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Background: Postmenopausal rheumatoid arthritis (RA) patients are at high risk for developing osteoporosis (OP). The most common osteoporotic fractures are vertebral fractures (VFs) due to well-known consequences of VF. Therefore, screening is important. Vertebral Fracture Assessment (VFA) is a convenient technique for routinely screening VFs using the DXA-device (Dual-energy X-ray Absorptiometry). Design and patients: Longitudinal observational single centre study over a period of five years with 96 postmenopausal RA and 57 controls patients (50-80 years of age) which were enrolled in the Rheumatology Department of the University Hospitals Leuven, conducted between February 2016 and April 2018. Main Outcome Measures Prevalence of new VFs as detected by quantitative morphometric and Genant semiquantitative methods. The second purpose is to determine the predictive power of various fracture risk assessment tools which have an effect on the prevalence VF by clinical questionnaires and clinical examination. Results: The prevalence of osteopenia and osteoporosis was 64.58% and 17.7% in RA patients. We observed a slightly lower T-scores and BMD values compared to those without VF. There was no significant difference in T-scores and BMD values of RA patients with VF compared to those without VF. However, FRAX+BMD and FRAX-TBS were significantly higher in the VF patients compared to the patients without VF in the RA cohort. The prevalence of VF was higher in RA patients in comparison with the control group (22.9% vs 19.6%). No significant difference was detected when comparing the RA group with the control group, except that the control group was significantly older and shorter in height (p=0.007, p=0.048). Conclusion: These data suggest that postmenopausal RA patients have a high risk for developing VFs. Therefore, routinely screening is necessary for OP and consequently VFs.

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Objectives The CareRA trial showed that methotrexate (MTX) with a moderate-dose glucocorticoid (GC) remission induction scheme (COBRA Slim) is an effective, safe, low-cost and feasible initial treatment strategy for patients with early rheumatoid arthritis (eRA) regardless of their prognostic profile. Updated EULAR guidelines now suggest the initial use of MTX as the anchor drug in mono-therapy combined with a short-term course of glucocorticoids. However, data on the long-term effects of such treatment strategies are limited. In CareRA plus, patients were followed three additional years after completing the CareRA trial. The main objective was to obtain longitudinal information on the long-term effect of intensive initial treatment strategies. This paper specifically focuses on a subpopulation in CareRA plus. Methods The CareRA plus trial is a 3-year longitudinal observational, multicentre, follow-up of early RA patients after participation in the original CareRA trial. In CareRA, DMARD-inexperienced patients with eRA were stratified into a high-risk or low-risk group based upon a theranostic model. High-risk patients were randomised to a COBRA Classic (MTX + sulfasalazine + prednisone step-down from 60mg), COBRA Slim (MTX + prednisone step-down from 30mg) or COBRA Avant Garde (MTX + leflunomide + prednisone step-down from 30mg) scheme. Low-risk patients were randomised to MTX tight step-up (MTX-TSU) or COBRA Slim. During CareRA plus, patients were followed-up for three additional years. The primary outcomes were the proportion of patients in remission at M36, patient functionality and safety profile. Secondary outcomes were the number of treatment adjustments, radiographic evolution and work status at M36. Results Data from 21 Classic, 24 Slim (high-risk), 29 Avant Garde, 8 Slim (low-risk) and 8 MTX-TSU patients of the University Hospitals Leuven were analysed. Remission at M36, according to DAS28(CRP)-score, was achieved in 76.2%, 63.6% and 63.0% of COBRA Classic, COBRA Slim (high-risk) and COBRA Avant Garde patients respectively (p= 0.573); and in 75.0% and 100.0% of COBRA Slim (low-risk) and MTX-TSU patients respectively (p=0.186). Remission according to CDAI- and SDAI-scores showed proportionally similar results. In the high risk group, there was no significant difference in the proportion of patients with therapy-related adverse events between the treatment arms (p=0.139). The number of patients with therapy-related adverse events in the low-risk group was equal (p=0.693). At M36, the mean dose of MTX per patient was higher for COBRA Classic patients (13.9mg vs. 10.6mg for COBRA Slim patients and 11.0mg for COBRA Avant Garde patients). During CareRA plus, 10 patients initiated 13 biologicals and 28.9% of all patients was intermittently treated with GCs. At M36, 18.9% of all patients was using a biological. Conclusions For high-risk patients, COBRA Classic showed numerically better remission rates at M36. Temporal trends on disease activity during CareRA plus do not suggest a long-term benefit for any treatment arm. Safety profile during CareRA plus was not in favour for any treatment arm. In low-risk patients, MTX-TSU showed numerically better remission rates at M36. Safety profile was comparable for all low-risk patients. This is a preliminary analysis of CareRA plus based on part of the data, which needs to be confirmed on the complete dataset.