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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

Objective The few published estimates of the risk of renal complications in ankylosing spondylitis (AS) are established on clinic-based studies. Our objective was to estimate the age- and sex-specific risks of renal complications in a population-based cohort of AS subjects in Quebec between 1996 and 2006, relative to the general population. Methods A retrospective cohort design was implemented using population-based administrative data collected from 1996 to 2006 in Quebec, Canada. The study cohort included subjects diagnosed with AS on physician billing records, and the comparison cohort comprised a 1% random sample of subjects without AS. Age- and sex-stratified prevalence ratios for acute kidney injury, chronic kidney disease, amyloidosis, and hypertensive renal disease were compared between subjects with and without AS. Results The AS cohort included 4,836 men and 3,780 women. Renal complications were diagnosed among 3.4% of men and 2.1% of women with AS compared with 2.0% and 1.6% of persons without AS, respectively. Renal complications were 72% more prevalent among persons with AS and an increase was observed in each of the conditions. The magnitude of the risk of renal complications was highest among younger individuals and decreased with advancing age. Conclusion These findings indicate that renal complications may be elevated among persons with AS, especially at younger ages. Despite the limitations of administrative data pertaining to onset of disease, these findings warrant further investigation because of their clinical relevance.

No head-to-head trial has compared the efficacy of adalimumab vs etanercept and infliximab for psoriatic arthritis (PsA). This study implements a matching-adjusted indirect comparison technique to address that gap.Patient-level data from a placebo-controlled trial of adalimumab (ADEPT) were re-weighted to match average baseline characteristics from pivotal published trials of etanercept and infliximab. ADEPT patients were re-weighted by odds of enrollment in comparator trials, estimated using logistic regression. Matched-on characteristics included PsA duration, age, gender, severity, active psoriasis, and concomitant treatment. After matching, placebo-adjusted treatment arms were compared at weeks 12 (or 14) and 24. Outcomes included ACR20/50/70, PsARC, HAQ, and modified TSS. PASI50/75/90 were compared for patients with active psoriasis. Cost per responder (CPR) was assessed in the US and Germany using matching-adjusted end-points and drug list prices. Statistical significance was assessed using weighted t-tests.After matching, adalimumab-treated patients had greater placebo-adjusted rates of ACR70 and PASI50/75/90 at week 24 compared with etanercept (all p 0.05). Adalimumab patients had a higher placebo-adjusted rate of ACR70 than infliximab at week 14 (p = 0.034). Adalimumab treatment had lower CPR for ACR70 and PASI50/75/90 compared with etanercept at week 24, in both the US and Germany (all p 0.02). Adalimumab had lower CPR than infliximab for all outcomes at week 24 (all p 0.05).Adalimumab is associated with higher ACR70 and PASI50/75/90 response rates than etanercept at week 24 and a higher ACR70 response rate than infliximab at week 14. Adalimumab has significant advantages over etanercept and infliximab in CPR across multiple end-points.The matching-adjusted indirect comparison method cannot account for unobserved differences in patient characteristics across trials, and only a head-to-head randomized clinical trial can fully avoid the limitations of indirect comparisons. CPR findings are limited to the US and German markets, and may not be generalizable to other markets with different relative pricing.

