This study aimed to determine the prevalence of rheumatoid arthritis in the United States (US) adult insured population from 2004 to 2014. This was an observational, retrospective, cross-sectional ...study based on US administrative health insurance claims databases (Truven Health MarketScan
®
Research database and IMS PharMetrics Plus database). Trends in RA prevalence focusing on the 10-year period covering January 1, 2004–December 31, 2014 were analyzed using a validated algorithm for the identification of RA. Prevalence rates in the databases were determined and age- and gender-adjusted rates were projected to the US population in 2014. Analysis of data from the two databases indicated that the RA prevalence rate in commercially insured adult US population ranged from 0.41 to 0.54% from 2004 to 2014. The prevalence varied substantially by gender and age in each year and increased gradually across the years for most subgroups. In 2014, out of 31,316,902 adult patients with continuous enrollment in the Truven Health MarketScan
®
Research database, 157,634 (0.50%) patients met our criteria for RA. Similarly, out of 35,083,356 adult patients in the IMS PharMetrics Plus database, 139,300 (0.50%) patients met our criteria for RA. In 2014, the overall age-adjusted prevalence of RA ranged from 0.53 to 0.55% (0.29–0.31% for males and 0.73–0.78% for females). The prevalence of RA in the US appeared to increase during the period from 2004 to 2014, affecting a conservative estimate of 1.28–1.36 million adults in 2014.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Tumor necrosis factor inhibitors (TNFi) are common second-line treatments for rheumatoid arthritis (RA). This study was designed to compare the real-world clinical and economic outcomes between ...patients with RA who responded to TNFi therapy and those who did not.
For this retrospective cohort analysis we used medical and pharmacy claims from members of 14 large U.S. commercial health plans represented in the HealthCore Integrated Research Database. Adult patients (aged ≥18 years) diagnosed with RA and initiating TNFi therapy (index date) between 1 January 2007 and 30 April 2014 were included in the study. Treatment response was assessed using a previously developed and validated claims-based algorithm. Patients classified as treatment responders in the 12 months postindex were matched 1:1 to nonresponders on important baseline characteristics, including sex, age, index TNFi agent, and comorbidities. The matched cohorts were then compared on their all-cause and RA-related healthcare resource use, and costs were assessed from a payer perspective during the first, second, and third years postindex using parametric tests, regressions, and a nonparametric bootstrap.
A total of 7797 patients met the study inclusion criteria, among whom 2337 (30%) were classified as treatment responders. The responders had significantly lower all-cause hospitalizations, emergency department visits, and physical/occupational therapy visits than matched nonresponders during the first-year postindex. Mean total all-cause medical costs were $5737 higher for matched nonresponders, largely driven by outpatient visits and hospitalizations. Mean all-cause pharmacy costs (excluding costs of biologics) were $354 higher for matched nonresponders. Mean RA-related pharmacy costs (conventional synthetic and biologic drugs), however, were $8579 higher in the responder cohort, driven by higher adherence to their index TNFi agent (p < 0.01 for all comparisons). A similar pattern of cost differentiation was observed over years 2 and 3 of follow-up.
In this real-world study we found that, compared with matched nonresponders, patients who responded to TNFi treatments had lower all-cause medical, pharmacy, and total costs (excluding biologics) up to 3 years from initiation of TNFi therapy. These cost differences between the two cohorts provide a considerable offset to the cost of RA medications and should encourage close monitoring of treatment response to minimize disease progression with appropriate therapy choices.
This study describes the current treatment landscape in adult atopic dermatitis (AD), overall and by disease severity.
Adult patients with an AD diagnosis in dermatology-specific electronic medical ...records during 2018 were identified and linked to an administrative claims database. Disease severity was determined using Physician's Global Assessment (PGA). Written and dispensed prescriptions, within and between class cycling for AD therapies occurring in 2018 were assessed.
