Ixekizumab has demonstrated efficacy in pivotal trials in patients with psoriatic arthritis (PsA), both those naïve to prior biologic therapy and those with prior inadequate response or intolerance ...to biologics; however, minimal information is currently available on the effectiveness of ixekizumab in routine clinical practice. The objective of this study was to investigate the clinical effectiveness of ixekizumab for the treatment of PsA over 6- and 12-month follow-up periods in a real-world setting.
This retrospective cohort study included patients who initiated treatment with ixekizumab from the OM1 PremiOM
PsA dataset, a dataset of over 50,000 patients with claims and electronic medical record (EMR) data. Changes in musculoskeletal outcomes, such as tender and swollen joint count and patient-reported pain, as well as physician and patient global assessment, as measured using the Clinical Disease Activity Index (CDAI), and Routine Assessment of Patient Index Data 3 (RAPID3) were summarized at 6 and 12 months. The RAPID3, CDAI score, and their individual components were assessed in multivariable regressions adjusting for age, sex, and baseline value. The results were stratified by biologic disease-modifying antirheumatic drug (bDMARD) status (naïve vs. experienced) and monotherapy status (monotherapy vs. combination therapy with conventional synthetic DMARDs). Changes in a 3-item composite score derived from a physician global assessment, patient global assessment, and patient-reported pain score were summarized.
Among the 1,812 patients identified receiving ixekizumab, 84% had prior bDMARD treatment and 82% were monotherapy users. All outcomes improved at 6 and 12 months. For RAPID3, the mean (SD) change at 6 and 12 months was -1.2 (5.5) and -1.2 (5.9), respectively. Patients overall, bDMARD experienced, and monotherapy patients achieved statistically significant mean change in CDAI and all components from baseline to 6 and 12 months in adjusted analyses. Patients experienced an improvement in the 3-item composite score at both time points.
Treatment with ixekizumab was associated with improvements in musculoskeletal disease activity and PROs as assessed by several outcome measures. Future research should assess ixekizumab's clinical effectiveness in the real world across all PsA domains using PsA-specific endpoints.
Background
There is limited evidence on the clinical and economic benefit of achieving disease control in psoriatic arthritis (PsA) and ankylosing spondylitis (AS), thus we aimed to assess the impact ...of disease control on healthcare resource use (HCRU) and direct medical costs among US patients with PsA or AS over 1 year.
Methods
Data were derived from the US OM1 PsA/AS registries (PsA: 1/2013–12/2020; AS: 01/2013–4/2021) and the Optum Insight Clinformatics® Data Mart to identify adult patients with PsA or AS. Two cohorts were created: with disease control and without disease control. Disease control was defined as modified Disease Activity Index for Psoriatic Arthritis (DAPSA28) ≤ 4 for PsA and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) < 4 for AS. Outcomes were all-cause inpatient, outpatient, and emergency department (ED) visits and associated costs over a 1-year follow-up period. Mean costs per person per year (PPPY) were assessed descriptively and adjusted odds ratios (aOR) with 95% confidence intervals (CI) were estimated for the likelihood of HCRU by logistic regression.
Results
The study included 1235 PsA (with disease control:
N
= 217; without:
N
= 1018) and 581 AS patients (with disease control:
N
= 342; without:
N
= 239). Patients without disease control were more likely to have an inpatient (aOR 95% CI; PsA: 3.0 0.9, 10.1; AS: 7.7 2.3, 25.1) or ED (PsA: 1.6 0.6, 4.2; AS: 3.5 1.5, 8.3) visit than those with disease control. Those without disease control, vs. those with disease control, had greater PPPY costs associated with inpatient (PsA: $1550 vs. $443), outpatient (PsA: $1789 vs. $1327; AS: $2498 vs. $2023), and ED (PsA: $114 vs. $57; AS: $316 vs. $50) visits.
Conclusions
Findings from this study demonstrate lower disease activity among patients with PsA and AS is associated with less HCRU and lower costs over the following year.
Patients with psoriasis and psoriatic arthritis have a higher prevalence of cardiometabolic comorbidities compared to the general population. Clinical data suggest apremilast may reduce weight and ...glycated hemoglobin (HbA1c).
To describe changes in cardiometabolic parameters among patients with psoriasis and psoriatic arthritis newly treated with apremilast by prediabetes/diabetes or obesity status.
