BACKGROUND:Cognitive dysfunction (CD) is among the most common neuropsychiatric manifestations of systemic lupus erythematosus (SLE). There are two methods which have been used to detect CD in patients with SLE: traditional neuropsychological tests (NPT) and the Automated Neuropsychological Assessment Metrics (ANAM). Both are time-consuming and neither is readily available for screening purposes.PURPOSE:The aim of our study was to evaluate the Montreal Cognitive Assessment (MoCA) test as a screening tool for detection of CD in SLE. Methods. SLE patients fulfilling ACR criteria were administered the ANAM, a computerized test battery which measures various cognitive domains and the MoCA, a one-page, performance-based screening test designed to detect mild cognitive impairment in the elderly. With the ANAM as the gold standard, the performance characteristics of the MoCA were assessed.RESULTS:In total, 44 patients were evaluated. Of these, 11 (25%) were identified by the ANAM as being impaired in comparison with 13 (29.5%) by the MoCA. The scores were significantly correlated (r = 0.57, p < 0.001). Using the standard cutoff of 26, the sensitivity of MoCA was 83% and specificity 73%.CONCLUSION:The MoCA appears to be a promising screening tool for the detection of CD in SLE both for epidemiologic studies and for routine clinical care.

Background: In Japan, more than 20 rheumatoid arthritis (RA) patients died of interstitial pneumonia (IP) caused by leflunomide (LEF) were reported, but many of them were considered as the victims of opportunistic infection currently. In this paper, efficacy and safety of low-dose LEF classified by body weight (BW) were studied. Methods: Fifty-nine RA patients were started to administrate LEF from July 2007 to July 2009. Among them, 25 patients were excluded because of the combination with tacrolimus, and medication modification within 3 months before LEF. Remaining 34 RA patients administered 20 to 50 mg/week of LEF were followed up for 1 year and enrolled in this study. Dose of LEF was classified by BW (50 mg/week for over 50 kg, 40 mg/week for 40 to 50 kg and 20 to 30 mg/week for under 40 kg). The average age and RA duration of enrolled patients were 55.5 years old and 10.2 years. Prednisolone (PSL), methotrexate (MTX) and etanercept were used in 23, 28 and 2 patients, respectively. In case of insufficient response or adverse effect, dosage change or discontinuance of LEF were considered. Failure was defined as dosages up of PSL and MTX, or dosages down or discontinuance of LEF. Last observation carried forward method was used for the evaluation of failed patients at 1 year. Results: At 1 year after LEF start, good/ moderate/ no response assessed by the European League Against Rheumatism (EULAR) response criteria using Disease Activity Score, including a 28-joint count (DAS28)-C reactive protein (CRP) were showed in 14/ 10/ 10 patients, respectively. The dosage changes of LEF at 1 year were dosage up: 10, same dosage: 5, dosage down: 8 and discontinuance: 11 patients. The survival rate of patients in this study was 23.5% (24 patients failed) but actual LEF continuous rate was 67.6% (11 patients discontinued) at 1 year. The major reason of failure was liver dysfunction, and pneumocystis pneumonia was occurred in 1 patient resulted in full recovery. One patient died of sepsis caused by decubitus ulcer infection. DAS28-CRP score was decreased from 3.9 to 2.7 significantly. Although CRP was decreased from 1.50 to 0.93 mg/dl, it wasn’t significant. Matrix metalloproteinase (MMP)-3 was decreased from 220.0 to 174.2 ng/ml significantly. Glutamate pyruvate transaminase (GPT) was increased from 19 to 35 U/l and number of leukocyte was decreased from 7832 to 6271 significantly. DAS28-CRP, CRP, and MMP-3 were improved significantly with MTX, although they weren’t without MTX. Increase of GPT and leukopenia were seen significantly with MTX, although they weren’t without MTX. Conclusions: It was reported that the risks of IP caused by LEF in Japanese RA patients were past IP history, loading dose administration and low BW. Addition of low-dose LEF is a potent safe alternative for the patients showing unsatisfactory response to current medicines, but need to pay attention for liver function and infection caused by leukopenia, especially with MTX. Disclosure statement: The authors have declared no conflicts of interest.

