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Objectives This study aimed to evaluate the cost-effectiveness, from a US commercial payer perspective, of cemiplimab versus other first-line treatments for advanced non-small cell lung cancer with programmed death-ligand 1 expression ≥50%. Methods A 30-year “partitioned survival” model was constructed. Overall survival and progression-free survival were estimated by applying time-varying hazard ratios from a network meta-analysis of randomized clinical trials. Overall survival and progression-free survival were estimated from EMPOWER-Lung 1 (cemiplimab monotherapy vs chemotherapy) and KEYNOTE-024 and KEYNOTE-042 (pembrolizumab monotherapy vs chemotherapy). Drug acquisition costs were based on published 2020 US list prices. A 3% discount rate was applied to life-years, quality-adjusted life-years (QALYs), and costs. A deterministic analysis was performed on the base case; 1-way sensitivity and probabilistic sensitivity analyses assessed model and parameter uncertainties. Results Cemiplimab was associated with increased time in the “preprogression” (13.08 vs 7.90 and 6.08 months) and “postprogression” (47.30 vs 29.49 and 14.78 months) health states versus pembrolizumab and chemotherapy, respectively. Compared with pembrolizumab and chemotherapy, cemiplimab generated 1.00 (95% CI −0.266 to 2.440) and 1.78 (95% CI 0.607-3.20) incremental QALYs, respectively, with incremental cost-effectiveness ratios of $68 254 and $89 219 per QALY for cemiplimab versus pembrolizumab and cemiplimab versus chemotherapy, respectively. The probability of cemiplimab being cost-effective at a willingness-to-pay threshold of $100 000 to $150 000 per QALY was 62% to 76% versus pembrolizumab and 56% to 84% versus chemotherapy. Conclusions Findings suggest that cemiplimab, versus pembrolizumab or versus chemotherapy, is a cost-effective first-line treatment option for advanced non-small cell lung cancer with programmed death-ligand 1 expression ≥50%.

BACKGROUND: Most cutaneous squamous cell carcinomas (CSCCs) can be treated with surgical excision or radiation; however, approximately 1% of patients develop advanced disease. In 2018, the FDA appr...

We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%.In EMPOWER-Lung 1, a multicentre, open-label, global, phase 3 study, eligible patients recruited in 138 clinics from 24 countries (aged ≥18 years with histologically or cytologically confirmed advanced non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0-1; never-smokers were ineligible) were randomly assigned (1:1) to cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. Crossover from chemotherapy to cemiplimab was allowed following disease progression. Primary endpoints were overall survival and progression-free survival per masked independent review committee. Primary endpoints were assessed in the intention-to-treat population and in a prespecified PD-L1 of at least 50% population (per US Food and Drug Administration request to the sponsor), which consisted of patients with PD-L1 of at least 50% per 22C3 assay done according to instructions for use. Adverse events were assessed in all patients who received at least one dose of the assigned treatment. This study is registered with ClinicalTrials.gov, NCT03088540 and is ongoing.Between June 27, 2017 and Feb 27, 2020, 710 patients were randomly assigned (intention-to-treat population). In the PD-L1 of at least 50% population, which consisted of 563 patients, median overall survival was not reached (95% CI 17·9-not evaluable) with cemiplimab (n=283) versus 14·2 months (11·2-17·5) with chemotherapy (n=280; hazard ratio [HR] 0·57 [0·42-0·77]; p=0·0002). Median progression-free survival was 8·2 months (6·1-8·8) with cemiplimab versus 5·7 months (4·5-6·2) with chemotherapy (HR 0·54 [0·43-0·68]; p0·0001). Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%). Grade 3-4 treatment-emergent adverse events occurred in 98 (28%) of 355 patients treated with cemiplimab and 135 (39%) of 342 patients treated with chemotherapy.Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%, providing a potential new treatment option for this patient population.Regeneron Pharmaceuticals and Sanofi.

In 2018, cemiplimab-rwlc became the first systemic treatment approved by the US FDA for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In 2019, conditional approvals were granted by Health Canada and the European Commission for the same indications. Limited data exist pertaining to the clinical characteristics, disease progression and survivorship of patients with advanced CSCC in real-world clinical practice. CemiplimAb-rwlc Survivorship and Epidemiology (CASE) is a prospective Phase IV, noninterventional, survivorship and epidemiology study that will enroll patients with advanced CSCC who have recently initiated or who plan to receive cemiplimab in a real-world setting. Trial registration number: NCT03836105.

Introduction Assess the cost-effectiveness (US healthcare payer perspective) of sarilumab subcutaneous (SC) 200 mg + methotrexate versus conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) or targeted DMARD + methotrexate for moderate-to-severe rheumatoid arthritis (RA) in adults with inadequate response to methotrexate. Methods Microsimulation based on patient profiles from MOBILITY (NCT01061736) was conducted via a 6-month decision tree and lifetime Markov model with 6-monthly cycles. Treatment response at 6 months was informed by a network meta-analysis and based on American College of Rheumatology (ACR) response. Responders: patients with ACR20 response who continued with therapy; non-responders: ACR20 non-responders who transitioned to the subsequent treatment. Utilities and quality-adjusted life-years (QALYs) were estimated via mapping 6-month ACR20/50/70 response to relative change in Health Assessment Questionnaire Disability Index score (short term) and based on published algorithms (long term). Direct costs considered drugs (wholesale acquisition costs), administration and routine care. Results Lifetime QALYs and costs for treatment sequences on the efficiency frontier were 3.43 and $115,019 for active csDMARD, 5.79 and $430,918 for sarilumab, and 5.94 and $524,832 for etanercept (all others dominated). Sarilumab was cost-effective versus tocilizumab and csDMARD (incremental cost-effectiveness ratios of $84,079/QALY and $134,286/QALY). Probabilistic sensitivity analysis suggested comparable costs and slightly improved health benefits for sarilumab versus tocilizumab, irrespective of threshold. Conclusion In patients with moderate-to-severe RA, sarilumab 200 mg SC every 2 weeks + methotrexate can be considered a cost-effective treatment option, with lower costs and greater health benefits than alternative treatment sequences (+ methotrexate) beginning with adalimumab, certolizumab, golimumab and tofacitinib and below commonly accepted cost-effectiveness thresholds against tocilizumab + methotrexate or csDMARD active treatment. Funding Sanofi and Regeneron Pharmaceuticals, Inc. Electronic supplementary material The online version of this article (10.1007/s12325-019-00946-1) contains supplementary material, which is available to authorized users.

Objective.We evaluated the effect of sarilumab on patient-perceived impact of rheumatoid arthritis (RA) using the 7-domain RA Impact of Disease (RAID) scale.Methods.Two phase III, randomized, controlled trials of sarilumab in patients with active, longstanding RA were analyzed: (1) sarilumab 150 mg and 200 mg every 2 weeks plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARD) versus placebo + csDMARD [TARGET (NCT01709578)]; and (2) sarilumab 200 mg versus adalimumab (ADA) 40 mg monotherapy [MONARCH (NCT02332590)]. Least-squares mean (LSM) differences in RAID total score (range 0–10) and 7 key RA symptoms, including pain and fatigue (baseline to Weeks 12 and 24), were compared. “Responders” by RAID total score were defined by improvements from baseline ≥ minimal clinically important difference (MCID), and ≥ patient-acceptable symptom-state (PASS) at endpoint.Results.Sarilumab 150 mg and 200 mg + csDMARD were nominally superior (p < 0.05) versus placebo + csDMARD and 200 mg sarilumab versus ADA 40 mg in LSM differences for RAID total score at weeks 12 (−0.93 and −1.13; −0.49, respectively) and 24 (−0.75 and −1.01; −0.78), and all effects of RA (except functional impairment in MONARCH Week 12). Effects were greater in physical domains (e.g., pain) than mental domains (e.g., emotional well-being). More patients receiving sarilumab versus placebo or ADA reported improvements ≥ MCID and PASS in total RAID scores at both assessments.Conclusion.Based on the RAID, sarilumab + csDMARD or as monotherapy reduced the effect of RA on patients’ lives to a greater extent than placebo + csDMARD or ADA monotherapy. (ClinicalTrials.gov: NCT01709578 and NCT02332590)

Introduction To evaluate the comparative efficacy and safety of subcutaneous sarilumab 200 mg monotherapy administered every 2 weeks (q2w) versus other monotherapies of biologic, targeted and conventional synthetic disease-modifying antirheumatic drugs (bDMARDs, tsDMARDs, csDMARDs) at recommended doses for treatment of rheumatoid arthritis in patients who are intolerant of or inadequate responders to csDMARDs (csDMARD-IR). Methods A systematic literature review and network meta-analysis (NMA) were conducted on 24-week efficacy outcomes: Health Assessment Questionnaire Disability Index (HAQ-DI) score, American College of Rheumatology (ACR) 20/50/70 criteria, and European League Against Rheumatism Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28)

BackgroundTo provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL).MethodsPatients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 weeks; group 3: 9 weeks).ResultsMedian duration of follow-up was 15.7 months. Overall, ORR per ICR was 46.1% (95% CI: 38.9% to 53.4%). Complete response (CR) rates were 20.3%, 12.8%, and 16.1% for groups 1, 2, and 3, respectively. Median time to CR was 11.2 months. Among patients with partial response or CR, the estimated proportion of patients with ongoing response at 12 months from the first objective response was 87.8% (95% CI: 78.5% to 93.3%), with median DOR not reached. Kaplan-Meier estimated probability of overall survival (OS) was 73.3% (95% CI: 66.1% to 79.2%) at 24 months, with median OS not reached. Global Health Status (GHS)/QoL improvements were observed as early as cycle 2 and were significantly improved and durable until last assessment. Kaplan-Meier estimate of median time to first clinically meaningful improvement for pain was 2.1 (95% CI: 2.0 to 3.7) months and was significantly improved in responders versus non-responders (pConclusionsThis is the largest (n=193) clinical dataset for a programmed cell death-1 inhibitor against advanced CSCC, confirming the sustained substantial clinical activity of cemiplimab in these patients, including new findings of improved CR rates over time, increasing DOR, and durable pain control and GHS/QoL improvement.Trial registration numberClinicalTrials.gov Registry (NCT02760498), https://clinicaltrialsgov/ct2/show/NCT02760498.

Aim: To estimate the comparative efficacy of cemiplimab, a programmed cell death protein 1 inhibitor, versus EGFR inhibitors, pembrolizumab and platinum-based chemotherapy in terms of overall survival (OS) and progression-free survival. Patients & methods: We performed an indirect treatment comparison of cemiplimab and other available systemic therapies for patients with advanced cutaneous squamous cell carcinoma. Results: Cemiplimab was associated with benefits in OS (hazard ratios range: 0.07–0.52) and progression-free survival (hazard ratios range: 0.30–0.67) versus EGFR inhibitors and pembrolizumab (data from KEYNOTE-629). Cemiplimab was more efficacious versus platinum-based chemotherapy in terms of OS. Conclusion: Cemiplimab may offer improvements in survival for advanced cutaneous squamous cell carcinoma patients compared with existing systemic therapies.

