Dave Nicholls

A multi‐center, observational study shows high proportion of Australian rheumatoid arthritis patients have inadequate disease control

To evaluate the disease activity and current pharmacological interventions used to achieve remission in rheumatoid arthritis (RA) patients in Australia.

Barriers to optimal disease control for rheumatoid arthritis patients with moderate and high disease activity

To evaluate barriers that prevent rheumatoid arthritis (RA) patients from achieving Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28‐ESR) scores within the current recommended levels for low disease activity (LDA) or clinical remission (DAS28‐ESR score <3.2).

The SMILE Study -- Safety of Methotrexate in Combination with Leflunomide in Rheumatoid Arthritis

Objective. To assess the safety of treating patients with rheumatoid arthritis with a combination of methotrexate (MTX) and leflunomide (LEF) in comparison to MTX monotherapy, in clinical practice. Methods. The Safety of Methotrexate in Combination with Leflunomide in Rheumatoid Arthritis (SMILE) study was a multicenter, observational, cross-sectional, retrospective safety study. The study was conducted by the Optimising Patient Outcomes in Australian Rheumatology-Quality Use of Medicines Initiative (OPAL QUMI). Data were deidentified for patient, clinic, and clinician prior to collection from 13 participating rheumatology practices (25 rheumatologists). Comparative analysis of safety for the different treatments, primarily with regard to neutropenia and liver abnormalities, was performed. Results. In total, 2975 patients were included in the study: 74% female, 26% male, mean age 62 years (SD 13.6). Distribution of therapy: MTX monotherapy 52.2%, LEF monotherapy 7.3%, MTX plus LEF 13.9%, and neither MTX nor LEF 26.6%. Comorbid liver disease was reported in 8.1% of patients. Liver function abnormalities were reported in 12% of the MTX monotherapy group, 16% of the LEF monotherapy group, 19% of the MTX-LEF combination group, and 14% of the group not taking either drug. Neutropenia was reported in 2.3% of the MTX monotherapy group, 5.5% of the LEF monotherapy group, 3.9% of the MTX-LEF combination group, and 4.2% of the group not taking either drug. Conclusion. The combination of MTX and LEF was well tolerated, with adverse events comparable to those of monotherapy and the other nonbiologic disease-modifying antirheumatic drug treatment group.

Patients with rheumatoid arthritis in the Australian OPAL cohort show significant improvement in disease activity over 5 years: a multicenter observational study

Objective. To evaluate disease activity trends in a large cohort of Australian patients with rheumatoid arthritis (RA) from 2009 to 2014. Methods. This is a multicenter, cross-sectional, noninterventional study of patients with RA treated in Australia. Patients with RA treated at participating OPAL (Optimising Patient outcome in Australian RheumatoLogy) clinics were included in the study. Data, deidentified by patient, clinic, and clinician, were identified using a purpose-written electronic medical record. Patient demographics, disease onset, medications, and disease measures were analyzed. The Disease Activity Score at 28 joints (DAS28) was used to classify patients into the disease activity states of remission: low disease activity, moderate disease activity (MDA), and high disease activity. Choice of therapy was at the discretion of the treating clinician. Results. At the time of analysis, the database contained 15,679 patients with RA, 8998 of whom fulfilled the inclusion criteria. Mean age was 63.2 years, mean disease duration was 13.8 years, and the majority were women (72.4%). A total of 37,274 individual DAS28-erythrocyte sedimentation rate scores were recorded for the 8998 patients. The frequency of remission increased significantly from 36.7% in 2009 to 53.5% in 2014 (p < 0.001), and that of MDA decreased from 33% (2009) to 22.2% (2014). The use of biologic disease-modifying antirheumatic drugs for the patients in remission increased from 17% in 2009 to 36.9% in 2014. Conclusion. Contemporary management of RA in Australia shows improvements in disease activity toward the target of remission over a 5-year period.

Longitudinal study of clinical prognostic factors in patients with early rheumatoid arthritis: the PREDICT study

To assess the association between baseline clinical prognostic factors and subsequent Disease Activity Score of 28 joints (DAS28) remission in early rheumatoid arthritis (RA).

