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Treatment guidelines for rheumatoid arthritis (RA) recommend early, aggressive treatment with nonbiologic and biologic disease-modifying antirheumatic drugs (DMARDs) to minimize long-term disability. We aimed to assess differences in medical resource utilization, drug therapy, and health outcomes among RA patients by insurance type in the United States.Individuals with a self-reported diagnosis of RA were identified in the Medical Expenditure Panel Survey (MEPS) database, 2006-2009. Data regarding sociodemographic characteristics, insurance type and status, and outcomes (including health care resource utilization, prescription medication use, health status, and patient-reported barriers to health care) were extracted. Multivariable regression analyses were used to examine the impact of insurance type (private, Medicare, Medicaid, or uninsured) on outcome measures while controlling for age group, sex, and race/ethnicity.A total of 693 individuals with a self-reported diagnosis of RA during the study period were identified; 423 were aged 18-64 years and 270 were aged ≥65 years. Among patients aged 18-64, those with Medicaid or who were uninsured were less likely than those with private insurance to visit a rheumatologist (adjusted odds ratio [aOR] 0.13 and 0.17, respectively; p .001) and to receive biologic DMARDS (aOR 0.09 [p .001] and 0.16 [p .01], respectively); those with Medicaid were also less likely to receive nonbiologic DMARDS (aOR 0.26 [p .01]). Those with Medicaid were more likely than those with private insurance to be unable/delayed in getting prescription drugs (aOR 2.9 [p .05]), to experience cognitive, social, and physical limitations (aOR 8.7 [p .001], 4.7 [p .001], and 2.5 [p .05], respectively); they also reported significantly lower general health and health-related quality of life. Patients aged ≥65 experienced greater equity in care and outcomes.Younger RA patients with Medicaid (including those who receive coverage under the Medicaid expansion component of the Affordable Care Act) may be at risk for inadequate treatment.

ObjectiveThe objective was to evaluate the psychometric properties of the Rheumatoid Arthritis-Work Instability Scale (RA-WIS) in a clinical trial setting.MethodsSecondary analyses were conducted using data from a 56-week, randomized controlled trial of patients with early rheumatoid arthritis (RA). Patient-reported outcome measures included the RA-WIS, the Health Assessment Questionnaire (HAQ), the Rheumatoid Arthritis Quality of Life Questionnaire, and the Global Assessment of Disease Activity and Pain, data for which were collected at baseline and at weeks 12, 16, 24, and 56. Data were analyzed for reliability, validity, and responsiveness.ResultsAmong 148 patients whose data were analyzed, more than half were women (56.1%) with a mean age of 46.8 years. On average, patients experienced RA symptoms for 8.7 months; the mean 28-Joint Disease Activity Score (DAS28) was 5.9, and the mean HAQ – Disability Index was 1.3. The RA-WIS demonstrated excellent internal consistency and test-retest reliability (α = 0.89 and intraclass correlation coefficient = 0.91, respectively). At baseline and week 24, moderate to strong correlations were seen between RA-WIS total scores and the HAQ, the Global Assessment of Disease Activity, and the Pain Rheumatoid Arthritis Quality of Life Questionnaire, ranging from 0.47 to 0.81 (all P < 0.0001). Mean RA-WIS total scores and work disability risk levels discriminated between clinical severity scores on the DAS28, the HAQ – Disability Index, and the Physician Global Assessment of Disease Activity (all P < 0.05). Mean baseline to week 24 RA-WIS total change scores were significantly different among American College of Rheumatology responder groups (P ≤ 0.0001) and between DAS28 remission status groups (P < 0.001).ConclusionsThese findings provide evidence supporting the reliability, validity, and responsiveness of the RA-WIS for evaluating work disability in patients with RA in a clinical trial setting.