Cheryl P Ferrufino,1 Julie Munakata,1 Wenhui Wei,2 Clare Proudfoot,3 Andreas Kuznik,4 Susan H Boklage,4 Chieh-I Chen4 1IQVIA, Fairfax, VA, USA; 2Sanofi, Bridgewater, NJ, USA; 3Sanofi, Guildford, UK; 4Regeneron Pharmaceuticals, Inc., Tarrytown, NY,USA Objective: To estimate the 5-year budget impact (BI) on a US health plan of introducing sarilumab – a human immunoglobulin G1 anti-IL-6 receptor α monoclonal antibody – as combination treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or monotherapy in patients with moderate-to-severe rheumatoid arthritis (RA).Methods: BI analysis was conducted from a commercial payer perspective. Treatment-eligible populations included adult patients with moderate-to-severe RA and inadequate response (IR) to csDMARDs or tumor necrosis factor (TNF)-α inhibitors-IR. All licensed biologic treatments recommended by the American College of Rheumatology guidelines were included.Results: For a hypothetical plan of one million members, 409 csDMARD-IR and 345 TNF-IR patients were annually eligible for combination therapy and 226 csDMARD and TNF-IR patients for monotherapy with sarilumab. Based on 2018 US direct treatment costs, the introduction of sarilumab was estimated to save $526,424, $322,637 and $264,306 over 5 years for csDMARD-IR combination therapy patients, TNF-IR combination therapy patients, and csDMARD-IR/TNF-IR monotherapy patients, respectively. As sarilumab absorbed a greater market share over the horizon, annual savings increased from years 1 to 5, $28,610 (–0.14%) to $194,646 (–0.83%) in csDMARD-IR, $16,986 (–0.11%) to $120,893 (–0.67%) in TNF-IR, and $14,256 (–0.13%) to $98,040 (–0.79%) in monotherapy. One-way sensitivity analyses revealed that the model was most sensitive to variations in sarilumab adherence.Conclusion: Total cost savings of introducing sarilumab to a health-care plan accrued from years 1 to 5, attributable to the lower treatment cost, stable dosing paradigm, and price parity for the two available doses (150 and 200 mg every 2 weeks) compared with alternative biologic DMARDs that have substantial variability in dose titration/schedules. Keywords: treatment costs, disease-modifying anti-rheumatic drug, IL-6 inhibitorCorrigendumfor this paper has been published

Introduction After a patient with rheumatoid arthritis (RA) fails tumor necrosis factor inhibitor (TNFi) treatment, clinical guidelines support either cycling to another TNFi or switching to a different mechanism of action (MOA), but payers often require TNFi cycling before they reimburse switching MOA. This study examined treatment persistence, cost, and cost per persistent patient among MOA switchers versus TNFi cyclers. Methods This study of Commercial and Medicare Advantage claims data from the Optum Research Database included patients with RA and at least one claim for a TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between January 2012 and September 2015 who changed to another TNFi or a different MOA therapy (abatacept, tocilizumab, or tofacitinib) within 1 year. The index date was the date of the change in therapy. Treatment persistence was defined as no subsequent switch or 60-day gap in therapy for 1 year post-index. RA-related costs included plan-paid and patient-paid amounts for inpatient, outpatient, and pharmacy claims. Medication costs included index and post-index costs of TNFi and different MOA therapies. Results There were 581 (38.3%) MOA switchers and 935 (61.7%) TNFi cyclers. The treatment persistence rate was significantly higher for MOA switchers versus TNFi cyclers (47.7% versus 40.2%, P = 0.004). Mean 1-year healthcare costs were significantly lower among MOA switchers versus TNFi cyclers for total RA-related costs ($37,804 versus $42,116; P

To examine treatment patterns, treatment effectiveness, and treatment costs for 1 year after patients with rheumatoid arthritis switched from a tumor necrosis factor inhibitor (TNFi) (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab), either cycling to another TNFi ("TNFi cyclers") or switching to a new mechanism of action (abatacept, tocilizumab, or tofacitinib) ("new MOA switchers").This retrospective cohort study used administrative claims data for a national insurer. Treatment persistence (without switching again, restarting, or discontinuing), treatment effectiveness (defined below), and costs were assessed for the 12-month post-switch period. Patients were "effectively treated" if they satisfied all six criteria for a treatment effectiveness algorithm (high adherence, no dose increase, no new conventional synthetic disease-modifying anti-rheumatic drug, no subsequent switch in therapy, no new/increased oral glucocorticoids, and2 glucocorticoid injections). Multivariable logistic models were used to adjust for baseline factors.The database included 581 new MOA switchers and 935 TNFi cyclers. New MOA switchers were 39% more likely than TNFi cyclers to persist after the switch (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.12-1.74; p = .003) and 36% less likely to switch therapy again (OR = 0.64; 95% CI = 0.51-0.81; p .001). New MOA switchers were 43% more likely than TNFi cyclers to be effectively treated (OR = 1.43; 95% CI = 1.11-1.85; p = .006). New MOA switchers had 16% lower drug costs than TNFi cyclers (cost ratio = 0.84; 95% CI = 0.79-0.88; p .001) and 11% lower total costs of rheumatoid arthritis-related medical care (cost ratio = 0.89; 95% CI = 0.84-0.94; p .001).Claims payments may not reflect rebates or other cost offsets. Medical and pharmacy claims do not include clinical end-points or reasons that lead to new MOA switching vs TNFi cycling.These results support switching to a new MOA after a patient fails treatment with a TNFi, which is consistent with recent guidelines for the pharmacologic management of established rheumatoid arthritis.

Despite a substantial number of treatment options in rheumatoid arthritis (RA) following tumor necrosis factor inhibitor (TNFi) inadequate response or intolerance (TNF-IR), a lack of clarity on the optimal approach remains. Sarilumab, a human monoclonal anti-interleukin-6 receptor alpha antibody, can be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) in TNF-IR patients.To conduct a cost-utility analysis from a U.S. health care system perspective for sarilumab subcutaneous 200 mg + methotrexate versus abatacept + methotrexate or a bundle of TNFi + methotrexate for treatment of adult patients with moderately to severely active RA and TNF-IR.Analysis was conducted via individual patient simulation based on patient profiles from the TARGET trial (NCT01709578); a 6-month decision tree was followed by lifetime semi-Markov model with 6-month cycles. Treatment response at 6 months, informed by network meta-analysis, was based on American College of Rheumatology (ACR) 20/50/70 criteria; patients achieving ≥ ACR20 continued with current therapy, and other patients moved to the next line of biologic DMARD therapy or conventional synthetic DMARD palliative treatment. Direct costs included wholesale acquisition drug costs and administration and routine care costs. Routine care costs and quality-adjusted life-years (QALYs) were estimated by predicting the Health Assessment Questionnaire Disability Index score based on treatment response and were imputed from published equations.Sarilumab + methotrexate dominated the TNFi bundle + methotrexate, achieving lower costs ($319,324 vs. $356,096) and greater effectiveness (4.27 vs. 4.15 QALYs), and was on the cost-efficiency frontier with abatacept + methotrexate ($360,211 and 4.29 QALYs). Abatacept + methotrexate was not cost-effective versus sarilumab + methotrexate. Scenario analyses indicated the results were robust; sarilumab + methotrexate became dominant against abatacept + methotrexate after reduced model horizon, minimum response based on ACR50 or ACR70, or time to discontinuation per treatment class. Sarilumab + methotrexate was also dominant versus the TNFi bundle; when class-specific time to treatment discontinuation was specified, sarilumab remained cost-effective with an incremental cost-effectiveness ratio of $36,894.Sarilumab + methotrexate can be considered an economically dominant (more effective, less costly) option versus a second TNFi + methotrexate; compared with abatacept + methotrexate, it is a less costly but less effective option for patients with moderately to severely active RA who have previously failed TNFi.This study was funded by Sanofi and Regeneron Pharmaceuticals. Kiss and Gal are employees of Evidera, which received consulting fees from Sanofi/Regeneron for conducting this study. Muszbek was employed by Evidera at the time of this study. Kuznik and Chen are current employees of and stockholders in Regeneron Pharmaceuticals. Fournier is an employee of and stockholder in Sanofi. Proudfoot is a former employee of and current stockholder in Sanofi and current employee and stockholder in ViiV Healthcare/GlaxoSmithKline. Michaud has received grant funding from Pfizer and the Rheumatology Research Foundation. The sponsors were involved in the study design, collection, analysis, and interpretation of data as well as data checking of information provided in the manuscript. The authors had unrestricted access to study data, were responsible for all content and editorial decisions, and received no honoraria related to the development of this publication.

Background Heterogeneity in assessments of rheumatoid arthritis (RA) disease remission, based on physician judgment and patient self-reports versus standardized measures, have previously been reported. This study explored the prevalence and types of discordance between physician perception versus objective data of RA disease activity in real-world clinical practice in the US. Methods Data were from the Adelphi RA Disease Specific Programme (DSP; January to March 2014), a cross-sectional survey of US rheumatologists and their patients. RA remission based on physician judgment versus Disease Activity Score in 28 joints (3)-erythrocyte sedimentation rate (DAS28(3)-ESR) and Clinical Disease Activity Index (CDAI) scores were compared using descriptive analyses; patient and physician factors associated with discordance were identified using bivariate and multivariate analyses. Results Of 101 rheumatologists participating (completing patient-record forms for 843 patients), 56.4% based assessment of remission on clinical judgment alone. Of 531 patients eligible for the discordance analysis, 49.7% were in remission based on rheumatologists’ evaluation, and 30.7% were eligible based on DAS28(3)-ESR. Compared with DAS28(3)-ESR criteria, 25.8% of patients’ disease remission was negatively discordant (overestimated remission) based on clinical perception. These patients were mostly administered biologic disease-modifying antirheumatic drugs and were without a treat-to-target strategy followed by their rheumatologist (P

