Yanjun Bao

ASAS40 and ASDAS clinical responses in the ABILITY-1 clinical trial translate to meaningful improvements in physical function, health-related quality of life and work productivity in patients with non-radiographic axial spondyloarthritis

Objective. To assess the impact of achieving Assessment in SpondyloArthritis international Society 40% (ASAS40) response or an Ankylosing Spondylitis Disease Activity Score inactive disease (ASDAS-ID) state on patient-reported outcomes (PROs) among patients with non-radiographic axial SpA (nr-axSpA). Methods. Data are from ABILITY-1, a phase 3 trial of adalimumab vs placebo in nr-axSpA patients. PROs included the HAQ for Spondyloarthropathies (HAQ-S), 36-item Short Form Health Survey (SF-36) physical component summary (PCS) score and Work Productivity and Activity Impairment Questionnaire. Patients were grouped by clinical response using ASAS40 response and ASDAS disease states at week 12. Changes in PROs from baseline to week 12 were compared between groups using analysis of covariance with adjustment for baseline scores. Results. At week 12, 47 of 179 patients were ASAS40 responders and 26 of 176 patients achieved ASDAS-ID (ASDAS <1.3). Compared with non-responders (n = 132), ASAS40 responders (n = 47) had a significantly greater improvement in mean HAQ-S (–0.65 vs -0.05, P < 0.0001), SF-36 PCS (12.4 vs 0.7, P < 0.0001), presenteeism (–24.7 vs -2.2, P < 0.0001), overall work impairment (–23.9 vs -2.5, P < 0.0001) and activity impairment (–33.5 vs -0.9, P < 0.0001) at week 12. Similarly, ASDAS-ID, ASDAS clinically important improvement (ASDAS-CII; improvement >1.1) and major improvement (ASDAS-MI; improvement >2.0) were associated with significantly greater improvements from baseline in the majority of the PROs. Conclusion. Among nr-axSpA patients, ASAS40, ASDAS-CII and ASDAS-MI response and achievement of ASDAS-ID were associated with statistically significant and clinically meaningful improvements in physical function, health-related quality of life and work productivity in a higher percentage of patients.

Comparing the risk of developing uveitis in patients initiating anti-tumor necrosis factor therapy for ankylosing spondylitis: an analysis of a large US claims database

Abstract Objective: To compare the risk of developing uveitis in patients initiating anti-tumor necrosis factor (anti-TNF) agents (adalimumab, etanercept, and infliximab) for ankylosing spondylitis (AS). Methods: Anti-TNF-naive patients with a diagnosis of AS and without a history of uveitis (N = 2115) who subsequently initiated anti-TNF therapy for AS were identified in a large claims database (2005 to 2011). A multivariate Cox proportional-hazards model was used to compare the risk of uveitis in patients who received etanercept or infliximab vs adalimumab. Results: The median number of days to the first occurrence of uveitis after initiation of anti-TNF was 191. Among the three anti-TNF groups, the median time to event of uveitis was longest in patients taking adalimumab (243 days), followed by etanercept (182 days) and infliximab (144 days). The incidence rate for uveitis over 1 year was lowest for patients who received adalimumab (2.4%, N = 717), highest for patients who received etanercept (4.5%, N = 1087), and intermediate for patients who received infliximab (3.2%, N = 311). The risk of uveitis was 1.9 times higher in patients receiving etanercept compared with those taking adalimumab (hazard ratio [HR]: 1.91, 95% confidence interval [CI]: 1.1 to 3.31). For patients taking infliximab, the risk of uveitis was not statistically significantly different (HR: 1.35, 95% CI: 0.62 to 2.95) compared to adalimumab. Conclusion: The results indicated that initial adalimumab therapy is associated with a significantly lower risk of developing uveitis compared to initial etanercept therapy in patients diagnosed with AS and no prior history of uveitis; however, the risk was not different between adalimumab and infliximab. Limitations to consider when interpreting this conclusion include that disease-level clinical data, such as disease duration, were not available for inclusion in the model and that risk of uveitis beyond 1 year was not evaluated.

The impact of biologic treatment on use of mechanical devices among rheumatoid arthritis patients in a large united states patient registry

To assess trends and predictors of mechanical devices/aids use by rheumatoid arthritis (RA) patients since the introduction of biologic disease‐modifying antirheumatic drugs (DMARDs).