Onur Başer (MEF Author) Purpose: Despite improved clinical outcomes for the majority of patients, nearly 30% of patients with rheumatoid arthritis (RA) who initiate tumor necrosis factor antagonist (anti-TNF) biologic agents fail to respond to their first-line anti-TNF and switch to another anti-TNF or a non-TNF biologic. How this change affects health care costs and resource utilization is unknown. We therefore compared RA patients taking first-line anti-TNFs who switched to a second anti-TNF versus those patients who switched to an alternate biologic. Methods: Health care claims data were obtained from a large US database for eligible adults with confirmed RA diagnoses who initiated anti-TNF treatment and switched to another biologic. Health care costs and utilization during the first 12 months' postswitch were compared. Generalized linear models were used to adjust for differences in demographic and clinical characteristics before switching. Findings: Patients who switched to a second anti-TNF rather than a non-TNF biologic were generally younger (53.0 vs. 55.3 years; P < 0.0001) and less likely to be female (79.7% vs. 82.7%; P = 0.0490). Of the 3497 eligible patients who switched from first-line anti-TNFs, 2563 (73.3%) switched to another anti-TNF and 934 (26.7%) switched to a non-TNF. Adalimumab was the most frequently prescribed (43.4%) second-line anti-TNF, and abatacept was the most common non anti-TNF (71.4%). Patients who switched to a second anti-TNF remained on their first medication for a significantly shorter period (342.5 vs 420.6 days; P < 0.0001) and had lower comorbidity indices and higher disease severity at baseline than those who switched to a non anti-TNF. After adjusting for baseline differences, patients who switched to second anti-TNFs versus a non-TNF incurred lower RA-related costs ($20,938.9 vs $22,645.2; P = 0.0010) and total health care costs ($34,894.6 vs $38,437.2; P = 0.0010) 1 year postswitch. These differences were driven by increased physician office visit costs among the non-TNF group. Implications: Among the anti-TNF initiators who switched therapy, more patients switched to a second anti-TNF than to a non-TNF. Switching to a second anti-TNF treatment was associated with lower all-cause and RA-related health care costs and resource utilization than switching to a non-TNF. Because switching therapy may be unavoidable, finding a treatment algorithm mitigating this increase to any extent should be considered. These data are limited by their retrospective design. Additional confounding variables that could not be controlled for may affect results. (C) 2015 The Authors. Published by Elsevier HS journals, Inc. WOS:000359392100008 2-s2.0-84937640448 PMID: 25999184 Science Citation Index Expanded Q2 Article Uluslararası işbirliği ile yapılan - EVET Temmuz 2015 YÖK - 2014-15

The objective of the Outcome Measures in Rheumatology (OMERACT) Worker Productivity working group is to identify worker productivity outcome measures that meet the requirements of the OMERACT filter. At the OMERACT 11 Workshop, we focused on the at-work limitations/productivity component of worker productivity (i.e., presenteeism) — an area with diverse conceptualization and instrumentation approaches. Various approaches to quantify at-work limitations/productivity (e.g., single-item global and multi-item measures) were examined, and available evidence pertaining to OMERACT truth, discrimination, and feasibility were presented to conference participants. Four candidate global measures of presenteeism were put forth for a plenary vote to determine whether current evidence meets the OMERACT filter requirements. Presenteeism globals from the Work Productivity and Activity Impairment Questionnaire (72% support) and Rheumatoid Arthritis-specific Work Productivity Survey (71% support) were endorsed by conference participants; however, neither the presenteeism global item from the Health and Work Performance Questionnaire nor the Quantity and Quality method achieved the level of support required for endorsement at the present time. The plenary was also asked whether the central item from the Work Ability Index should also be considered as a candidate measure for potential endorsement in the future. Of participants at the plenary, 70% supported this presenteeism global measure. Progress was also made in other areas through discussions at individual breakout sessions. Topics examined include the merits of various multi-item measures of at-work limitations/productivity, methodological issues related to interpretability of outcome scores, and approaches to appraise and classify contextual factors of worker productivity. Feedback gathered from conference participants will inform the future research agenda of the working group.

Biologic therapies have demonstrated efficacy and safety in several chronic systemic disorders. The authors indirectly compared response rates and costs per responder associated with biologic treatments for moderate-to-severe Crohn's disease (CD), psoriasis (Ps), and/or rheumatoid arthritis (RA).A systematic literature search was performed to identify phase 3 randomized controlled trials of biologics for CD (adalimumab, infliximab), Ps (adalimumab, etanercept, infliximab, ustekinumab 45 mg, ustekinumab 90 mg), or methotrexate-refractory RA (abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab). Food and Drug Administration-approved dosing schedules were evaluated. Published response rates were extracted, with response defined in CD, Ps, and RA as: ≥70-point reduction in CD Activity Index at 12 months; ≥75% improvement in Psoriasis Area and Severity Index at 3 months; and ≥50% improvement in American College of Rheumatology component scores at 6 months. Within each indication, mixed-treatment comparison meta-analyses were conducted to derive pooled estimates and 95% CIs of response rate difference versus placebo for each biologic, adjusting for cross-trial variation in control-arm response rates. Cost per responder was estimated for each biologic as projected per patient drug costs (2011 US$) divided by response rate difference.Altogether, 23 publications were selected. In CD, 12-month cost per responder was estimated at $116,291 (95% CI $71,637-208,348) for adalimumab and $125,169 (95% CI $60,532-267,101) for infliximab. Among biologics approved in Ps, 3-month cost per responder was lowest for adalimumab ($9,756; 95% CI $8,668-11,131), infliximab ($12,828; 95% CI $11,772-13,922), and ustekinumab 45 mg ($13,821; 95% CI $12,599-15,167). In RA, biologics with the lowest 6-month cost per responder were adalimumab ($27,853; 95% CI $19,284-40,270), etanercept ($29,140; 95% CI $14,170-61,030), and tocilizumab ($31,363; 95% CI $14,713-64,232).Meta-analyses of clinical trials found considerable variation in cost-effectiveness of biologic therapies for CD, Ps, and RA. These results may help determine biologic utilization in these chronic diseases.

