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Objectives Osteoarthritis can have a profound effect on patients’ quality of life. The Burden of Disease and Management of Osteoarthritis and Chronic Low Back Pain: Health Care Utilization and Sick Leave in Sweden, Norway, Finland and Denmark (BISCUITS) study aimed to describe the impact of osteoarthritis on quality of life and determine the association with factors such as pain severity and pharmacological treatment. Methods An observational study was performed with a cross-sectional design including patients with a confirmed osteoarthritis diagnosis enrolled in the National Quality Register for Better management of patients with Osteoarthritis (BOA) between 2016 and 2017 in Sweden. Patient-reported information from BOA was linked to administrative data from three national health registers. The impact of osteoarthritis on quality of life was estimated using the EQ-5D-5L and the first developed experienced-based time-trade-off value set for Sweden to calculate the EQ-5D-5L index scores. EQ-5D-3L index scores were also estimated based on a UK hypothetical value set via a crosswalk method. Ordinary least squares regression models were used to analyse the association between quality of life and potential influencing factors. Results For the 34,254 patients evaluated, mean EQ-5D-5L index score was 0.792 (SD 0.126). Stratifications showed that the index score varied across different levels of pain severity. Increased pain severity and use of pain-relieving medications remained significantly associated with a lower quality of life index score when controlled for potential confounders. The mean EQ-5D-3L index score was 0.605 (SD 0.192). Conclusions This large population-based study from Sweden highlights the substantial impact of osteoarthritis on quality of life amongst different patient groups and that currently available treatment options for osteoarthritis pain do not appropriately address the needs for many osteoarthritis patients.

Objectives: Examine short-term disability (STD) and workers’ compensation (WC) associated leave and wage replacements, and overall direct healthcare payments, among employees with osteoarthritis (OA) versus other chronically painful conditions; quantifying the impact of opioid use. Methods: Analysis of employees with more than or equal to two STD or WC claims for OA or pre-specified chronically painful conditions (control) in the IBM MarketScan Research Databases (2014 to 2017). Results: The OA cohort (n = 144,355) had an estimated +1.2 STD days, +$152 STD payments, and +$1410 healthcare payments relative to the control cohort (n = 392,639; P

Background: While prior research has shown that patients with osteoarthritis (OA) who are prescribed opioids have higher rates of falls and fractures following drug initiation, there is a limited body of work establishing a comprehensive model of factors that influence the risk of falls or fractures among these patients. Objective: Opioids are associated with negative clinical outcomes, including increased risk of falls and fractures. This study assessed the frequency, treatment characteristics, and risk factors associated with falls or fractures among patients with OA taking opioids. Methods: Optum Healthcare Solutions, Inc data (January 2012–March 2017) were used to identify patients over 18 with at least 2 diagnoses of hip and/or knee OA, and at least 90 days’ supply of opioids. Patients with cancer were excluded. Falls or fractures outcomes were assessed in the 36-month follow-up period after the date of the first opioid prescription after first OA diagnosis. Demographic, treatment, and clinical characteristics associated with falls or fractures were assessed using logistic regression. Results: Of 16 663 patients meeting inclusion criteria, 3886 (23%) had at least 1 fall or fracture during follow-up. Of these 3886 patients, 1349 (35%) had at least 1 fall with an average of 3 fall claims, and 3299 (85%) patients had at least 1 fracture with an average of 8 claims during follow-up. Spine (15.8%) and hip (12.5%) fractures were most common. Median time to fall or fracture was 18.6 and 13.9 months, respectively. Significant (PDiscussion: This study is among only a few that clearly identifies the substantial impact and frequency of falls and fractures associated with prescribing non-tramadol opioids to patients with OA. Findings suggest that fall or fracture risks need to be considered when managing OA pain with opioids. Conclusion: Falls and fractures impose a major clinical burden on patients prescribed opioids for OA-related pain management. Falls or fracture risks should be an important consideration in the ongoing treatment of patients with OA.

