Désirée van der Heijde

Leiden University Medical Centre, Leyden, South Holland, Netherlands

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Publications (564)3356.36 Total impact

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    ABSTRACT: The "Discrimination" part of the OMERACT Filter asks whether a measure discriminates between situations that are of interest. "Feasibility" in the OMERACT Filter encompasses the practical considerations of using an instrument, including its ease of use, time to complete, monetary costs, and interpretability of the question(s) included in the instrument. Both the Discrimination and Reliability parts of the filter have been helpful but were agreed on primarily by consensus of OMERACT participants rather than through explicit evidence-based guidelines. In Filter 2.0 we wanted to improve this definition and provide specific guidance and advice to participants.
    The Journal of Rheumatology 04/2014; · 3.26 Impact Factor
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    ABSTRACT: The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter requires that criteria be met to demonstrate that the outcome instrument meets the criteria for content, face, and construct validity. Discussion groups critically reviewed a variety of ways in which case studies of current OMERACT Working Groups complied with the Truth component of the Filter and what issues remained to be resolved. The case studies showed that there is broad agreement on criteria for meeting the Truth criteria through demonstration of content, face, and construct validity; however, several issues were identified that the Filter Working Group will need to address. These issues will require resolution to reach consensus on how Truth will be assessed for the proposed Filter 2.0 framework, for instruments to be endorsed by OMERACT.
    The Journal of Rheumatology 04/2014; · 3.26 Impact Factor
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    ABSTRACT: To establish reference intervals (RIs) for spinal mobility measures as recommended for patients with axial spondyloarthritis, and to determine the effect of age, height and gender on spinal mobility, in normal individuals. A cross-sectional study (MOBILITY) was conducted among normal individuals aged 20-69 years. Recruitment was stratified by gender, age (10-year categories) and height (10 cm categories). Eleven spinal mobility measures were assessed. Age specific RIs and percentiles were derived for each measure. 393 volunteers were included. All spinal mobility measures decreased with increasing age. Therefore, age specific RIs were developed. The 95% RIs (2.5th and 97.5th percentiles), as well as the 5th, 10th, 25th, 50th, 75th and 90th percentiles for each spinal mobility measure and different ages are presented. Mobility percentile curves were also plotted for each of the measures. For instance, the 95% RI for lateral spinal flexion was 16.2-28.0 cm for a 25-year-old subject, 13.2-25.0 cm for a 45-year-old subject and 10.1-21.9 cm for a 65-year-old subject. After adjustment for age, there was no need for gender specific RIs, while RIs of some measures are height-adjusted. Age specific RIs and percentiles were derived for each of the spinal mobility measures for normal individuals. These may guide clinicians when assessing the mobility of patients with axial spondyloarthritis. The RIs may serve as cut-off levels for 'normal' versus 'abnormal', whereas the mobility percentile curves may be used to assess the level of mobility of patients with axial spondyloarthritis.
    Annals of the rheumatic diseases 03/2014; · 8.11 Impact Factor
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    ABSTRACT: The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter presupposes an explicit framework for identifying the relevant core outcomes that are universal to all studies of the effects of intervention effects. There is no published outline for instrument choice or development that is aimed at measuring outcome, was derived from broad consensus over its underlying philosophy, or includes a structured and documented critique. Therefore, a new proposal for defining core areas of measurement ("Filter 2.0 Core Areas of Measurement") was presented at OMERACT 11 to explore areas of consensus and to consider whether already endorsed core outcome sets fit into this newly proposed framework. Discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed framework, whether these observations had a more general application, and what issues remained to be resolved. Although there was broad acceptance of the framework in general, several important areas of construction, presentation, and clarity of the framework were questioned. The discussion groups and subsequent feedback highlighted 20 such issues. These issues will require resolution to reach consensus on accepting the proposed Filter 2.0 framework of Core Areas as the basis for the selection of Core Outcome Domains and hence appropriate Core Outcome Sets for clinical trials.