This was a retrospective cohort study of electronic medical records from patients with psoriasis and/or psoriatic arthritis in the OM1 Real-World Data Cloud who newly initiated apremilast. Changes from baseline in body mass index, weight, HbA1c, and lipids were evaluated at 6 and 12 months using a multivariable linear regression model stratified by prediabetes/diabetes or obesity status.
Of 8487 patients initiating apremilast, 24% had diabetes. Of 8250 patients with body mass index available, 27% were obese and 34% were severely obese. Patients experienced decreases in body mass index and weight at 6 and 12 months regardless of diabetes or obesity status, with the greatest reductions seen in those with diabetes and obesity. Reductions in HbA1c at 6 months were seen in patients without diabetes and patients with severe obesity.
Treatment with apremilast may provide the greatest cardiometabolic benefit to those with the greatest burden of cardiometabolic disease.
Abstract only
e18347
Background: DLBCL, the most common type of non-Hodgkin lymphoma in the US, is associated with significant morbidity and mortality. In October 2015, DLBCL was differentiated from ...other related lymphoma entities with the advent of ICD-10-CM DLBCL-specific codes. With limited real-world data on patients (pts) with DLBCL in the modern treatment era, this study was conducted to characterize these pts. Methods: A retrospective study was conducted using the Optum Clinformatics Data Mart database (01/2013–03/2018). Pts ≥ 18 years of age with ≥ 1 hospitalization or ≥ 2 outpatient visits with an ICD-10-CM diagnosis code for DLBCL (or an antecedent diagnosis of other lymphoma, which may have been assigned before confirmation of DLBCL) after October 1
st
, 2015 (index date) and no prior ICD-9-CM code for unspecified DLBCL were identified as incident. Pts with an ICD-9-CM code for unspecified DLBCL before October 2015 (index date) were classified as prevalent. At least 12 months of continuous enrollment pre-index date (baseline period) was required. Pts with ICD-10-CM code for primary mediastinal B-cell lymphoma (PMBCL), baseline diagnoses of other malignancies such as Hodgkin lymphoma and multiple myeloma were excluded. Characteristics, including baseline comorbidities, healthcare resource utilization, and costs were assessed. Results: Among 4,074 DLBCL pts (3,201 incident; 873 prevalent), mean age ± standard deviation (SD) was 71 ± 12 years; 46% were female. Incident and prevalent pts had mean Charlson comorbidity index scores of 2.7 and 2.3, respectively. Most common baseline Elixhauser comorbidities were hypertension (68.4%), diabetes (31.1%), and cardiac arrhythmia (25.3%) in incident pts and hypertension (62.5%), diabetes (28.3%), and chronic pulmonary disease (20.6%) in prevalent pts. Mean ± SD number of baseline hospitalizations was 0.32 ± 0.83 and 0.21 ± 0.49 in incident and prevalent pts, respectively. Total mean ± SD baseline healthcare costs (before diagnosis) were $24,621 ± 45,628 for incident pts and $19,137 ± 29,307 for prevalent pts. Conclusions: This study documents substantial co-morbid and economic burden of incident as well as prevalent pts with DLBCL.
Abstract only Introduction: Real-world data describing acute pericarditis (AP) etiology in the US are limited. Data on the characteristics of recurrent pericarditis (RP) patients (pts) are also ...sparse. To fill this gap, our study assesses longitudinal data from a nationwide privately-insured population. Methods: OptumHealth Reporting and Insights employer claims data (1/2007-3/2017) were used. AP pts were identified and categorized as idiopathic or non-idiopathic etiology based on presence or absence of attributable conditions. Among idiopathic AP pts, a subgroup of RP pts was identified. Recurrence was defined as ≥2 AP events separated by >4 weeks. First recurrence date marked the index date. Pts aged ≥18 years with ≥12 months of continuous enrollment pre-index (baseline) were included. Results: Of 17,168 AP pts, 4,175 (24.3%) had non-idiopathic and 12,993 (75.7%) had idiopathic etiology (Table 1). Application of inclusion criteria left 8,822 idiopathic AP pts, of whom 1,604 (18.2%) had ≥1 recurrence during a mean observation period of 29 months. On average, idiopathic RP pts were aged 50.7 years, 51.6% female, and 42.3% had baseline history of hypertension, 23.8% of coronary artery disease, 11.7% of hypercholesterolemia, and 7.3% of myocardial infarction. Mean (±SD) time from initial AP diagnosis to first recurrence was 8.7 (±12.1) months and mean (±SD) number of recurrences was 1.7 (±1.3) per pt. In idiopathic RP pts with ≥4 years of follow-up after the initial AP diagnosis (N=512), 35.9% had ≥2, 18.2% had ≥3, and 9.8% had ≥4 recurrences within 4 years. Conclusions: The etiologic distribution and proportion of pts with RP are consistent with previous reports. About 36% of RP pts experience ≥2 recurrences after AP diagnosis over 4 years. RP represents a significant clinical burden for affected pts.
