Objective
To estimate prevalence and incidence of cardiovascular (CV) risk factors of hypertension, diabetes mellitus, hyperlipidemia, and obesity in patients with rheumatoid arthritis (RA), ...psoriasis, or psoriatic arthritis (PsA).
Methods
Patients with RA, psoriasis, or PsA were identified based on medical and pharmacy claims from the MarketScan claims databases from January 1, 2002 through December 31, 2014. Primary outcomes included age‐ and sex‐standardized prevalence of CV risk factors during the 12 months preceding diagnosis date and incidence rates per 1,000 patient‐years, with 95% confidence intervals (95% CIs) during followup.
Results
Prevalence for RA, psoriasis, and PsA cohorts for hypertension was 18.6% (95% CI 18.3–18.8), 16.6% (95% CI 16.3–17.0), and 19.9% (95% CI 19.4–20.4), respectively; for diabetes mellitus 6.2% (95% CI 6.1–6.4), 6.3% (95% CI 6.0–6.5), and 7.8% (95% CI 7.4–8.2); for hyperlipidemia 9.9% (95% CI 9.7–10.1), 10.4% (95% CI 10.2–10.7), and 11.6% (95% CI 11.2–12.0); and for obesity 4.4% (95% CI 4.2–4.6), 3.8% (95% CI 3.5–4.0), and 6.0% (95% CI 5.6–6.5). Incidence rates per 1,000 patient‐years during followup for RA, psoriasis, and PsA cohorts, respectively, for hypertension were 74.0 (95% CI 72.5–75.5), 68.2 (95% CI 65.9–70.4), and 79.8 (95% CI 76.3–83.3); for diabetes mellitus 10.6 (95% CI 10.1–11.1), 13.0 (95% CI 12.1–13.8), and 14.7 (95% CI 13.5–16.0); for hyperlipidemia 40.3 (95% CI 39.4–41.3), 47.1 (95% CI 45.4–48.7), and 52.0 (95% CI 49.6–54.3); and for obesity 24.4 (95% CI 23.4–25.4), 26.4 (95% CI 25.0–27.8), and 32.9 (95% CI 30.6–35.2).
Conclusion
Patients with RA, psoriasis, and PsA have high prevalence and incidence of CV risk factors, suggesting the need for risk factor monitoring of these patients.
Background/Objective
Compared with the adult psoriasis population, knowledge about the incidence of comorbidities in the pediatric psoriasis population is limited. The objective of this study was to ...assess the prevalence and incidence of comorbidities, including psychiatric comorbidities, in patients with pediatric psoriasis.
Methods
In this claims‐based, retrospective cohort study, patients with pediatric psoriasis were matched 1:3 with a nonpsoriasis cohort based on age, sex, and index date (the earliest of inpatient claims or the latter of two outpatient claims).
Results
Obesity, serious infection, and juvenile idiopathic arthropathy had higher prevalence and incidence rates in the psoriasis cohort than the nonpsoriasis cohort. Psychiatric comorbidities were also more common in the psoriasis cohort than the nonpsoriasis cohort, as were ulcerative colitis and Crohn disease. Stratifying the psoriasis cohort by disease severity—mild and moderate‐to‐severe—found no differences in incidence rates of comorbidities between the two subsets.
Conclusion
The incidence rates of many comorbid conditions were higher for patients with pediatric psoriasis compared with patients without pediatric psoriasis, and similar between patients with moderate‐to‐severe and mild pediatric psoriasis.
Objective
This retrospective analysis examined how sustained remission impacted risk of serious infections in patients with rheumatoid arthritis (RA) enrolled in a clinical registry.
Methods
...Inclusion criteria included RA diagnosis, age ≥18 years, and ≥2 Clinical Disease Activity Index (CDAI) scores followed by a followup visit. Index date was the second of 2 visits in which a patient had sustained remission (CDAI ≤2.8), low disease activity (LDA; 2.8 < CDAI ≤10), or moderate‐to‐high disease activity (MHDA; CDAI >10). Followup extended from the index date until first serious infection (requiring intravenous antibiotics or hospitalization) or last followup visit. The crude incidence rate (IR) per 100 patient‐years for serious infections was calculated for the sustained remission, LDA, and MHDA groups. The multivariable‐adjusted incidence rate ratio (IRR) (adjusted for age, sex, and prednisone dose) compared serious infection rates across disease activity groups.