In total, 4,364 patients were included. Among patients with available PGA, 43.2% had clear-to-mild, 37.3% had moderate, and 19.6% had severe disease. Most patients (71.0%) had written prescriptions for topical therapies only in 2018. Among the patients with claims for topical therapies alone, 80.7% used topical corticosteroids only. Within and between class cycling was observed in 33.7% and 12.8% of topical users, respectively. In patients with systemic therapy (40.6%), nearly 84.9% also used topical therapy, 25.8% cycled within systemic drug classes, and 24.8% cycled between systemic drug classes. Overall, cycling was more prevalent in patients with more severe disease.
Cycling within and between both topical and systemic drug classes was more common in patients with more severe disease, indicating difficulty of managing these patients and highlighting a need for more treatment options.
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DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Treatment for atopic dermatitis (AD) is complex, particularly in patients with inadequate response to topical therapies. Currently, there is little clinical guidance for the treatment of these ...patients.
A real-world retrospective study utilizing electronic medical records (EMR) and administrative claims data selected patients with AD between January 01 2016 and June 30 2018. Patients had a written prescription for a topical therapy (first observed script = index date) and no prior systemic treatment. Disease severity at index, follow-up treatment response and prescriptions patterns were assessed. A subset of patients linked to claims was evaluated for treatment patterns.
We identified 137,214 adult topical-treated AD patients with no prior systemic therapy. Among the 16,035 patients with available Physician Global Assessment (PGA) at index, 8169 (50.9%) had the moderate-to-severe disease. Among these patients, 60% had an inadequate response to topical therapy. Of 4475 patients linked to claims, 13.0% had claims for systemic therapy during follow-up, most initiated systemic steroids (95.2%), and oral immunosuppressants and biologics were initiated in 3.3% and 3.8%, respectively.
In this real-world study, inadequate response to topical therapy among moderate-to-severe AD patients was high and initiation of systemic treatment was low which suggests a need for additional AD-indicated systemic treatment options in this patient population.
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DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Although previous studies have reported the economic burden of atopic dermatitis (AD) in adults, updates are needed using more current data and measure of disease severity.
To describe the health ...care resource utilization (HCRU) and associated costs in US adults diagnosed with AD overall and by disease severity.
This real-world retrospective study identified adults aged at least 18 years who received a clinical diagnosis of AD in a dermatology electronic medical record (EMR) database between 2016 and 2018 (first record = index date), which was linked to an administrative claims database. Patients were required to have an AD diagnostic code and at least 6 months of continuous enrollment in medical and pharmacy benefits before and after the index date. Baseline severity was assessed using the Physician Global Assessment score closest to the index date. Inpatient and outpatient services, visits to specialists and its seasonality, treatment use, and associated annual direct health care costs were reported using descriptive statistics.
Annual all-cause direct health care costs were $10,474 per patient per year and primarily driven by outpatient visits and pharmacy use. Compared with patients with clear to mild disease, more AD patients with severe disease had at least 1 dermatology (73.0% vs 58.5%) and allergy/immunology office visit (16.0% vs 5.5%) and AD-related medications (90.0% vs 64.3%). All-cause total annual costs in patients with severe disease ($23,242) were significantly higher than in patients with clear to mild disease ($8,936;
= 0.0002). Little seasonal variation in dermatology office visits was observed.
Significant economic burden primarily driven by outpatient and pharmacy utilization was observed in AD patients, which increased with disease severity.
This work was sponsored by Eli Lilly and Company. Gorritz and Wade are employees of IQVIA, which was contracted by Eli Lilly and Company to conduct this study and develop the manuscript. Wang was employed by IQVIA at the time of this study. Malatestinic and Goldblum are employees and stockholders of Eli Lilly and Company. Boytsov was an employee of Eli Lilly at the time of this research.
Disease-modifying antirheumatic drugs (DMARDs) are recommended as the standard of care for patients with rheumatoid arthritis (RA) due to their ability to reduce pain and disability; however, DMARD ...use is low in some subgroups of the RA population.
To identify characteristics associated with DMARD use in the overall cohort of patients with RA and newly diagnosed RA patients.