Objective: To evaluate the safety and efficacy of abatacept during 2 years of the ATTAIN ( A batacept T rial in T reatment of A nti-TNF IN adequate responders) trial in patients with rheumatoid arthritis. Methods: Patients completing the 6-month, double-blind period were eligible to enter the long-term extension; patients received abatacept ∼10 mg/kg, plus disease-modifying antirheumatic drugs. Safety and efficacy (American College of Rheumatology (ACR) criteria responses, DAS28 (C-reactive protein), HAQ-DI, SF-36, Medical Outcomes Study Sleep Problems Index, fatigue VAS) were assessed through 2 years. Results: 317 patients (218 from the abatacept and 99 from the placebo group) entered and 222 (70%) completed 18 months of long-term extension treatment. The incidence and type of adverse events were consistent between the double-blind and cumulative (double-blind plus long-term extension) periods. Rates of serious adverse events were 25.6 and 23.4 per 100 patient-years in the double-blind versus cumulative period. At 6 months and 2 years, using non-responder analyses, ACR responses in abatacept-treated patients were: ACR 20, 59.4% and 56.2%; ACR 50, 23.5% and 33.2%; ACR 70, 11.5% and 16.1%; HAQ-DI responses were 54.4% and 47.9%. At 6 months and 2 years, using post-hoc as-observed analyses, the percentage of patients (95% confidence interval) achieving DAS28 (C-reactive protein) low disease activity score (⩽3.2) and DAS28 (C-reactive protein)-defined remission (<2.6) increased from 18.3% (13.0, 23.5) to 32.0% (24.6, 39.4) and 11.1% (6.8, 15.3) to 20.3% (13.9, 26.6). Clinically meaningful improvements in SF-36, pain, fatigue and sleep problems were also maintained throughout the 2 years of abatacept treatment. Conclusion: No unique safety observations were reported during open-label exposure. Improvements in the signs and symptoms of rheumatoid arthritis, physical function and health-related quality of life observed after 6 months, were maintained throughout the 2 years in this population with difficult-to-treat disease. Trial registration number: NCT00124982.

Response to disease modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA) is often heterogeneous. We aimed to identify types of disease activity trajectories following the initiation of a new biologic DMARD (bDMARD).Pooled analysis of nine national registries of patients with diagnosis of RA, who initiated Abatacept and had at least two measures of disease activity (DAS28). We used growth mixture models to identify groups of patients with similar courses of treatment response, and examined these patients' characteristics and effectiveness outcomes.We identified three types of treatment response trajectories: ‘gradual responders’ (GR; 3576 patients, 91·7%) had a baseline mean DAS28 of 4·1 and progressive improvement over time; ‘rapid responders’ (RR; 219 patients, 5·6%) had higher baseline DAS28 and rapid improvement in disease activity; ‘inadequate responders’ (IR; 103 patients, 2·6%) had high DAS28 at baseline (5·1) and progressive worsening in disease activity. They were similar in baseline characteristics. Drug discontinuation for ineffectiveness was shorter among inadequate responders (p = 0.03), and EULAR good or moderate responses at 1 year was much higher among ‘rapid responders’ (p < 0.001).Clinical information and baseline clinical characteristics do not allow a reliable prediction of which trajectory the patients will follow after bDMARD initiation.

Purpose: Determine the effect of HCQ use on incidence of diabetes in an RA cohort. Methods: RA history, comorbid conditions, height, weight, medication use, and functional status were obtained by self-report in RA subjects with Health Assessment Questionnaires (HAQ) semiannually over 20 years. DM was defined by newly reported disease or use of DM medications. Patients were observed (OBS) from study entry date or start date for HCQ use, whichever was later. Using Cox proportional hazards analysis, the effect of HCQ on risk of developing DM was determined. Covariates tested in univariate analysis were sex, age at entry, race, years of education, maximum body-mass index (maxBMI), RA duration at entry, ever use and # of questionnaire phases of prednisone (Pred) and methotrexate (MTX) use, and disability score. Variables associated with DM risk at p<0.10 in univariate analysis were included in the multivariable model where all were tested at p<0.05. Results: Of 4905 RA patients without DM at entry,1808 (37%) reported HCQ use (+HCQ) at some time during OBS (total OBS= 29,677 person-years); 3.0% +HCQ developed DM, with mean OBS 5.7 yr, compared with 5.5% of those never exposed (0HCQ), mean OBS 6.2 yr. At entry, the +HCQ group was younger (53.7 v 58.2 yr), more educated (13.3 v 12.6 yr), more likely female (80.4 v 75.0%) and had shorter RA duration (8.4 v 13.0 yr), p<0.001 for all comparisons; maxBMI (28.0 v 27.7) was comparable in the two groups. More +HCQ patients took Pred (72.0 v 58.5%, p<0.001) and MTX (64.1 v 49.5%, p<0.001) at least for one phase during OBS. Both time (# phases) on Pred and on MTX were greater in the +HCQ group after adjusting for OBS duration (p<0.001). In multivariable analysis, significant predictors of DM were 0HCQ, greater age at entry, lower education level, noncaucasian race, and greater maxBMI; sex, disability score, Pred use, and MTX use were not associated with incident DM. After adjusting for significant predictors, the HR for incident DM in +HCQ was 0.67 (95%CI, 0.48-0.93), a reduction in risk of one-third compared to 0HCQ. Conclusion: Hydroxychloroquine use in RA appears to protect against incident diabetes, a traditional risk factor for CV disease, after adjusting for other predictors, including maximum BMI. However, disability score and use of prednisone and MTX had no effect on risk, perhaps due to the interrelationship between maxBMI and these variables. While effects on synovitis are modest, this drug may be an important component of longterm RA therapy to reduce the health burden of comorbid conditions. Disclosures: M. Wasko, None.