SAT0578 Value of Treating Both Skin and Joint Manifestations of Psoriatic Arthritis: Post-HOC Analysis of the Adept Clinical Trial

Background Psoriatic arthritis (PsA) is a complex chronic inflammatory disease associated with psoriasis that primarily affects peripheral joints. The impact of both skin and joint manifestations of PsA on disease burden is not well characterized. Objectives To assess the relative contributions of skin and joint manifestations of PsA to the overall disease burden. Methods This post-hoc analysis of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) evaluated the subset of patients aged ≥18 years with active PsA (≥3 swollen joints and ≥3 tender joints) and an inadequate response to NSAID therapy with ≥3% body surface area [BSA] skin involvement of psoriasis. Joint damage (modified Total Sharp Score [mTSS]), physical function (Health Assessment Questionnaire disability index [HAQ-DI]), HRQoL (Short Form-36 [SF-36] and Dermatology Life Quality Index [DLQI]), pain, fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and physicians global assessment (PGA) were assessed at baseline and week 24. Multivariate linear regression was used to investigate associations of outcomes with skin and joint manifestations in patients with moderate (Psoriasis Area and Severity Index [PASI] ≤median, 6) or high (PASI >median, 6) skin involvement and low (DAS28 <3.2), moderate (DAS28 3.2–5.1) or high (DAS28 >5.1) joint involvement, with adjustment for age, sex, body weight, PsA duration, and methotrexate use. Results 140 patients were included. At baseline, increasing skin involvement (high vs moderate after controlling for DAS28 value) was associated with worse SF-36 mental component summary score (MCS; difference = 4.2, P=0.0371), FACIT-F (difference = 5.0, P=0.0095), DLQI (difference = 4.5, P=0.0001), and PGA (difference = 6.5, P=0.0141). Greater joint involvement (high vs low and moderate vs low after controlling for PASI score) was associated with worse HAQ-DI (difference = 0.98, P<0.0001; 0.41, P=0.0097), SF-36 physical component summary score (PCS; difference = 16.0 and 9.9, both P<0.0001), pain (difference = 40.8 and 25.4, both P<0.0001), FACIT-F (difference = 12.8, P=0.0002; 4.6, P=0.1222), DLQI (difference = 5.0, P=0.0120; 1.3, P=0.4686), and PGA (difference=17.3, P=0.0003; 6.9, P=.0963). Among the 41 patients who achieved joint remission (DAS28 <2.6) at week 24, those who also achieved skin remission (PASI ≤3) experienced greater improvements in most outcomes vs those who did not (Table). Conclusions Joint manifestations of PsA contributed to impaired physical function, physical health, pain, and fatigue. Skin manifestations contributed to decreased mental health, physical health, and fatigue. Despite achievement of joint remission, patients without skin remission experienced worse physical and functional impairments, pain, and physician-assessed outcomes. Management of PsA should aim to minimize both joint and skin involvement. Acknowledgements Financial support for the study and medical writing support (Eric Bertelsen, Arbor Communications, Ann Arbor, MI) was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. All authors contributed to the development of the publication and maintained control over the final content. Disclosure of Interest P. Mease Grant/research support from: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, M. Mittal Shareholder of: AbbVie, Employee of: AbbVie, A. Joshi Shareholder of: AbbVie, Employee of: AbbVie, N. Chen Shareholder of: AbbVie, Employee of: AbbVie, J. Anderson Shareholder of: AbbVie, Employee of: AbbVie, Y. Bao Shareholder of: AbbVie, Employee of: AbbVie

THU0436 Real-World Comparative Effectiveness of Adalimumab and Tocilizumab for the Treatment of Rheumatoid Arthritis: Results of an Administrative Claims Analysis

