A Linked Electronic Medical Record-Claims Analysis of the Clinical and Economic Outcomes of Patients Coded for Erosive Esophagitis in the United States.

INTRODUCTION: Erosive esophagitis (EE) is a severe form of gastroesophageal reflux disease commonly treated with proton pump inhibitors (PPIs). The aim of this retrospective, observational cohort study was to describe the characteristics and healthcare burden of patients with EE. METHODS: We identified adults in the USA with an EE diagnosis between January  1, 2016 and February 28, 2019 in a linked dataset containing electronic health records (EHR) from the Veradigm Network EHR and claims data from Komodo Health. Patients were required to have 1 year of baseline data and 3 years of follow-up data. Patients were stratified by the number of PPI lines of therapy (LOT) during the 4-year study period. We descriptively captured patient characteristics and treatment patterns, along with all-cause and EE-related healthcare utilization and costs. RESULTS: Among the 158,347 qualifying adults with EE, 71,958 (45.4%) had 1 PPI LOT, 14,985 (9.5%) had 2 LOTs, 15,129 (9.6%) had 3+ LOTs, and 56,275 (35.5%) did not fill a PPI prescription. Omeprazole and pantoprazole comprised more than 70% of any LOT, with patients commonly switching between the two. Mean (standard deviation) annualized all-cause and EE-related healthcare costs in the follow-up period were $16,853 ($70,507) and $523 ($3659), respectively. Both all-cause and EE-related healthcare costs increased with LOTs. CONCLUSIONS: Patients with EE are commonly treated with prescription PPIs; however, 19.0% of patients cycled through multiple PPIs. Higher PPI use was associated with a higher comorbidity burden and higher healthcare costs compared to 0 PPI use.

Healthcare costs among patients with newly diagnosed helicobacter pylori infection in the United States: a linked claims-EHR study.

AIMS: The study objectives were to 1) characterize the cost drivers of patients with Helicobacter pylori (HP) and 2) estimate HP-related cost savings following lab-confirmed HP eradication with US guideline-recommended treatment compared to failed eradication. METHODS: We identified adults newly diagnosed with HP between 1/1/2016-12/31/2019 in the Veradigm Electronic Health Record Database linked to claims data (earliest HP diagnosis = index date). For the overall costs analysis, we required patients to have data available for ≥12 months before and after the index date. Then, we used multivariable modeling to assess the marginal effects of comorbidities on all cause-healthcare costs in the 12 months following HP diagnosis. For the eradication savings analysis, we identified patients with ≥1 HP eradication regimen, a subsequent HP lab test result, and ≥1 year of data after the test result. Then we used multivariable modeling to estimate HP-related cost while adjusting for eradication status, demographics, post-testing HP-related clinical variables, and the interactions between eradication status and each HP-related clinical variable. RESULTS: The overall cost analysis included 60,593 patients with HP (mean age 54.2 years, 65.5% female). Mean (SD) 12-month unadjusted all-cause costs were $23,693 ($78,089). Rare comorbidities demonstrated the highest marginal effect. The marginal effects of gastric cancer and PUD were $15,705 and $7,323, respectively. In the eradication savings analysis, 1,835 (80.0%) of the 2295 patients had lab test-confirmed HP eradication. Compared to failed eradication, there were significant one-year cost savings among patients with successful HP eradication and select conditions: $1,770 for PUD, $518 for atrophic gastritis, $494 for functional dyspepsia, and $352 for gastritis. CONCLUSIONS: The healthcare costs of patients with HP are partially confounded by their burden of high-cost comorbidities. In the subset of patients with available results, confirmed vs. failed eradication of HP was associated with short-term cost offsets among those with specific to HP-related sequelae.

Helicobacter pylori (HP) is a common infection. We aimed to better understand healthcare costs for people infected with HP. Specifically, we were interested in 1) investigating whether complications from HP were causing high costs. 2) whether successful eradication of HP would lead to lower healthcare costs. We captured data on adults diagnosed with HP between 2016 and 2019. The data used in this study came from medical records and insurance bills. In the first part of the study, we found that patients with HP often have other health issues, and these other health issues were driving high healthcare costs. The majority of cost savings associated with HP eradication accrue from the prevention of potential complications of long-term infection, such as peptic ulcer disease and, rarely, gastric cancer.