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 estimate the excess risk of cardiovascular and cerebrovascular diseases among individuals with ankylosing spondylitis (AS) in Quebec compared with the general population of Quebec. Methods A retrospective cohort study was conducted using population-based administrative data from Quebec. The cohort included all adult individuals with at least 1 AS diagnosis on physician billing or hospital discharge records between 1996 and 2006. A comparison cohort was generated using a 1% random sample of individuals without AS. Cardiovascular and cerebrovascular diseases, and associated hospitalizations, were classified into 1 of 6 subcategories: congestive heart failure, valvular (aortic or nonaortic) heart disease, ischemic heart disease, cerebrovascular disease, or “other” cardiovascular disease. The age- and sex-stratified prevalence estimates, and standardized prevalence ratios, of cardiovascular or cerebrovascular disease in patients with AS, compared to that in the general population, were calculated. Results The AS cohort included 8,616 individuals diagnosed over the period 1996–2006. The prevalence of cardiovascular and cerebrovascular diseases increased with increasing age for all cardiovascular disease subgroups, and was similar for individuals of both sexes. Age- and sex-stratified prevalence ratios were highest in younger individuals with AS. The age- and sex-standardized prevalence ratios comparing the risk among those with AS to the risk in the general population were as follows: for aortic valvular heart disease 1.58 (95% confidence interval [95% CI] 1.31–1.91), for nonaortic valvular heart disease 1.58 (95% CI 1.43–1.74), for ischemic heart disease 1.37 (95% CI 1.31–1.44), for congestive heart failure 1.34 (95% CI 1.26–1.42), for “other” cardiovascular disease 1.36 (95% CI 1.29–1.44), for cerebrovascular disease 1.25 (95% CI 1.15–1.35), and for any hospitalization for a cardiovascular or cerebrovascular disease 1.31 (95% CI 1.22–1.41). Conclusion Compared with the general population, patients with AS are at increased risk for many types of cardiovascular and cerebrovascular diseases, and are more likely to be hospitalized for these diseases. The excess risk is greatest in younger patients with AS.

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 (

ObjectiveTo estimate the comparative lifetime cost-effectiveness of sequenced therapy with tumor necrosis factor (TNF) antagonists as the initial therapeutic intervention for patients with early rheumatoid arthritis (RA).MethodsBecause patients with RA switch regimens many times throughout the course of disease, sequenced therapeutic interventions were modeled, continuing until the last effective agent failed or death occurred. The model used published clinical outcomes from short-term, randomized controlled trials. Direct treatment costs and costs of lost productivity were modeled for each of 5 alternative treatment sequences. Incremental cost-effectiveness ratios are expressed as quality-adjusted lifeyears (QALY) gained.ResultsTreatment sequences that included TNF antagonists produced a greater number of QALY than conventional disease modifying antirheumatic drug regimens alone. The cost-effectiveness of sequenced therapy initiated with adalimumab plus methotrexate (MTX) extendedly dominated both infliximab-plus-MTX–initiated and etanercept sequences. The cost of adalimumab plus MTX per QALY was US $47,157 excluding productivity losses, and $19,663 including productivity losses. A supplementary sequence that incorporated adalimumab-plus-MTX–initiated first-line therapy followed by another TNF antagonist as second-line therapy was modeled; this sequence resulted in additional QALY gained and extendedly dominated all single-TNF strategies.ConclusionOf the 3 single-TNF antagonist sequences, the adalimumab-plus-MTX–initiated sequence was cost-effective in producing the greatest number of QALY. Multiple TNF strategies, such as the supplementary sequence modeled in this analysis, may be cost-effective in producing even greater health gain.

Background The ASsessment in Ankylosing Spondylitis (ASAS) international Society working group has proposed and validated new classification criteria for patients with axial SpA. 1 Currently, there are no epidemiology data specific to axial SpA following the ASAS criteria. To our knowledge, this is the first study to estimate the prevalence of axial SpA using ASAS criteria. Objectives To estimate the prevalence of axial SpA in a representative sample of rheumatology practices and apply it to US census data. Methods 101 US rheumatology practices were selected in a stratified random fashion to assure geographic representativeness. Screening forms were used to identify at-risk patients aged 18 to 44 years with chronic low back pain, and medical records were randomly selected from this pool for review against ASAS axial SpA criteria. Overall prevalence was estimated by calculating the ratio of Axial SpA patients who met ASAS criteria and applying this ratio to the total number of at-risk patients treated at participating sites. Following post-stratification weighting to reflect geographic distribution, the average proportion of patients with axial SpA treated at selected sites was multiplied by the total number of US rheumatology practices to obtain an estimate of total at-risk patients treated by rheumatologists. Finally, US census data 2 were used to obtain a national prevalence estimate. Results In a sample of 816 randomly selected records of at-risk patients, 553 (68%) were men, and 263 (32%) were women. 514 patients (63%) met ASAS criteria for prevalent axial SpA. Of these 389 (76%) were men, and 125 (24%) were women. By applying the prevalence estimates to the pool of 1,217,097 at-risk Americans, we estimated that 766,771 at-risk patients treated by rheumatologists would meet ASAS criteria for axial SpA. This estimate corresponds to a national prevalence of 0.70% or 701 per 100,000 individuals. Rheumatologists diagnosed axial SpA in 491 (60%) patients in the at-risk pool, regardless of whether or not they reported using ASAS criteria. The prevalence of axial SpA diagnosed by rheumatologists’ assessment was 0.66%. Finally, the prevalence estimate of non-radiographic axial SpA based on ASAS criteria was 0.35%. Conclusions This is the first systematic epidemiology study of axial SpA. The prevalence estimates according to ASAS criteria are 0.70% for axial SpA and 0.35% for non-radiographic axial SpA, with a proportionally higher prevalence in men than women. Overall, diagnosis of axial SpA in US rheumatology practices appears to be consistent with ASAS classification criteria. References Rudwaleit M, et al. Ann Rheum Dis. 2009;68:770–83. http://www.census.gov/population/www/projections/projectionsagesex.html. Disclosure of Interest S. Rao Shareholder of: Abbott, Employee of: Abbott, A. Shillington Employee of: EPI-Q, under contract with Abbott, V. Strand Consultant for: Abbott, M. McGuire Employee of: EPI-Q, under contract with Abbott, M. Cifaldi Shareholder of: Abbott, Employee of: Abbott