Patricia Schepman,1 Sheena Thakkar,1 Rebecca Robinson,2 Deepa Malhotra,1 Birol Emir,1 Craig Beck1 1Pfizer Inc., New York, NY, USA; 2Eli Lilly and Company, New York, NY, USACorrespondence: Sheena ThakkarPfizer Inc., 235 East 42nd Street, New York, NY, 10017, USATel +1 347 961-9174Email sheena.thakkar@pfizer.comPurpose: Osteoarthritis (OA) is one of the most common causes of chronic pain and a leading cause of disability in the US. The objective of this study was to examine the clinical and economic burden of OA by pain severity.Patients and Methods: We used nationally representative survey data. Adults ≥ 18 years with self-reported physician-diagnosed OA and experiencing OA pain were included in the study. OA pain severity was measured using the Short Form McGill Pain Questionnaire Visual Analog Scale (SF-MPQ-VAS). Data were collected for demographics, clinical characteristics, health-related quality of life (HRQoL), productivity, OA treatment, adherence to pain medication, and healthcare resource utilization. Univariate analysis was performed to examine differences between respondents with moderate-to-severe OA pain vs those with mild OA pain.Results: Higher proportions of respondents with moderate-to-severe OA pain (n=3798) compared with mild OA pain (n=2038) were female (69.4% vs 57.3%), < 65 years of age (54.8% vs 43.4%), and not employed (70.6% vs 64.5%). Respondents with moderate-to-severe OA pain experienced OA pain daily (80.8% vs 48.8%), were obese (53.0% vs 40.5%), had more comorbidities (sleep disturbance, insomnia, depression, and anxiety), and reported significantly poorer health status and HRQoL, and greater productivity and activity impairment (all P< 0.05). Moderate-to-severe OA pain respondents were prescribed significantly more pain medications than mild OA pain respondents (41.0% vs 17.0%) and had higher adherence (75.9% vs 64.1%) yet were less satisfied with their pain medications (all P< 0.001). Outpatient and emergency room visits, and hospitalizations in the 6 months prior to the survey were significantly higher in moderate-to-severe OA pain respondents vs those with mild OA pain (all P< 0.05).Conclusion: Patient and clinical burden was significantly greater in moderate-to-severe OA pain respondents vs mild OA pain respondents and may inform decision-making for appropriate resource allocation and effective management strategies that target specific subgroups.Keywords: osteoarthritis, moderate-to-severe pain, pain severity, health-related quality of life, HRQoL, healthcare resource utilization, HCRU, medication adherence, treatment satisfaction

Background: Individuals experiencing osteoarthritis (OA) pain can pose significant costs for governments due to reduced work activity in these individuals and increasing reliance on public support benefits. In this analysis we capture the broader economic impact of OA pain by applying a government perspective, public economic framework to assess controlled and uncontrolled pain. Methods: We used a Markov model to compare labour market participation in people with uncontrolled OA hip or knee pain compared to a cohort with controlled OA pain. The likelihood of employment, long-term sickness, disability, and early retirement in those with controlled pain used publicly available UK data. The relative effect of uncontrolled OA pain on fiscal outcomes is drawn from peer reviewed publications reporting reduced work activity and reliance on public benefits for people with uncontrolled OA pain. Lost tax revenue was derived using UK tax rates and national insurance contributions applied to annual earnings. Social benefit rules were applied to calculate government financial support to individuals. Health-care costs were calculated based on estimates from an UK observational study. The base case analysis compared the projected lost tax revenue and transfer payments for a 50-year-old cohort with severe OA pain, retiring at age 65. Results: For a 50-year-old individual with moderate uncontrolled OA pain with 15-years remaining work expectancy, the model estimated a £62 383 reduction in employment earnings, a £24 307 reduction in tax contributions and a need for £16 034 in government benefits, compared to a person with controlled OA pain. In people with severe uncontrolled OA pain incremental foregone earnings were estimated to be £126 384, £44 925 were not paid through taxation and £25 829 were received in public benefits, compared to the controlled pain cohort. Health-care costs represented 13% and 12% of all OA-related fiscal cost in the moderate uncontrolled OA pain and severe uncontrolled OA pain comparison, respectively. Conclusions: For governments, maintaining an active workforce is paramount to maintaining economic growth and reducing spending on government programs. The approach described here can be used to augment cost-effectiveness models to inform a range of stakeholders of benefits attributed to controlled OA pain.