Development and validation of a psoriasis treatment acceptability measure through group concept mapping.

BACKGROUND: Psoriasis is a common autoimmune dermatologic condition which has a pronounced negative impact on patient quality of life and disease burden. Currently, there are a number of treatments available for psoriasis, with differences in efficacy, mechanism of action, mode of administration, adverse effects, and tolerability. However, a reliable, validated patient-reported instrument to address patient expectations and of psoriasis treatment has not been developed. This project was undertaken with the aim of developing a fit-for-purpose self-reported instrument to inform patient expectations and preferences of psoriasis treatments. METHODS: Two studies, both utilizing qualitative and quantitative methods, were conducted in patients within the entire spectrum of psoriasis severity. In Study 1, a group concept mapping (GCM) exercise was conducted with dermatologists and moderate-to-severe psoriasis patients to identify concepts important in the treatment of psoriasis. In Study 2, a preliminary Treatment Acceptability Questionnaire (TAQ) was developed using GCM-derived concepts from Studies 1 and 2, followed by cognitive debriefing (CD) telephone interviews of the preliminary TAQ. In Study 2, another GCM exercise was conducted with mild and newly diagnosed psoriasis patients. Psychometric analyses were performed on the TAQ to evaluate validity and reliability. RESULTS: The Study 1 GCM exercise generated 43 concepts from moderate-to-severe psoriasis patients (n = 20) and dermatologists (n = 10). In Study 2, 37 GCM concepts were generated from mild and newly diagnosed psoriasis patients (n = 20). From the 2 GCM exercises, 28 concepts were selected to form the preliminary TAQ; CD interviews indicated strong understanding and relevance of TAQ items among patients with disease ranging from mild to severe. The final TAQ consisted of 20 items; psychometric analysis demonstrated strong validity and reliability of the TAQ. CONCLUSIONS: The TAQ is a novel psychometrically validated patient-reported instrument to inform healthcare providers of patients' expectations of and preferences for treatment of their psoriasis and can help in shared decision making between patients and physicians.

Brief communication: global temporal trends in the efficacy of clarithromycin-based regimens for the treatment of Helicobacter pylori infection.

Background: Helicobacter pylori eradication rates achieved with clarithromycin-based triple therapies are declining due to antibiotic resistance, but data regarding temporal changes in efficacy with these eradication therapies are scarce. Objective: To evaluate the efficacy of clarithromycin-based triple eradication regimens over time. Design: A comprehensive literature review and time-trend analysis. Data sources and methods: Bibliographies of recently published systematic literature reviews were searched and supplemented with a targeted literature review conducted using Medline and Embase databases and ProQuest from conception to May 2021. Studies reporting H. pylori eradication rates of clarithromycin-based triple therapies were included and temporal trends were estimated using a random-effects model. Results: Eradication rates for triple therapies containing proton pump inhibitors (PPIs), clarithromycin, and amoxicillin showed a significant decline over the past 23 years (p = 0.0315). However, this decline was not significant when eradication rates achieved with vonoprazan-based triple therapy were included (p = 0.3910). Conclusion: Vonoprazan-based triple therapy partially mitigated the decline in eradication rates seen with PPI-based triple therapy, likely due to more powerful acid suppression of vonoprazan.

Real-world outcomes associated with vonoprazan-based versus proton pump inhibitor-based therapy for Helicobacter pylori infection in Japan.