Results
Most patients were female (>70%); mean age was approximately 60 years. The crude IR (95% confidence interval 95% CI) per 100 patient‐years for serious infections was 1.03 (0.85–1.26) in the sustained remission group (n = 3,355), 1.92 (1.68–2.19) in the sustained LDA group (n = 3,912), and 2.51 (2.23–2.82) in the sustained MHDA group (n = 5,062). Compared to sustained remission, the serious infection rate was higher in sustained LDA (adjusted IRR 1.69 95% CI 1.32–2.15). Compared to sustained LDA, the serious infection rate was higher in sustained MHDA (adjusted IRR 1.30 95% CI 1.09–1.56).
Conclusion
In this study, lower RA disease activity was associated with lower serious infection rates. This finding may motivate patients and health care providers to strive for remission rather than only LDA.
Background OBSERVE-5 was a 5-year Food and Drug Administration–mandated surveillance registry of patients with psoriasis. Objective We sought to assess long-term etanercept safety and effectiveness. ...Methods Patients with moderate to severe psoriasis enrolled; a single baseline dose of etanercept was required. Key outcome measures included serious adverse events, serious infectious events, events of medical interest, psoriasis-affected body surface area, physician global assessment score, and Dermatology Life Quality Index score. Safety outcomes were assessed relative to data from the MarketScan database. Results For 2510 patients, 5-year cumulative incidence was 22.2% (95% confidence interval CI 20.3%-24.2%) for serious adverse events; 6.5% (95% CI 5.4%-7.7%) for serious infectious events; 3.2% (95% CI 2.3%-4.1%) for malignancies excluding nonmelanoma skin cancer; 3.6% (95% CI 2.7%-4.5%) for nonmelanoma skin cancer; 2.8% (95% CI 2.0%-3.6%) for coronary artery disease; 0.7% (95% CI 0.3%-1.2%) for psoriasis worsening; 0.2% (95% CI 0.0%-0.4%) for central nervous system demyelinating disorder; 0.1% (95% CI 0.0%-0.3%) for lymphoma and for tuberculosis; and 0.1% (95% CI 0.0%-0.2%) for opportunistic infection and for lupus; 55 fatal events were reported. Rates of malignancies, lymphomas, nonmelanoma skin cancer, and hospitalization-associated infections were not higher than expected relative to administrative claims data. The percentage of patients rated as clear/almost clear was 12% at baseline, which increased to 51% at month 6 and remained relatively stable throughout 5 years. Limitations No internal comparator group was included; rare events may not have been detected. Conclusion No new safety signals were observed with long-term, real-world etanercept use.
Objective
To describe the incidence of subsequent serious infections in patients who received systemic drug therapy after an initial serious infection.
Methods
Patients with rheumatic conditions ...(rheumatoid arthritis RA, psoriatic arthritis, ankylosing spondylitis) or psoriasis who experienced a serious infection between January 1, 2006 and December 31, 2011 were identified in a claims database. Patients were required to be continuously enrolled in the Truven Health Analytics MarketScan Research Database for 12 months prior to and at least 60 days after the date of discharge or the end of intravenous antibiotic therapy for the index serious infection. Subsequent serious infection incidence rates per 100 patient‐years with 95% confidence intervals (95% CIs) were calculated for up to 18 months post‐index, starting 60 days post‐index. Cox proportional hazards models were used to adjust for baseline demographic and clinical characteristics, treatment duration, and changes during followup.
Results
Among the 21,699 patients who met the inclusion criteria, the majority (84.3%) had RA. Patients who received tumor necrosis factor (TNF) inhibitor therapy after their index infection had a lower rate of subsequent serious infections (18.1 per 100 patient‐years for those treated with a TNF inhibitor alone and 17.3 per 100 patient‐years for those treated with a TNF inhibitor plus a nonbiologic disease‐modifying antirheumatic drug DMARD) compared with those treated with a nonbiologic DMARD alone (21.4 per 100 patient‐years). Etanercept, either alone (adjusted hazard ratio HR 0.87, 95% CI 0.77–0.99) or in combination with a nonbiologic DMARD (adjusted HR 0.76, 95% CI 0.66–0.88), and infliximab (only in combination with a nonbiologic DMARD) (adjusted HR 0.80, 95% CI 0.67–0.95) were associated with a significantly lower risk of subsequent serious infections compared with a nonbiologic DMARD alone.