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 Clinical evidence points to an increased risk of renal comorbidity in ankylosing spondylitis (AS) compared to the general population. However, there are no population-based estimates available in the literature. An increased risk of renal comorbidity would have substantial implications for the monitoring and treatment of AS because the mainstay of pharmacological treatment is the use of non-steroidal anti-inflammatory agents (NSAIDs). Objectives To estimate the prevalence and age- and sex-standardized increased risk of renal comorbidity, including acute and chronic kidney disease, and amyloidosis in a population-based cohort of persons diagnosed with AS in Quebec between 1996 and 2006, compared to the general population. Methods A retrospective cohort study was conducted using the administrative physician-billing database of the Regie de l’Assurance Maladie du Quebec. The cohort included individuals with at least one International Classification of Diseases, 9th Revision (ICD-9) billing code for AS between 1996 and 2006. A comparison cohort was generated using a 1% random sample of individuals without AS. Renal complications were identified by ICD-9 codes for amyloidosis, hypertensive chronic renal disease, acute and chronic renal disease. Age- and sex-stratified prevalence, and standardized prevalence ratios with 95% confidence intervals (CI), of renal complications in AS compared with the general population were calculated. Sensitivity analysis was conducted using two ICD-9 codes for AS. Results There were 8,616 individuals identified with AS; 56% were male and the median age at diagnosis was 42 years. Overall, renal complications were diagnosed among 3.4% and 2.1% of males and females with AS, compared to 2.0% and 1.6% of males and females in the general population cohort, respectively. Prevalence of renal complications increased with age in both the AS and general population cohort. Age- and sex-stratified prevalence ratios, comparing the risk of renal complications among those with AS to the general population, demonstrated a significantly excess risk of renal complications that was highest among younger individuals with AS. Overall, individuals with AS were at a significantly increased risk of renal complications compared to members of the general population (irrespective of a coding for hypertension), with a standardized prevalence ratio of 1.7 (1.5-2.0). Standardized prevalence ratios were 6.0 (2.0-18.0) for amyloidosis; 1.7 (1.4-2.0) for chronic kidney disease; 3.2 (0.8 – 12.4) for hypertensive kidney disease, and 1.9 (1.5 – 2.3) for acute kidney disease. The excess risk was highest among younger individuals with AS, and results were similar when two ICD codes were used to identify AS. Conclusions This population-based analysis shows that individuals with AS are at increased risk of many types of renal complications, with the excess risk being greatest among younger individuals. These data highlight the importance of careful monitoring for renal complications among those with AS, particularly during long-term continuous use of NSAIDs. Disclosure of Interest None Declared