Background Previous meta-analyses suggest improved efficacy of ADA+MTX compared to TCZ+MTX, however, no comparison was made to TCZ monotherapy.1 Objectives To compare the real-world effectiveness of ADA+MTX vs TCZ in treating biologic-naïve RA patients. Methods A retrospective (2005–2013), longitudinal cohort study was performed using a large US commercial administrative claims database. Biologic-naïve patients aged ≥18 years with a 1st diagnosis of RA and no diagnosis of spondyloarthritis, psoriasis, psoriatic arthritis, ulcerative colitis, or Crohns disease within the study period were included. Patients who initiated ADA+MTX therapy were matched 1:1 with patients who initiated TCZ monotherapy, based on RA duration (±30 days) and date of biologic initiation (±360 days). Effective disease control over 1 year was defined using a validated algorithm that included the following elements: high adherence to the target biologic therapy (≥80% ADA adherence by medication possession ratio or receipt of 11–12 TCZ infusions), biologic dose escalation, switching to/adding a biologic or nonbiologic disease-modifying antirheumatic drug (nbDMARD), escalation of oral corticosteroid dose, or receipt of >1 glucocorticoid joint injection2. Effectiveness was compared after adjusting for the following covariates using multivariate logistic regression and Cox proportional hazard analyses: age, sex, Charlson Comorbidity Index, insurance type, geographic region, RA duration, number of prior DMARDs used, and number of rheumatologist visits between baseline and 1 year. Results Mean age among 648 patients included (324 ADA+MTX; 324 TCZ) was 49.4 years; 18.1% were male. Baseline sociodemographic and clinical characteristics were similar between patient cohorts. At year 1, a significantly greater proportion of patients on ADA+MTX achieved effective disease control vs those on TCZ (29.6% vs 15.4%; P<0.001). Patients on ADA+MTX were less likely than those on TCZ to switch or add nbDMARDS (3.4% vs 10.8%; P<0.001), to escalate their biologic dose (17.0% vs 48.8%; P<0.001), or to have a 2nd corticosteroid injection (4.9% vs 11.4%; P=0.003). When controlling for baseline sociodemographic and clinical characteristics, patients on ADA+MTX were more likely than those on TCZ to be effectively treated (odds ratio=2.43, 95% CI=1.36 to 4.32). Compared to TCZ monotherapy, ADA+MTX treatment was associated with lower probability of switching or adding nbDMARDs, biologic dose escalation, or >1 corticosteroid joint injection (Table). Table 1. Factors associated with effective treatment (Cox proportional hazard modeling) Hazard ratio (ADA+MTX vs TCZ) P value Biologic dose escalation 0.32 <0.001 Corticosteroid 2nd injection 0.45 0.016 Oral corticosteroid dose escalation 0.89 0.580 Switch/add biologic DMARD 1.44 0.113 Switch/add nbDMARDs 0.39 0.010 Conclusions This study demonstrated real-world superiority of ADA+MTX therapy over TCZ monotherapy among RA patients. Future research to examine these findings in a randomized clinical trial may provide further evidence in this area. References Liu Y et al. Adv Ther. 2012;29(7):620–34. Curtis JR et al. Arthritis Res Ther. 2011;13:R155. Disclosure of Interest V. Garg Shareholder of: AbbVie, Employee of: AbbVie, J. Griffith Shareholder of: AbbVie, Employee of: AbbVie, O. Hayes Shareholder of: AbbVie, Employee of: AbbVie, Y. Bao Shareholder of: AbbVie, Employee of: AbbVie

FRI0129 Assessing the Economic Impact of Comprehensive Disease Control on Total Direct Medical Expenditures for Rheumatoid Arthritis

Background Comprehensive disease control (CDC) of Rheumatoid Arthritis (RA) is simultaneous achievement of clinical remission (Disease Activity Score [DAS28]<2.6), normal physical functioning (Health Assessment Questionnaire Disability Index [HAQ-DI]<0.5), and radiographic non-progression (modified Total Sharp Score [ΔmTSS]≤0.5). CDC has been linked to clinical benefits including improvements in quality of life (QoL) and reductions in pain and fatigue, but its economic impact has not been quantified.1 Objectives To quantify the impact of CDC achievement on direct medical expenditures from a US third party payer perspective and compare the medical expenditures of CDC achievers to the medical expenditures of CDC non-achievers, including patients who achieve other disease control targets. Methods This study used data from the 2011 Medical Expenditure Panel Survey (MEPS) Household Component, and the PREMIER and DE-019 randomized controlled trials. Adult RA patients with complete SF-12 physical (PCS) and mental (MCS) component scores were selected from the MEPS data. The annual direct medical expenditures of these patients were modeled as a function of PCS, MCS, and patient characteristics (age, sex, race, disease duration, obesity, and comorbidities). MEPS estimates were adjusted with survey weights to make them nationally representative. A log transformation was applied due to the non-normality of the cost data. Using the PREMIER and DE-019 clinical trial data, annual direct medical expenditures were estimated using the MEPS model and compared between CDC achievers and non-achievers (including those who achieved HAQ-DI<0.5, DAS28<2.6, ΔmTSS≤0.5, or Clinical Disease Activity Index [CDAI] remission without achieving CDC). Results A total of 498 RA patients (representative of the US RA population) from MEPS were identified. After adjusting for patient characteristics, each 1-point increase in PCS and MCS were associated with total medical expenditure reductions of 3% and 1%, respectively. In the clinical trial data, patients who achieved CDC were estimated to have approximately half the mean total annual costs compared with those not achieving CDC (

AB0406 Effect of Adalimumab and Impact of Disease Activity and Functional Impairment on Work Instability in Patients with Rheumatoid Arthritis

2,078 v.

SAT0339 Asas40 and ASDAS Responses Are Associated with Improved Physical Function, Hrqol, and Work Productivity in Patients with Non-Radiographic Axial Spondyloarthritis

3,923, p<0.001). CDC achievers also had significantly lower (p<0.001) costs than patients who achieved HAQ-DI<0.5 (

Ankylosing spondylitis diagnosis in US patients with back pain: identifying providers involved and factors associated with rheumatology referral delay

2,409), DAS28<2.6 (

Spondyloarthritis Epidemiology and Burden Phase 2 [SPEED 2] Study: Disease Progression In Axial Spondyloarthropathy (SpA)

2,690), or ΔmTSS≤0.5 (