Conclusion
We did not observe an increased risk of subsequent infection in patients who received TNF inhibitor treatment following a serious infection. The risk of a subsequent serious infection was lower in patients treated with both a TNF inhibitor and a nonbiologic DMARD compared with that in patients treated with a nonbiologic DMARD alone.
Objective
To examine disease‐modifying antirheumatic drug (DMARD) treatments and estimate the risk of a subsequent cardiovascular (CV) event following an initial CV event in patients with rheumatoid ...arthritis (RA), psoriatic arthritis (PsA), or psoriasis.
Methods
We analyzed data from MarketScan claims databases (January 1, 2006 to June 30, 2015) for adults with RA, PsA, or psoriasis and an initial/index CV event (acute myocardial infarction, stroke, or coronary revascularization) while receiving DMARDs (tumor necrosis factor inhibitor TNFi biologic DMARDs bDMARDs, conventional synthetic DMARDs csDMARDs, or non‐TNFi bDMARDs). We studied DMARD treatment patterns following the index event and rates of subsequent CV events. We used Cox regression to investigate predictors of DMARD discontinuation and risk factors for subsequent CV events.
Results
Among 10,254 patients, 15.3% discontinued and 15.5% switched DMARD therapy after the index CV event. Independent predictors of DMARD discontinuation included a psoriasis diagnosis, renal disease, hypertension, heart failure, diabetes mellitus, older age, and baseline csDMARD or non‐TNFi bDMARD use (versus TNFi bDMARDs). Rates per 1,000 patient‐years of subsequent events were 75.2 (95% confidence interval 95% CI 54.4–96.0) for patients taking TNFi bDMARDs, 83.6 (95% CI 53.3–113.9) for csDMARDs, and 122.4 (95% CI 60.6–184.3) for non‐TNFi bDMARDs. A diagnosis of RA (versus psoriasis) and heart failure at baseline, but not a DMARD pattern after the index event, were independently associated with an increased risk of subsequent CV event.
Conclusion
In this large nationwide study, nearly one‐third of patients with RA, PsA, or psoriasis switched or discontinued DMARD therapy following a CV event. There was no association between DMARD class and the risk of a subsequent CV event.
Evaluated real world use of bevacizumab-awwb (MVASI
), a bevacizumab biosimilar, for treating metastatic colorectal cancer (mCRC).
Adult mCRC patients who received bevacizumab-awwb during the first ...year after market availability were identified from the ConcertAI oncology dataset.
Of 304 patients, 47% initiated bevacizumab-awwb as reference product (RP) naive patients and 53% received bevacizumab-awwb with prior exposure to RP. Overall, 78% received bevacizumab-awwb as first-line therapy; the proportion was higher (91%) in RP-naive patients. Among RP-experienced patients, 83% were transitioned from RP to bevacizumab-awwb in the same line without disease progression; of those, the majority (83%) were transitioned within 28 days.
Early evidence from US oncology practices suggests clinical adoption of bevacizumab-awwb in treating mCRC patients.
Abstract
Background
A previous analysis of the Veterans Affairs Rheumatoid Arthritis (VARA) registry showed that more than half of the patients with rheumatoid arthritis (RA) did not receive a major ...therapeutic change (MTC) despite moderate or severe disease activity. We aimed to empirically determine disease activity thresholds associated with a decision by rheumatologists and nurse practitioners to institute a MTC in patients with RA and to report the impact of that change on RA disease activity.
Methods
We analyzed data from the VARA registry between January 1, 2006, and September 30, 2017. Eligible patients had a visit with 3 disease activity measures (DAMs) recorded: Disease Activity Score for 28 joints (DAS28), Clinical Disease Activity Index (CDAI), and Routine Assessment of Patient Index Data 3 (RAPID3). The Youden Index was used to identify disease activity thresholds that best discriminated rheumatologist/nurse practitioner decision to initiate MTC. Clinical outcome was 20% improvement in the American College of Rheumatology criteria (ACR20 response). The effect of MTC on ACR20 response was presented as crude descriptive statistics and evaluated using G-computation for marginal and conditional effects with established disease activity level combined with an empirical threshold from Youden analysis.