Purpose To evaluate the relationship between self-reported concerns about becoming addicted to a medication and health-related quality of life (HRQoL) in patients with osteoarthritis (OA). Methods This real-world study used patient-level cross-sectional survey data collected from the US Adelphi Disease Specific Programme (DSP). The DSP for OA selected 153 physicians who collected de-identified data on their next nine adult patients with OA. Each patient completed a disease-relevant survey, which included the Likert-scale question, “I am concerned about becoming addicted to my medicine,” (CAA) with responses ranging from “completely disagree” [1] to “completely agree” [5]. HRQoL was measured by the EQ-5D-5L index value and the EQ Visual Analogue Scale (VAS). A set of ordinary least squares regressions using HRQoL measures as outcomes and CAA as a continuous predictor were estimated. Standardized effect size (ES) was used to gauge the magnitude of effects. Results A total of 866 patients with OA completed the survey (female, 61.2%; White, 77.7%; mean age, 64.2 years). Of the 775 patients who completed the CAA question, almost one-third responded that they “agree” (18%) or “completely agree” (11%), while 27% responded “completely disagree” and 20% “disagree.” Regression analyses found that patients who have concerns about medication addiction have significantly different EQ-5D-5L index values and EQ VAS scores compared with patients who do not have this concern (p Conclusion Our findings suggest that concern about medication addiction in patients with OA may have an impact on patient HRQoL, with more concerned patients reporting poorer HRQoL outcomes.

Use of tramadol and nontramadol opioids among patients with osteoarthritis is associated with increased rates of negative clinical outcomes, resource use, and costs., In 2019, the American College of Rheumatology conditionally recommended tramadol and conditionally recommended against nontramadol opioids for patients with hip and knee osteoarthritis. Although tramadol is known to be less prone to opioid use disorders, little is known about the differing magnitude of negative clinical outcomes, health care resource utilization, and costs of tramadol relative to nontramadol opioids. Administrative claims records for commercially insured patients with osteoarthritis who were prescribed opioids were used to compare clinical and cost outcomes during a 3-year follow-up period by conducting a pre–post analysis and a matched case–cohort analysis. Data for 14,491 patients were analyzed: 4048 (28%) were initiated on tramadol, and 10,443 (72%) were initiated on nontramadol opioids. After matching, 4048 patients per cohort were analyzed. In each empirical analysis, tramadol patients did develop opioid use disorders; however, opioid use disorder rates were 3.5-fold higher in the nontramadol cohort (1.2% vs 4.2%). In addition, rates of other opioid-related clinical outcomes (falls, fractures, nausea, fatigue, and constipation) were also directionally lower among the tramadol cohort, although quantitatively similar (

Viktor V Chirikov,1 Chris Walker,2 Jennifer M Stephens,1 Patricia Schepman,3 Richard Chambers,4 Mahmoud Bakir,5 Gregory W Poorman,1 Seema Haider,6 Mohammed Farghaly7 1OPEN Health, Bethesda, MD, USA; 2Global Medical Affairs, Viatris, Tadworth, UK; 3Global Health Economics and Outcomes Research, Pfizer Inc, New York, NY, USA; 4Biostatistics, Pfizer Inc, Collegeville, PA, USA; 5Upjohn Export B.V., Jeddah, Saudi Arabia; 6Pfizer Inc., Groton, CT, USA; 7Dubai Medical College, Dubai, United Arab EmiratesCorrespondence: Jennifer M StephensOPEN Health, Bethesda, MD, USATel +1 703 625 5943Email jstephens@pharmerit.comObjective: Data on osteoarthritis patients from the PRECISION trial were used to evaluate the cost-effectiveness of celecoxib (100 mg twice daily) versus ibuprofen (600– 800 mg three times daily) and naproxen (375– 500 mg twice daily). The perspective was that of the United Arab Emirates (UAE) healthcare system.Methods: Discrete-state Markov model with monthly cycles, 30-month horizon, and 3% discount rate was constructed to assess incremental costs per quality adjusted life year (QALYs) gained from reduced incidence of three safety domains examined in PRECISION: renal, serious gastrointestinal (GI), and major adverse cardiovascular events (MACE). Costs for managing these toxicities were derived from Dubai Administrative Billing Claims (2018). Median monthly drug costs were derived from UAE Ministry of Health and Prevention’s published prices ($26.98 celecoxib; $20.25 ibuprofen; $20.50 naproxen). Health utility and excess mortality associated with toxicities were sourced from the literature. The willingness-to-pay thresholds used were 1 and 3 GDP per capita ($40,000–$120,000).Results: The total