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Introduction: Real-world use of immunomodulating therapy (IMT) in patients with systemic sclerosis (SSc) was investigated for the first time in a descriptive, retrospective cohort analysis of claims made in a healthcare insurance database to characterize treatment patterns and their alignment with SSc disease manifestations. Methods: Treatment patterns and disease manifestations, symptoms, complications, and comorbidities were assessed in patients with SSc enrolled in a US healthcare claims database who received treatment between January 2006 and December 2013 and for whom data were available 6 months before and 12 months after SSc diagnosis. Results: Among 7812 eligible patients, 6852 received treatments of interest for SSc and 2404 (30.8%) received IMT during the first year after SSc diagnosis. In the first year after diagnosis, the most common claims were for antibiotics (61.7%), opioids (50.6%), glucocorticoids (46.5%), and proton pump inhibitors (35.4%); the most common organs involved with complications among patients with SSc were lung (30.5%), heart (17.4%), and gastrointestinal tract (22.4%); the most common signs or symptoms were musculoskeletal (16.1%) and fatigue (10.5%); 1035 patients (15.1%) had infections and 14 (0.2%) had malignancies. Among patients who received IMT, 43.8% received at least hydroxychloroquine and 21.1% received at least methotrexate; 460 patients switched to a second IMT, 23.0% to at least methotrexate and 22.8% to at least mycophenolate mofetil. The most common comorbidities reported with first IMT were in lung (11.8%), overlap syndrome (8.4%), heart (5.3%), and gastrointestinal (6.8%) categories. Conclusion: One-third of patients with SSc in the healthcare claims population received IMTs during the first year after diagnosis. However, patients who received IMTs had disease manifestations similar to those of the overall SSc healthcare claims population.

Using the UKClinical Practice Research Datalink, we examined the incidence of glucocorticoid (GC)‐related serious adverse events (SAEs) in rheumatoid arthritis (RA) and non‐RApatients and quantified the risk of SAEs in patients with RA. We matched incident patients with RAto an age‐ and sex‐matched, non‐RAcomparison group of equal size. In a cohort analysis, we estimated incidence rates (IRs) and IRratios (IRRs) for GC‐related AEs (i.e., diabetes mellitus [DM], osteoporosis, fractures, glaucoma, hypertension, gastrointestinal [GI] perforation or bleeding, thrombotic stroke or myocardial infarction [MI], or death), stratified by GCuse. We conducted a series of nested case–control analyses among patients with RA, evaluating the effects of increasing cumulative and average daily GCdose. Cases of each outcome were matched to controls for age, sex, and general practice. We calculated adjusted odds ratios (ORs) with 95% confidence intervals (95% CIs) for each outcome. Patients with RAhad a higher incidence for all investigated SAEs except glaucoma, compared to non‐RApatients. IRRs were greater in those patients prescribed a GCthan in those without. In patients with RA,GCs were associated with an elevated risk of DM(adjusted OR1.33 [95% CI1.14–1.56]), osteoporosis (adjusted OR1.41 [95% CI1.25–1.59]), thrombotic stroke or MI(adjusted OR1.28 [95% CI1.07–1.52]), serious infection (adjusted OR1.28 [95% CI1.11–1.48]), and death (adjusted OR1.33 [95% CI1.19–1.48]). There was a trend of increasing risk with increasing cumulative and average daily GCdose for all outcomes other than glaucoma, hypertension, and GIperforations or bleeding (P< 0.05). Patients with RAhad an increased incidence of GC‐related AEs. Increasing cumulative and average daily GCdoses were found to be associated with an increasing risk of developing an AE.