    The Journal of Rheumatology 03/2014; · 3.26 Impact Factor
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    ABSTRACT: To compare the efficacy of etanercept (ETN) and methotrexate (MTX) versus MTX monotherapy for remission induction in patients with early inflammatory arthritis. In a 78-week multicentre randomised placebo-controlled superiority trial, 110 DMARD-naïve patients with early clinical synovitis (≥1 tender and swollen joint, and within 3 months of diagnosis) and either rheumatoid factor, anticitrullinated protein antibodies or shared epitope positive were randomised 1:1 to receive MTX+ETN or MTX+placebo (PBO) for 52 weeks. Injections (ETN or PBO) were stopped in all patients at week 52. In those with no tender or swollen joints (NTSJ) for >26 weeks, injections were stopped early. If patients had NTSJ >12 weeks after stopping the injections, MTX was weaned. The primary endpoint was NTSJ at week 52. No statistically significant difference was seen for the primary endpoint (NTSJ at week 52 (32.5% vs 28.1% [adjusted OR 1.32 (0.56 to 3.09), p=0.522]) in the MTX+ETN and MTX+PBO groups, respectively). The secondary endpoints did not differ between groups at week 52 or 78. Exploratory analyses showed a higher proportions of patients with DAS28-CRP<2.6 in the MTX+ETN group at week 2 (38.5% vs 9.2%, adjusted OR 8.87 (2.53 to 31.17), p=0.001) and week 12 (65.1% vs 43.8%, adjusted OR 2.49 (1.12 to 5.54), p=0.026). In this group of patients with early inflammatory arthritis, almost a third had no tender, swollen joints after 1 year. MTX+ETN was not superior to MTX monotherapy in achieving this outcome. Clinical responses, however, including DAS28-CRP<2.6, were achieved earlier with MTX+ETN combination therapy. The EMPIRE trial is registered on the following trial registries: Eudract-2005-005467-29; ISRCTN 55428162 (http://www.controlled-trials.com/ISRCTN55428162/EMPIRE). The full trial protocol can be obtained from the corresponding author.
    Annals of the rheumatic diseases 03/2014; · 8.11 Impact Factor
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    ABSTRACT: To evaluate the presence of spinal inflammation with and without sacroiliac (SI) joint inflammation on magnetic resonance imaging (MRI) in patients with active nonradiographic axial spondyloarthritis (SpA), and to compare the disease characteristics of these subgroups. ABILITY-1 is a multicenter, randomized, controlled trial of adalimumab versus placebo in patients with nonradiographic axial SpA classified using the Assessment of SpondyloArthritis international Society axial SpA criteria. Baseline MRIs were centrally scored independently by 2 readers using the Spondyloarthritis Research Consortium of Canada (SPARCC) method for the SI joints and the SPARCC 6-discovertebral unit method for the spine. Positive evidence of inflammation on MRI was defined as a SPARCC score of ≥2 for either the SI joints or the spine. Among patients with baseline SPARCC scores, 40% had an SI joint score of ≥2 and 52% had a spine score of ≥2. Forty-nine percent of patients with baseline SI joint scores of <2, and 58% of those with baseline SI joint scores of ≥2, had a spine score of ≥2. Comparison of baseline disease characteristics by baseline SI joint and spine scores showed that a greater proportion of patients in the subgroup with a baseline SPARCC score of ≥2 for both SI joints and spine were male, and patients with spine and SI joint scores of <2 were younger and had shorter symptom duration. SPARCC spine scores correlated with baseline symptom duration, and SI joint scores correlated negatively with the baseline Bath Ankylosing Spondylitis Disease Activity Index, but neither correlated with the baseline Ankylosing Spondylitis Disease Activity Score, total back pain, the patient's global assessment of disease activity, the Bath Ankylosing Spondylitis Functional Index, morning stiffness, nocturnal pain, or C-reactive protein level. Assessment by experienced readers showed that spinal inflammation on MRI might be observed in half of patients with nonradiographic axial SpA without SI joint inflammation.
    Arthritis & rheumatology (Hoboken, N.J.). 03/2014; 66(3):667-73.
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    ABSTRACT: The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting, and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient-centered or disease-centered variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondyloarthritis, and knee osteoarthritis were then evaluated using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure. Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0.