Introduction: Patients with psoriasis and psoriatic arthritis have a higher prevalence of cardiometabolic comorbidities compared to the general population. Clinical data suggest apremilast may reduce ...weight and glycated hemoglobin (HbA1c). Objective: To describe changes in cardiometabolic parameters among patients with psoriasis and psoriatic arthritis newly treated with apremilast by prediabetes/diabetes or obesity status. Methods: This was a retrospective cohort study of electronic medical records from patients with psoriasis and/or psoriatic arthritis in the OM1 Real-World Data Cloud who newly initiated apremilast. Changes from baseline in body mass index, weight, HbA1c, and lipids were evaluated at 6 and 12 months using a multivariable linear regression model stratified by prediabetes/diabetes or obesity status. Results: Of 8487 patients initiating apremilast, 24% had diabetes. Of 8250 patients with body mass index available, 27% were obese and 34% were severely obese. Patients experienced decreases in body mass index and weight at 6 and 12 months regardless of diabetes or obesity status, with the greatest reductions seen in those with diabetes and obesity. Reductions in HbA1c at 6 months were seen in patients without diabetes and patients with severe obesity. Conclusions: Treatment with apremilast may provide the greatest cardiometabolic benefit to those with the greatest burden of cardiometabolic disease.
To compare obesity-related costs of employees of the healthcare industry versus other major US industries.
Employees with obesity versus without were identified using the Optum Health Reporting and ...Insights employer claims database (January, 2010 to March, 2017). Employees working in healthcare with obesity were compared with employees of other industries with obesity for absenteeism/disability and direct cost differences. Multivariate models estimated the association between industries and high costs compared with the healthcare industry.
Obesity-related absenteeism/disability and direct costs were higher in several US industries compared with the healthcare industry (adjusted cost differences of $-1220 to $5630). Employees of the government/education/religious services industry (GERS) with obesity (BMI of 30 or greater) had significantly higher odds of direct costs at the 80th percentile and above (odds ratio vs healthcare industry = 2.20; P < 0.05).
Relative to the healthcare industry, employees of other industries, especially GERS, incurred higher obesity-related costs.
IntroductionReal-world data describing acute pericarditis (AP) etiology in the United States are limited. Information on characteristics of recurrent pericarditis (RP) patients (pts) are also sparse. ...To fill this gap, our study assesses longitudinal data from a nationwide privately-insured population.MethodsOptumHealth Reporting and Insights employer claims data (1/2007-3/2017) were used. AP pts were identified and categorized as idiopathic or non-idiopathic etiology based on presence or absence of attributable conditions. Among idiopathic AP pts, a subgroup of RP pts was identified. Recurrence was defined as ≥2 AP events separated by >4 weeks. First recurrence date marked the index date. Pts aged ≥18 years with ≥12 months of continuous enrollment pre-index were included.ResultsOf 17,168 AP pts, 4,175 (24.3%) had non-idiopathic and 12,993 (75.7%) had idiopathic etiology (Table 1). Application of inclusion criteria left 8,822 idiopathic AP pts, of whom 1,604 (18.2%) had ≥1 recurrence during a mean observation period of 29 months. Idiopathic RP pts were aged 50.7 years (mean), 51.6% female, and had history ofhypertension (42.3%), coronary artery disease (23.8%), hypercholesterolemia (11.7%), and prior MI (7.3%). Mean (±SD) time from initial AP diagnosis to first recurrence was 8.7 (±12.1) months and mean (±SD) number of recurrences was 1.7 (±1.3) per pt. In idiopathic RP pts with ≥4 years of follow-up after the initial AP diagnosis (N=512), 35.9% had ≥2, 18.2% had ≥3, and 9.8% had ≥4 recurrences within 4 years.ConclusionsUse of claims data to infer etiology is a limitation that may explain lower rates of idiopathic etiology vs. prior studies. Nevertheless, high rates of cardiovascular disease and persistent recurrences suggest a subset of pts with significant clinical burden.
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