Background: Japanese guidelines recommend triple therapy with vonoprazan or a proton pump inhibitor (PPI) in combination with antibiotics to treat Helicobacter pylori (H. pylori) infection. While studies have shown improved eradication rates and reduced costs with vonoprazan versus PPIs, there is little data describing healthcare resource use (HCRU) and treatment patterns. Objectives: To compare patients treated with a vonoprazan-based or PPI-based regimen for H. pylori infection in Japan in terms of their characteristics, HCRU, healthcare costs, clinical outcomes, and treatment patterns. Design: Retrospective matched cohort. Methods: We used data from the Japan Medical Data Center claims database (July 2014-January 2020) to identify adult patients with H. pylori infection and a first observed use of vonoprazan or a PPI in 2015 or later (index date). Patients prescribed a vonoprazan-based or a PPI-based regimen were matched 1:1 using propensity score matching. HCRU, healthcare costs, diagnostic tests, a proxy for H. pylori eradication (i.e. no triple therapy with amoxicillin in combination with metronidazole or clarithromycin >30 days after the index date), and second-line treatment were described during the 12-month follow-up period. Results: Among 25,389 matched pairs, vonoprazan-treated patients had fewer all-cause and H. pylori-related inpatient stays and outpatient visits than PPI-treated patients, resulting in lower all-cause healthcare costs [185,378 Japanese yen (JPY) versus 230,876 JPY, p < 0.001]. Over 80% of patients received a post-treatment test for H. pylori. Fewer vonoprazan-treated than PPI-treated patients subsequently received an additional triple regimen for H. pylori infection (7.1% versus 20.0%, p < 0.001) or a prescription for vonoprazan or a PPI as monotherapy (12.4% versus 26.4%, p < 0.001) between 31 days and 12 months after the index date. Conclusion: Patients with H. pylori infection who were treated with vonoprazan-based therapy had lower rates of subsequent H. pylori treatment, lower overall and H. pylori-related HCRU, and lower healthcare costs than patients treated with PPI-based therapy.

Diagnosis and treatment patterns among patients with newly diagnosed Helicobacter pylori infection in the United States 2016-2019.

Approximately 36% of the United States (US) population is infected with Helicobacter pylori (HP), a known major risk factor for peptic ulcer disease and gastric cancer. HP eradication reduces the rate of complications; however, the benefits are undermined by rising rates of HP eradication treatment failure. This real-world observational cohort analysis aims to describe HP diagnostic and treatment patterns among insured patients in the US. Using diagnoses, lab results, and treatment patterns, we identified adults (18+) with new diagnoses of HP in the Veradigm Health Insights EHR Database linked to Komodo claims data (1/1/2016-12/31/2019). Patients were required to have ≥ 12 months of data pre-/post-index. We captured patient characteristics, HP-related diagnostic testing, and the use of US guideline-recommended HP eradication regimens. HP eradication rates following first-line eradication treatment were measured among patients with available lab results. Overall, 31.8% of the 60,593 included patients did not receive guideline-recommended treatment. Among the 68.2% (41,340) with first-line treatment, 80.2% received clarithromycin-based triple therapy, and 6.6% received bismuth quadruple therapy. Of the 4569 patients with a repeated course of eradication therapy, 53.4% received the same regimen as their first-line, the majority (90.7%) of whom received two rounds of clarithromycin-based triple therapy. Among the 2455 patients with results of HP non-serology testing following first-line treatment, the 180-day eradication rate was 80.2% overall, with differences based on treatments and demographics. This study highlights gaps between guideline-recommended HP management and real-world patterns, underscoring the need to improve HP testing, treatment, and follow-up practices.

Induction and maintenance of healing in erosive esophagitis in the United States.

INTRODUCTION: Erosive esophagitis (EE) occurs when refluxate from the stomach causes T-lymphocyte infiltration of the esophageal mucosa, resulting in mucosal breaks. Currently, therapy with proton-pump inhibitors (PPIs) is the standard treatment for EE in the United States, but few comprehensive reviews exist on the efficacy of PPIs in US populations. Here, we present the most contemporary, thorough analysis of PPI efficacy rates, and identify and characterize patient subgroups at risk for poor healing outcomes. AREAS COVERED: We searched the literature to identify studies reporting rates of endoscopic healing and maintained healing of EE with PPI therapies in the US and found a paucity of recent evidence and real-world evidence. Twenty-two studies from 2009 and earlier were included in the final dataset. EXPERT OPINION: Rates of EE healing with PPIs were highest after 8 weeks of treatment, with over 80% of patients in most treatment arms demonstrating endoscopic healing, compared to lower efficacy (<80%) at 4 weeks. Rates of maintained healing with PPIs at 6 and 12 months were mostly lower than 80%, although the data were limited. Symptomatic patients and those with severe EE were less likely to achieve healing. Obese patients experienced similar healing rates as non-obese patients.