average cost per patient was $812.88 for celecoxib, $775.26 for ibuprofen, and $731.17 for naproxen while cost components attributed to toxicities were lowest with celecoxib ($360.26, $438.31, and $388.60, respectively). Patients on celecoxib had more QALYs (1.339), compared with ibuprofen (1.335) and naproxen (1.337), resulting in an incremental cost-effectiveness ratio of $11,502/QALY gained for celecoxib versus ibuprofen and $39,779 for celecoxib versus naproxen. Probabilistic sensitivity analyses demonstrated celecoxib to be 81% cost-effective versus ibuprofen and 50% versus naproxen at $40,000/QALY. The most influential model parameters were MACE relative safety and drug costs.Conclusion: From UAE third payer perspective, celecoxib is a long-term cost-effective treatment for osteoarthritis patients when compared with ibuprofen, and equally likely as naproxen to be cost-effective. With the expected increasing burden of chronic diseases in the Gulf region, study findings can inform decisions regarding the cost-effective pain management of osteoarthritis in UAE.Clinicaltrials.gov Registration Number: NCT00346216.Keywords: Markov, NSAIDs, comparative effectiveness, safety, Gulf region, AfME, MENA

Background:The 2019 American College of Rheumatology (ACR) guidelines strongly recommend oral nonsteroidal anti-inflammatory drugs (NSAIDs) for management of hip and knee osteoarthritis (OA) and strongly recommend topical NSAIDs for knee OA. There are, however, important safety considerations with NSAIDs in terms of increased rates of gastrointestinal, cardiovascular, and renal events. Given these risks, it is important to understand the characteristics and drug utilization of the patients who start treatment on these different treatments (i.e., traditional NSAIDs [tNSAIDs] and cyclooxygenase-2 inhibitors [COX-2s]).Objectives:The goal of this research was to describe and compare baseline characteristics of commercially-insured patients diagnosed with OA of the hip and/or knee who started treatment on different types of NSAIDs (i.e., oral tNSAIDs, topical tNSAIDs, and COX-2s).Methods:The Optum Healthcare Solutions, Inc. claims database (1/2012-3/2017) was used to identify patients ≥18 years old, with ≥2 diagnoses of hip and/or knee OA, and ≥90 days supply of oral tNSAIDs, topical tNSAIDs, or COX-2s during the one-year follow up period. The index date was defined as the first prescription after the first OA diagnosis. Patients were assigned to cohorts based on the type of NSAID prescribed on index date. Patients were required to be continuously-enrolled six months before (baseline period) and 36 months after (follow-up period) the index date. Demographic and clinical characteristics including age, sex, comorbidities, and healthcare resource use (HRU) were summarized during baseline. Drug utilization characteristics including days supply and number of prescriptions for the different NSAIDs types were summarized during follow-up period.Results:Data for 23,796 patients were analyzed: 18,100 patients received oral tNSAIDs, 4,825 received COX-2s, and 871 topical tNSAIDs. Patients who initiated treatment on oral tNSAIDs were the youngest (mean age of 60.6 vs. 64.6 for COX-2s and 65.0 for topical tNSAIDs) and topical tNSAIDs had the highest proportion of female patients (71% vs. 62% for oral tNSAIDs and 63% for COX-2s). The topical tNSAIDs cohort had the highest presence of chronic kidney disease (2.6% vs. 1.0% and 1.5% for oral tNSAIDs and COX-2s, respectively) and congestive heart failure (2.5% vs. 0.8% and 1.7% for oral tNSAIDs and COX-2s, respectively) at baseline. In terms of HRU during baseline, topical tNSAIDs had the most patients with emergency department visits (20.8% vs. 16.7% in both COX-2s and oral tNSAIDs), and COX-2 had the most patients with inpatient visits (18.1% vs. 15.4% for topical tNSAIDs and 11.8% for oral tNSAIDs). Oral tNSAIDs had the lowest total all-cause cost ($6,504), and the topical tNSAIDs cohort had the highest costs ($8,455), but fairly comparable with COX-2s ($8,289). During follow-up, oral tNSAIDs patients stayed mostly on oral tNSAIDs as less than 15% of oral tNSAIDs patients later had a prescription for COX-2s or topical tNSAIDs. 