This retrospective observational study used claims from a large national health plan. Use of DMARDs was measured according to the Healthcare Effectiveness Data and Information Set (HEDIS) as the proportion of patients with RA receiving DMARDs. Following HEDIS measure technical specifications, we identified patients aged 18-89 years with continuous enrollment during 2014 (measurement year) with ≥ 2 claims for RA outpatient visits and/or discharges on different dates between January and November 2014. Additionally, we identified a subset of patients newly diagnosed with RA in 2014 based on absence of any claims for RA or DMARDs in 2013. Descriptive analyses and bivariate associations were used to compare demographic and clinical characteristics of patients with RA with or without DMARD use in 2014. Health care resource utilization (HCRU) and costs were compared in 2014 for patients enrolled in Medicare Advantage Prescription Drug (MAPD) plans during both 2014 and 2015. Regression models were used to evaluate patient and provider characteristics associated with DMARD use in 2014 and the effect on HCRU and costs.
Among the 33,880 patients identified with RA in 2014, most patients received a DMARD (75.2%); 29.4% of patients newly diagnosed with RA had been treated with DMARDs in 2014. Patients with DMARD use, on average, were younger (aged 67 years ± 10.7 vs. 69 years ± 10.7) and healthier (Deyo-Charlson Comorbidity Index DCCI 2.4 ± 1.9 vs. 2.6 ± 2.1) and included a greater proportion of women (75.9% vs. 71.0%) than those with no DMARD use (
< 0.0001). Use of DMARDs (
< 0.0001) was associated with 14.5% fewer hospitalizations and 18.0% fewer emergency department visits. Although total costs increased by 15.0% with use of DMARDs, when the cost of DMARDs was excluded, the total cost decreased by 13.7% (
< 0.0001). Female gender (32.2%), higher claims-based index for RA severity score (47.0%), higher RxRisk-V score (26.7%), visit to a rheumatologist (34.3%), and use of glucocorticoids (17.7%) increased the odds of DMARD use (
< 0.0001). Use of certain classes of medication, such as nonsteroidal anti-inflammatory drugs (12.3%), opioids (19.5%), antidepressants (20.0%), muscle relaxants (12.5%), and anticonvulsants (15.5%), were associated with lower use of DMARDs (
< 0.0001).
We found significant differences in demographic and clinical characteristics between patients with and without DMARD use, which can potentially inform treatment decisions regarding DMARD use as deemed necessary by the provider. Future research should investigate the reasons for lack of treatment.
This study was supported by funding from Eli Lilly to Humana as a collaborative research project involving employees of both companies. Boytsov, Saverno, Zhang, and Gaich are employees of Eli Lilly. Nair, Bhattacharya, Abbott, and Dixon are employees of Humana, which received funding from Eli Lilly to complete this research.
BACKGROUND:Osteoporosis is prevalent in the United States, with an increasing need for management. In this study, we evaluated the effectiveness of a private orthopaedic practice-based osteoporosis ...management service (OP MS) in reducing subsequent fracture risk and improving other aspects of osteoporosis management of patients who had sustained fractures.
METHODS:This was a retrospective cohort study using the 100% Medicare data set for Michigan residents with any vertebral; hip, pelvic or femoral; or other nonvertebral fracture during the period of April 1, 2010 to September 30, 2014. Patients who received OP MS care with a follow-up visit within 90 days of the first fracture, and those who did not seek OP MS care but had a physician visit within 90 days of the first fracture, were considered as exposed and unexposed, respectively (first follow-up visit = index date). Eligible patients with continuous enrollment in Medicare Parts A and B for the 90-day pre-index period were followed until the earliest of death, health-plan disenrollment, or study end (December 31, 2014) to evaluate rates of subsequent fracture, osteoporosis medication prescriptions filled, and bone mineral density (BMD) assessments. Health-care costs were evaluated among patients with 12 months of post-index continuous enrollment. Propensity-score matching was used to balance differences in baseline characteristics. Each exposed patient was matched to an unexposed patient within ± 0.01 units of the propensity score. After propensity-score matching, Cox regression examined the hazard ratio (HR) of clinical and economic outcomes in the exposed and unexposed cohorts.
