POS0307 A PHASE 2 TRIAL OF PERESOLIMAB FOR ADULTS WITH RHEUMATOID ARTHRITIS

BackgroundRemission has become a key target in the management of rheumatoid arthritis (RA) patients[1]. In 2022, American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) has revised the...

Composite indices to assess disease activity in rheumatoid arthritis: need of the hour

The objective of this study was to verify the usefulness of a simple disease activity index (SDAI) for rheumatoid arthritis (RA). The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity [visual analogue scale (VAS) 0-10 cm] and level of C-reactive protein (mg/dl, normal <1 mg/dl). Analysis initially focused on MN301, one of the three phase III clinical trials of leflunomide, in order to assess possible correlations between the SDAI and the Health Assessment Questionnaire (HAQ) and Disease Activity Score 28 (DAS 28). Results were then compared with the other two trials, MN302 and US301. A total of 1839 patients were evaluated. At baseline, 6 and 12 months, the SDAI, DAS 28, American College of Rheumatology (ACR) response criteria and mean HAQ scores were determined for each patient and compared by linear regression for significant correlation. The SDAI was compared qualitatively to the ACR 20% at 3, 6 and 12 months. The index was further validated by comparing the SDAI with survey results obtained from rheumatologists' evaluations of disease activity in test cases. The survey results included defining categorical changes in the SDAI indicating major, minor or no improvement in disease activity in response to treatment. Changes in total Sharp score at 6 and 12 months of treatment were determined for each of these categories of the SDAI and for comparable categories of the DAS 28. The mean SDAI calculated for patients at baseline in study MN301 was 50.06 (range 25.10-96.10) and was, respectively, 50.55 (range 22.10-98.10) and 43.20 (range 12.90-78.20) in studies MN302 and US301. In all three trials, the SDAI was correlated with a high level of statistical significance to the DAS 28 and HAQ scores at baseline, endpoint and change at endpoint. Patients achieving the ACR 20, 50, 70 or 90% response showed proportionate changes in the SDAI. Analysis of surveyed physician responses showed a significant association between the perception of disease activity and the SDAI, as well as changes in the SDAI. Qualitative analysis of radiographic progression at 6 and 12 months for patients showing either major, minor or no improvement of the SDAI showed correspondingly larger increases of the total Sharp score at 12 months. The SDAI is a valid and sensitive assessment of disease activity and treatment response that is comparable with the DAS 28 and ACR response criteria; it is easy to calculate and therefore a viable tool for day-to-day clinical assessment of RA treatment. Overall results indicate that the SDAI has content, criterion and construct validity.

THU0344 DAS-28, SDAI and CDAI in the patients with rheumatoid arthritis and concomitant fibromyalgia

BackgroundRheumatoid arthritis impact of disease (RAID) is a well validated patient reported outcome (PRO) in patients with Rheumatoid Arthritis (RA) [1]. RAID score involves the active participation of patients and...

Background:Remission in rheumatoid arthritis (RA) is a state with an absence of disease activity. Remission at 6 months has been shown to predict future good outcomes such as arresting radiographic...

Rheumatology meeting: Efficacy, safety of biologics central focus

BackgroundA subcutaneous (SC) formulation of infliximab biosimilar CT-P13 is approved in Europe for the treatment of adult patients with rheumatoid arthritis (RA). It may offer improved efficacy versus intravenous (IV) infliximab formulations.MethodsA network meta-regression was conducted using individual patient data from two randomised trials in patients with RA, which compared CT-P13 SC with CT-P13 IV, and CT-P13 IV with reference infliximab IV. In this analysis, CT-P13 SC was compared with CT-P13 IV, reference infliximab IV and pooled data for both reference infliximab IV and CT-P13 IV. Outcomes included changes from baseline in 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI), and rates of remission, low disease activity or clinically meaningful improvement in functional disability per Health Assessment Questionnaire–Disability Index (HAQ-DI).ResultsThe two studies enrolled 949 patients with RA; pooled data for 840 and 751 patients were evaluable at weeks 30 and 54, respectively. For the CT-P13 SC versus pooled IV treatment arm comparison, differences in changes from baseline in DAS28-CRP (− 0.578; 95% confidence interval [CI] − 0.831, − 0.325; p < 0.0001), CDAI (− 3.502; 95% CI − 5.715, − 1.289; p = 0.002) and SDAI (− 4.031; 95% CI − 6.385, − 1.677; p = 0.0008) scores at 30 weeks were statistically significant in favour of CT-P13 SC. From weeks 30 to 54, the magnitude of the differences increased and remained statistically significant in favour of CT-P13 SC. Similar results were observed for the comparison of CT-P13 SC with CT-P13 IV and with reference infliximab IV. Statistically significant differences at week 30 favoured CT-P13 SC over the pooled IV treatment arms for the proportions of patients achieving EULAR-CRP good response, American College of Rheumatology (ACR) 50 and ACR70 responses, DAS28-CRP-defined remission, low disease activity (DAS28-CRP, CDAI and SDAI criteria) and clinically meaningful HAQ-DI improvement.ConclusionsCT-P13 SC was associated with greater improvements in DAS28-CRP, CDAI and SDAI scores and higher rates of clinical response, low disease activity and clinically meaningful improvement in functional disability, compared with CT-P13 IV and reference infliximab IV.Trial registrationEudraCT, 2016-002125-11, registered 1 July 2016; EudraCT 2010-018646-31, registered 23 June 2010.