Patient journey in erosive oesophagitis: real-world perspectives from US physicians and patients.

OBJECTIVE: Management of erosive oesophagitis (EE) remains suboptimal, with many patients experiencing incomplete healing, ongoing symptoms, and relapse despite proton pump inhibitor (PPI) treatment. The Study of Acid-Related Disorders investigated patient burden of individuals with EE in a real-world setting. DESIGN: US gastroenterologists (GIs) or family physicians (FPs)/general practitioners (GPs) treating patients with EE completed a physician survey and enrolled up to four patients with EE for a patient survey, with prespecified data extracted from medical records. RESULTS: 102 GIs and 149 FPs/GPs completed the survey; data were available for 73 patients (mean age at diagnosis, 45.4 years). Omeprazole was healthcare professional (HCP)-preferred first-line treatment (60.8% GIs; 56.4% FPs/GPs), and pantoprazole preferred second line (29.4% and 32.9%, respectively). Price and insurance coverage (both 55.5% HCPs) and familiarity (47.9%) key drivers for omeprazole; insurance coverage (52.0%), price (50.0%), familiarity (48.0%), initial symptom relief (46.0%), and safety (44.0%) key drivers for pantoprazole. Only 49.3% patients took medication as instructed all the time; 56.8% independently increased medication frequency some of the time. Despite treatment, 57.5% patients experienced heartburn and 30.1% regurgitation; heartburn was the most bothersome symptom. 58.9% patients believed that their symptoms could be better controlled; only 28.3% HCPs were very satisfied with current treatment options. 83.6% patients wanted long-lasting treatment options. Fast symptom relief for patients was a top priority for 66.1% HCPs, while 56.6% would welcome alternatives to PPIs. CONCLUSION: This real-world multicentre study highlights the need for new, rapidly acting treatments in EE that reduce symptom burden, offer durable healing and provide symptom control.

Helicobacter pylori infection treatment in the United States: clinical consequences and costs of eradication treatment failure.

INTRODUCTION: Helicobacter pylori (Hp) is causal in benign and malignant gastrointestinal diseases. Accordingly, current guidelines recommend Hp eradication in patients with active infection. Unfortunately, treatment failure is common, exposing patients to complications associated with persistent Hp infection and consequences of repeated treatment, including promotion of antibiotic resistance. In the United States (US), data regarding eradication rates with available therapies are limited. Moreover, the clinical and economic burden of eradication treatment failure have not been thoroughly described. AREAS COVERED: We aimed to characterize Hp eradication rates and the clinical consequences and associated costs of persistent Hp infection among US adults. We conducted focused literature reviews using initial searches in Embase, MEDLINE, and Cochrane Database of Systematic Reviews via Ovid followed by manual searches to identify relevant publications. EXPERT OPINION: Hp eradication rates were suboptimal, with most studies reporting rates ≤80% with clarithromycin-based triple therapy and bismuth quadruple therapy. There was direct evidence supporting numerous benefits of successful Hp eradication, including decreased risk of recurrent or complicated peptic disease and non-cardia gastric cancer. Cost benefits of eradication were related to mitigation of conditions associated with persistent Hp infection, (e.g. complicated peptic ulcer disease, and gastric cancer) which altogether exceed US$5.3 billion.

Switch rates and total cost associated with apremilast and biologics in biologic-naive patients with psoriatic arthritis.

