (completed prior to protocol amendment) and 22 in intermediate RA trials (initiated before but completed after the introduction of more stringent PPD screening criteria in 2007). *Of the 22 TB cases in patients with RA from intermediate RA trials (RAPID1 and RAPID2), 9 cases were reported after protocol amendment. AxSpA, axial spondyloarthritis; PsA, psoriatic arthritis; IR, incidence rates; PY, patient-years; TB, tuberculosis. X Mariette et al. RMD Open 2015;1:e000044 Copyright © BMJ Publishing Group & EULAR. All rights reserved.