Objective.Rheumatoid arthritis (RA) is associated with significant impairments in health-related quality of life (HRQOL). We evaluated patient-reported outcomes including HRQOL outcomes following adalimumab plus methotrexate (MTX) therapy in patients with early RA.Methods.PREMIER was a phase III, multicenter, randomized, double-blind, active-comparator clinical trial in early RA. Patients aged ≥ 18 years were randomly assigned to receive adalimumab 40 mg every other week (eow) plus weekly MTX, weekly MTX, or adalimumab 40 mg eow for 104 weeks. American College of Rheumatology (ACR) criteria were used to evaluate clinical efficacy and response. Outcomes were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Short-Form 36 Health Survey (SF-36), Short-Form 6 Dimension (SF-6D), visual analog scale (VAS) assessments of global disease activity (patient’s global assessment; PtGA) and pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Health Utility Index Mark 3 (HUI-3).Results.Of 799 patients enrolled, 268 received adalimumab plus MTX, 257 received MTX monotherapy, and 274 received adalimumab monotherapy. Patients treated with adalimumab plus MTX demonstrated significant baseline to Week 104 improvements in HAQ-DI (p < 0.0001), SF-36 Physical Component Summary (p < 0.0001), 4 SF-36 domains [physical function (p < 0.0001), bodily pain (p Conclusion.Adalimumab plus MTX significantly improved physical functioning and HRQOL in patients with early RA over 2 years of treatment. (ClinicalTrials.gov identifier NCT00195663).

Rheumatoid arthritis (RA) is a common chronic condition with substantial morbidity that can now be treated with disease-modifying biologic agents that target tumor necrosis factor (TNF) or related mechanisms. The anti-TNF biologic agents are available in either intravenous (IV) or subcutaneous dose forms. The biologic agents with an indication for rheumatoid arthritis and administered only by IV infusion in medical offices include abatacept, infliximab, and rituximab. Although the literature on RA treatments, their outcomes, and aspects of their costs is substantial, the costs of administration by the IV route have not been directly studied.To assess the detailed costs of administering IV biologic agents for the treatment of RA in relation to the total cost of the medication itself in the United States.The sample included all patients with at least 1 medical claim with an ICD-9-CM diagnosis code for RA (codes 714.XX) in any claim field and at least 1 claim for infliximab, abatacept, or rituximab (HCPCS codes J1745, J0129, and J9310, respectively) at any time from January 1, 2006, through December 31, 2008, in a database associated with billing and claims administration for 72 U.S. medical clinics. Costs were determined using the payer allowed payment, which is the total contractual amount that the provider should receive, including the patient cost share. Costs were measured as the average cost per IV administration visit and in relation to the dose of medication billed. The authors verified that an RA diagnosis was present on 100% of infusion claims for the study drugs.Over the study period for claims with dates of service from January 1, 2006, through December 31, 2008, 72 medical clinics had claims for a total of 4,248 unique patients with RA and a total of 33,354 clinic visits in which these patients received at least 1 infusion of 1 of 3 biologic agents (26,586 for infliximab, 4,807 for abatacept, and 1,961 for rituximab). Mean (SD) total payment for all drugs and other cost components was $2,874 ($1,515) per visit, of which IV administration costs were $226 (7.9%); the mean cost of the biologic agent itself was $2,616 (91.0%), and other visit-related services were $33 (1.1%). For individual agents, the total costs of visits were $2,828, $1,827, and $6,076; and the costs of IV administration were $224, $171, and $390, respectively, for infliximab, abatacept, and rituximab.For patients who received an IV biologic agent to treat RA, IV administration costs accounted for 7.9% of the total cost of the visit.