Marie Fournier,1 Chieh-I Chen,2 Andreas Kuznik,2 Clare Proudfoot,3 Usha G Mallya,4 Kaleb Michaud5,6 1Health Economics & Value Assessment, Sanofi France, Chilly-Mazarin, France; 2Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; 3Sanofi, Guildford, UK; 4Sanofi, Bridgewater, NJ, USA; 5University of Nebraska Medical Center, Omaha, NE, USA; 6The National Databank for Rheumatic Diseases, Wichita, KS, USA Purpose: Treatment outcomes and direct medical costs were examined, from a US health payer perspective, of monotherapy with sarilumab 200 mg subcutaneous (SC) every 2 weeks (Q2W) vs adalimumab 40 mg SC Q2W/QW in adult patients with moderately to severely active rheumatoid arthritis who are intolerant of, inadequate responders to, or considered inappropriate candidates for continued methotrexate treatment.Patients and methods: Short-term analysis was based on 24-week wholesale acquisition costs of drugs and treatment response observed in the MONARCH Phase III trial (NCT02332590) per American College of Rheumatology (ACR) 20/50 criteria and European League Against Rheumatism (EULAR) Moderate/Good Disease Activity Score 28-joint count erythrocyte sedimentation rate. Long-term analysis, which also considered drug administration and routine care costs, was conducted via a 6-month decision tree and a 1- to 10-year Markov model with microsimulation of patient profiles from the MOBILITY Phase III trial (NCT01061736). Utilities and quality-adjusted life-years (QALYs) were estimated by mapping 6-month ACR levels to a relative change in Health Assessment Questionnaire – Disability Index score and via published algorithms.Results: For sarilumab and adalimumab, respectively, 24-week drug costs were $18,954 and $29,232, and costs per responder were $26,435 vs $50,055 on ACR20; $41,475 vs $98,425 on ACR50; and $22,511 vs $41,230 on EULAR Moderate/Good. Base case results at 10 years for total costs and QALYs were $176,977 and 2.75 for sarilumab and $212,136 and 2.61 for adalimumab, respectively. Sarilumab was consistently the more effective and cost-saving treatment across all short-term and long-term incremental analyses.Conclusion: Sarilumab monotherapy was the economically dominant treatment on incremental cost per responder and incremental cost per QALY compared with adalimumab monotherapy. These results were maintained within the sensitivity analyses. Keywords: treatment costs, disease-modifying anti-rheumatic drug, IL-6 inhibitor, rheumatoid arthritis, cost per responser

e18742 Background: HHIs are the only approved 1L systemic Tx for aBCC. Many pts develop resistance or are intolerant to HHIs and may require second-line (2L) Tx. Little is known about patient outcomes following HHI discontinuation. In this study, we describe characteristics and outcomes among pts with aBCC who discontinued 1L HHIs due to progression or toxicity. Methods: In this retrospective cohort study, we identified adult pts diagnosed with aBCC who discontinued 1L HHI monotherapy between January 2012 and November 2019 in The US Oncology Network (Network), a community-based network of > 450 oncology clinics. Pts with ≥2 Network visits and no Tx for other primary malignancy 3 years prior to index date were included. Structured and unstructured data in the electronic health records were used to extract information on pt characteristics and outcomes. Pts were grouped based on initiation of 2L systemic Tx post-HHI discontinuation into 2L initiators and 2L non-initiators. 2L non-initiators were followed for ≥90 days post-HHIs discontinuation, and those undergoing surgery or radiation during this period (i.e. potential neoadjuvant HHI use) were excluded. Index date was date of 2L Tx initiation for 2L initiators and 90 days post 1L HHI discontinuation for 2L non-initiators. Pts were followed from index date until death, Tx initiation for another primary cancer, loss to follow-up, or end of study (February 1, 2020), whichever occurred first. Pt disposition and outcomes were described separately for each group. Results: We identified 73 aBCC pts who discontinued 1L HHI monotherapy during the specified period. Of those, 19 (26%) pts (4 [21%] 2L initiators and 15 [79%] 2L non-initiators) were included in the study: 12 (63%) were male and 3 (21%) were metastatic at diagnosis, with a mean age of 73 years. Median (range) follow-up time from index date was 10 (3‒42) months for 2L non-initiators and 6 (1‒61) months for 2L initiators. Fourteen (74%) pts discontinued HHI due to toxicity (all 2L non-initiators) and 5 (26%) due to progression (4 2L initiators and 1 2L non-initiator). Median time to discontinuation of 1L HHI was 7 (2‒9) months in 2L non-initiators and 9 (7‒42) months in 2L initiators. 2L initiators received subsequent Tx 2‒130 days following discontinuation of 1L HHI. Time to discontinuation of 2L Tx ranged 4–11 months. Six deaths (32%) were observed during study period (5 2L non-initiators and 1 2L initiator). Conclusions: The short duration of 1L HHI Tx in our small cohort of aBCC pts who did not respond to and/or tolerate HHI is consistent with previous findings. During the study period, limited therapeutic options existed post-HHI, highlighting the unmet need for more effective Tx strategies in a 2L aBCC setting.

e18740 Background: HHIs are the only approved 1L systemic Tx for aBCC and Tx options following HHI Tx failure are limited. The objective of this study was to assess frequency, characteristics, and subsequent Tx patterns of pts with aBCC discontinuing 1L HHIs due to toxicity or disease progression. Methods: We conducted a retrospective cohort study using electronic health records of pts treated in The US Oncology Network (Network), a community-based network of > 450 oncology clinics. We identified adults (18+ years) with aBCC, not treated for another primary malignancy in the past 3 years, with ≥2 Network visits who discontinued 1L HHI monotherapy between January 2012 and November 2019 due to documented toxicity or progression without evidence of complete response (CR) who subsequently initiated second-line (2L) systemic Tx (2L initiators) or not (2L non-initiators). To exclude pts potentially using neoadjuvant HHIs, we required 2L non-initiators to be followed for ≥90 days after HHI discontinuation and excluded pts who underwent surgery or radiation during this period. Index date was Tx initiation for 2L initiators and 90 days after HHI discontinuation for 2L non-initiators. We describe cohort attrition and characteristics of 2L initiators and 2L non-initiators as well as Txs initiated among 2L initiators. Results: We identified 138 aBCC pts treated with HHIs regardless of line of therapy with fully accessible charts: 115/138 (83.3%) received HHIs as 1L systemic therapy for aBCC; 73/115 (63.5%) discontinued 1L HHIs; 37/73 (50.7%) discontinued due to documented toxicity or progression without evidence of CR. 4/37 pts (10.8%) initiated 2L systemic Tx (1 carboplatin & paclitaxel; 1 cemiplimab; 1 nivolumab; 1 pembrolizumab) within a median of 75 days (range: 2‒130) from HHI discontinuation. 2L initiators were 68.7 years of median age (range: 48.4‒71.1); 100% female; 75% White; 75% immunocompetent; 100% treated with 1L vismodegib for a median of 8.6 months (range: 6.8‒42.2); 100% discontinued 1L HHIs due to documented disease progression. We identified 15 2L non-initiators; median age 80.2 years (range: 49.6‒90+); 20% female; 100% White; 86.7% immunocompetent; 100% treated with 1L vismodegib for a median of 6.8 months (range: 1.9‒20.6); 93.3% discontinued 1L HHIs due to documented toxicity and 6.7% due to progression. Conclusions: In this small cohort of aBCC pts discontinuing 1L HHIs, ̃50% discontinued due to toxicity or disease progression. There was no clear standard of care among pts who experienced HHI Tx failure, with only a minority initiating subsequent 2L Tx. Effective Tx strategies for pts who do not respond to or cannot tolerate HHIs are needed.

9566 Background: Cemiplimab-rwlc is the first immunotherapy to receive approval in the US, fully for pts with laBCC and accelerated for metastatic BCC, post hedgehog inhibitors or for whom hedgehog inhibitors are not appropriate. Cemiplimab resulted in clinically meaningful anti-tumor activity in pts with laBCC who progressed on or were intolerant to hedgehog inhibitor therapy (NCT03132636). This analysis evaluated HRQoL in these pts. Methods: Adults with laBCC and ECOG performance status ≤1 (n=84) received IV cemiplimab 350 mg Q3W for up to 9 treatment cycles. At baseline (BL) and day 1 of each cycle (C), pts completed EORTC QLQ-C30 and SKINDEX-16 questionnaires that assess Global Health Status (GHS)/QoL, functioning, and BCC-related symptoms. Mixed-effects repeated measures (MMRM) models were used to estimate least squares (LS) mean (standard error [SE]) change from BL during treatment (i.e., across C2 to C9); changes ≥|10| points were considered clinically meaningful. Responder analyses were conducted in pts with non-missing data from BL to determine the proportions with clinically meaningful improvement or deterioration, or stability on QLQ-C30 and SKINDEX-16 at C2 and C9; a 10-point threshold was considered meaningful for both instruments. Results: BL scores showed moderate to high levels of functioning and low symptom burden. In MMRM models, overall changes from BL on QLQ-C30 indicated stability for GHS/QoL and all scales except for clinically meaningful worsening of fatigue (LS mean [SE] change 12.5 [3.9]; P

9078 Background: Cemiplimab, a PD-1 inhibitor, improved survival and progression-free survival vs platinum doublet chemotherapy (chemo) in patients (pts) with advanced NSCLC and PD-ligand(L)1 expression ≥50% in the EMPOWER-Lung 1 Phase 3 study (NCT03088540). Since pts with advanced NSCLC have a high symptom burden that adversely impacts QoL and functioning, these outcomes were evaluated as secondary endpoints in the clinical trial. Methods: Pts with advanced NSCLC with PD-L1 expression ≥50% and ECOG performance status ≤1 were randomized to IV cemiplimab 350 mg Q3W (n=356) or platinum doublet chemo (n=354). At baseline (BL) and day 1 of each treatment cycle (C) to C15, pts were administered the EORTC core questionnaire (QLQ-C30) and its lung cancer specific module (QLQ-LC13) to assess symptoms, functioning, and Global Health Status (GHS)/QoL. In the intent-to-treat population, mixed-effects repeated measures models were used to estimate least squares (LS) mean change from BL on all scales. Kaplan–Meier analysis estimated time to definitive deterioration, defined as worsening ≥10 points from BL observed at all subsequent time points or patient withdrawal after worsening; hazard ratios (HR) with 95% CIs estimated the likelihood of definitive deterioration. Results: BL scores showed moderate to high levels of functioning and low symptom burden. Cemiplimab-treated pts had lower likelihood of definitive deterioration vs chemo on key symptoms of dyspnea, cough, pain in chest, pain in other body parts, fatigue, nausea/vomiting, appetite loss, constipation, and diarrhea vs chemo (all P

not available.

Objectives After treatment failure with a tumor necrosis factor inhibitor (TNFi), patients with rheumatoid arthritis (RA) can switch to another TNFi (TNFi cyclers) or to a targeted disease-modifying antirheumatic drug (DMARD) with a non-TNFi mechanism of action (non-TNFi switchers). This study compared treatment patterns and treatment effectiveness between TNFi cyclers and non-TNFi switchers in patients with RA. Methods The analysis included a cohort of patients from the Truven Health Analytics MarketScan Commercial database with RA who switched from a TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) either to another TNFi or to a non-TNFi targeted DMARD (abatacept, tocilizumab, or tofacitinib) between January 1, 2010 and September 30, 2014. A claims-based algorithm was used to estimate treatment effectiveness based on six criteria (adherence, no dose increase, no new conventional therapy, no switch to another targeted DMARD, no new/increased oral glucocorticoid, and intra-articular injections on

not available.