Aim: Real-world treatment data for psoriatic arthritis are limited. We evaluated switch rates, adherence, and costs for patients initiating apremilast versus tumor necrosis factor inhibitor (TNFi) and interleukin inhibitor (ILi) among biologic-naive psoriatic arthritis patients. Materials & methods: This retrospective analysis used IBM MarketScan claims data to assess treatment switches, adherence and costs. Results: Twelve-month switch rates were significantly lower for apremilast versus TNFi (15.5% vs 26.6%; p < 0.0001) and similar to ILi (15.5% vs 14.0%; p = 0.71). Apremilast initiators had lower total costs versus TNFi and ILi (US$39,854 vs US$57,243 and US$65,687; p < 0.05) and adherence was slightly lower versus TNFi and higher versus ILi. Conclusion: Biologic-naive apremilast initiators had lower switch rates versus TNFi initiators and lower total costs versus TNFi or ILi initiators.

Confirmed disability progression provides limited predictive information regarding future disease progression in multiple sclerosis.

BACKGROUND: Although confirmed disability progression (CDP) is a common outcome in multiple sclerosis (MS) clinical trials, its predictive value for long-term outcomes is uncertain. OBJECTIVE: To investigate whether CDP at month 24 predicts subsequent disability accumulation in MS. METHODS: The Comprehensive Longitudinal Investigation of Multiple Sclerosis at Brigham and Women's Hospital includes participants with relapsing-remitting MS or clinically isolated syndrome with Expanded Disability Status Scale (EDSS) scores ≤5 (N = 1214). CDP was assessed as a predictor of time to EDSS score 6 (EDSS 6) and to secondary progressive MS (SPMS) using a Cox proportional hazards model; adjusted models included additional clinical/participant characteristics. Models were compared using Akaike's An Information Criterion. RESULTS: CDP was directionally associated with faster time to EDSS 6 in univariate analysis (HR = 1.61 [95% CI: 0.83, 3.13]). After adjusting for month 24 EDSS, CDP was directionally associated with slower time to EDSS 6 (adjusted HR = 0.65 [0.32, 1.28]). Models including CDP had worse fit statistics than those using EDSS scores without CDP. When models included clinical and magnetic resonance imaging measures, T2 lesion volume improved fit statistics. Results were similar for time to SPMS. CONCLUSIONS: CDP was less predictive of time to subsequent events than other MS clinical features.

Postinfusion monitoring costs by site of care for patients with relapsed/refractory large B-cell lymphoma receiving third- or later-line treatment with lisocabtagene maraleucel in the TRANSCEND NHL 001 and OUTREACH trials.

This retrospective study estimated postinfusion health care resource utilization (HCRU) by site of care among 303 patients with relapsed/refractory large B-cell lymphoma who received third- or later-line treatment with lisocabtagene maraleucel (liso-cel) in the TRANSCEND NHL 001 and OUTREACH trials. Inpatients (n = 256) had higher rates of hospitalization versus outpatients (n = 47; >99% vs 62%), by definition, and higher rates of tocilizumab use for cytokine release syndrome and/or neurological events (22% vs 9%). Rates of intensive care unit admission, corticosteroid use, vasopressor use, hemodialysis, and intubation were generally low and similar between groups. Median (range) total hospital length of stay was 15 (0-88) days (inpatients) and 4 (0-77) days (outpatients). Over 6 months, estimated mean postinfusion cost of care was $89,535 (inpatients) and $36,702 (outpatients). Most costs were incurred in the first month post infusion (inpatients, $50,369 [56%]; outpatients, $19,837 [54%]). Lower overall HCRU was observed with outpatient postinfusion monitoring.

Cytokine release syndrome and neurological event costs in lisocabtagene maraleucel-treated patients in the TRANSCEND NHL 001 trial.