37% of COX-2 patients and 56% of topical tNSAIDs patients later took oral tNSAIDs. Topical tNSAIDs patients had an average of 184.4 days of supply for topical tNSAIDs yet also extensively used oral NSAIDs during follow-up (average days of supply for oral tNSAIDs was 315.5 days and for COX-2s was 383.5 days).Conclusion:This study suggests that patients with more complex comorbidity profiles, including higher rates of adverse effects, often start pharmacological treatment with topical tNSAIDs. However, patients who start treatment with topical tNSAIDs switch to other types of NSAIDs; oral tNSAIDs were the most frequently prescribed treatment across the cohorts. Thus, despite the safety concerns with oral tNSAIDs and COX-2s, patients are still placed on these treatments to manage their OA pain. There is a need for new innovative treatments as there is currently a lack of other options.Disclosure of Interests:Stuart Silverman Consultant of: Stuart Silverman is a paid consultant to Pfizer and Eli Lilly and Company in connection with this study, Patricia Schepman Shareholder of: Patricia Schepman is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, James B Rice Consultant of: Brad Rice is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Craig Beck Shareholder of: Craig Beck is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, Alan White Consultant of: Alan White is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Sheena Thakkar Shareholder of: Sheena Thakkar is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, Michaela Johnson Consultant of: Michaela Johnson is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Rebecca Robinson Shareholder of: Rebecca Robinson is an employee and minor stockholder of Eli Lilly and Company, Employee of: Eli Lilly and Company, Birol Emir Shareholder of: Birol Emir is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer

Background:Osteoarthritis (OA) is a common disease that varies in severity among patients. A standardized definition to classify patients into different severity levels is lacking, however, due to the disease’s complex pathogenesis and presentation. Prior studies have shown associations between pain severity and higher healthcare resource utilization (HRU) and costs. We investigated an association between pain severity and higher healthcare resource utilization by examining the use of specific OA-related treatments across pain intensity levels in a large, integrated health system’s OA population over an 18-year period.Objectives:Our aim was to compare use of medications and other treatments among OA patients experiencing mild, moderate, or severe pain.Methods:This was a retrospective study of electronic health records from 2001 to 2018 at Geisinger, an integrated health system in Pennsylvania. Patients were included with a diagnosis code for OA (ICD-9: 715.*, ICD-10 M15-19) on a problem list or encounter or an OA-specific procedure (hip or knee replacement, arthroscopy or injection). We examined pain scores (0-10 scale, with 10 being worst pain) taken after the first OA diagnosis date and defined pain episodes starting on the pain score’s date and lasting for 90 days. If a new pain score was measured before 90 days elapsed, the episode was extended for an additional 90 days, with this process repeated as necessary. Each episode was categorized as mild (pain score 0-3), moderate (4-6), or severe (7-10) based on initial score, and patients could contribute multiple episodes to the analysis. Descriptive statistics were used to quantify treatment utilization during each patients’ mild, moderate and severe episodes. Percentages of patients who had any use of 10 medication types (tramadol, non-tramadol opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), injectable corticosteroids, acetaminophen, salicylates, duloxetine, homeopathic medications, other topical medications, and other over-the-counter (OTC) medications were compared across pain episode types. Percentages of patients with knee or hip surgeries, spine or joint imaging procedures (x-ray, computed tomography or magnetic resonance) and consults to OA-related care (pain management, orthopedics or physical medicine and rehabilitation) were also compared. All analyses used logistic regression with p-values Results:We identified 290,897 patients with OA, representing 34% of the health system population in 2018; 58% were female with mean age of 49 years and mean BMI of 30.5 kg/m2. A total of 801,144 pain episodes were defined, with 75% of patients having at least one pain score. The two most frequently occurring pain scores were 0 (17%) and 5 (13%), and pain episodes were classified as 43% mild, 32% moderate and 25% severe. Significantly higher percentages of patients used certain medication types (NSAIDs, injectable corticosteroids, non-tramadol opioid, duloxetine) in both moderate and severe pain episodes as compared to mild episodes, but other medication types were less likely to be used as pain severity increased (acetaminophen, salicylates, homeopathic medications, other OTC medications). Knee or hip surgeries, imaging, and consults to OA-related specialists were all consistently significantly more likely to occur in patients during moderate or severe pain episodes versus mild episodes (relative risk ratios of 1.76, 1.25 and 1.35 for moderate vs mild, respectively, and 2.00, 1.44 and 1.46 for severe vs mild, all p-values