Baseline In DAS28 Research Articles

AB0316 Patient’s global assessment of general health by vas at baseline predicts ACR/EULAR remission after 3, 6 and 12 month’s of efficient treatment in DMARD- and steroid naÏve early rheumatoid arthritis patients. The danish cimestra-study

BackgroundAt the time of diagnosis, easy-to-use and cost-effective predictors of remission are needed in rheumatoid arthritis (RA) to improve patient care.ObjectivesDuring one year of efficient treatment aiming for remission (1)...

THU0095 Early response to abatacept plus MTX in MTX-IR RA patients using power doppler ultrasonography: An open-label study

BackgroundThe global power Doppler ultrasound (PDUS) scoring system combining synovial hypertrophy, joint effusion and PD signal developed by the OMERACT-EULAR-US Task Force has good intra- and inter-observer reliability in metacarpophalangeal...

SAT0492 Treatment Effects Measured by Dynamic Contrast Enhanced MRI and Ramris for Rheumatoid Arthritis

BackgroundSensitive imaging biomarkers are needed to complement clinical measures for development of drugs for rheumatoid arthritis (RA).ObjectivesIn this double-blind randomized methodology study, Dynamic Contrast Enhanced (DCE)-MRI and RA MRI Score...

AB0510 Monitoring disease activity and response through power doppler ultrasonography in rheumatoid arthritis patients treated with rituximab – correlations with antibodies pannel

BackgroundRituximab is a a chimeric anti-CD20 monoclonal antibody approved to reduce the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) in patients with inadequate response to first...

FRI0181 Sirukumab, a human anti-IL-6 monoclonal antibody, improves physical function in patients with active ra despite methotrexate therapy: Results from a 2-part, proof-of-concept, dose-ranging, randomized, double-blind, placebo-controlled, phase 2 study

BackgroundSirukumab (formerly named CNTO136) is a human mAb that binds with high affinity to the cytokine IL-6. In the proof of concept part (Part A) of this multicenter, randomized, double...

SAT0010 Generalization and Extrapolation of Treatment Effects from Clinical Studies in Rheumatoid Arthritis

BackgroundRandomized clinical trials (RCTs) are accepted as the ‘gold standard’ to evaluate the efficacy/effectiveness of treatment. However, generalizing results from RCTs to daily practice poses a challenge with treatment effectiveness...

AB0467 Rapid achievement of remission with certolizumab pegol was maintained for one year: interim results from fast, a german non-interventional study in rheumatoid arthritis real life patients

BackgroundCertolizumab pegol (CZP) demonstrated a fast response and acceptable safety profile in clinical studies in rheumatoid arthritis (RA).1-3ObjectivesTo assess use of CZP in daily clinical practice in Germany.MethodsThe efficacy and...

FRI0200 Relative effectiveness of rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis and an inadequate response to a single previous TNF inhibitor: Results from switch-RA, a global, comparative-effectiveness, observational study

BackgroundRecent studies indicate that RA patients (pts) with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi) may achieve greater clinical benefit from switching to rituximab (RTX) than...

Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial

Roughly a third of patients with rheumatoid arthritis treated with biological treatments receive them as monotherapy. Tocilizumab--an inhibitor of interleukin 6 receptor signalling--has been studied as monotherapy in several clinical trials. We assessed the efficacy and safety of tocilizumab monotherapy compared with adalimumab monotherapy for patients with rheumatoid arthritis. We did this randomised, double-blind, parallel-group, phase 4 superiority study in 76 centres in 15 countries in North and South America, Australasia, and Europe. We enrolled patients who were aged at least 18 years, had severe rheumatoid arthritis for 6 months or more, and were intolerant to methotrexate or were inappropriate for continued methotrexate treatment. Patients were randomly assigned (1:1; block size of four) to receive tocilizumab 8 mg per kg bodyweight intravenously every 4 weeks plus placebo subcutaneously every 2 weeks or adalimumab 40 mg subcutaneously every 2 weeks plus placebo intravenously every 4 weeks for 24 weeks. Investigators, patients, and sponsor personnel were masked to assignment. The primary endpoint was change in disease activity score using 28 joints (DAS28) from baseline to week 24. This trial is registered with ClinicalTrials.gov, number NCT01119859. We screened 452 patients and enrolled 326 patients. The intention-to-treat population contained 325 patients (163 assigned to tocilizumab, 162 assigned to adalimumab). Week 24 mean change from baseline in DAS28 was significantly greater in the tocilizumab group (-3·3) than in the adalimumab group (-1·8) patients (difference -1·5, 95% CI -1·8 to -1·1; p<0·0001). 16 of 162 (10%) patients in the adalimumab group versus 19 of 162 (12%) in the tocilizumab group had serious adverse events. More patients in the tocilizumab group than in the adalimumab group had increased LDL-cholesterol, increased alanine aminotransferase concentrations, and reduced platelet and neutrophil counts. Tocilizumab monotherapy was superior to adalimumab monotherapy for reduction of signs and symptoms of rheumatoid arthritis in patients for whom methotrexate was deemed inappropriate. The adverse event profiles of tocilizumab and adalimumab were consistent with previous findings. F Hoffmann-La Roche.

Safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of the monoclonal antibody ASK8007 blocking osteopontin in patients with rheumatoid arthritis: a randomised, placebo controlled, proof-of-concept study

ObjectivesOsteopontin is an extracellular matrix protein with diverse immunomodulatory functions. The authors assessed the safety, tolerability, pharmacokinetics, pharmacodynamics and initial efficacy of the humanised monoclonal antibody ASK8007, which blocks osteopontin.MethodsIn...

Effectiveness of a Third Tumor Necrosis Factor-α-blocking Agent Compared with Rituximab After Failure of 2 TNF-blocking Agents in Rheumatoid Arthritis

To compare the effectiveness of a third tumor necrosis factor-α (TNF-α)-blocking agent with rituximab after failure of 2 TNF-blocking agents in patients with rheumatoid arthritis (RA) in daily clinical practice. Patients receiving a third TNF-blocking agent or rituximab after failure of 2 TNF-blocking agents were selected from a Dutch biologic registry. The primary outcome was the results from the Disease Activity Score of 28 joints (DAS28) over the first 12 months after start of the third biologic using mixed-model analyses. Secondary outcomes included the course of the Health Assessment Questionnaire (HAQ) and the separate components of the DAS28 over the first 12 months and the change from baseline in DAS28 and HAQ at 3 and 6 months. The overall course of the DAS28 over the first 12 months was significantly better for rituximab (p = 0.0044), as also observed for the HAQ, although the latter results were not statistically significant (p = 0.0537). The erythrocyte sedimentation rates, C-reactive protein, and swollen joint counts showed a better course for rituximab (p = 0.0008, p = 0.0287, p = 0.0547, respectively), but not the tender joint counts or visual analog scale for general health. DAS28 decreased significantly in both groups at 3 and 6 months (p ≤ 0.024), but the change in HAQ was significant for rituximab only at 3 months (p = 0.009). During the first 12 months of therapy, a larger improvement in disease activity and a trend toward a larger decrease in functional disability was observed in patients receiving rituximab. Switching to a biologic with another mechanism of action might be more effective after failure of 2 TNF-blocking agents in RA.