Chimeric antigen receptor (CAR) T-cell therapies have demonstrated high response rates in patients with relapsed/refractory large B-cell lymphoma (LBCL); however, these therapies are associated with 2 CAR T cell-specific potentially severe adverse events (AEs): cytokine release syndrome (CRS) and neurological events (NEs). This study estimated the management costs associated with CRS/NEs among patients with relapsed/refractory LBCL using data from the pivotal TRANSCEND NHL 001 trial of lisocabtagene maraleucel, an investigational CD19-directed defined composition CAR T-cell product with a 4-1BB costimulation domain administered at equal target doses of CD8+ and CD4+ CAR+ T cells. This retrospective analysis of patients from TRANSCEND with prospectively identified CRS and/or NE episodes examined relevant trial-observed health care resource utilization (HCRU) associated with toxicity management based on the severity of the event from the health care system perspective. Cost estimates for this analysis were taken from publicly available databases and published literature. Of 268 treated patients as of April 2019, 127 (47.4%) experienced all-grade CRS and/or NEs, which were predominantly grade ≤2 (77.2%). Median total AE management costs ranged from $1930 (grade 1 NE) to $177 343 (concurrent grade ≥3 CRS and NE). Key drivers of cost were facility expenses, including intensive care unit and other inpatient hospitalization lengths of stay. HCRU and costs were significantly greater among patients with grade ≥3 AEs (22.8%). Therefore, CAR T-cell therapies with a low incidence of severe CRS/NEs will likely reduce HCRU and costs associated with managing patients receiving CAR T-cell therapy. This clinical trial was registered at www.clinicaltrials.gov as #NCT02631044.

Real-world treatment patterns, healthcare use and costs in triple-class exposed relapsed and refractory multiple myeloma patients in the USA.

Aim: To estimate treatment patterns and healthcare costs among triple-class exposed relapsed and refractory multiple myeloma (RRMM) patients. Materials & methods: Eligible patients had ≥1 line of therapy (LOT) each of proteasome inhibitors, immunomodulatory drugs and daratumumab in December 2015-September 2018 and received a new LOT. Results: A total of 154 patients were included with a median follow-up of 6.2 months. Median time from diagnosis to new LOT was 41.0 months. Kaplan-Meier estimate of median time to therapy discontinuation was 4.2 months. Mean per-patient, per-month MM-related costs were USD 35,657. Most frequently observed regimens were lenalidomide or pomalidomide + daratumumab (18.2%), lenalidomide or pomalidomide + proteasome inhibitors (15.6%) and lenalidomide or pomalidomide monotherapy (11.0%). Conclusion: Triple-class exposed RRMM patients receive heterogeneous treatments for a short duration with high healthcare resource utilization and costs.

Productivity Loss and Associated Costs Among Employed Patients Receiving Disease-Modifying Treatment for Multiple Sclerosis.

OBJECTIVES: The aim of this study was to examine the indirect burden of employed multiple sclerosis (MS) patients initiating disease-modifying therapies (DMTs) in the US. METHODS: DMT-treated MS patients (DMT users) and direct-matched controls without MS (1:3) were captured using the IBM MarketScan Commercial Claims and Encounters Database and the Health and Productivity Management Database between 1 January 2009 and 1 January 2017. DMT users were also stratified by route of administration. Time loss and costs from absenteeism, short-term disability, and long-term disability were assessed for DMT users and matched controls. RESULTS: A total of 3022 DMT users were matched to 9066 controls. Compared with injectable DMT users, oral DMT users took twice as long to initiate therapy but had numerically lower absenteeism costs and significantly lower long-term disability costs in the first year after DMT initiation. The mean (standard deviation) indirect costs of absenteeism, short-term disability, and long-term disability were US$6474 (US$6779), US$2368 (US$5777), and US$280 (US$2578), respectively, for DMT users and US$4468 (US$3814), US$328 (US$1950), and US$36 (US$938), respectively, for controls in the first year (all p < 0.001). CONCLUSIONS: Employed DMT users in the US incurred incremental increased indirect burden ($2007 in absenteeism, $2040 in short-term disability, and $244 in long-term disability) compared with matched controls. Despite evidence of delays in treatment initiation, oral DMT users had evidence of reduced work loss compared with injectable users, suggesting that open access to all treatment options may reduce the indirect burden of MS. Additional research into the impact of route of administration on the burden of long-term disability among MS patients is needed.

Treatment Patterns and Relapses Among Newly Treated Multiple Sclerosis Patients From a Retrospective Claims Analysis.

