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Hetland M.L.,Glostrup Hospital | Ostergaard M.,Glostrup Hospital | Ejbjerg B.,Slagelse Hospital | Jacobsen S.,Copenhagen University | And 36 more authors.
Annals of the Rheumatic Diseases | Year: 2012

Objective: To investigate the short-term and long-term efficacy of intra-articular betamethasone injections, and the impact of joint area, repeated injections, MRI pathology, anticyclic citrullinated peptide (CCP) and immunoglobulin M rheumatoid factor (IgM-RF) status in patients with early rheumatoid arthritis (RA). Methods: During 2 years of follow-up in the CIMESTRA trial, 160 patients received intra-articular betamethasone in up to four swollen joints/visit in combination with disease-modifying antirheumatic drugs. Short-term efficacy was assessed by EULAR good response. Long-term efficacy by Kaplan-Meier plots of the joint injection survival (ie, the time between injection and renewed flare). Potential predictors of joint injection survival were tested. Results: 1373 Unique joints (ankles, elbows, knees, metacarpophalangeal (MCP), metatarsophalangeal, proximal interphalangeal (PIP), shoulders, wrists) were injected during 2 years. 531 Joints received a second injection, and 262 a third. At baseline, the median numbers of injections (dose of betamethasone) was 4 (28 mg), declining to 0 (0 mg) at subsequent visits. At weeks 2, 4 and 6, 50.0%, 58.1% and 61.7% had achieved a EULAR good response. After 1 and 2 years, respectively, 62.3% (95% CI 58.1% to 66.9%) and 55.5% (51.1% to 60.3%) of the joints injected at baseline had not relapsed. All joint areas had good 2-year joint injection survival, longest for the PIP joints: 73.7% (79.4% to 95.3%). 2-Year joint injection survival was higher for first injections: 56.6% (53.7% to 59.8%) than for the second: 43.4% (38.4% to 49.0%) and the third: 31.3% (25.0% to 39.3%). Adverse events were mild and transient. A high MRI synovitis score of MCP joints and anti-CCP-negativity were associated with poorer joint injection survival, whereas IgM-RF and C-reactive protein were not. Conclusion: In early RA, intra-articular injections of betamethasone in small and large peripheral joints resulted in rapid, effective and longlasting inflammatory control. The cumulative dose of betamethasone was low, and the injections were well tolerated. Source

Hetland M.L.,Center for Rheumatology and Spine Diseases | Hetland M.L.,Copenhagen University | Jensen D.V.,Center for Rheumatology and Spine Diseases | Krogh N.S.,Zitelab Aps
Clinical and Experimental Rheumatology | Year: 2014

Objective. Advances in aggressive use of conventional synthetic diseasemodifying anti-rheumatic drugs (csDMARDs) as well as biological DMARDs (bDMARDs) have improved the treatment armamentarium for rheumatologists, and modern treatment principles include a treat-to-target (T2T) strategy. However, little is known about the feasibility of a T2T strategy in patients with rheumatoid arthritis (RA) treated in routine care. The aim of the present study was to (i) present the annual number of patients included in DANBIO between 2006 and 2013 and their disease characteristics and (ii) estimate coverage of DANBIO by 2013. Methods. Patients who were registered with RA for the first time in the nationwide Danish DANBIO database between year 2006 and 2013 were included. Baseline characteristics were assessed in patients treated with bDMARDs and csDMARDs, respectively. The fraction of patients with low/ moderate/high disease activity (i.e. DAS28 (CRP-based, 4 variables) was calculated for each calendar year. Results. From 2006-2013 the number of patients increased from 2,395 to 14,249. By 2013, 29.8% of patients were receiving bDMARD. Patients in the csDMARD group were older, had shorter disease duration, lower disease activity, less disability and radiographic damage. By 2013, 19% of csDMARD (15% of bDMARD) patients were in ACR/Boolean remission. Coverage had increased to between 41% and 79% for patients with RA, for the bDMARD group it was 94%. Conclusion. Systematic monitoring of RA patients with real-time feedback to the physician is feasible, although the goal of treat-to-target is not achieved in a substantial proportion of patients in routine care. © Clinical and Experimental Rheumatology 2014. Source

Moller-Bisgaard S.,Copenhagen University | Horslev-Petersen K.,University of Southern Denmark | Ejbjerg B.J.,Copenhagen University | Boesen M.,Copenhagen University | And 6 more authors.
Trials | Year: 2015

Background: Rheumatoid arthritis (RA) is a chronic, progressive joint disease, which frequently leads to irreversible joint deformity and severe functional impairment. Although patients are treated according to existing guidelines and reach clinical remission, erosive progression still occurs. This demonstrates that additional methods for prognostication and monitoring of the disease activity are needed. Bone marrow edema (BME) detected by magnetic resonance imaging (MRI) has proved to be an independent predictor of subsequent radiographic progression. Guiding the treatment based on the presence/absence of BME may therefore be clinically beneficial. We present the design of a randomized controlled trial (RCT) aiming to evaluate whether an MRI-guided treatment strategy compared to a conventional treatment strategy in anti-CCP-positive erosive RA is better to prevent progression of erosive joint damage and increase the remission rate in patients with low disease activity or clinical remission. Methods/design: The study is a non-blinded, multicenter, 2-year RCT with a parallel group design. Two hundred anti-CCP-positive, erosive RA patients characterized by low disease activity or remission, no clinically swollen joints and treatment with synthetic disease-modifying antirheumatic drugs (DMARDs) will be included. Patients will be randomized to either a treatment strategy based on conventional laboratory and clinical examinations (control group) or a treatment strategy based on conventional laboratory and clinical examinations as well as MRI (intervention group). Treatment is intensified according to a predefined treatment algorithm in case of inflammation defined as a disease activity score (DAS28) >3.2 and at least one clinically swollen joint (control and intervention groups) and/or MRI-detected BME (intervention group only). The primary outcome measures are DAS28 remission (DAS28 < 2.6) and radiographic progression (Sharp/vdHeijde score). Discussion: The perspectives, strengths and weaknesses of this study are discussed. Trial registration: The study is registered in http://www.ClinicalTrials.gov identifier: NCT01656278 (5 July 2012). © Møller-Bisgaard et al.; licensee BioMed Central. Source