Conclusion:While pain is generally recognized to be a subjective measure that could be influenced by other unmeasured factors and can be confounded with treatment effectiveness, it is nevertheless the primary symptom of OA. It is important to understand the relationship between pain intensity and treatment utilization, and our results support an overall association between pain and utilization but provide new details on the extent to which it depends on specific utilization type.Acknowledgements:Pfizer and Eli Lilly and Company for sponsoring this study.Disclosure of Interests:Jove Graham Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Tonia Novosat Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Haiyan Sun Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Brian Piper Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Joseph Boscarino Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Vanessa Duboski Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Melissa Kern Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Eric Wright Grant/research support from: I am an employee of Geisinger which received financial support from Pfizer and Eli Lilly and Company in connection with the development of this abstract, Rebecca Robinson Shareholder of: Eli Lilly & Co., Employee of: Eli Lilly & Co., Edward Casey Shareholder of: Pfizer, Inc., Paid instructor for: As an employee of Pfizer, Inc. this is part of my role., Employee of: Pfizer, Inc., Craig Beck Shareholder of: Pfizer, Inc., Employee of: Pfizer, Inc., Jerry Hall Shareholder of: Eli Lilly & Co., Employee of: Eli Lilly & Co., Patricia Schepman Shareholder of: Pfizer, Inc., Employee of: Pfizer, Inc.

Introduction Multiple sclerosis (MS) is an autoimmune disorder with large annual costs. This study evaluated utilization and costs for the management of MS relapses with H.P. Acthar® Gel (repository corticotropin injection; Acthar; Mallinckrodt) compared to receipt of plasmapheresis (PMP) or intravenous immunoglobulin (IVIG) among patients with MS who experienced multiple relapses. Methods We identified patients with MS diagnoses who had relapses treated with intravenous methylprednisolone (IVMP), the first-line treatment for MS relapse. Patients who were treated for the subsequent relapses were eligible for the study. We analyzed 12- and 24-month healthcare utilization and costs among patients who received Acthar prescriptions compared to patients who were treated with PMP/IVIG using generalized linear and logistic regression models to calculate unadjusted and adjusted means and 95% confidence intervals. Results For the 12-month analysis, a total of 213 patients received Acthar prescriptions and 226 were treated with PMP or IVIG. Patients who received Acthar prescriptions were similar to those who received other treatments in terms of most demographic variables. Acthar recipients had fewer hospitalizations (0.2 vs. 0.4; P = 0.01) and received fewer outpatient services (29 vs. 43; P

Introduction The purpose of this study was to describe healthcare resource utilization and costs resulting from early (within 30 days of diagnosis) versus late (>30 days after diagnosis) treatment with prescriptions for H.P. Acthar® Gel (repository corticotropin injection; Acthar; Mallinckrodt) to manage infantile spasms (IS). Methods We included all patients in the Truven Health MarketScan® Commercial Claims and Encounters Database and the Truven Health MarketScan Multi-State Medicaid Database who were diagnosed with IS from 2007 to 2012. We performed unadjusted and adjusted regressions examining the relationship between healthcare resource utilization variables and their associated costs to compare outcomes in the early and late Acthar users. Results A total of 252 patients with IS who received Acthar fit our study criteria; 191 (76%) were early Acthar users. In adjusted analyses, we found that early Acthar use was associated with, on average, 3.8 fewer outpatient services (99% CI 0.7–6.7 fewer services). We did not find significant associations between early prescriptions for Acthar and number of hospitalizations, emergency room visits, prescription medications filled, or total costs of health services. Conclusion Patients prescribed Acthar within 30 days of their IS diagnoses tended to have fewer outpatient services performed compared to patients prescribed Acthar later in the disease process. Although additional research is needed to confirm these exploratory findings, physicians may consider early treatment with Acthar to manage IS. Funding This study was funded by a grant to the University of Washington from Mallinckrodt Pharmaceuticals. Electronic supplementary material The online version of this article (doi:10.1007/s12325-016-0361-2) contains supplementary material, which is available to authorized users.