10033 Background: Cemiplimab-rwlc (cemiplimab), a PD-1 Inhibitor, showed a robust clinical response in patients (pts) with metastatic (mCSCC) or locally advanced (laCSCC) CSCC not eligible for curative surgery/radiation. This post hoc exploratory analysis examined data from the EORTC cancer specific 30-item HRQL questionnaire (QLQ-C30) for pts participating in a cemiplimab phase 2 clinical trial (clinicaltrials.gov NCT02760498). Methods: Adults (N = 193) with invasive CSCC, ≥1 lesion and ECOG performance status ≤1 received IV cemiplimab 3mg/kg q2w (mCSCC n = 59; laCSCC n = 78) or 350mg q3w (mCSCC n = 56). At baseline (BL) and day 1 of each treatment cycle, pts were administered the QLQ-C30. Mixed effects repeated measures (MMRM) models were used to estimate mean change from BL to cycle 5 (C5) for domains/items of the QLQ-C30. For pts with data from BL to C5, the proportion who reported clinically meaningful improvement or worsening (≥10 points) or maintenance (those who did not have ≥10 point change) on each domain was determined for combined and individual treatment groups. Results: BL scores indicated moderate to high levels of functioning and low symptom burden. From BL to C5, a clinically meaningful improvement in pain score was observed (least squares [LS] mean [standard error] change -12.1 [2.1]; P< .0001); other domains/items remained stable or showed a trend towards improvement (LS mean changes < 10 points). By C5, the majority of pts experienced clinically meaningful improvement or remained stable across key domains (Table). Similar findings were observed on individual symptoms (85%-94% for dyspnea, nausea/vomiting, diarrhea, constipation, appetite loss) and in each treatment group. Conclusions: Cemiplimab-treated patients achieved a clinically meaningful reduction in pain and most pts either improved or maintained their HRQL, function with low symptom burden. Clinical trial information: NCT02760498. [Table: see text]

Objectives The study aimed to assess the burden of RA among the US Medicare population (aged ≥65 years) by comparing co-morbidities, health-care resource utilization (HCRU) and costs against matched non-RA Medicare patients. Methods Data were obtained from the Medicare fee-for-service claims database from 2010 to 2013. RA Medicare patients were identically matched with Medicare patients without RA (controls) based on demographics. Bivariate analyses were conducted to examine differences between cohorts for co-morbidities, HCRU and costs. A generalized linear model was used to test relationships between patient-level characteristics, HCRU and costs. Results The study population included 115 867 RA patients and 115 867 age-, sex-, race- and region-matched non-RA controls. Mean age was 75.2 years; 79.4% were female. Co-morbidities were greater in RA vs non-RA patients [Charlson Co-morbidity Index (excluding RA): 1.86 vs 1.00; P

Background Patients with RA experience a variety of signs and symptoms and report significant physical and psychological impairment. The RA Impact of Disease (RAID) scale is a disease-specific measure of the impact of RA on patients9 lives. RAID was assessed in two Phase 3 randomized trials of sarilumab, a human monoclonal antibody directed against the IL-6 receptor-α (TARGET [NCT01709578]; MONARCH [NCT02332590]). Objectives To evaluate patient-perceived impact of sarilumab on RA using the RAID scale vs either placebo + conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) or adalimumab. Methods TARGET assessed sarilumab 150mg and 200mg added to csDMARDs vs placebo in patients with RA intolerant of or not responding to anti-TNF therapy. MONARCH assessed sarilumab 200mg monotherapy vs adalimumab 40mg monotherapy in patients with RA either intolerant of, inadequate responders to, or considered inappropriate candidates for continued treatment with methotrexate. Treatments were administered subcutaneously every 2 weeks. RAID has 7 single-item domains, each rated by patients on an 11-point numeric rating scale from 0 (absence) to 10 (extreme). A total score from 0 to 10 (with lower scores indicative of less impact of disease) is calculated by weighting responses for each item based on patient assessment of the relative importance of the item. RAID was assessed at baseline (BL), Weeks 12 and 24. Least square mean (LSM) changes from BL in total score (Weeks 12 and 24) and domains (Week 24 only) were analysed with a mixed model for repeated measures, including treatment, region, visit, and treatment-by-visit interaction (and prior csDMARD therapy in TARGET) as fixed effects and BL as a covariate. RAID was tested outside of trial hierarchy and statistical significance is not claimed; nominal p-values are provided. Post-hoc categorical change analyses were conducted to identify “responders” in the total score (improvements ≥ minimum clinically important difference from BL to Week 24 [absolute change of 3 or relative change of 50% in total score]). Patients discontinuing therapy/requiring rescue medication prior to endpoint were classified as non-responders. Results Sarilumab was superior (nominal p Conclusions Assessed using RAID, sarilumab either with csDMARDs or as monotherapy reduced the impact of RA on patients9 lives to a greater extent than placebo+csDMARDs or adalimumab monotherapy, with benefits shown on total RAID and all 7 individual domain scores. Acknowledgements This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interest L. Gossec Consultant for: Abbvie, Celgene, Janssen, Lilly, Novartis, MSD, Roche, and UCB, V. Strand Consultant for: AbbVie, Amgen, AstraZeneca, Biogen, BMS, Celltrion, CORRONA, Crescendo, Genentech/Roche, GSK, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals, Sandoz, Sanofi, and UCB, C. Proudfoot Shareholder of: Sanofi, Employee of: Sanofi, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, S. Guillonneau Shareholder of: Sanofi, Employee of: Sanofi, T. Kimura Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, H. van Hoogstraten Shareholder of: Sanofi, Employee of: Sanofi, E. Mangan Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, M. Reaney Shareholder of: Sanofi, Employee of: Sanofi

Background The phase 3 MONARCH superiority study (NCT02332590) compared efficacy and safety of sarilumab (a human anti-IL-6Rα monoclonal antibody [mAb]) 200 mg administered subcutaneously every 2 weeks (q2w), with adalimumab (an anti-TNF-α mAb) 40 mg administered q2w, in patients with active rheumatoid arthritis (RA) who were either intolerant of, or inadequate responders to methotrexate treatment. Sarilumab monotherapy demonstrated superiority to adalimumab monotherapy in reduction of disease activity and improvements in physical function and signs and symptoms of RA, with safety and tolerability consistent with IL-6R or TNF blockade. Objectives To compare patient-reported outcomes (PROs) with sarilumab vs adalimumab from MONARCH. Methods PROs assessed at baseline, weeks 12 and 24 included ACR components (Patient Global Assessment of Disease Activity [PtGA], Pain visual analog scale [VAS], Health Assessment Questionnaire Disability Index [HAQ-DI]), Medical Outcomes Study Short Form-36 (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Morning Stiffness VAS, RA Impact of Disease (RAID) and RA-specific Work Productivity Survey (WPS-RA). Least-squares mean (LSM) between-group differences were determined by mixed-model for repeated measures with treatment, visit, treatment-by-visit interaction and region as fixed effects, and the corresponding baseline PRO scores as continuous covariates. A P-value Results Baseline demographics, disease characteristics and PROs were generally balanced between treatment groups (n=184 sarilumab; n=185 adalimumab). Improvements from baseline to week 24 were greater with sarilumab vs adalimumab across PtGA, Pain VAS, HAQ-DI, SF-36 PCS, Morning Stiffness VAS, RAID and WPS-RA global scores (all P Conclusions Sarilumab monotherapy compared with adalimumab monotherapy resulted in greater and clinically meaningful improvements in many PROs, including patient-reported disease activity, pain, physical function, morning stiffness, productivity, health related quality of life and health status. Acknowledgements This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interest V. Strand Consultant for: AbbVie, Amgen, AstraZeneca, Biogen, BMS, Celltrion, CORRONA, Crescendo, Genentech/Roche, GSK, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals, Sandoz, Sanofi, and UCB, L. Gossec Grant/research support from: Member of institution that received research funding for the current study, C. Proudfoot Shareholder of: Sanofi, Employee of: Sanofi, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., M. Reaney Shareholder of: Sanofi, Employee of: Sanofi, S. Guillonneau Shareholder of: Sanofi, Employee of: Sanofi, T. Kimura Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., J. van Adelsberg Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., Y. Lin Shareholder of: Sanofi, Employee of: Sanofi, E. Mangan Shareholder of: Pfizer Inc. and Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., H. van Hoogstraten Shareholder of: Sanofi, Employee of: Sanofi, G. R. Burmester Grant/research support from: Member of institution that received research funding for the current study

Overactive bladder (OAB) and related conditions, such as urge urinary incontinence (UI), can interfere with work, leisure activities, and healthy sleep patterns.To report (a) employee urinary antispasmodic (UA) medication persistence and adherence; (b) the impact of salary and copay on adherence; and (c) the impact of UA adherence on medical, pharmacy, sick leave (SL), short- and long-term disability (STD, LTD), workers' compensation costs, work absence days, and turnover.This retrospective study used a 2001-2011 database of claims, payroll, and demographic data from 27 large U.S. employers. Employees aged 18-64 years taking UA medications with health plan enrollment from 6 months before the index UA medication prescription to 12 months after were included. Persistence (days until first ≥ 30-day gap in UA medication supply) and adherence (percentage of the annual post-index period with available medication) were assessed using survival analysis and generalized linear regression models that controlled for demographics, job-related factors, copay, and pre-index employee benefit utilization. 2,960 employees met study criteria. Median days of persistence by OAB subtype were 76, 82, 43, 66, and 60 for urge UI, mixed UI, nocturnal UI, other OAB, and no diagnosis, respectively (P less than 0.05 for urge and mixed vs. no diagnosis). Increased copay and copay as a percentage of salary were associated with lower adherence. Employees with ≥ 80% adherence had lower medical, SL, and STD and higher overall drug costs than employees with less than 80% adherence. This study suggests potential economic benefits to employers from increased UA adherence. Additionally, economic factors such as ability to pay influence adherence to UA medications.

Objective: To estimate the cost-effectiveness of intravenous linezolid as a first-line agent against intravenous vancomycin in treating methicillin-resistant Staphylococcus aureus–confirmed nosocomial pneumonia in four Chinese cities. Methods: A decision-analytic model of 4-week time horizon was used to conduct costeffectiveness analyses from the payer’s perspective. Clinical outcomes and resource use data were derived from a head-to-head trial, supplemented with local cost estimates based on hospital data via an expert panel. A series of scenario analyses were conducted to evaluate the impact of uncertainty around model inputs. All results were reported in 2012 Chinese Renminbi. Results: The predicted probability of overall treatment success was 0.629 and 0.602 for linezolid and vancomycin, respectively. Total inpatient costs varied across the four cities, ranging from ¥58,835 to ¥86,894 for linezolid and ¥58,390 to ¥87,033 for vancomycin, respectively. Linezolid was demonstrated to be a dominant treatment strategy in Guangzhou. In Beijing, Nanjing, and Xi’an, incremental cost-effectiveness ratios in terms of additional successfully treated patient were ¥1,861, ¥163, and ¥16,509, respectively. Dominance by linezolid was observed in some scenario analyses with parameters such as treatment duration, inclusion of cost of managing adverse events, and drug acquisition costs being the main drivers of cost-effectiveness results. Conclusions: Despite linezolid’s higher drug acquisition cost, its superior clinical efficacy renders it a likely cost-effective alternative for the treatment of methicillinresistant Staphylococcus aureus–confirmed nosocomial pneumonia as compared with branded vancomycin from the payer perspectives of Beijing, Guangzhou, Nanjing, and Xi’an.