Background Axial spondyloarthritis (axSpA) is a new classification that includes ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA). Little is known about the severity and progressive nature of nr-axSpA relative to AS. An analysis of the German Spondyloarthritis Inception Cohort (GESPIC) indicated that clinical manifestations and disease activity measures are highly comparable between nr-axSpA and early AS. 1 We analyzed data from Phase III clinical trials of adalimumab in patients with AS and nr-axSpA compared to the results from the GESPIC study. Objectives To compare the burden of disease experienced by patients with nr-axSpA to that of AS patients with similar disease duration and AS patients with differing disease duration. Methods Baseline data from the ATLAS (N=315) and ABILITY-1 (N=185) trials were used. These were both Phase III trials to evaluate the safety and efficacy of adalimumab in the treatment of moderate to severe AS and nr-axSpA, respectively. Three cohorts were established: those with nr-axSpA ≤5 years’ duration, established AS ≤5 years’ duration, and AS >5 years’ duration. Clinical impairment, pain, and physical function were measured using the Bath AS Disease Activity Index (BASDAI), total back pain (TBP) VAS, Patient’s Global Assessment (PGA), and Bath AS Functional Index (BASFI) scales. Spinal mobility was assessed with the Bath AS Metrology Index (BASMI). Statistical methods included the Student t -test comparing the 2 groups with baseline scores. P -values Results AS patients with longer disease duration were older and had significantly less mobility than those with a shorter disease duration (BASMI 4.3 vs. 3.3, P P Conclusions AS and nr-axSpA patients experienced a similar burden of disease with a relatively high degree of clinical and functional impairment. Impairment of spinal mobility, as measured by BASMI, appears to be progressive, with less involvement in nr-axSpA, more involvement in AS, and a clear increase over time. Therefore, BASMI potentially could be an indicator of progression in nr-axSpA. References Rudwaleit M. Arthritis Rheum. 2009;60:717–27. Disclosure of Interest J. Sieper Grant/Research support from: Abbott, Consultant for: Abbott, Speakers Bureau: Abbott, S. Rao Shareholder of: Abbott, Employee of: Abbott, N. Chen Shareholder of: Abbott, Employee of: Abbott, M. Cifaldi Shareholder of: Abbott, Employee of: Abbott

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

Background The ASsessment in Ankylosing Spondylitis (ASAS) international Society working group has proposed and validated new classification criteria specific for axial SpA. 1 Objectives We applied these criteria to clinical data from a sample of German rheumatology practices to estimate the overall prevalence of nonradiographic axial SpA (nr-axSpA) and ankylosing spondylitis (AS) in Germany. Methods Patients experiencing chronic low back pain (at risk cohort) with age of onset between 18–44 years were identified among the patients in 41 German rheumatology practices. The at risk cohort was an estimate provided by the rheumatologists. Medical records were randomly selected from this at-risk cohort for review against ASAS axial SpA criteria. The proportion of patients meeting the ASAS criteria or using the diagnostic algorithm 2 was compared to an estimate of the total number of at risk patients treated at participating sites and was extrapolated to 1550 German rheumatology practices. Assuming 41 rheumatologists selected in this study are representative of the universe of rheumatologists in Germany, the prevalence estimate was calculated by dividing the estimate of patients with axial SpA by the total population aged ≥18 years. 3 Results In a sample of 206 randomly selected records of at-risk patients, rheumatologists diagnosed 179 (87%) patients with axial SpA of which 45.3% were considered to have nr-axSpA and 54.7% were considered to have AS. The diagnostic algorithm identified between 84–98 (40.7–47.5%) patients with nr-axSpA, based on the upper/lower range of probabilities and 53 (26%) patients with AS. The ASAS criteria was assessed against a population of 138 patients with radiographic imaging results (X-ray and MRI), 114 patients met the criteria for axial SpA of whom 61 (42.3%) had nr-axSpA and 53 (57.7%) patients with AS. By applying each of these ratios to the total pool of 209,250 at-risk patients, 174,375 patients were projected to meet ASAS criteria. This projection corresponds to a national prevalence estimate of 0.25% (ASAS; 95% CI: 0.23–0.27%). Similarly, our prevalence numbers of nr-axSpA estimated 0.13% (ASAS; 95% CI: 0.11–0.16%) and 0.12–0.14% (diagnostic algorithm; 95% CI: 0.10-0.14–0.12-0.16), showing a degree of overlap between the 2 methods in identifying nr-axSpA. The prevalence estimates for AS are 0.12% (95% CI: 0.09–0.15%). The ratio of axial SpA diagnosed by rheumatologists corresponds to a prevalence of 0.26% (95% CI: 0.25–0.28%). Conclusions This is the first retrospective epidemiology study of Axial SpA among rheumatologists in Germany. The prevalence of axial SpA based on the ASAS classification criteria was estimated to be approximately 0.25%, including 0.13% for nr-axSpA and 0.12% for AS. Sampling bias present from rheumatologist recruitment methodology and the projection of data to registered rheumatologists may have an indeterminate affect on the external validity of the results. Additionally, this study is only based on the patient population seen by rheumatologists and does not take into account patients that could be treated by orthopedics. References Rudwaleit M, et al. Ann Rheum Dis. 2009;68:770–83. Rudwaleit M, et al. Ann Rheum Dis. 2004;63:535–43. Statistisches Bundesamt, Wiesbaden 2009. Acknowledgements The authors would like to thank Eric Bertelsen and Cathryn M. Carter of Arbor Communications who provided medical writing and editing services in the development of this abstract. The financial support for these services was provided by AbbVie. Disclosure of Interest S. Rao 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., 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., A. Joshi 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. Shillington Employee of: EPI-Q, under contract w/AbbVie, M. McGuire Employee of: Medical Data Analytics, under contract w/AbbVie, B. Wittig 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., M. Rudwaleit Speakers bureau: AbbVie, BMS, MSD, Pfizer, Roche, UCB