Objective To estimate the cost-effectiveness of adalimumab plus methotrexate (MTX) versus MTX monotherapy in early, aggressive rheumatoid arthritis (RA) when explicitly modelling short-term (reversible) and long-term (irreversible, ie, joint damage) disease activity and physical function. Methods A microsimulation model was developed to unify, in a single cost-effectiveness model, measures of reversible and irreversible disease activity and physical function based on data from the PREMIER trial. Short term, reversible disease activity was modelled using DAS28 variables, including swollen joint counts, tender joint counts, C reactive protein concentration and pain. The DAS28 variables were then used in a logistic regression to predict short-term American College of Rheumatology (ACR) responses, which informed treatment continuation and switches. Long term, irreversible, radiographically documented joint damage was modelled using modified Total Sharp Score (mTSS). The model then linked both short-term disease activity and mTSS to the Health Assessment Questionnaire score, which was used to calculate direct and indirect costs, and quality adjusted life-years (QALYs). Results When both reversible and irreversible effects of therapy were included, combination therapy was estimated to produce 6-month 50% ACR responses in 75% of patients versus 54% in MTX monotherapy. Compared to MTX monotherapy, combination therapy resulted in 2.68 and 3.04 discounted life years and QALYs gained, respectively. Combination therapy also resulted in a net increase in direct costs of £106 207 for a resulting incremental cost/QALY gain of £32 425. When indirect costs were included in the analysis, the ICER (incremental cost-effectiveness ratio) decreased to £27 238. Disregarding irreversible effects increased the incremental cost-effectiveness ratio to £78 809 (when only direct costs were included). Conclusions Starting with adalimumab plus MTX combination therapy in early, aggressive RA is cost-effective when irreversible damage is adequately considered.

Objective To evaluate household and work place outcomes for patients with rheumatoid arthritis (RA) who were homemakers or employed workers, respectively, and who were treated with adalimumab plus methotrexate versus methotrexate monotherapy. We also determined baseline predictors of household and work place outcomes. Methods Data were from a health economic companion study to PREMIER, a 2-year, randomized controlled trial of methotrexate-naive patients with early RA (

Background Within 2 to 3 years of disease, approximately 20 to 30% of patients with early rheumatoid arthritis (RA) become permanently work disabled (Allaire, 2008). Disability-associated ‘work instability’ defined as the mismatch between their functional capabilities and job demands, is a risk factor for loss of employment. The RA-WIS was developed to assess the level of risk for work disability in RA patients; however there is limited information on its responsiveness and minimal important difference (MID). Objectives The objective of this study was to evaluate the responsiveness and MID of the RA-WIS in patients with early RA. Methods A secondary analysis was conducted using data from PROWD study, a 56-week, randomized, and controlled trial of patients with early RA (Bejarano, 2008). Clinical measures included American College of Rheumatology (ACR) response and Disease Activity Score-28 (DAS28), and patient-reported outcomes included the RA-WIS and Health Assessment Questionnaire Disability Index (HAQ-DI), which were collected at Baseline and at Weeks 12, 16, 24 and 56. Responsiveness of the RA-WIS was evaluated at Weeks 24 and 56 based on DAS28 ( 3.2) and ACR response criteria ( Results A total of 148 patients were included in the analysis sample, and was 56% female, with a mean age of 46.8 years. Patients experienced RA symptoms for a mean 8.7 months with mean DAS scores of 5.9 and mean HAQ-DI scores of 1.3. Mean Baseline to Week 24 RA-WIS Total change scores were significantly different among ACR responder groups ( P ≤0.0001) and between DAS28 remission status groups ( P Conclusions These findings provide evidence on the responsiveness of the RA-WIS for evaluating work disability in RA patients. The MID for the RA-WIS is estimated at 5 to 7 points. Disclosure of Interest D. Revicki Consultant for: AbbVie, M. Cifaldi Shareholder of: AbbVie, Employee of: AbbVie. The design, study conduct, and financial support for the study/trial was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract., S. Safikhani Consultant for: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie. The design, study conduct, and financial support for the study/trial was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract., A. Ganguli Shareholder of: AbbVie, Employee of: AbbVie. The design, study conduct, and financial support for the study/trial was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract.