A retrospective chart review of the use of rituximab for the treatment of rheumatoid arthritis in Australian rheumatology practice

Rituximab is one of nine biologic agents approved for the treatment of rheumatoid arthritis (RA) in Australia. The primary study objective was to analyze the factors that lead to the therapeutic decision to use rituximab in RA.

The CEDAR Study: A Longitudinal Study of the Clinical Effects of Conventional DMARDs and Biologic DMARDs in Australian Rheumatology Practice

Objectives To observe the choices of conventional disease modifying antirheumatic drugs (cDMARDs) and biologic DMARDs (bDMARDs) in the management of rheumatoid arthritis (RA) in Australian routine clinical practice, to assess treatment survival and determine the effect of cDMARDs/bDMARDs on disease activity. Methods Routinely collected, deidentified clinical data was sourced from 20 Australian rheumatology practices. RA patients aged ≥18 years, who had received cDMARDs/bDMARDs and a recorded subsequent visit, were included. A linear mixed model was used to determine the change over time and the percentage reduction in disease activity was summarized. Results 12,526 RA patients were included: 72% females, mean age 62 years. cDMARDs and bDMARDs were used in 92% and 30% of patients, respectively. The most commonly prescribed cDMARD was methotrexate (76% patients); median time to stopping treatment was 337 months [95% CI: 279–ND]. Etanercept was the most commonly prescribed bDMARD (12% patients); median time to stopping treatment was 79 months [95% CI: 57–93]. Of 5,341 patients with a first change in medication (cDMARD or bDMARD), 87% had therapy escalation and 13% deescalation. Reduction in DAS28-ESR, 6-month post-DMARDs initiation ranged from 3%, adalimumab, to 14%, leflunomide and tocilizumab. Conclusions In this large Australian cohort of unselected community RA patients, the choices of cDMARDs/bDMARDs are aligned with current international guidelines.

Effectiveness of biologics in Australian patients with rheumatoid arthritis: a large observational study: REAL: bDMARD effectiveness in Australia

The comparative effectiveness of biologic treatment regimens in a real world Australian population is unknown.

AB0344 A Retrospective Non-Interventional Study on The Use of Biologics in The Treatment of Australian Patients with Rheumatoid Arthritis-The Real Study

Background Medication choices offered to rheumatoid arthritis (RA) patients are based in part on results from randomised controlled trials (RCTs). While these trials form a valuable evidence-base for rational prescribing, extrapolation of RCTs data to every day clinical practice is hampered by the highly selected patient (pt) groups that are accepted into RCTs. The comparative effectiveness of biologic treatment regimens in a real world Australian population is unknown. Objectives To assess effectiveness of biologic (b) DMARDs, as monotherapy, in combination with conventional (c) DMARDs other than MTX and in combination with cDMARDs regimens including MTX in the Australian OPAL database. Methods A retrospective non-interventional study. Data was extracted from participating Australian rheumatology centres using point of care software. Pts ≥18 years (yrs) with probable/definite RA, who had been prescribed a bDMARD and have had a visit recorded 12 months prior to and at least 12–40 weeks (wks) after commencement of a bDMARD were included. Bouts of treatment (BTs) refer to cycles of continuous, individual biologics prescribing in individual pts; if pts change biologics then this was defined as a new BT. Wk12 (-4/+8) analyses included any measurement between wk8 and wk20 post bDMARDs initiation and wk24 (-4/+8) included any measurements between wk20 and wk32. Results 2971 pts met criteria; median age 60 yrs (min 19, max 94) and median disease duration prior to 1st bDMARD of 6.1 yrs (min 0.2, max 58.3). Median number of bDMARDs per pt was 1 (min 1, max 8). At least 1 bDMARD was taken by 2971 pts, 1177 received 2 bDMARDs and 507 received 3 or more. There were 4923 bDMARD BTs recorded for this population with median treatment duration of 0.7 yrs (min 0, max 11.8). Median duration of 1st bDMARD (n=2971 pts)=0.8 yrs (min 0, max 11.8); 2nd bDMARD (n=1177)=0.6 yrs (min 0, max 9.9) and 3rd bDMARD (n=507)=0.6 yrs (min 0, max 6.4). The most commonly used bDMARDs were etanercept (n=1358), adalimumab (n=1098), abatacept (n=642) and tocilizumab (n=629); median duration of BTs=0.7 (min 0, max 11.8), 0.8 (min 0, max 10.5), 0.7 (min 0, max 6.1) and 1.0 (min 0, max 7.4) yrs respectively. bDMARD monotherapy (no cDMARD overlap) was administered in 10% BTs (n=488); bDMARDs + MTX +/− other cDMARD(s) were administered in 74% BTs (n=3639) and bDMARDs + cDMARD(s) other than MTX were administered in 16% BTs (n=796). Median CDAI and DAS28 by biologic presented in Table 1. Conclusions The majority in this cohort of Australian RA pts receive 1 line of bDMARD. Pts tend to persist longer on 1st bDMARD than subsequent biologics. bDMARDs as monotherapy or in combination (+/− MTX) are valid treatment strategies in the real world. Acknowledgement The study was sponsored by Roche Products Pty. Limited. Medical writing was provided by Dr Joseline Ojaimi from Roche. Disclosure of Interest D. Nicholls: None declared, H. Griffiths: None declared, R. Barrett Employee of: Roche Products, Pty. Limited, P. Button Employee of: Roche Products, Pty. Limited, M. Truman Employee of: Roche Products, Pty. Limited, P. Bird: None declared, L. Roberts: None declared, K. Tymms: None declared, G. Littlejohn: None declared