RESULTS:Two well-matched cohorts of 1,304 patients each were produced. The exposed cohort had a longer median time to subsequent fracture (998 compared with 743 days; log-rank p = 0.001), a lower risk of subsequent fracture (HR = 0.8; 95% confidence interval CI = 0.7 to 0.9), and a higher likelihood of having osteoporosis medication prescriptions filled (HR = 1.7; 95% CI = 1.4 to 2.0) and BMD assessments (HR = 4.3; 95% CI = 3.7 to 5.0). The total 12-month costs ($25,306 compared with $22,896 USD; p = 0.082) did not differ significantly between the cohorts.
CONCLUSIONS:A private orthopaedic practice-based OP MS effectively reduced subsequent fracture risk, likely through coordinated and ongoing comprehensive patient care, without a significant overall higher cost.
LEVEL OF EVIDENCE:Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Introduction
The aim of this work is to assess the feasibility of probabilistically linking randomized controlled trial (RCT) data to claims data in a real-world setting to inform future rheumatoid ...arthritis (RA) research.
Methods
This retrospective cohort study utilized IQVIA’s Patient Centric Medical Claims (Dx) Database, IQVIA’s Longitudinal Prescription Claims (LRx) Database, and Lilly’s baricitinib RCT data from a sample of patients that consented to the linkage of their de-identified insurance claims to their de-identified RCT data. Patients were initially matched on age, gender, and three-digit ZIP code of the provider and further matched according to a point scoring system using additional clinical variables.
Results
A total of 245 patients from 49 US clinical trial sites were eligible for the study and 78 (31.8%) of these patients consented to participate. Of the 78 consented patients, 69 (88%) were successfully matched on age, gender, and three-digit ZIP code of the provider. Of the 69 patients successfully matched on age, gender, and three-digit ZIP code of the provider, 44 (63.8%) had at least one sufficient match using the point scoring system. Of these 44, 23 (52.3%) patients matched at a ratio of one RCT patient to one Dx/LRx patient, 11 (25.0%) at a ratio of 1:2, 7 (15.9%) at a ratio of 1:3 and three (6.8%) at a ratio of 1:4 or greater. To further improve match ratios, a variable hierarchy was applied to the 18 RCT patients with 2–3 matches. Overall, 38 of the 78 (48.7%) consented RCT patients were successfully matched 1:1 to claims database patients.
Conclusions
This probabilistic linkage methodology demonstrates the feasibility, at a moderate linkage rate, of linking patients from RCTs to real-world data, which can provide a means to assess additional information not usually collected within or following a clinical trial.
Introduction
To describe treatment patterns in newly diagnosed rheumatoid arthritis (RA) patients in a large, nationally representative managed-care database.
Methods
Newly diagnosed RA patients were ...identified from 07/01/2006–08/31/2014. Patients had ≥ 1 RA diagnosis by a rheumatologist, or ≥ 2 non-rheumatologist RA diagnoses ≥ 30 days apart, or RA diagnosis followed by a disease-modifying antirheumatic drug (DMARD) prescription fill within 1 year. Patients were ≥ 18 years old at index (earliest date fulfilling diagnostic criteria) and had ≥ 6 and 12 months of pre- and post-index health plan enrollment, respectively. Patterns of DMARD treatment, including conventional synthetic DMARDs (csDMARD), tumor necrosis factor inhibitors (TNFi), non-TNFi, and Janus kinase inhibitors (JAKi), were captured during follow-up.
Results
Of the 63,101 RA patients identified, 73% were female; mean age was 57 years. During an average of 3.5 ± 2.1 years of follow-up, 45% of patients never received a DMARD, 52% received a csDMARD (94 ± 298 mean ± SD days from index), 16% a TNFi (315 ± 448 days), 4% a non-TNFi (757 ± 660 days), and < 1% a JAKi. Among DMARD recipients, the most common treatment patterns were: receiving csDMARDs only (68%), adding a TNFi as second-line therapy after initiation of a csDMARD (12%), and receiving only a TNFi (6%) during follow-up. Among those not on DMARDs, the all-cause usage of an opioid was 56% and 19% had chronic opioid use (≥ 180 days supplied).
Conclusions
Despite American College of Rheumatology recommendations for DMARD treatment of RA, nearly half of newly diagnosed RA patients received no DMARD therapy during follow-up. These data identify a treatment gap in RA management.
Funding
Eli Lilly & Company.
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