The safety profile of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) is well established. TCZ was approved to treat giant cell arteritis (GCA) in 2017 in the USA and Europe, and its safety profile in patients with GCA continues to be defined. The objective of this analysis was to examine incidence rates (IRs) of adverse events of special interest (AESI) occurring during the TCZ clinical development program and in healthcare claims data in patients with GCA or RA. TCZ-naïve patients with GCA or RA were identified in the MarketScan administrative healthcare claims database. TCZ-treated patients with GCA from the GiACTA trial and TCZ-treated patients with RA from pooled clinical trial data were analyzed. The IRs of AESI (AESI IRs) were calculated for all cohorts. In the claims cohorts, risks of AESI were estimated using Poisson regression. TCZ-naïve claims cohorts comprised 4804 patients with GCA [mean (standard deviation) age 73.4 (9.8) years; follow-up 3.9 (3.1) years] and 15,164 patients with RA [age 60.3 (8.2) years; follow-up, 4.5 (2.8) years]. TCZ-treated clinical trial cohorts comprised 149 patients with GCA [age 69.5 (8.4) years; exposure approx. 138 patient-years (PY)] and 7647 with RA [age 52 (12.6) years; exposure approx. 22,394 PY]. The IRs of infections, stroke, malignancies, myocardial infarction, and gastrointestinal perforations in the GCA claims cohort exceeded those in the RA claims cohort; the risk of AESI (adjusted for age and glucocorticoid use) was higher in patients with GCA than in those with RA. Similar patterns to the claims cohorts in terms of the AESI IRs were observed in clinical trial cohorts, although the number of events was limited in the GCA trial cohort. Higher IRs of AESI were observed in patients with GCA versus those with RA in both TCZ-naïve and -treated cohorts. Differences in underlying disease, age, and glucocorticoid use may influence AESI incidence, irrespective of intervention. This study was funded by F. Hoffmann-La Roche Ltd and Genentech, Inc. Article processing charges were funded by F. Hoffmann-La Roche Ltd. Plain language summary is available for this article.

Introduction: Treatment of giant cell arteritis (GCA) involves immediate initiation of high-dose glucocorticoid therapy with slow tapering of the dose over many months. Chronic exposure to glucocorticoids is associated with serious comorbidities. The objective of this analysis was to determine the glucocorticoid exposure and risk of glucocorticoid-related adverse events (AEs) in real-world patients with GCA. Methods: Data from the Truven Healthcare MarketScan®database (from January 1, 2000, to June 30, 2015) and the Clinical Practice Research Datalink (CPRD; from January 1, 1995, to August 31, 2013) were used to retrospectively analyze patients aged ≥ 50 years with GCA in the USA and UK, respectively. Outcomes included oral glucocorticoid use (cumulative prednisone-equivalent exposure), glucocorticoid-related AEs and the association of AE risk with glucocorticoid exposure over 52 weeks. Results: Of the 4804 patients in the US MarketScan database and 3973 patients in the UK CPRD database included, 71.3 and 74.6% were women and mean age was 73.4 and 73.0 years, respectively. Median starting glucocorticoid dose and cumulative glucocorticoid dose at 52 weeks were 20–50 mg/day and 4000–4800 mg, respectively. The most frequent glucocorticoid-related AEs were hypertension and eye, bone health, and glucose tolerance conditions. In the first year after diagnosis, the likelihood of any glucocorticoid-related AE was significantly increased for each 1 g increase in cumulative glucocorticoid dose in the US and UK cohorts (odds ratio [95% CI], 1.170 [1.063, 1.287] and 1.06 [1.03, 1.09], respectively; P&lt; 0.05 for both). Similar trends were observed for the risk of glucocorticoid-related AEs over full follow-up (mean, USA: 3.9 years, UK: 6.3 years). Conclusions: In real-world patients with GCA, increased cumulative glucocorticoid exposure was associated with an increased risk of glucocorticoid-related AEs. Funding: F. Hoffmann-La Roche Ltd. Plain Language Summary: Plain language summary available for this article.

Objective.Oral glucocorticoid (OGC) use for rheumatoid arthritis (RA) is debated because of the adverse event (AE) profile of OGC. We evaluated the associations between cumulative doses of OGC and potential OGC-related AE, and quantified the associated healthcare expenditures.Methods.Using the MarketScan databases, patients ≥ 18 years old who have RA with continuous enrollment from January 1 to December 31, 2012 (baseline), and from January 1 to December 31, 2013 (evaluation period), were identified. Cumulative OGC dose was measured using prescription claims during the baseline period. Potential OGC-related AE (osteoporosis, fracture, aseptic necrosis of the bone, type 2 diabetes, ulcer/gastrointestinal bleeding, cataract, hospitalization for opportunistic infection, myocardial infarction, or stroke) and AE-related expenditures (2013 US$) were gathered during the evaluation period. Multivariable regression models were fitted to estimate OR of AE and incremental costs for patients with AE.Results.There were 84,357 patients analyzed, of whom 48% used OGC during the baseline period and 26% had an AE during the evaluation period. A cumulative OGC dose > 1800 mg was associated with an increased risk of any AE compared with no OGC exposure (OR 1.19, 99.65% CI 1.09–1.30). Incremental costs per patient with any AE were significantly greater for cumulative OGC dose > 1800 mg compared with no OGC exposure (incremental cost = $3528, 99.65% CI $2402–$4793).Conclusion.Chronic exposure to low to medium doses of OGC was associated with significantly increased risk of potential OGC-related AE in patients with RA, and greater cumulative OGC dose was associated with substantially higher AE-related healthcare expenditures among patients with AE.