PURPOSE: Although all disease-modifying therapies (DMTs) reduce risk of relapse in multiple sclerosis (MS), many factors, including route of administration, influence selection of first-line DMT. Knowledge of real-world treatment patterns and effectiveness in reducing relapses across DMTs is important to understanding factors influencing this choice. This study sought to describe treatment patterns and relapses among newly treated adults with MS and by DMT route of administration (oral, injectable, and infusion). METHODS: IBM MarketScan research databases were used to identify MS adults newly initiating DMTs (index event) from January 1, 2011-April 1, 2016, who had 12 months of continuous preindex and postindex medical and pharmacy benefits. Newly treated patients were those with ≥2 nondiagnostic claims with an International Classification of Diseases, Ninth Revision, Clinical Modification (340) or Tenth Revision, Clinical Modification (G35) code and no DMT prescription claims in the 12 months' preindex. Persistence and adherence were measured from index until the earliest of ≥60 days without DMT, switching DMTs, or end of follow-up. Relapses were defined using a validated claims-based algorithm and measured in the 12-month preindex and postindex periods. Regression analysis adjusting for patient characteristics and prior relapses was used to determine the association between DMT route of administration and odds of 12-month persistence, odds of postindex relapse, and number of postindex relapses. FINDINGS: Of 9378 newly treated MS patients meeting inclusion criteria; average age was 46.7 years, and 73.3% were female. Most patients initiated an injectable (65.5%) or oral (26.1%) DMT. Relapses decreased markedly from preindex to postindex (32.9%-24.0%), which was highest among oral users (35.8%-21.6%). Patients with no (vs ≥3) relapses preindex were more likely to be relapse free postindex (81.6% vs 31.4%). Nonpersistence (39.1% overall) was lowest among oral users (33.4%) and higher among those with versus without a postindex relapse (50.6% vs 35.5%). Patients initiating oral versus injectable agents were more likely to be persistent at 12 months (odds ratio [OR], 1.45; p < 0.0001) and less likely to relapse (OR, 0.75; p < 0.0001) postindex. Switches were uncommon (~10%) across cohorts. Preindex relapses were associated with increased odds of postindex relapses (OR, 1.73; p < 0.0001) but not with odds of persistence at 12 months. IMPLICATIONS: The 12-month nonpersistence rate was high among all MS patients but lower among oral users. Oral users were also less likely to relapse postindex. Despite the effectiveness of DMTs in reducing relapses, the low persistence, lack of switching to a new DMT, and continued relapses highlight an unmet need in the MS treatment landscape.

Switch Rates and Total Cost of Care Associated with Apremilast and Biologic Therapies in Biologic-Naive Patients with Plaque Psoriasis.

PURPOSE: Compare treatment switching rates and costs among biologic-naive psoriasis patients initiating apremilast or biologics. METHODS: This retrospective claims analysis used IBM MarketScan Commercial and Medicare Supplemental databases to identify patients who initiated apremilast or a biologic (ie, tumor necrosis factor [TNF] or interleukin [IL] inhibitor) for psoriasis treatment between January 1, 2015, and December 31, 2016. A 1:1 propensity score matching was used to adjust for possible selection bias and maximize the number of patients available for analysis. Treatment switching, days to switch, and healthcare costs were assessed at 12 months. T-test and chi-square test were used to evaluate differences between cohorts for continuous and categorical variables as appropriate; Wilcoxon rank-sum tests were used to assess cost differences. RESULTS: In total, 88,025 patients newly initiated apremilast, a TNF inhibitor, or an IL inhibitor. After inclusion/exclusion criteria were applied and patients were propensity score matched, 1645 (apremilast), 1207 (TNF inhibitor), and 438 (IL inhibitor) patients were included in this analysis. Twelve-month switch rates were significantly lower for apremilast initiators compared with TNF inhibitor initiators (14% vs 25%; p<0.01) and comparable to IL inhibitors (14% vs 11%; p>0.05). No statistical difference was observed in days to switch at 12 months for any treatment group. Total healthcare costs were lower for apremilast initiators compared with TNF and IL inhibitor initiators ($34,028 vs $55,973 and $64,430; p<0.0001). Per-patient per-month (PPPM) costs were significantly lower for apremilast initiators compared with TNF inhibitor and IL inhibitor initiators ($2834 vs $4662 and $5366; p<0.0001). CONCLUSION: Over a 12-month follow-up, biologic-naive psoriasis patients initiating apremilast had significantly lower switching rates compared with patients on TNF inhibitors and similar rates as patients on IL inhibitors. PPPM and total healthcare costs were significantly lower for patients initiating apremilast vs TNF or IL inhibitors, primarily due to lower pharmacy costs.