SAT0137 Disease Activity Measures Associate Differently with Demographics and Comorbidities in Patients with Rheumatoid Arthritis in Routine Practice Settings

BackgroundFatigue is common among patients with rheumatoid arthritis (RA) with a substantial impact on quality of life (1). Biological disease-modifying antirheumatic drugs (bDMARDs) have been shown to significantly improve fatigue...

Objective To compare disease activity score 28 joints DAS28, simplified disease activity index(SDAI) and clinical disease activity index(CDAI) for assessing disease activity in patients with rheumatoid arthritis (RA). Method Total of 423 patients with RA hospiltalized in the department of the first Affiliated Hospital of Anhui Medical University between January 2006 and December 2014 were enrolled in this study.DAS28, CDAI and SDAI were used to evaluate disease activity.According to the classification criteria of RA, patients were divided into three groups: group of remission or low-disease activity, group of moderate-disease activity and high-disease activity. Results ①According to classification criteria of DAS28, the patients in the above three groups were respectivelly accounted for 4.14%(17/423), 38.2%(157/423) and 57.66%(237/423). For CDAI, the ratios were 6.86%(29/423), 29.79%(126/423) and 63.36%(268/423). For SDAI, to ratio were 5.26%(22/423), 32.78%(137/423) and 61.96%(259/423). There were good correlations among CDAI, SDAI and DAS28 (Spearman correlation=0.812, 0.796; both P<0.05), and both CDAI and SDAI had well consistency with DAS28 (Kappa=0.719, 0.740, both P<0.05). ② Correlation analyses showed that CDAI and SDAI were positively correlated with DAS28(r=0.913, 0.912, both P<0.05), and there was a higher positive linear correlation between CDAI and SDAI(r=0.973, P<0.05). ③There was significant difference regarding swollen joint count, tender joint count, healthy assessment questionnaive(HAQ) score, blood platelet count, erythrocyte sedimentation Rate(ESR), C-reaction protein(CRP), rheumatoid factor(RF) among patients with different disease activity(P<0.05). All of the above indexes increased along with the rising disease activity.Serum hemoglobin(HB) levels(P<0.05) decreased along with the rising disease activity.④DAS28, CDAI and SDAI positively correlated with swollen joint count, tender joint count, HAQ score, blood platelet count, ESR, CRP and RF(P<0.05). DAS28, CDAI and SDAI negatively correlated with HB levels(P<0.05). Conclusion CDAI, SDAI and DAS28 have good association and consistency.SDAI and CDAI have better correlations with disease activity in RA. Key words: Rheumatoid arthritis; Disease activity index; Disease activity score 28 joint; Clinical disease activity idex; Simplified disease activity index

BackgroundRemission is a state, not change or transition with absence of disease activity in rheumatoid arthritis (RA) [1]. Remission at 6 months has been shown to predict future good outcomes...

To describe the profile of rheumatoid arthritis (RA) patients treated with infliximab in Canadian routine care and to assess the real-world effectiveness and safety of infliximab. Biologics-naive RA patients from the Biologic Treatment Registry Across Canada were stratified based on their enrollment year. Effectiveness was assessed with the changes in clinical/laboratory parameters and patient-reported outcomes and the achievement of minimal disease activity and remission. Safety was assessed with the incidence of treatment-emergent adverse events (AEs). Among 628 patients, 45.9%, 34.6%, and 19.6% were enrolled between 2002-2005, 2005-2008, and 2008-2011, respectively. Patients recruited in more recent years had significantly lower Disease Activity Score with a 28-joint count using the C-reactive protein level (DAS28-CRP), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), swollen joint count in 28 joints, tender joint count in 28 joints, physician's global assessment of disease activity, patient's global assessment of disease activity, Health Assessment Questionnaire disability index, pain, erythrocyte sedimentation rate, and CRP level (P < 0.01 for all). Patient management also changed with a trend to initiate infliximab after failure of fewer disease-modifying antirheumatic drugs (DMARDs). Six-month treatment with infliximab resulted in statistically significant and clinically important improvements in all disease parameters examined, which were sustained over 36 months. The cumulative probability of achieving remission by 36 months, as defined by the DAS28, SDAI, and CDAI, was 56.2 (95% confidence interval [95% CI] 47.8-64.8), 31.0 (95% CI 23.8-39.8), and 36.2 (95% CI 28.5-45.3), respectively, which was significantly greater in patients with lower baseline disease activity. The profile and incidence of AEs were comparable to data previously reported for tumor necrosis factor α inhibitors. RA patient characteristics at infliximab initiation changed over time toward lower disease activity. Furthermore, a trend to treat patients with fewer DMARDs before initiation of infliximab was observed. However, treatment with infliximab was effective in significantly reducing disease activity independent of the treatment initiation year.

Evaluating disease activity in rheumatoid arthritis: Which composite index is best? A systematic literature analysis of studies comparing the psychometric properties of the DAS, DAS28, SDAI and CDAI

Background:The management of Rheumatoid arthritis (RA) is characterized by a “treat-to-target” approach with regular assessment of disease activity. Therefore, various RA composite disease activity scores have become important tools in...