The aim of this study was to use multiple data sources to update information on gastrointestinal perforations (GIPs) during tocilizumab (TCZ) treatment in patients with rheumatoid arthritis (RA). Reporting rates of GIP events were estimated from three distinct patient data sets: a TCZ-IV RA clinical trial all-exposure population, a global TCZ postmarketing safety database population, and a US healthcare claims database population of patients with RA, including patients who received TCZ, anti-tumor necrosis factor (aTNF) agents, or abatacept. The clinical trial, global postmarketing, and healthcare claims populations provided 17,906, 382,621, and 3268 patient-years (PYs) of TCZ exposure, respectively. GIP incidence rates [95% confidence interval (CI)] were 1.9 (1.3–2.7), 1.2 (1.1–1.3), and 1.8 (0.7–4.0; specific definition) to 2.8 (1.3–5.2; sensitive definition) per 1000 PYs for the clinical trial, postmarketing, and healthcare claims populations, respectively. The GIP incidence rate (95% CI) for the comparator aTNF healthcare claims population ranged from 0.6 (0.3–1.2) to 0.9 (0.5–1.5) per 1000 PYs, for an absolute rate difference between TCZ and aTNFs of 1.2 (−0.3 to 2.5) to 1.9 (0.0–3.7) per 1000 PYs, corresponding to a number needed to harm between 533 and 828. The TCZ GIP event rates from multiple data sources were consistent with previously reported rates, did not increase over time, and were significantly associated with the number of prior biologics. Comparison of GIP incidence rates among patients with prior biologic exposure suggests that, for every 1000 patients treated with TCZ per year, an additional 1–2 GIP events might occur compared with patients treated with aTNFs. Roche.

Interstitial lung disease (ILD) is a common extra-articular condition in rheumatoid arthritis (RA), but few studies have systematically investigated its incidence and risk factors in patients receiving anti-tumor necrosis factor-alpha (anti-TNFα) agents or alternate mechanisms of action (MOAs) (e.g., T-cell, B-cell, and interleukin-6 inhibitors). RA patients at least 18 years old were selected from the MarketScan databases (2010–2012) if they had at least one prescription/administration of abatacept, rituximab, tocilizumab, or anti-TNF after having discontinued a different biologic agent and meeting enrollment criteria. Cox models estimated the risk of incident ILD and ILD-related hospitalization. Sensitivity analyses used an alternate ILD case definition. We identified 13,795 episodes of biologic exposure in 11,219 patients. Mean (standard deviation) follow-up was 0.7 (0.5) years. Patients receiving alternate MOA agents were more likely to have had recent exposure to steroids, prior exposure to a greater number of biologics, and history of ILD, anemia, chronic obstructive pulmonary disease, and other pulmonary conditions. When the sensitive definition was used, unadjusted ILD incidence rates (95 % confidence interval, or CI) ranged from 4.0 (1.6–8.2, abatacept) to 12.2 (5.6–23.2, infliximab) per 1000 person-years. Being older (hazard ratio (HR) 3.5; 95 % CI 2.1–6.0), being male (HR 3.1; 95 % CI 1.2–8.4), and having another pulmonary condition (HR 4.8; 95 % CI 1.7–13.7) were associated with increased ILD incidence in either sensitive and/or specific models. There were no significant differences by biologic class. Hospitalization rates (95 % CI) when the sensitive definition was used ranged from 55.6 (6.7–200.7, tocilizumab) to 262.5 (71.5–672.2, infliximab). In Cox models, recent methotrexate exposure was associated with reduced ILD hospitalization (HR 0.16; 95 % CI 0.06–0.46), whereas being male (HR 2.5; 95 % CI 1.3–4.8) and having had a hospitalization for asthma (HR 3.4; 95 % CI 1.2–9.8) or ILD/pneumonia (HR 2.3; 95 % CI 1.1–4.7) in the 12 months prior to index were associated with increased hospitalization risk. There were no significant differences in the risk of ILD and its related complications between RA patients receiving anti-TNFα agents and those receiving alternate MOA agents. Further studies are needed that account for differences in baseline characteristics in order to fully evaluate the risk of ILD and its complications.