Results
The study population comprised 1776 patients (12,094 visits: 3077 with MTC, 9017 without MTC). Empirical thresholds (95% bootstrap confidence interval with 1000 replications) for MTC were 4.03 (3.70–4.36) for DAS28, 12.9 (10.4–15.4) for CDAI, and 3.81 (3.32–4.30) for RAPID3. Visits with MTC had increased likelihood of ACR20 response: risk ratios for ACR20 response for visits with MTC vs without MTC ranged 1.2–2.6 across DAMs; risk differences ranged 0.2–14.5%.
Conclusions
MTC was associated with clinical improvement across all DAMs with the greatest change in patients with RA disease activity above the Youden threshold identified in this work.
Trial registration
VARA Registry,
https://www.hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141698764
Objective
To examine the impact of major therapeutic change (MTC) on clinical response across a broad range of disease activity in US veterans with rheumatoid arthritis (RA).
Methods
This historical ...cohort analysis evaluated patient visits from the Veterans Affairs RA registry between January 1, 2006 and September 30, 2017. Eligible patient visits were a rheumatology visit with 3 disease activity measures, including the Disease Activity Score in 28 joints, the Clinical Disease Activity Index, and the Routine Assessment of Patient Index Data 3; the follow‐up visit for all 3 disease activity measures was 2–6 months later. The full population and a subset of patients with active disease (≥6 tender joints, ≥6 swollen joints) were evaluated. Clinical outcome was based on the American College of Rheumatology criteria for 20% improvement in disease activity (ACR20). The effect of MTC on ACR20 response was presented as crude descriptive statistics and evaluated using standardized regression for population‐ and disease activity–level conditional effects.
Results
The full population comprised 1,208 patients (6,138 visits) and the active disease subpopulation included 383 patients (1,109 visits). Overall, visits with MTC were associated with increased likelihood of ACR20 response across all disease activity measures for the full population. Risk ratios for overall risk of ACR20 response for visits with MTC versus those without MTC ranged from 1.67 to 2.22 across disease activity measures among the full population and from 1.51 to 1.60 for the subpopulation with active disease.
Conclusion
MTC was associated with clinical improvement, even among patients with longstanding RA who had received multiple prior therapies, which emphasizes the utility of therapy modifications for patients with established and active RA.
Purpose
Objectives were to quantify prevalence estimates of pregnancy and infant outcomes including major congenital malformations (MCMs) by etanercept (ETN) exposure among infants born to women with ...chronic inflammatory arthritis (cIA) or psoriasis (PsO).
Methods
Claims‐based data delineated pregnancy exposures and outcomes of live or nonlive births among women with cIA and PsO (ETN exposed, unexposed) and general population (GP) comparators. Infant outcomes were determined for live‐born infants covered by the mother's insurer. Medical records were obtained from all accessible mother‐infant pairs with claims for MCMs and a random sample of mothers. Multivariable logistic regression estimated the odds ratios (ORs) of having at least one algorithm‐defined MCM in the ETN‐exposed cohorts versus unexposed comparators.
Results
Prevalence estimates for pregnancy outcomes were comparable across cIA and PsO cohorts. Algorithm‐defined prevalence estimates of having at least one MCM were 6.1% (ETN exposed), 5.5% (unexposed), and 5.7% (GP cohort) for the cIA cohort; PsO cohort estimates were 2.0%, 4.2%, and 4.7%, respectively. The ETN‐exposure ORs for having at least one algorithm‐defined MCM among infants of cIA mothers was 1.03 (95%CI: 0.51‐2.10) and 0.39 (95%CI: 0.05‐2.98) among infants of PsO mothers. Logistic regression with inverse probability of treatment weighting that included disease state resulted in an OR of 0.65 (0.24, 1.72).
Conclusions
Overall, this study did not identify any new safety concerns associated with the use of etanercept during pregnancy. Etanercept, along with the other TNFis, remains a treatment without well‐controlled clinical trials in pregnant women. Patients should continue to consult their doctor regarding benefit risk decisions of TNFi therapy during pregnancy.
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