Real-world switch patterns and healthcare costs in biologic-naive psoriasis patients initiating apremilast or biologics.

Aim: Treatment switching and healthcare costs were compared among biologic-naive psoriasis patients initiating apremilast or biologics with ≥12 months pre-/post-index continuous enrollment in Optum Clinformatics™ Data Mart. Methods: After propensity score matching, switch rates (new therapy post-index) and days between index and switch were assessed. Total and per-patient per-month costs by service type were assessed. Results: Apremilast initiators (n = 533) were matched and compared with biologic initiators (n = 955). Twelve-month cumulative switch rates and days to switch were similar. Apremilast initiators had significantly lower total healthcare costs than biologic initiators; apremilast switchers and nonswitchers had significantly lower per-patient per-month costs than biologic switchers and nonswitchers, driven mainly by reduced outpatient pharmacy costs. Conclusion: Apremilast initiators had lower healthcare costs even with treatment switching.

Causal inference and adjustment for reference-arm risk in indirect treatment comparison meta-analysis.

Aim: To illustrate that bias associated with indirect treatment comparison and network meta-analyses can be reduced by adjusting for outcomes on common reference arms. Materials & methods: Approaches to adjusting for reference-arm effects are presented within a causal inference framework. Bayesian and Frequentist approaches are applied to three real data examples. Results: Reference-arm adjustment can significantly impact estimated treatment differences, improve model fit and align indirectly estimated treatment effects with those observed in randomized trials. Reference-arm adjustment can possibly reverse the direction of estimated treatment effects. Conclusion: Accumulating theoretical and empirical evidence underscores the importance of adjusting for reference-arm outcomes in indirect treatment comparison and network meta-analyses to make full use of data and reduce the risk of bias in estimated treatments effects.

Treatment Patterns Among Patients with Multiple Sclerosis Initiating Second-Line Disease-Modifying Therapy.

OBJECTIVE: Disease-modifying therapies (DMTs) can reduce multiple sclerosis (MS) relapse rates; however, effectiveness of treatments may vary. It is important to understand real-world treatment patterns in the context of MS relapses. We describe MS relapses related to treatment patterns among patients who switch treatment after their first DMT. METHODS: IBM MarketScan research databases were used to identify adult patients with MS who switched DMTs (index-first switch) after being newly treated with a DMT from January 2009 through March 2017, with 12 months of continuous enrollment pre- and post-index. Non-persistence was defined as discontinuing (at least 60 days without DMT) or switching DMTs. MS relapses were defined using a validated claims-based algorithm. Multivariable analysis was used to examine odds of 12-month persistence, odds of post-index relapse, and number of relapses. RESULTS: In total, 4121 patients with MS met all inclusion criteria (mean age 46.4 years; female 76.2%). Overall, 49.6% switched to an oral DMT, 36.5% to an injectable DMT, and 13.9% to an infusion DMT. Switching DMTs resulted in a 32.4% reduction in relapses between pre- and post-index. Only 54.6% of patients were persistent throughout the first year. Patients who switched to oral DMTs had 95% higher adjusted odds of persistence and 18% lower adjusted odds of a post-index period relapse than patients who switched to injectable DMTs. The number of baseline relapses was not associated with persistence but with 68% higher odds of a post-index relapse, with each additional baseline relapse associated with a 44% increase in number of post-index relapses. CONCLUSIONS: Among patients with MS who switched DMTs, persistence was consistently low regardless of treatment. Although persistence with oral DMTs was slightly higher than with injectable DMTs, overall results indicate poor persistence to second-line therapy and highlight the need to improve long-term persistence with DMTs.