Background The definition of axial spondyloarthritis is evolving with a new ASAS classification. Maintenance of physical function and patient mobility are primary goals in the treatment of ankylosing spondylitis (AS) and nonradiographic axial SpA (nr-axSpA). Bath AS Functional Index (BASFI) and Bath AS Mobility Index (BASMI) were developed to measure physical function and mobility in AS patients. HAQ-S is a measure of physical function for Spondyloarthropathies. Predictors for these outcomes may be different for nr-axSpA. Objectives To identify physical function and mobility predictors in nr-axSpA and AS patients. Methods Baseline data from ABILITY-1 (N=185) and ATLAS (N=315) clinical trials were analyzed. Separate stepwise regression analyses were conducted for AS and nr-axSpA groups. For physical function, the dependent variables were BASFI for (AS) and HAQ-S for (nr-axSpA). Model selection included age, sex, disease duration, Bath AS Disease Activity Index (BASDAI), CRP level, SF-36 Mental Component Summary (MCS), nocturnal pain, total back pain, Patient’s Global Assessment (PGA), Physician’s Global Assessment (PhGA), and BASMI. For mobility the dependent variable was BASMI for both diseases. Model selection included the same variables plus other measures of physical function; BASFI, SF-36 Physical Component Summary (PCS), and SF-36 Physical Function (PF). Results Physical Function: Based on the stepwise regression, disease activity, age and mobility were predictors in both AS and nr-axSpA. For nr-axSpA, these were the only predictors for physical function. For AS patients, PGA of disease activity explained most of the variance in the model. CRP levels were also significant predictors of physical function in AS (Table 1). Mobility: Based on the stepwise regression, age and physical function were predictors of mobility in AS (BASFI) and nr-axSpA patients (HAQ-S) (Table 2). For AS patients, disease activity, PhGA of disease activity, and disease duration were also predictors of BASMI. Conclusions In AS and nr-axSpA, age, disease severity, and mobility predict physical functioning at baseline, while physical function and age are consistent predictors for mobility. Both emphasize the importance of early treatment. Self-assessment of disease activity is a key predictor of physical function in AS, suggesting that these patients judge disease activity based on ability to function. For mobility, physician’s assessment of disease activity is a key predictor. Disclosure of Interest J. Sieper Grant/Research support from: Abbott, Consultant for: Abbott, Speakers Bureau: Abbott, S. Rao Shareholder of: Abbott, Employee of: Abbott, N. Chen Shareholder of: Abbott, Employee of: 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.