Objective The goal of this study was to analyze the economic benefits of introducing the 7-valent pneumococcal conjugate vaccine (PCV7) into the City Immunity Program in Shanghai. Methods A decision-analytic model designed for pneumococcal disease and outcomes of pneumococcal infection was populated with local, age-specific incidence and cost data to estimate the expected economic benefits from vaccinating a birth cohort of 172,183 infants in Shanghai over a 1-year period using a cross-sectional approach. The analysis was assumed to occur in a year at which time the direct and indirect effects of vaccination have reached a steady state. Costs were calculated from a payer perspective and included vaccination program costs and direct medical expenditures from pneumococcal-related disease. Results The model predicts that 112,629 cases of pneumococcal-related disease could be prevented during a given year following the introduction of the PCV7 vaccine into the City Immunity Program in Shanghai, leading to a reduction of ¥187,923,359 (US $29,067,790) in direct medical costs. Overall, the inclusion of the PCV7 vaccine is estimated to have a cost-per-life-year saved of ¥37,468 (US $5,796) and a cost-per-quality-adjusted-life-year gained of ¥41,603 (US $6,435) when both the direct and indirect effects of the vaccine resulting from herd protection are taken into account. Conclusions Results suggest that including PCV7 into the City Immunity Program in Shanghai could be considered cost-effective under generally accepted willingness-to-pay thresholds when both the direct and indirect effects of the vaccine are considered in the analysis.

Adherence with oral medication for overactive bladder syndrome is suboptimal. To improve adherence, the YourWay plan was developed to assist patients and health care providers in defining treatment expectations and facilitating communication.To evaluate medication adherence among patients with overactive bladder syndrome enrolled in the YourWay patient support plan, patient adoption of behavioral interventions, patient satisfaction with the plan, and physician experience with the plan.In this 13-week, single-arm, open-label, multicenter, noninterventional study, fesoterodine-naïve patients received a prescription for fesoterodine 4 or 8 mg and a packet including a 14-day fesoterodine sample, educational materials, and progress tracker. Patients registered for the YourWay plan, which included an educational resource kit, interactive voice-response calls, and optional online and mail support. The primary end point was the proportion of patients who filled a prescription for a ≥ 90-day supply of fesoterodine within 90 days of enrollment. Secondary end points were the proportion of patients who filled ≥ 1 prescription and ≥ 2 prescriptions (post hoc), patient evaluation of their experience and satisfaction with the YourWay plan, and differences between prescription fillers and nonfillers in plan adoption and assessment (post hoc). We surveyed an independent sample of physicians to assess their experience with YourWay.Of 500 study completers, 10.4% filled a prescription for a ≥ 90-day supply of fesoterodine. Of those filling a prescription, 26.2% filled ≥ 1 prescription and among those, 61.0% refilled their prescription at least once. Many behavioral recommendations were adopted by 82% to 94% of patients. Fillers were more likely to take fesoterodine as directed, whereas adoption of behavioral recommendations or plan satisfaction did not differ between fillers and nonfillers. Most patients reported that the plan was informative and feasible to implement, and that they were satisfied with various aspects of the plan. Physicians also reported positive experiences.Most patients adopted YourWay components and viewed the plan positively, although adherence remained a challenge.

OBJECTIVE Quantify incremental employee medical, pharmacy, sick leave, short- and long-term disability, and workers' compensation costs, absence days, and turnover associated with urge urinary incontinence (UUI) in employees. METHODS This retrospective 2001-2011 database comparison of employees with UUI versus those without UUI (controls) included employees aged 18.5 to 64.0 years at index, with 6-month preindex and 12-month postindex health plan enrollment. Logistic and generalized linear models measured postindex costs, absences, and turnover. RESULTS The study included 1448 employees with UUI and 337,796 controls. Employees with UUI had statistically significantly higher medical (131% higher), pharmacy (52%), sick leave (30%), and short-term disability (74%) costs and more sick leave (22%) and short-term disability (99%) days than controls (all P < 0.02). CONCLUSIONS Employees with UUI had 117% greater medical and pharmacy costs, 47% greater total absence costs, and 63% more absence days than employees without UUI.

e21034 Background: CSCC is the second most common skin cancer. Most CSCC cases can be cured with surgical excision alone (5-year cure rate > 95%). We sought to evaluate patterns of major surgeries among patients with CSCC, overall and among those requiring systemic therapy. Methods: From Truven MarketScan claims data, we identified patient’s first CSCC diagnosis between 2013 and 2018 and required that they be continuously enrolled in their healthcare plan and have no CSCC diagnosis in the previous 12 months. Major surgeries included facial excisions over 3.1 cm, parotidectomy, removal of ear/eye/nose, amputations, craniectomy, excision of extracranial nerves, sentinel lymph node biopsy, lymphadenectomy, complex repairs of over 7.5 cm, integra, free flaps, and large grafts over 20 sq cm. Risk of a major surgery was assessed using Kaplan-Meier estimators for patients with CSCC overall and for those who received prior or concurrent systemic therapy, stratified by immune status. Results: A total of 240,122 patients with CSCC (mean age [SD]: 67.7 [12.9] years; male: 56.5%; immunocompromised: 12.4%) were identified with a mean (SD) follow-up of 1.34 (1.15) years. Risk of major surgery (95% confidence interval [CI]) at 1 and 2 years was 15.1% (14.9–15.2) and 18.6% (18.4–18.8), respectively. 782 patients received prior or concurrent systemic therapy, of which 22.4% (n = 175) were immunocompromised. Among those who received systemic therapy, 1- and 2-year risks (95% CI) were 8.4% (5.8–11.0) and 14.2% (10.0–18.2) for immunocompetent and 14.1% (7.7–20.0) and 19.3% (10.7–27.0) for immunocompromised patients, respectively. Conclusions: Over 2 years, approximately one in five patients with CSCC will undergo at least one major surgery. Prior or concurrent treatment with systemic therapy did not appreciably diminish the risk of requiring major surgery. For patients who received systemic therapy, the 1-year and 2-year risk of major surgery was higher for immunocompromised patients compared to immunocompetent patients.

ObjectiveTo compare efficacy and safety of subcutaneous sarilumab 200 mg and 150 mg every 2 weeks plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARDs) versus other targeted DMARDs+csDMARDs and placebo+csDMARDs, in inadequate responders to csDMARDs (csDMARD-IR) or tumour necrosis factor α inhibitors (TNFi-IR).MethodsSystematic literature review and network meta-analyses (NMA) conducted on 24 week efficacy and safety outcomes: Health Assessment Questionnaire Disability Index, modified total sharp score (mTSS, including 52 weeks), American College of Rheumatology (ACR) 20/50/70, European League Against Rheumatism Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28)Results53 trials were selected for NMA. csDMARD-IR: Sarilumab 200 mg+csDMARDs and 150 mg+csDMARDs were superior versus placebo+csDMARDs on all outcomes. Against most targeted DMARDs, sarilumab 200 mg showed no statistically significant differences, except superiority to baricitinib 2 mg, tofacitinib and certolizumab on 24 week mTSS. Sarilumab 150 mg was similar to all targeted DMARDs. TNFi-IR: Sarilumab 200 mg was similar to abatacept, golimumab, tocilizumab 4 mg and 8 mg/kg intravenously and rituximab on ACR20/50/70, superior to baricitinib 2 mg on ACR50 and DAS28ConclusionsResults suggest that in csDMARD-IR and TNFi-IR (a smaller network), sarilumab+csDMARD had superior efficacy and similar safety versus placebo+csDMARDs and at least similar efficacy and safety versus other targeted DMARDs+csDMARDs.

Objective To evaluate effects of the anti-interleukin-6 receptor monoclonal antibody sarilumab administered with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on patient-reported outcomes (PROs) in the TARGET trial in patients with rheumatoid arthritis (RA) with inadequate response or intolerance to tumour necrosis factor inhibitors (TNF-IR). Methods 546 patients (81.9% female, mean age 52.9 years) were randomised to placebo, sarilumab 150 or 200 mg subcutaneously every 2 weeks + csDMARDs. PROs included patient global assessment (PtGA); pain and morning stiffness visual analogue scales; Health Assessment Questionnaire Disability Index (HAQ-DI); Short Form-36 Health Survey (SF-36); FACIT-Fatigue (FACIT-F); Work Productivity Survey-Rheumatoid Arthritis (WPS-RA) and Rheumatoid Arthritis Impact of Disease (RAID). Changes from baseline at weeks 12 and 24 were analysed using a mixed model for repeated measures; post hoc analyses included percentages of patients reporting improvements ≥ minimum clinically important differences (MCID) and scores ≥ normative values. Results Sarilumab + csDMARDs doses resulted in improvements from baseline at week 12 vs placebo + csDMARDs in PtGA, pain, HAQ-DI, SF-36 and FACIT-F that were maintained at week 24. Sarilumab improved morning stiffness and reduced the impact of RA on work, family, social/leisure activities participation (WPS-RA) and on patients9 lives (RAID). Percentages of patients reporting improvements ≥MCID and ≥ normative scores were greater with sarilumab than placebo. Conclusions In patients with TNF-IR RA, 150 and 200 mg sarilumab + csDMARDs resulted in clinically meaningful patient-reported benefits on pain, fatigue, function, participation and health status at 12 and 24 weeks that exceeded placebo + csDMARDs, and were consistent with the clinical profile previously reported. Trial registration number NCT01709578; Results.

Sarilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-6 receptor complex. In the MOBILITY phase III randomized controlled trial (RCT), sarilumab + methotrexate (MTX) treatment resulted in clinical improvements at 24 weeks that were maintained at 52 weeks in adults with rheumatoid arthritis (RA), who have inadequate response to MTX (MTX-IR). These analyses indicate the effects of sarilumab + MTX versus placebo on patient-reported outcomes (PROs) in this RCT. Patients (n = 1197) were randomized to receive placebo, sarilumab 150 or 200 mg subcutaneously + MTX every 2 weeks for 52 weeks; after 16 weeks, patients without ≥20 % improvement from baseline in swollen or tender joint counts on two consecutive assessments were offered open-label treatment. PROs included patient global assessment of disease activity (PtGA), pain, health assessment questionnaire disability index (HAQ-DI), Short Form-36 Health Survey (SF-36), and functional assessment of chronic illness therapy-fatigue (FACIT-F). Changes from baseline at weeks 24 and 52 were analyzed using a mixed model for repeated measures. Post hoc analyses included percentages of patients reporting improvements equal to or greater than minimal clinically important differences (MCID) and normative values in the FACIT-F and SF-36. Pearson correlation between observed PRO scores and clinical measures of disease activity was tested at week 24. Both doses of sarilumab + MTX vs placebo + MTX resulted in improvement from baseline by week 24 in PtGA, pain, HAQ-DI, SF-36 and FACIT-F scores (p

Tobacco use remains the leading cause of preventable death. The outpatient medical clinic represents an important venue for delivering evidence-based interventions to large numbers of tobacco users. Extensive evidence supports the effectiveness of brief interventions. In a retrospective database analysis of 11,827 adult patients captured in the 2005 National Ambulatory Medical Care Survey (of which 2,420 were tobacco users), we examined the degree to which a variety of patient demographic, clinical and physician-related variables predict the delivery of tobacco counseling during a routine outpatient visit in primary care settings. In 2005, 21.7% of identified tobacco users received a tobacco intervention during their visit. The probability of receiving an intervention differed by gender, geographic region and source of payment. Individuals presenting with tobacco-related health conditions were more likely to receive an intervention. Most physicians classified as specialists were less likely to intervene. The provision of tobacco intervention services appears to be increasing at a modest rate, but remains well below desirable levels. It is a priority that brief interventions be routinely implemented to reduce the societal burden of tobacco use.

e18703Background: Unlike other cancers, information on CSCC is not captured in national cancer registries, and little is known about the management and costs of CSCC. In contrast, more is known abo...

The International Continence Society (ICS) identifies several urinary incontinence (UI) subtypes: urgency urinary incontinence (UUI), stress UI (SUI), and mixed UI (MUI). UUI is a common symptom of overactive bladder (OAB) syndrome. Based on the current ICS definition of OAB, all patients with UUI have OAB, whereas not all patients with OAB have UUI. Because UUI is a chronic condition that is expected to increase in prevalence as the population of elderly individuals grows, it is important to understand its economic burden on society and patients and its cost components. To summarize the published English language medical literature on estimates of the economic burden of UUI in the United States from a societal and patient perspective, including direct costs (diagnosis, treatment, routine care [including incontinence pads], and UUI-associated comorbidities/complications); indirect costs (lost wages by patients and caregivers and lost work productivity due to absenteeism and presenteeism); and intangible costs (pain, suffering, and decreased health-related quality of life). A PubMed search of the literature for articles on the economic burden of UUI in the United States was conducted using the search terms (urgency urinary incontinence OR urge incontinence OR mixed incontinence OR overactive bladder) AND (burden OR cost OR economic) AND (United States), with limits for English language, publication from 1991 to 2011, humans, and adults (19+ years). Only primary articles of non-neurogenic UUI in the United States were retained. Seven studies were identified that included data on the economic burden of UUI in the United States from a societal and patient perspective. Although estimates of the total economic burden of UUI include direct, indirect, and intangible costs, none of the 7 U.S. studies included all of these cost components. Furthermore, the costs of UUI often could not be fully extracted from the costs of OAB, which include patients with and without UUI, or the costs of other types of UI. The most recent cost analysis incorporated OAB with UUI prevalence rates and data on use of each cost component to calculate the total annual direct costs in 2007 for adults aged ≥ 25 years. The estimated total national cost of OAB with UUI in 2007 was $65.9 billion, with projected costs of $76.2 billion in 2015 and $82.6 billion in 2020. This 2007 estimate was markedly higher than those reported in older studies. Direct costs are the main driver of the overall cost of UUI in the United States. Studies that assessed patient costs indicated that the personal costs of routine care items for UUI and MUI represent a meaningful contribution to the overall economic burden of these conditions. These substantial personal expenditures may explain why patients reported that they were willing to pay considerable amounts for a treatment that would reduce the frequency of their UUI episodes. UUI in the United States is associated with a substantial economic burden from both a societal and patient perspective. Studies evaluating the impact of interventions that reduce the frequency of UUI episodes on the overall economic burden of UUI are warranted.

Summary Aims Studies on the burden and comorbidities associated with urgency urinary incontinence (UUI) are difficult to compare, partly because of the evolution of definitions for lower urinary tract symptoms and the various instruments used to assess health-related quality of life (HRQL). This article summarises published evidence on comorbidities and the personal burden associated specifically with UUI to provide clinicians with a clear perspective on the impact of UUI on patients. Methods A PubMed search was conducted using the terms: (urgency urinary incontinence OR urge incontinence OR mixed incontinence OR overactive bladder) AND (burden OR quality of life OR well-being OR depression OR mental health OR sexual health OR comorbid), with limits for English-language articles published between 1991 and 2011. Results Of 1364 identified articles, data from 70 retained articles indicate that UUI is a bothersome condition that has a marked negative impact on HRQL, with the severity of UUI a predictor of HRQL. UUI is significantly associated with falls in elderly individuals, depression, urinary tract infections, increased body mass index, diabetes and deaths. The burden of UUI appears to be greater than that of stress urinary incontinence or overactive bladder symptoms without UUI. UUI adversely impacts physical and mental health, sexual function and work productivity. Conclusions UUI is associated with numerous comorbid conditions and inflicts a substantial personal burden on many aspects of patients’ lives. Healthcare providers should discuss UUI with patients and be aware of the impact of UUI and its associated comorbidities on patients’ lives.

Context The prevalence and economic burden of urgency urinary incontinence (UUI) are difficult to ascertain because of overlap with data on overactive bladder and other types of incontinence. Objective To summarize the evidence on the global prevalence and economic burden of UUI. Evidence acquisition A PubMed search was performed used the following terms: (urgency urinary incontinence OR urge incontinence OR mixed incontinence OR overactive bladder) AND (burden OR cost OR economic OR prevalence). A similar search was conducted using Embase. English-language articles published from 1991 through 2013 on non-neurogenic UUI were retained. Evidence synthesis We retained 54 articles (50 studies); 22 large-scale, population-based surveys indicated varying UUI prevalence estimates with ranges of 1.8−30.5% in European populations, 1.7−36.4% in US populations, and 1.5−15.2% in Asian populations, with prevalence dependent on age and gender. Nineteen smaller-scale studies supported these findings. Despite varying methods, 11 studies estimating the costs of UUI worldwide consistently concluded that the economic burden is substantial and will increase markedly as the population ages. In a 2005 multinational study, the annual cost-of-illness estimate for UUI in Canada, Germany, Italy, Spain, Sweden, and the United Kingdom was €7 billion. A US cost-of-illness study reported a total cost of $66 billion in 2007 US dollars. The costs of routine care and nursing home admissions for UUI were major contributors to the cost. Conclusions UUI affects millions of men and women worldwide. Current evidence demonstrates the substantial economic burden of UUI to patients and society. Worldwide public health and clinical management programs are needed to improve UUI awareness and highlight the need for early diagnosis and management.

Background When tumor necrosis factor inhibitor (TNFi) therapy fails in rheumatoid arthritis (RA), a majority of patients switch to another TNFi instead of a non-TNFi biologic disease-modifying antirheumatic drug (bDMARD). 1 The effectiveness of TNFi cycling compared with switching to a non-TNFi agent is not well established. Objectives This study examined treatment effectiveness among patients with RA in a large, commercially insured population who cycled to another TNFi (“TNFi cyclers”) compared with those who switched to a non-TNFi agent (“non-TNFi switchers”). Methods Administrative claims from January 2010 to September 2014 were analyzed from the Truven Health MarketScan Commercial database. Eligible patients received a TNFi in the 12 months before the “index” drug (a different TNFi or non-TNFi [bDMARDs or tofacitinib]). The study included adults ages 18 to 64 years with ≥12 months of continuous medical and pharmacy enrollment pre- and post-index, and ≥1 claim for RA (ICD-9-CM 714.0x) pre-index or 30 days post-index with no other autoimmune condition. Treatment effectiveness was defined using a validated algorithm 2 that was applied to medical and pharmacy claims for 12 months post-index for each patient. Treatment was considered to be effective if the patient satisfied all 6 algorithm criteria in this period: (1) ≥80% adherence (subcutaneous medication possession ratio or number of intravenous infusions); (2) no increase in dose; (3) no switch to another bDMARD; (4) no new conventional DMARD; (5) no new/increased oral glucocorticoid; and (6) less than 2 glucocorticoid injections in the first 90 days after the index date. Logistic regression was used to compare effectiveness rates by treatment cohort, controlling for baseline demographic and clinical characteristics, including number of prior biologic therapies. Results Of the 6,945 patients who switched from a pre-index TNFi, 5,020 (72.3%) were TNFi cyclers and 1,925 (27.7%) were non-TNFi switchers. Achievement rates for all 6 algorithm criteria combined and for individual criteria in the 12 months post-index are shown in the table. In the logistic regression model, non-TNFi switchers were 1.25 times as likely as TNFi cyclers to achieve all algorithm criteria for effectiveness (odds ratio, 1.248; 95% CI, 1.103–1.414; P Conclusions On the basis of a claims-based algorithm of treatment effectiveness for RA, it appears that patients who switch from TNFi to non-TNFi agents are more likely to achieve treatment effectiveness criteria for 12 months after switching than patients who cycle to another TNFi. References Bonafede M et al. Adv Ther. 2012;29:664–674. Curtis JR, et al. Arthritis Res Ther. 2011;13:R155. Acknowledgement This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Jonathan Latham assisted with preparation and submission of the abstract. Disclosure of Interest M. Bonafede Employee of: Truven Health, which was awarded a research contract from Sanofi and Regeneron Pharmaceuticals for this work, J. Curtis Consultant for: Sanofi and Regeneron Pharmaceuticals, Inc., D. McMorrow Employee of: Truven Health, which was awarded a research contract from Sanofi and Regeneron Pharmaceuticals for this work, P. Mahajan Shareholder of: Sanofi, Employee of: Sanofi, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc.