OBJECTIVE: To assess the influence of biologic treatment patterns on healthcare costs for patients with rheumatoid arthritis (RA) initiating tumor necrosis factor-α (TNF-α) antagonist therapy. METHODS: Patients with 2 RA diagnoses (International Classification of Diseases, 9th ed, 714.xx), and without psoriasis or Crohn’s disease, were identified in a US employer-based insurance claims database. A sample of 2545 was constructed based on an index event of initiating TNF-α antagonist therapy and 30 months of continuous enrollment. Baseline characteristics were assessed in the 6-month pre-index period and treatment patterns were determined during the 12-month post-index period. Medical service and prescription drug costs were analyzed for Months 13–24 using multivariate regression analysis to control for baseline characteristics and time-varying confounding associated with treatment and disease severity. RESULTS: In the first year after TNF-α initiation, 89% used a single TNF-α antagonist; only 9% and 2% had switched TNF-α antagonists or received non-TNF biologic disease-modifying antirheumatic drugs, respectively. Descriptive analyses revealed pairwise differences between groups (p < 0.05) in baseline characteristics (comorbidities, RA-related procedure use, and prescription drug use). Controlling for observed baseline characteristics, costs were greater for those treated with multiple vs single TNF-α antagonists: annual RA-related prescription drug costs ($8,340 vs $7,058; p = 0.012), RA-related healthcare costs ($15,048 vs $13,312; p = 0.008), and total healthcare costs ($26,697 vs $21,381; p < 0.001). CONCLUSION: In this sample, the majority of patients with RA were treated with a single TNF-α antagonist over the first year on therapy. For those who switched therapy, Year 2 RA-related and total direct healthcare costs were higher, adjusting for claims-based measures of RA disease severity.

Insomnia is a chronic condition with significant burden on health care and productivity costs. Despite this recognized burden, very few studies have examined associations between insomnia severity and healthcare and productivity costs.

The individual contributions of behavior problems to key and related outcomes in dementia, such as nursing home admission (NHA) or caregiver burden, remain unclear.

Introduction:Despite advances in treatment, MM remains an incurable disease. RWD are key to improving our understanding of treatment patterns for patients with MM. This study examined the proportion of patients with MM (1) treated with an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), an anti-CD38 monoclonal antibody (aCD38), or Other in first line (1L) through fourth line or greater (4L+) by calendar year; and (2) who had a change in treatment regimen at line change. Subgroup analyses were performed by cytogenetic risk status (high vs. standard), stem cell transplant (SCT) eligibility (eligible vs. ineligible), and practice type (community vs. academic).

Gershon: Genentech, Inc./ F. Hoffmann-La Roche: Current Employment, Current equity holder in publicly-traded company. Liu:Genesis Research receives consulting fees from Genentech, Inc. a member of the F. Hoffmann-La Roche Group: Consultancy; Genesis Research: Current Employment. James:Genentech, Inc./ F. Hoffmann-La Roche: Current Employment, Current equity holder in publicly-traded company. Williamson:Amgen: Current equity holder in publicly-traded company; F. Hoffmann-La Roche: Current Employment, Current equity holder in publicly-traded company. Hong:Genentech, Inc.: Current Employment; F. Hoffmann-La Roche: Current equity holder in publicly-traded company. Sarsour:F. Hoffmann-La Roche: Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment.

BackgroundDespite widespread acceptance of NCEP guidelines, the extent of treatment of hyperlipidemia in patients with cardiovascular disease (CVD) remains poor. This analysis investigated factors associated with treatment with antihyperlipidemic agents in a US representative cohort of patients with evidence of CVD.

BackgroundThe Emerging Risk Factors Collaboration and JUPITER trial suggest elevated C-reactive protein (CRP) has an association with cardiovascular risk factors and outcomes in primary prevention populations. Less is known about CRP elevation frequency in subjects with known cardiovascular disease (CVD), particularly those with well-controlled traditional lipids (LDL, HDL, triglycerides). Our study objective was to quantify prevalence of and examine predictors of CRP elevation in a nationally representative secondary prevention sample meeting NCEP lipid targets.