8 research outputs found
Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination.
OBJECTIVES: We examined patient-reported outcomes (PROs) in The Study of Etanercept And Methotrexate in Patients with Psoriatic Arthritis (PsA); a 48-week, phase 3, randomised controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept monotherapy, and MTX+ etanercept in patients with PsA.
METHODS: Efficacy endpoints included: mean changes from baseline and proportion of patients who reported improvements≥minimal clinically important difference (MCID) at week 24 in treatment groups for Health Assessment Questionnaire-Disability Index, Patient Global Assessment (PtGA), Patient Global Assessment of Joint Pain (PtGAJP) and Medical Outcomes Study Short Form-36 Questionnaire (SF-36) Physical Component Summary (PCS), and Mental Component Summary, and eight domain scores. PROs were analysed as reported (observed), without multiplicity adjustment; therefore, p values are descriptive.
RESULTS: At week 24, patients receiving etanercept monotherapy or MTX+ etanercept combination reported greater improvements (p≤0.05) in PtGA, PtGAJP and SF-36 PCS scores compared with those receiving MTX monotherapy. Compared with MTX monotherapy, higher proportions of patients receiving etanercept monotherapy and combination therapy reported improvements≥MCID in PtGA (etanercept vs MTX, p=0.005) and PtGAJP (MTX +etanercept vs MTX, p=0.038). Across PROs, proportions of patients reporting scores≥age and gender-matched normative values at week 24 ranged from 20.8% to 51.0% with MTX monotherapy, 30.9% to 48.8% with etanercept monotherapy, and 30.6% to 52.3% with MTX+ etanercept combination.
CONCLUSIONS: Patients receiving etanercept monotherapy or MTX+ etanercept reported greater improvements from baseline in several PROs compared with those receiving MTX monotherapy. PROs should be incorporated in discussions between patients and clinicians regarding their treatment choices as they can help determine which treatments are more beneficial in patients with PsA
The prognostic value of Cardiopulmonary Exercise Testing in Idiopathic Pulmonary Fibrosis
Rationale: Idiopathic pulmonary fibrosis (IPF) is characterized by progressive
dyspnea, impaired gas exchange, and ultimate mortality.
Objectives: To test the hypothesis that maximal oxygen uptake
during cardiopulmonary exercise testing at baseline and with
short-term longitudinal measures would predict mortality in
patients with idiopathic pulmonary fibrosis.
Methods: Data from 117 patients with IPF and longitudinal cardiopulmonary
exercise tests were examined retrospectively. Survival
was calculated from the date of the first cardiopulmonary exercise
test.
Measurements and Main Results: Patients with baseline maximal
oxygen uptake less than 8.3 ml/kg/min had an increased risk of
death (n=8; hazard ratio, 3.24; 95% confidence interval, 1.10–9.56;
P = 0.03) after adjusting for age, gender, smoking status, baseline
forced vital capacity, and baseline diffusion capacity for carbon
monoxide. We were unable to define a unit change in maximal
oxygen uptake that predicted survival in our cohort.
Conclusions: We conclude that a threshold maximal oxygen uptake of
8.3 ml/kg/min during cardiopulmonary exercise testing at baseline
adds prognostic information for patients with IPF.Supported by National Institute of Health NHLBI grant P50HL-56402, NHLBI, 2
K24 HL04212, 1 K23 HL68713, and 1K23 HL077719. C.D.F. was supported by
the Alberta Heritage Foundation for Medical Research.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/91965/1/2009 AJRCCM The prognostic value of Cardiopulmonary Exercise Testing in Idiopathic Pulmonary Fibrosis.pd
Clinical Predictors of a Diagnosis of Idiopathic Pulmonary Fibrosis
Rationale: Idiopathic pulmonary fibrosis (IPF) and other idiopathic
interstitial pneumonias (IIPs) have similar clinical and radiographic
features, but their histopathology, response to therapy, and natural
history differ. A surgical lung biopsy is often required to distinguish
between these entities.
Objectives: We sought to determine if clinical variables could predict
a histopathologic diagnosis of IPF in patients without honeycomb
change on high-resolution computed tomography (HRCT).
Methods: Data from 97 patients with biopsy-proven IPF and 38
patients with other IIPs were examined. Logistic regression models
were built to identify the clinical variables that predict histopathologic
diagnosis of IPF.
Measurements and Main Results: Increasing age and average total
HRCT interstitial score on HRCT scan of the chest may predict
a biopsy confirmation of IPF. Sex, pulmonary function, presence
of desaturation, or distance walked during a 6-minute walk test
did not help discriminate pulmonary fibrosis from other IIPs.
Conclusions: Clinical data may be used to predict a diagnosis of IPF
over other IIPs. Validation of these data with a prospective study is
needed.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/91953/1/2010 AJRCCM Clinical Predictors of a Diagnosis of Idiopathic Pulmonary Fibrosis.pd
Relationship between quantitative CT metrics and health status and BODE in chronic obstructive pulmonary disease
Background The value of quantitative CT (QCT) to
identify chronic obstructive pulmonary disease (COPD)
phenotypes is increasingly appreciated. The authors
hypothesised that QCT-defined emphysema and airway
abnormalities relate to St George’s Respiratory
Questionnaire (SGRQ) and Body-Mass Index, Airflow
Obstruction, Dyspnea and Exercise Capacity Index
(BODE).
Methods 1200 COPDGene subjects meeting Global
Initiative for Chronic Obstructive Lung Disease (GOLD)
criteria for COPD with QCT analysis were included. Total
lung emphysema was measured using the density mask
technique with a 950 Hounsfield unit threshold. An
automated programme measured mean wall thickness
(WT), wall area percentage (WA%) and 10 mm lumenal
perimeter (pi10) in six segmental bronchi. Separate
multivariate analyses examined the relative influence of
airway measures and emphysema on SGRQ and BODE.
Results In separate models predicting SGRQ score, a 1
unit SD increase in each airway measure predicted higher
SGRQ scores (for WT, 1.90 points higher, p=0.002; for
WA%, 1.52 points higher, p=0.02; for pi10, 2.83 points
higher p<0.001). The comparable increase in SGRQ for
a 1 unit SD increase in emphysema percentage in these
models was relatively weaker, significant only in the pi10
model (for emphysema percentage, 1.45 points higher,
p=0.01). In separate models predicting BODE, a 1 unit
SD increase in each airway measure predicted higher
BODE scores (for WT, 1.07-fold increase, p<0.001; for
WA%, 1.20-fold increase, p<0.001; for pi10, 1.16-fold
increase, p<0.001). In these models, emphysema more
strongly influenced BODE (range 1.24-1.26-fold increase,
p<0.001).
Conclusion Emphysema and airway disease both relate
to clinically important parameters. The relative influence
of airway disease is greater for SGRQ; the relative
influence of emphysema is greater for BODE.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/91946/1/2012 Thorax Relationship between quantitative CT metrics and health status and BODE in chronic obstructive pulmonary disease.pd
Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination
Objectives We examined patient-reported outcomes (PROs) in The Study of Etanercept And Methotrexate in Patients with Psoriatic Arthritis (PsA); a 48-week, phase 3, randomised controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept monotherapy, and MTX+ etanercept in patients with PsA.Methods Efficacy endpoints included: mean changes from baseline and proportion of patients who reported improvements≥minimal clinically important difference (MCID) at week 24 in treatment groups for Health Assessment Questionnaire-Disability Index, Patient Global Assessment (PtGA), Patient Global Assessment of Joint Pain (PtGAJP) and Medical Outcomes Study Short Form-36 Questionnaire (SF-36) Physical Component Summary (PCS), and Mental Component Summary, and eight domain scores. PROs were analysed as reported (observed), without multiplicity adjustment; therefore, p values are descriptive.Results At week 24, patients receiving etanercept monotherapy or MTX+ etanercept combination reported greater improvements (p≤0.05) in PtGA, PtGAJP and SF-36 PCS scores compared with those receiving MTX monotherapy. Compared with MTX monotherapy, higher proportions of patients receiving etanercept monotherapy and combination therapy reported improvements≥MCID in PtGA (etanercept vs MTX, p=0.005) and PtGAJP (MTX +etanercept vs MTX, p=0.038). Across PROs, proportions of patients reporting scores≥age and gender-matched normative values at week 24 ranged from 20.8% to 51.0% with MTX monotherapy, 30.9% to 48.8% with etanercept monotherapy, and 30.6% to 52.3% with MTX+ etanercept combination.Conclusions Patients receiving etanercept monotherapy or MTX+ etanercept reported greater improvements from baseline in several PROs compared with those receiving MTX monotherapy. PROs should be incorporated in discussions between patients and clinicians regarding their treatment choices as they can help determine which treatments are more beneficial in patients with PsA
Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA).
Objective: To evaluate the efficacy of etanercept and methotrexate as monotherapies and as combination therapy in subjects with active psoriatic arthritis (PsA).
Methods: The Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) is an ongoing, global, double-blind, 48-week, randomised, controlled study. Subjects are randomised (1:1:1) to etanercept monotherapy, methotrexate monotherapy or etanercept-methotrexate combination therapy. Endpoints include rates of ACR20 response and Minimal Disease Activity, measures to characterise extra-articular manifestations (dactylitis, enthesitis, nail disease) and safety.
Conclusion: SEAM-PsA will characterise the effects of etanercept with and without background methotrexate and methotrexate alone on PsA manifestations, and provide information of practical importance to clinicians on the optimal treatment of PsA
Impact of clinical domains other than arthritis on composite outcomes in psoriatic arthritis: comparison of treatment effects in the SEAM-PsA trial
Objective We used the Study of Etanercept And Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) data set to examine the impact of presence of enthesitis, dactylitis, nail disease and/or psoriasis on treatment response in patients with early psoriatic arthritis (PsA).Methods This post hoc analysis evaluated the effect of baseline Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (EI), Leeds Enthesitis Index (LEI), Leeds Dactylitis Index (LDI), modified Nail Psoriasis Severity Index (mNAPSI) scores and body surface area (BSA) on composite outcomes of minimal disease activity (MDA) responses, Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA), PASDAS changes and Good Responses and Disease Activity Index for Psoriatic Arthritis (DAPSA) scores at Week 24.Results Overall, 851 patients completed the SEAM-PsA trial and were included in the analysis. Baseline enthesitis (SPARCC EI>0 vs SPARCC EI=0 or LEI>0 vs LEI=0) was not associated with improved outcomes. Baseline dactylitis (LDI>0 vs LDI=0) was positively associated with improved MDA (OR: 1.4, p=0.0457), PASDAS LDA (OR: 1.8, p=0.0014) and Good Responses (OR: 1.6, p=0.0101) and greater reductions in PASDAS (estimate: –0.9, p<0.0001) and DAPSA scores (estimate: –3.8, p=0.0155) at Week 24. Similarly, baseline nail disease (mNAPSI >1 vs mNAPSI≤1) was positively associated with improved MDA (OR: 1.8, p=0.0233) and PASDAS LDA (OR: 1.8, p=0.0168) responses and greater reduction in PASDAS (estimate: –0.7, p=0.0005) at Week 24.Conclusions Results from our analysis suggest that presence of dactylitis and nail disease, but not enthesitis, are associated with improved outcomes in patients with early PsA who were treated with methotrexate and/or etanercept