Egholm C.L.,Copenhagen Center for Arthritis Research | Egholm C.L.,Regional Research Unit | Krogh N.S.,Zitelab Aps | Pincus T.,Rush University Medical Center | And 9 more authors.
Journal of Rheumatology | Year: 2015

Objective. To assess the frequency of discordance in patient's (PtGA) and physician's (PGA) global assessment, and to investigate whether higher discordance in female patients compared with male patients is associated with the physician's sex in patients with rheumatoid arthritis (RA), axial spondy-loarthritis (axSpA), and psoriatic arthritis (PsA). Methods. PtGA, PGA, and other patient-related variables were retrieved from the Danish DANBIO registry, used nationwide to monitor patients with RA, axSpA, and PsA. A questionnaire was sent to all physicians registering in DANBIO (n = 265) regarding individual physician characteristics including sex and age. Discordance was defined as PtGA > 20 mm higher (or lower) than PGA. First encounters between patients and physicians were analyzed using descriptive statistics and mixed model regression analysis. Results. Ninety physicians (34%) returned the questionnaire and were pairwise matched with 10,282 first patient encounters (8300 patients with RA, 524 axSpA, and 1458 PsA). The frequency of discordant (PtGA > PGA) encounters (not including PGA > PtGA seen in < 2%) in RA, axSpA, and PsA was 49.0%, 48.3%, and 56.5%, respectively. Discordance was more common in female patients with high scores on functional disability, pain, and fatigue across the 3 diseases, whereas it was independent of the physician's sex. Conclusion. In this study on Danish patients with RA, axSpA, and PsA, the PtGA was > 20 mm higher than the PGA in about half of the encounters, and more common in female patients of both female and male physicians. This finding highlights one of the challenges in shared decision making. Copyright © 2015. All rights reserved. Source

Glintborg B.,Copenhagen University | Ostergaard M.,Copenhagen Center for Arthritis Research | Ostergaard M.,Copenhagen University | Krogh N.S.,Zitelab Aps | And 10 more authors.
Arthritis and Rheumatism | Year: 2013

Objective To describe the frequency of treatment switching and outcomes among patients with psoriatic arthritis (PsA) who switched tumor necrosis factor α inhibitor (TNFi) agents in routine care. Methods We conducted an observational cohort study based on the Danish nationwide DANBIO registry. Treatment outcomes were evaluated using the American College of Rheumatology criteria for 20% improvement (ACR20)/ACR50/ACR70, European League Against Rheumatism (EULAR) response criteria for good response, and the 28-joint count Disease Activity Score (DAS28) (remission). Kaplan-Meier and regression analyses were used for drug survival analyses and to identify predictors of outcome after treatment switching. Results Of 1,422 patients starting TNFi agents, 548 patients (39%) switched to a second biologic drug during up to 10 years of followup. Median followup was 2.3 years (interquartile range [IQR] 1.0-4.3 years). Switchers were more frequently women (56% versus 45%), had a shorter disease duration (3 versus 4 years), a higher median Health Assessment Questionnaire (HAQ) score (1.1 [IQR 0.6-1.6] versus 0.9 [IQR 0.5-1.4]), DAS28 (4.8 [4.0-5.7] versus 4.4 [3.6-5.2]), pain score on a visual analog scale (VAS) (65 mm [46-77] versus 62 mm [40-75]), and fatigue score on a VAS (69 mm [50-83] versus 64 mm [42-80] mm) (all P < 0.05 at start of first TNFi). During the first and second treatment, HAQ, DAS28, and VAS scores and C-reactive protein levels had decreased after 6 months (all P < 0.05), and median drug survival was 2.2 versus 1.3 years (P < 0.001). Lower fatigue score increased survival of the second TNFi. After switching, the proportions of patients achieving a sustained ACR20, ACR50, ACR70, EULAR good response, and DAS28 remission after 3-6 months were 22% (number needed to treat [NNT] 4.5), 13% (NNT 7.9), 5% (NNT 20), 19% (NNT 5.3), and 34% (NNT 2.9), respectively. Response rates were lower during the second treatment (all P < 0.01 versus first TNFi). At the 2-year visit, 47% of switchers had achieved an ACR20 response. No differences between drug-drug combinations were found. Conclusion Thirty-nine percent of the patients with PsA switched TNFi agents. Response rates and drug survival were lower after switching; however, half of the switchers had an ACR20 response 2 years after starting the first TNFi. Copyright © 2013 by the American College of Rheumatology. Source

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