Background:Prescription NSAIDs/Cox-2s (“NSAIDs”) are commonly prescribed by physicians to treat patients with chronic pain, and much is known about the potential negative outcomes associated with their use1. Such negative outcomes include gastrointestinal (“GI”) issues and hepatorenal toxicity.1In addition, CV risk of Cox-2s has not been completely clarified.1,2However, less is known about the extent to which these outcomes are pervasive and problematic in specific patient populations such as those diagnosed with osteoarthritis (“OA”).Objectives:The goal of this research is to assess the clinical burden of commercially-insured patients diagnosed with OA of the hip and/or knee before and after treatment with prescription NSAIDs, in a large, national database in recent years.Methods:The Optum Healthcare Solutions, Inc. data (1/2012-3/2017) were used to identify patients ≥18 years old with ≥2 diagnoses of hip and/or knee OA, and ≥90 days supply of NSAIDs during the three-year period from first prescription (index date) after their first OA diagnosis. Patients were required to be continuously-enrolled during the six months before (baseline period) and 36 months after (follow-up period) the index date. Selected clinical outcomes such as GI issues, CV events, and renal toxicity were compared between the baseline and follow-up periods. Costs and resource use were normalized to account for differential duration in analytic time periods.Results:Data for 22,435 patients (60.8% as female, with an average age of 62) with hip and/or knee OA were analyzed. On average, patients were prescribed NSAIDs for 489 days during the follow-up period. From the baseline period to follow-up period, negative clinical outcomes associated with GI issues increased by 393% (1.5% v 7.5%), driven by a 667% (0.3% v 2.3%) increase in acute GI hemorrhages. Additionally, negative clinical outcomes associated with CV events increased by 73% (40.7% v 70.6%), largely due to a 600% (0.3% v 2.1%) increase in acute myocardial infarction. Lastly, negative clinical outcomes associated with renal toxicity increased by 433% (1.5% v 8.0%), with a 740% (0.5% v 4.2%) increase in acute renal failure being the most substantial.Conclusion:These findings suggest that prescribing of NSAIDs among OA patients is associated with an increase in negative clinical outcomes. This suggests that new treatment options other than NSAIDs should be evaluated.References:[1]van Laar M, et al. Pain treatment in arthritis-related pain: beyond NSAIDs.Open Rheumatol J. 2012;6:320–330.[2]Nissen SE, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis.NEJM2016;2519-2529.Disclosure of Interests:Stuart Silverman Consultant of: Pfizer and Eli Lilly for this project., Speakers bureau: Amgen, Radius, James Rice Consultant of: Pfizer and Eli Lilly have funded this project., Alan White Consultant of: Pfizer and Eli Lilly have funded this project., Nguyen Le Consultant of: Pfizer and Eli Lilly have funded this project., Michael Somma Consultant of: Eli Lilly and Pfizer have funded this project., Craig Beck Shareholder of: Pfizer, Employee of: Pfizer, Rebecca Robinson Shareholder of: Eli Lilly, Employee of: Eli Lilly, Patricia Schepman Shareholder of: Pfizer, Employee of: Pfizer