Background Recent studies suggested that in rheumatoid arthritis (RA) patients discontinuing their prior tumor necrosis factor inhibitor (TNFi), treatment persistence was greater in those switching to a disease-modifying antirheumatic drug (DMARD) with a new mechanism-of-action (MOA) than in those cycling to a second TNFi. Objectives To evaluate in RA patients real-world treatment persistence and clinical outcomes associated with TNFi cycling vs switching to a new MOA DMARD. Methods This retrospective analysis of RA patients used the US clinical JointMan® database, an evidence-based rheumatology software application that rheumatologists use to systematically document patient-level data in routine clinical practice. Adult RA patients were included if they had a physician prescription record of a TNFi from April 1, 2010 through March 31, 2015 and a subsequent DMARD that was a different TNFi (TNFi cycling cohort) or new MOA DMARD (new MOA DMARD switching cohort). Patients were indexed on the date of the subsequent TNFi or new MOA DMARD from a prior TNFi during the pre-index period. Treatment persistence was assessed, defined as neither discontinuing nor switching the drug post-index before the end of the observational period. Change in Clinical Disease Activity Index (CDAI) at 1 year post-index and its correlation with treatment persistence were evaluated. Kaplan-Meier survival analysis measured time to nonpersistence. Cox proportional hazards regression and ordinary least-squares regression were used to identify independent factors predicting time to nonpersistence and 1-year CDAI change, respectively. Results Included were 613 patients (mean age 56.5 years; 78.5% women; 82.9% white; baseline CDAI 22.7). After discontinuing a prior TNFi, 54.2% (n=332) of patients cycled to another TNFi and 45.8% (n=281) switched to a new MOA DMARD. During follow-up, 36.7% (n=225) of patients were persistent with their index drug, 34.1% (n=209) switched from their index drug to another drug, and 29.2% (n=179) discontinued their index drug. Compared with TNFi cyclers, new MOA DMARD switchers were more likely to be persistent at 1 year (45.2% vs 29.5%; P P P =0.027); however, this effect was not statistically significant when baseline CDAI was controlled for in the regression model (−5.83 vs −6.39; P =0.607). Overall, treatment persistence was associated with a significantly higher reduction in CDAI (−8.69 vs −3.16; P Conclusions This real-world study suggests that after discontinuing their prior TNFi, RA patients who switched to a new MOA DMARD demonstrated better treatment persistence than those cycling to another TNFi. Persistence with RA treatment was associated with better clinical outcome. Acknowledgement Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Editorial assistance provided by I. Ouwehand, PhD, of Excerpta Medica, funded by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interest W. Wei Shareholder of: Sanofi, Employee of: Sanofi, K. Knapp Employee of: Arthritis Northwest and Discus Analytics, Inc., L. Wang Consultant for: Sanofi and Regeneron Pharmaceuticals, Inc., Employee of: STATinMED research, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., G. Craig Shareholder of: Discus Analytics, Inc., Employee of: Arthritis Northwest and Discus Analytics, Inc., K. Ferguson Shareholder of: Discus Analytics, Inc., Employee of: Arthritis Northwest and Discus Analytics, Inc., S. Schwartzman Shareholder of: Discus Analytics, Inc., Consultant for: Discus Analytics, Inc.

Background Efficacy, including improvements in patient-reported outcomes (PROs), was demonstrated in 2 phase 3 trials, MOBILITY 1 (NCT01061736) and TARGET 2 (NCT01709578), of sarilumab, an investigational human anti–interleukin 6 receptor monoclonal antibody. The most common treatment-emergent adverse events in both studies were infections, neutropenia, injection site reactions, and increased transaminases. Objectives To evaluate the early onset of benefit of sarilumab treatment measured by PROs. Methods In both studies, adults with moderate-to-severe, active rheumatoid arthritis (RA) were randomized to 1 of 3 groups receiving placebo, sarilumab 150 mg, or sarilumab 200 mg subcutaneously (SC) every 2 weeks (q2w) plus methotrexate (MTX; MOBILITY) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TARGET). PROs assessed as early as week 2 included patient global assessment of disease activity (PtGA), pain assessed by visual analog scale (VAS), Health Assessment Questionnaire–Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), sleep by VAS (MOBILITY), and AM stiffness by VAS (TARGET). Changes from baseline were analyzed using mixed-model repeated measures with region, number of prior tumor necrosis factor inhibitors (TNFis) (TARGET) or prior biologic use (MOBILITY), visit, treatment, treatment-by-visit interaction, and baseline PRO scores as covariates. Results Greater improvements were reported by patients treated with sarilumab 150 and 200 mg SC q2w vs placebo as early as week 2 in PtGA, pain VAS, HAQ-DI, FACIT-F, sleep VAS, and AM stiffness VAS (nominal P Conclusions Sarilumab treatment rapidly improved a broad range of PROs in patients with RA with inadequate response to MTX (MOBILITY) or TNFis (TARGET); these improvements were observed as early week 2 and maintained through week 24. The results demonstrate the early benefit of sarilumab treatment based on patients9 own assessments of their disease. References Genovese et al. Arthritis Rheumatol. 2015;67:1424–1437. Fleischmann et al. Arthritis Rheumatol. 2015;67(suppl 10). Acknowledgement This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interest V. Strand Consultant for: AbbVie, Amgen, AstraZeneca, Biogen, BMS, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo/Myriad Genetics, EMD Serono, Genentech/Roche, GSK, Janssen, Eli Lilly, Novartis, Pfizer Inc, Regeneron Pharmaceuticals, Inc, Sandoz, Sanofi, and UCB, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, P. Mahajan Shareholder of: Sanofi, Employee of: Sanofi, M. Kosinski Consultant for: Sanofi and Regeneron, E. Mangan Shareholder of: in Pfizer Inc and Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, H. van Hoogstraten Shareholder of: Sanofi, Employee of: Sanofi, N. Graham Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, Y. Lin Shareholder of: Sanofi, Employee of: Sanofi, E. Keystone Consultant for: has consulting agreements/advisory board membership with Abbott, AstraZeneca, Biotest, BMS, F. Hoffman-La Roche, Genentech, Janssen, Eli Lilly, Merck, Pfizer Inc, and UCB; and has speaker honoraria agreements with Abbott, Amgen, AstraZeneca, BMS Canada, F. Hoffman-La Roche, Janssen, Pfizer Inc, and UCB., J. Braun Grant/research support from: received honoraria for talks, advisory boards, paid consultancies, and grants for studies from AbbVie (Abbott), Amgen, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer Inc (Wyeth), Roche, Sanofi-Aventis, and UCB, Consultant for: received honoraria for talks, advisory boards, paid consultancies, and grants for studies from AbbVie (Abbott), Amgen, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer Inc (Wyeth), Roche, Sanofi-Aventis, and UCB

Background When a patient with rheumatoid arthritis (RA) fails initial treatment with a tumor necrosis factor inhibitor (TNFi) because of inadequate response or lack of tolerability, switching to another TNFi or to a non-TNFi is recommended, but this is based on limited evidence. 1,2 Objectives This study examined real-world treatment patterns between patients with RA who switched from a TNFi to another TNFi (TNFi cyclers) compared with those who switched from a TNFi to a non-TNFi (non-TNFi switchers). Methods The data source was an administrative claims database from a large managed care organization of commercial and Medicare Advantage patients in the United States. The “index claim” was the first TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) claim between January 2010 and February 2014 after ≥6 months of continuous enrollment pre-index. Eligible patients were aged ≥18 years at index with RA and no other autoimmune condition for which the study drugs could be used. The study included patients who subsequently switched either to another TNFi or to a non-TNFi (abatacept, tocilizumab, or tofacitinib) within 12 months post-index and had ≥12 months of additional follow-up. Each patient had 1 of 4 treatment patterns in the 12 months after the initial switch: (1) switched to a third TNFi or non-TNFi; (2) restarted the second therapy after a treatment gap of ≥45 days without switching; (3) discontinued the second therapy without switching or restarting; or (4) persisted with the second therapy without switching, restarting, or discontinuing. Adherence was defined as a proportion of days covered (PDC) of ≥80% for the second therapy. Results Of 32,272 adult patients with RA who received ≥1 biologic, 1432 met all study criteria, including 379 non-TNFi switchers and 1053 TNFi cyclers. Most patients (81%) were female. Non-TNFi switchers were older (54.0 vs 51.1 y; P P P =0.021) and significantly less likely to switch to a third TNFi or non-TNFi (29% vs 37%; P =0.006); non-TNFi switchers and TNFi cyclers had similar rates of restarting therapy after a ≥45-day treatment gap (6% vs 8%; P =0.325) and discontinuation without restarting or switching therapy (14% vs 11%; P =0.185). In the 12 months after the initial switch, non-TNFi switchers were significantly more likely than TNFi cyclers to have high adherence (≥80% PDC) to the second medication (45% vs 38%; P =0.021). Conclusions Among patients with RA, those who switched from a TNFi to a non-TNFi were more likely than TNFi cyclers to be persistent on the second medication in the first year, had greater adherence to the second medication, and were less likely to switch therapy again in the first year. The implications for clinical treatment outcomes deserve further study. References Singh et al. Arthritis Care Res (Hoboken). 2012;64:625–639. Smolen et al. Ann Rheum Dis. 2014;73:492–509. Acknowledgement This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Jonathan Latham assisted with preparation and submission of the abstract. Disclosure of Interest B. Chastek Employee of: Optum, which was hired by Sanofi and Regeneron Pharmaceuticals to conduct the research, J. Curtis Consultant for: Sanofi and Regeneron Pharmaceuticals, L. Becker Employee of: Optum, which was hired by Sanofi and Regeneron Pharmaceuticals to conduct the research, P. Mahajan Shareholder of: Sanofi, Employee of: Sanofi, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc.

Background The effect of active rheumatoid arthritis (RA) on participation, active and meaningful engagement by patients in activities important to them, has significant individual and societal costs. Sarilumab is an investigational human anti–interleukin 6 (IL-6) receptor monoclonal antibody. In the phase 3 TARGET study (NCT01709578), sarilumab + conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) demonstrated efficacy in adults with moderate-to-severe, active RA and inadequate response to TNF inhibitors. The most common treatment-emergent adverse events were infections, neutropenia, and increased transaminases; laboratory changes were consistent with IL-6 signaling blockade. Objectives To evaluate the effect of sarilumab treatment on patient productivity within and outside of the home; requirement for outside help; and family, social, or leisure activities in the past month as assessed by the RA-specific Work Productivity Survey (WPS-RA). 1 Methods The intent-to-treat population included 546 patients randomized 1:1:1 to placebo, sarilumab 150 mg, or sarilumab 200 mg every 2 wks (q2w) subcutaneously (SC) + background csDMARDs. The WPS-RA was assessed for patients employed outside of (completed all 8 items) and within the home (completed only the 5 items related to productivity within the home and participation in family, social, and leisure activities) at baseline and wks 4 (not reported), 12, and 24. Mixed-model repeated measures analyses were used to evaluate differences in individual WPS-RA items at a significance level of 0.05 if O9Brien9s global test 2 showed significance ( P Results At baseline, 544 patients were administered the WPS-RA, 33.1%, 33.7%, and 35.7% (placebo, sarilumab 150, and sarilumab 200 mg q2w SC, respectively) of whom were currently employed outside of the home. Global testing indicated significantly greater overall improvement in patients treated with sarilumab 150 mg q2w SC (wk 12, P =0.0010; wk 24, P =0.0004) and sarilumab 200 mg q2w SC (wk 12, P =0.0036; wk 24, P =0.0003) vs placebo. At wk 24, patients currently employed outside of the home receiving sarilumab 200 mg q2w SC reported significantly greater reductions in number of work days missed due to RA and less interference with work productivity. Patients receiving both doses reported significantly greater reductions in number of days missed engaging in household work, days requiring hired help, and rate of arthritis interference in household work and less time missed engaging in family, social, and leisure activities. Conclusions Sarilumab treatment was associated with significant improvements in participation in work; household work; and family, social, and leisure activities. Improvements in productivity outside of the home were also significant among patients in the sarilumab 200 mg q2w SC group vs placebo, although only a proportion of patients worked outside of the home. These data indicate important improvements in overall participation following sarilumab treatment. References Osterhaus et al. Arthritis Res Ther. 2009;11:R73 Tandon. Stat Med. 1990;9:819–827 Acknowledgement This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interest V. Strand Consultant for: has received consulting fees from AbbVie, Amgen, AstraZeneca, Biogen, BMS, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo/Myriad Genetics, EMD Serono, Genentech/Roche, GSK, Janssen, Eli Lilly, Novartis, Pfizer Inc, Regeneron Pharmaceuticals, Inc, Sandoz, Sanofi, and UCB., P. Mahajan Shareholder of: Sanofi, Employee of: Sanofi, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, H. van Hoogstraten Shareholder of: Sanofi, Employee of: Sanofi, E. Mangan Shareholder of: an employee of Regeneron Pharmaceuticals, Inc, and may hold stock and/or stock options in Pfizer Inc and Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc, O. Hagino Shareholder of: Sanofi, Employee of: Sanofi, N. Graham Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, G. da R.C. Pinheiro Consultant for: has received consulting fees from AbbVie, AstraZeneca, GSK, Hospira, Janssen, Pfizer Inc, Roche, RuiYi, and Sanofi., A. Kivitz Consultant for: has received consulting fees from Celgene, Genentech/Roche, GSK, Janssen, Pfizer Inc, Regeneron Pharmaceuticals, Inc, Sanofi, and UCB.