AB0241 Rheumatoid Arthritis Patients in Australian Database Show Significant Improvement in Disease Activity over 5 Years

Background Rheumatoid arthritis (RA) treatment in Australia has undergone significant change in the last decade. New treatment paradigms of treat to target, with remission being the goal, supplemented by maintenance of tight control have become standard of care. We have established a network database, named OPAL-QUMI (Optimising Patient outcome in Australian RheumatoLogy – Quality Use of Medicines) whereby patient-specific details are captured on purpose-written software at the time of consultation. This information represents real-life data reflecting everyday care of the patient. We used this database to assess surrogates of disease activity over the 5-year period that our consortium has been in place (2009-2013). Objectives To evaluate the disease activity trends in rheumatoid arthritis (RA) patients in Australia over 5 years. Methods RA patients treated in participating Australian clinics were included in the study. Patient demographics, disease onset, medications and disease measures were analysed. Data, de-identified to the patient, clinic and clinician was captured using an electronic clinical management programme. The disease activity score (DAS28) was used to classify patients into the disease activity states of remission, low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA). Choice of therapy was at the discretion of the treating clinician. Results A total of 8,458 patients, 72.3% female, 27.3% male with mean age 62.1 (SD 13.9) years and mean disease duration of 13.0 (SD 10.9) years were analysed. There were 31,023 individual DAS28 ESR values recorded in the patient group. Of these patients 45.6% were in remission, 17.1% in LDA, 28.1% in MDA and 9.2% in HDA. The percentage of patients in remission increased from 37.4% (2009) to 52.5% (2013) over the 5-year analysis period, with those in MDA falling from 32.7% to 23.5%, with reduction also in LDA from 19.1% to 16.15% and HDA from 10.8% to 7.9%. The use of biologic disease modifying antirheumatic drugs increased from 22.8% to 37.9% over the same time period. Conclusions Serial cross-sectional assessment of this large cohort of Australian RA patients showed significant increases in lower disease activity scores, with more patients in the remission and less in moderate disease activity groups over 5 years. Contemporary management of RA in Australia shows improvement in disease activity targets. Disclosure of Interest G. Littlejohn: None declared, L. Roberts: None declared, P. Bird: None declared, J. de Jager: None declared, H. Griffiths: None declared, D. Nicholls: None declared, J. Young Employee of: Roche Products, Pty. Limited, J. Zochling: None declared, K. Tymms: None declared DOI 10.1136/annrheumdis-2014-eular.4834