Background Axial spondyloarthritis (axSpA) is a new umbrella term including patients with ankylosing spondylitis (AS), as well as those with non-radiographic axSpA (nr-axSpA). The new classification provides accepted evidence-based criteria to diagnose these patients. However, in practice, patients may be diagnosed using an earlier disease concept—undifferentiated SpA (uSpA)—for which an ICD-9 code exists. While clinical studies have found that a proportion of nr-axSpA patients experience radiographic progression (ie, to AS), little is known about progression to AS in a real-world setting. Objectives Explore the rate at which patients diagnosed with uSpA were subsequently diagnosed with AS using a large claims database. Methods Patients were selected from a de-identified US private insurer claims database (2000–2010). Potential nr-axSpA patients were defined as patients with ≥1 diagnosis for uSpA (ICD-9: 720.9) and a history of back disorders (724.0-724.9) prior to uSpA diagnosis. The date of first uSpA diagnosis was used as the study index date. Patients were required to have ≥6 months of continuous enrollment in a health plan prior to index (baseline period); be ≥18 years old on index; have no diagnoses for rheumatoid arthritis (714.0) or any type of SpA (AS: 720.0; Psoriatic Arthritis: 696.0; Reactive Arthritis: 099.3, 711.1; Inflammatory Bowel Disease: 713.1) on or before index; and have no diagnoses for any type of SpA other than AS post-index. Patients were followed until the earliest of: (a) diagnosis of AS (progression); (b) end of continuous eligibility; or (c) end of data availability. Baseline characteristics were measured separately for patients who were subsequently diagnosed with AS, and compared with those with no diagnosed progression. Results 6045 patients met the sample selection criteria. Median (IQR) available follow up was 14.2 (5.8-29) months. Two years post index, 8.9% of patients were diagnosed with AS, increasing to 13.7% by the 7 year mark. 5590 patients had no subsequent AS diagnosis. These patients averaged 47.6 years of age, and 61.4% were female. In comparison, patients progressing to AS were younger (43.8 years, P P =.002). AS progressors also had higher baseline rates of uveitis (8.4% vs. 1.5%, P P P Conclusions In a database study of real-world diagnostic patterns, approximately 14% of patients diagnosed with uSpA and with a history of back disorders progressed to AS over a 7 year period. Patients progressing to AS were younger and more likely to have a history of uveitis. To the extent that the combination of these ICD-9 codes serves as a proxy for nr-axSpA, the observed progression rates are on the lower end of previously reported findings in clinical studies. Disclosure of Interest A. Boonen: None Declared, N. Kirson Consultant for: Under contract with Abbott, Employee of: Analysis Group, S. Rao Shareholder of: Abbott, Employee of: Abbott, H. Birnbaum Consultant for: Under contract with Abbott, Employee of: Analysis Group, E. Swallow Consultant for: Under contract with Abbott, Employee of: Analysis Group, Y. Yushkina Consultant for: Under contract with Abbott, Employee of: Analysis Group, J. Jarvis Consultant for: Under contract with Abbott, Employee of: Analysis Group, P. Mease Consultant for: Abbott, M. Cifaldi Shareholder of: Abbott, Employee of: Abbott

Objective: To obtain detailed real-world data on persistence and dosing patterns in the utilisation of the TNF inhibitors adalimumab, etanercept, and infliximab in rheumatoid arthritis (RA) patients treated in Germany. Methods: In this retrospective observational study claims data of a major German health insurance fund between 2005 and 2008 were analysed. Patients receiving at least one prescription of adalimumab, etanercept or infliximab were identified and categorised as "TNF inhibitor naive" or "TNF inhibitor continuing". For the calculation of TNF inhibitor persistence a survival analysis with the Kaplan-Meier estimator was used. A Cox regression was used to analyse, if any relevant factors were influencing persistence. Dosage increase rates were analysed for adalimumab, etanercept and infliximab. Sensitivity analyses based on variations in gap length were conducted. Results: A total of 2,201 RA patients were identified. 1,468 of these patients were TNF inhibitor naive patients and 733 were defined as TNF inhibitor continuing patients. There were no significant differences in the treatment persistence rates between adalimumab, etanercept and infliximab for TNF inhibitor naive and continuing patients. The persistence rate after three years was 22.47% for adalimumab, 24.27% for etanercept and 21.49% for infliximab naive patients. For continuing patients, the persistence rate after three years was 32.88% for adalimumab, 30.95% for etanercept, and 33.90% for infliximab, respectively. Gender, medication and Charlson Comorbidities Index did not influence the persistence significantly. Dosage increase occurred in 7.3% adalimumab, 1.4% etanercept, and 17.2% infliximab naive patients and 5.8%, 1.1% and 11.9% respectively in the continuing patients. Conclusions: In this study, there were no significant differences in persistence among adalimumab, etanercept and infliximab treated patients. Consistent with previous research, there was a higher dose escalation for infliximab than for the two subcutaneous treatments, adalimumab or etanercept.