INTRODUCTION AND OBJECTIVES: Little is known as to the prevalence of OAB by race. OAB-POLL estimated the prevalence of OAB in a large population-based study in the US by oversampling minorities to evaluate impacts stratified by race. METHODS: This cross-sectional, population-representative survey was conducted via the Internet in the US among men and women age 18-70. The LUTS tool, which uses ICS definitions and was developed based on extensive qualitative research, was used to assess how often participants experienced urinary symptoms during the past 4 weeks on a 5-point Likert scale. OAB was defined by the presence of urinary urgency “sometimes” or “often” and/or the presence of urgency urinary incontinence (UUI). Descriptive statistics were used to evaluate group differences by race and age. RESULTS: Overall response rate was 56.7%; 10,000 men and women participated (blacks, 2,000; Hispanics, 2,000; whites, 6,000). Mean age was 41.3 for men and 42.2 for women. Rates of OAB “sometimes” and “often” were 17% and 8% in men and 30% and 20% in women ages 18–70 (Table). Regardless of the threshold used, OAB prevalence was significantly higher for black men compared to Hispanic and white men, but race was not statistically significant among women except for all ages 18–70 “often”. Statistically significant increases in prevalence were found with each decade increase in advancing age for both thresholds in men and women. CONCLUSIONS: Consistent with prior research, OAB is highly prevalent in both men and women and increases with advancing age. OAB has a similar high prevalence in blacks, Hispanics and whites. However, results suggest a higher prevalence in black males. Source of Funding: Pfizer Inc.

Background Smoking cessation pharmacotherapy is a critical component of smoking cessation treatment, but most smokers use neither pharmacotherapy nor behavior counseling in attempts to quit smoking. The low rate of smoking cessation medication use is of great concern because it can negatively influence the odds of success in smoking cessation. Objective This study was conducted to analyze how copayment may influence the likelihood of initiating smoking cessation pharmacotherapy following a reversed varenicline claim. Methods A retrospective cohort analysis was performed using pharmacy claims data from a large national pharmacy benefits management company. Reversed claims were claims first approved by the health plan and then reversed by the pharmacy. The study population included patients with over-the-counter nicotine replacement therapy coverage and a reversed varenicline claim between January 2007 and April 2008 and who were naive to varenicline before the reversed claim. A multivariate logistic regression analysis was conducted to evaluate the probability of initiating any smoking cessation pharmacotherapy (varenicline, bupropion, and prescribed or over-the-counter nicotine replacement therapy) within 183 days of the reversed claim. Results A total of 20,451 patients met the inclusion criteria. The mean (SD) age of patients was 47.8 (12.4) years, with 57.41% being female. The majority (87.72%) were covered in commercial managed care plans. A total of 17,028 patients (83.26%) had at least 1 smoking cessation medication filled 6 months after their reversed claim. The odds ratios for patients who had any smoking cessation medication filled and copayments of $31 to $40, $41 to $60, or >$60 were 0.68, 0.48, and 0.35, respectively (all, P Conclusions The findings suggest that some patients might have been deterred by a high copayment (≥$31) and, ultimately, did not fill any smoking cessation treatments within 183 days of reversed varenicline claims. It is important to address this potential treatment gap to improve the effectiveness of smoking cessation therapy.

Background Clinical and patient reported outcomes provide complimentary information about the efficacy of treatment in RCTs in RA. Linking these two may improve our understanding of treatment benefit. The MOBILITY intent-to-treat population included 1,197 patients randomized 1:1:1 to placebo+MTX, sarilumab 150mg every two weeks (q2w) +MTX or 200mg q2w+MTX. Most common TEAEs included infections and injection site reactions. A higher incidence of serious infections was observed with sarilumab 1 . Objectives To evaluate reported improvements in HRQoL by ACR20 responders in this phase 3 RCT. Methods HRQoL was measured using the SF-36v2; fatigue by FACIT-Fatigue. Only ACR20 responders were included, since there were few ACR50 responders in the placebo group and no differences in baseline characteristics of responders between treatment groups. At wk 24, we calculated the percentage of ACR20 responders that met or exceeded: 1) PASS 2,3 , a state of well-being which patients consider to be satisfactory, in 6 SF-36v2 domains; 2) general population normative values for SF-36v2 and FACIT-Fatigue scores. Differences from placebo were tested for statistical significance (p Results ACR20 responses were 33.5% in placebo, 58.4% in 150mg and 66.4% in 200mg sarilumab groups. The percentages of responders in both 150mg and 200mg sarilumab groups with scores ≥PASS at wk 24 exceeded placebo across all 6 SF-36 domains; statistically significant for physical functioning, vitality, social functioning and mental health domains. For example, 82.7% (150mg) and 87.6% (200mg) sarilumab patients reported improvements ≥PASS in SF-36v2 vitality domain vs 72.7% placebo. The percentages of responders receiving 150mg and 200mg sarilumab with scores ≥normative values at wk 24 exceeded placebo across all SF-36v2 domains and FACIT; statistically significant for SF-36v2 bodily pain, vitality, mental health domains; mental component summary score and FACIT. For example, 46.3% (150mg) and 54% (200mg) of sarilumab patients reported scores ≥normative values in SF-36v2 vitality domain vs 38.6% placebo. Similar findings were observed at wk 52. Conclusions Among ACR20 responders, those receiving sarilumab+MTX reported better HRQoL than with placebo+MTX, particularly in measures of bodily pain, vitality, and fatigue by SF-36 and FACIT. Largest percentage differences vs placebo were observed based on scores attaining normative values, which were more discriminative for the Sarilumab 200mg dose than PASS. Observed differences may be driven in part by more high level responders in the active treatment groups. References Genovese M et al. Abstr. EULAR14-SCIE-3001, EULAR 2014 Heiberg T et al. Ann Rheum Dis 2008;67:967-971 Strand V et al. J Rheumatol. 2011;38(8):1720-1727 Acknowledgements The study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Editorial support was provided by Jennifer Dunphy of Optum and was funded by Sanofi and Regeneron Pharmaceuticals Inc. Disclosure of Interest V. Strand Consultant for: AbbVie, Afferent, Amgen, Biogen Idec, Bioventus, BMS, Carbylan, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo, Genentech/Roche, GSK, Hospira, Iroko, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, SKK, Takeda, UCB, Vertex, M. Kosinski Consultant for: Sanofi, Regeneron, G. Joseph Shareholder of: Amgen Inc, Pfizer Inc., Employee of: Sanofi, C. Chen Employee of: Regeneron Pharmaceuticals, H. Van Hoogstraten Employee of: Sanofi, N. Graham Shareholder of: Regeneron Pharmaceuticals, Employee of: Regeneron Pharmaceuticals, T. Huizenga Consultant for: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boeringher, Takeda, Zydus, and Eli Lilly, Speakers bureau: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boeringher, Takeda, Zydus, and Eli Lilly, M. Genovese Grant/research support from: Sanofi, Regeneron Pharmaceuticals, Eli Lilly, Consultant for: Sanofi, Regeneron Pharmaceuticals, Eli Lilly

Background The ultimate goal of RA treatment is to achieve disease remission. Studies have shown that objective, measure-based treatment decision-making leads to improved patient outcomes. In addition, the National Quality Forum (NQF) recently endorsed three measures for RA, including assessment of disease activity using a standardized tool. However, in clinical practice physicians may still rely on subjective assessment of disease activity. Objectives To compare physician-reported and DAS28-based clinical assessments of RA disease remission. Methods Data were drawn from the Adelphi RA-DSP, a cross-sectional survey of United States rheumatologists and their RA patients between January and March 2014. Clinical remission status (DAS28 ESR Results Included in the analysis were 531 RA patients (75% female, mean age 56.4 years, 7.7 years since RA diagnosis, 53% treated with biologic) in the care of 78 rheumatologists (31% female, 37% practice only in office). 56% of physicians reported using only subjective criteria to assess remission; 30% of patients were evaluated using a standardized disease activity measure during last visit. While physicians reported 50% of patients were in remission, 32% were in remission by DAS28 criteria. Remission status was over-reported by physicians in 25% and underreported in 7% of patients. Regression analyses indicated that physician over-reporting was significantly higher among patients treated with biologics (Relative Risk Ratio (RRR)=2.01, P=0.003), those in the care of physicians with high RA workload (RRR=2.51, P=0.011), and patients considered by their physicians to have “satisfactory” RA control (RRR=6.09, P Physician under-reporting was significantly higher among obese patients (RRR=2.95, P=0.002), patients with average general health level (RRR=2.03, P=0.029), and those with more than 5 tender or swollen joints (RRR=2.72, P=0.019), but significantly lower among patients with medium to high current pain level (RRR=0.18, P=0.004) or those who saw physicians with high RA workload (RRR=0.43, P=0.029). Conclusions This study points out the need to increase the use of standardized measures of RA disease activity, and ensure consistency of use across clinical care. Addressing these gaps in care may help optimize treatment decisions, reduce variability in delivery of patient care and ultimately improve RA patient outcomes. Disclosure of Interest W. Wei Shareholder of: Sanofi, Employee of: Sanofi, C. Chen: None declared, E. Sullivan: None declared, S. Blackburn: None declared, J. Curtis Grant/research support from: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, Consultant for: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie