Healthcare Costs of SLE Patients Before Diagnosis

Objective We estimated the incremental (extra) direct medical costs of a population-based cohort of newlydiagnosed systemic lupus erythematosus (SLE) for five years before and after diagnosis, and the impact of sex and socioeconomic status (SES) on pre-index costs for SLE. Methods We identified all adults newly-diagnosed with SLE over 2001-2010 in British Columbia, Canada, and obtained a sample of non-SLE from the general population, matched on sex, age, and calendar-year of study entry. We captured costs for all outpatient encounters, hospitalisations, and dispensed medications each year. Using generalised linear models, we estimated incremental costs of SLE each year before/after diagnosis (difference in costs between SLE and non-SLE, controlling for covariates). Similar models were used to examine the impact of sex and SES on costs within SLE. Results We included 3,632 newly-diagnosed SLE (86% female, mean age 49.6±15.9) and 18,060 non-SLE individuals. Over the five years leading up to diagnosis, per-person healthcare costs for SLE patients increased year-over-year by 35%, on-average, with the biggest increases in the final two years: by 39% and 97%, respectively. Per-person all-cause medical costs for SLE the year after diagnosis (Year +1) averaged $12,019 (2013 Canadian) with 58$2,412. Following adjustment for age, sex, urban/rural residence, socioeconomic status, and prior year’s comorbidity score, SLE was associated with significantly greater hospitalisation, outpatient, and medication costs than non-SLE in each year of study. Altogether, adjusted incremental costs of SLE rose from $1,131 per-person in Year -5 (fifth year before diagnosis) to$2,015 (Year -2), $3,473 (Year -1), and$6,474 (Year +1). In Years -2, -1, and +1, SLE patients in the lowest-SES group had significantly-greater costs than the highest-SES. Unlike the non-SLE cohort, male patients with SLE had higher costs than females. Annual incremental costs of SLE males (versus SLE females) rose from $540 perperson in Year -2, to$1,385 in Year -1, and $2,288 in Year +1. Conclusion Even years before diagnosis, SLE patients incur significantly-elevated direct medical costs than the age- and sex-matched general population, for hospitalisations, outpatient care, and medications.Medicine, Faculty ofPharmaceutical Sciences, Faculty ofOther UBCNon UBCMedicine, Department ofRheumatology, Division ofReviewedFacultyOthe

Approaches for estimating minimal clinically important differences in systemic lupus erythematosus

A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 1989, studies focused primarily on statistical significance. As most recent clinical trials in systemic lupus erythematosus (SLE) have failed to show significant effects, determining a clinically relevant threshold for outcome scores (that is, the MCID) of existing instruments may be critical for conducting and interpreting meaningful clinical trials as well as for facilitating the establishment of treatment recommendations for patients. To that effect, methods to determine the MCID can be divided into two well-defined categories: distribution-based and anchor-based approaches. Distribution-based approaches are based on statistical characteristics of the obtained samples. There are various methods within the distribution-based approach, including the standard error of measurement, the standard deviation, the effect size, the minimal detectable change, the reliable change index, and the standardized response mean. Anchor-based approaches compare the change in a patient-reported outcome to a second, external measure of change (that is, one that is more clearly understood, such as a global assessment), which serves as the anchor. Finally, the Delphi technique can be applied as an adjunct to defining a clinically important difference. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the context of SLE. As the MCID can help determine the effect of a given therapy on a patient and add meaning to statistical inferences made in clinical research, we believe there ought to be renewed focus on this area. Here, we provide an update on the use of MCIDs in clinical research, review some of the work done in this area in SLE, and propose an agenda for future research

Impact of arthritis on the perceived need and use of mental healthcare among Canadians with mental disorders: nationally representative cross-sectional study

Objective To evaluate the association between having arthritis and the perceived need for mental healthcare and use of mental health support among individuals with mental disorders.Design A cross-sectional analysis using data from Canadian Community Health Survey—Mental Health (2012).Setting The survey was administered across Canada’s 10 provinces using multistage cluster sampling.Participants The study sample consisted of individuals reporting depression, anxiety or bipolar disorder.Study variables and analysis The explanatory variable was self-reported doctor-diagnosed arthritis, and outcomes were perceived need for mental healthcare and use of mental health support. We computed overall and gender-stratified multivariable binomial logistic regression models adjusted for age, gender, race/ethnicity, income and geographical region.Results Among 1774 individuals with a mental disorder in the study sample, 436 (20.4%) reported having arthritis. Arthritis was associated with increased odds of having a perceived need for mental healthcare (adjusted OR (aOR) 1.71, 95% CI 1.06 to 2.77). In the gender-stratified models, this association was increased among men (aOR 2.69, 95% CI 1.32 to 5.49) but not women (aOR 1.48, 95% CI 0.78 to 2.82). Evaluation of the association between arthritis and use of mental health support resulted in an aOR of 1.50 (95% CI 0.89 to 2.51). Individuals with arthritis tended to use medications and professional services as opposed to non-professional support.Conclusion Comorbid arthritis among individuals with a mental disorder was associated with an increased perceived need for mental healthcare, especially in men, underscoring the importance of understanding the role of masculinity in health seeking. Assessing the mental health of patients with arthritis continues to be essential for clinical care

Discovery of serum proteomic biomarkers for prediction of response to infliximab (a monoclonal anti-TNF antibody) treatment in rheumatoid arthritis: an exploratory analysis

Biologics such as TNF antagonists are a new class of drugs that have greatly improved Rheumatoid Arthritis (RA) treatment. However, for unknown reasons, individual patients with RA respond to one of these drugs but not to others even those targeting the same molecule. Methods to predict response are sorely needed because these drugs are currently selected by trial and error, what is very inefficient and prejudicial for the patient and the healthcare system. Here, we have explored the discovery of protein biomarkers in serum from patients treated with infliximab, one of the major anti-TNF drugs. The study was based in a quantitative proteomics approach using 8-plex iTRAQ labeling. It combined depletion of the most abundant serum proteins, two-dimensional LC fractionation, protein identification and relative quantification with a hybrid Orbitrap mass spectrometer. This approach allowed the identification of 315 proteins of which 237 were confidently quantified with two or more peptides. The detection range covered up to 6 orders of magnitude including multiple proteins at the ng/mL level. A new set of putative biomarkers was identified comprising 14 proteins significantly more abundant in the non-responder patients. The differential proteins were enriched in apolipoproteins, components of the complement system and acute phase reactants. These results show the feasibility of this approach and provide a set of candidates for validation as biomarkers for the classification of RA patients before the beginning of treatment, so that anticipated non-responders could be treated with an alternative drug