    The Journal of Rheumatology 03/2014; · 3.26 Impact Factor
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    ABSTRACT: Objectives. The objectives of this study were to characterize patients with predominantly axial SpA who received SSZ as their first DMARD, compare the response to treatment in patients with and without peripheral disease and identify predictors of discontinuation of SSZ. We also investigated response to TNF inhibitor (TNFi) after SSZ failure.Methods. We included DMARD-naive patients with predominantly axial SpA starting SSZ or TNFi treatment from a Norwegian, multicentre longitudinal observational study (NOR-DMARD). In patients starting SSZ, we compared the 3-month responses between patients with and without swollen joints and identified predictors of discontinuation by Cox regression analysis. Sixty-six SSZ-treated patients later switched to a TNFi, and we compared their 3-month responses and drug survival to patients starting a TNFi as their first DMARD.Results. Patients receiving SSZ (n = 181) as their first DMARD had shorter disease duration, were more frequently female and had more swollen joints than those starting TNFi (n = 543). There was a trend toward better 3-month responses to SSZ in patients with peripheral joint swelling, and they had significantly better 3-year drug survival than patients without swollen joints at baseline. Predictors of SSZ discontinuation were no peripheral joint swelling, higher CRP and higher BASDAI back pain score. TNFi response was similar in patients previously treated with SSZ, as in DMARD-naive patients.Conclusion. Our findings support current recommendations of SSZ as an optional treatment in SpA patients with peripheral disease, although overall responses were modest. Initial treatment with SSZ does not seem to impair later TNFi response.
    Rheumatology (Oxford, England) 02/2014; · 4.24 Impact Factor
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    ABSTRACT: Osteoarthritis (OA) is one of the most common musculoskeletal disorders, frequently affecting the hands. In the last decade there has been increased awareness concerning this disorder because of its clinical burden. Unfortunately, only limited treatments for symptom alleviation are available, and no effective treatment for disease modification exists. The lack of treatment is due not only to a lack of understanding of the disease process, but also to poor outcome measures to assess the condition. The OMERACT Hand OA Special Interest Group (SIG) has started to develop a core set of outcome measures for hand OA clinical trials, observational studies, and clinical record keeping. At OMERACT 11, results from a Delphi exercise were presented, and a preliminary set of core domains was discussed. The group attempted to adopt the new OMERACT Filter 2.0 in the process, and literature overviews of conventional radiographs, ultrasonography, and magnetic resonance imaging as outcome measures in hand OA were presented. Discussions that followed highlighted further suggestions for core domains, the heterogeneity of hand OA, and future research priorities.
    The Journal of Rheumatology 01/2014; · 3.26 Impact Factor
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    ABSTRACT: To evaluate the potential incremental value in detecting sacroiliitis of the T1 post-gadolinium diethylenetriaminepenta-acetic acid (Gd-DTPA) MRI sequence of the sacroiliac joints (SIJ) compared with the combination of short tau inversion recovery (STIR) MRI sequence and pelvic radiographs in patients with inflammatory back pain (IBP) suspected for axial spondyloarthritis. A 2-year follow-up study was conducted in patients with IBP of less than 2 years duration. Annual MRI of the SIJ (MRI-SIJ) was performed and scored for bone marrow oedema (BME). Pelvic radiographs were scored according to the modified New York (mNY) criteria. Agreement on the presence of BME detected by the STIR and post-Gd-DTPA sequence and the incremental value of post-Gd-DTPA sequence over STIR plus radiographs was analysed by descriptive methods and kappa statistics. At baseline, 20 (29%) out of 68 patients (38% male; mean (SD) age 34.9 (10.3) years) enrolled had BME both on the STIR and post-Gd-DTPA sequences; 4 patients (6%) on the STIR sequence only; none on the post-Gd-DTPA sequence only (kappa value: 0.87). Fifteen (22%) patients fulfilled the mNY criteria at baseline. Sixty-two (91%) patients had at least 1 follow-up MRI-SIJ. At 2-year follow-up, 2 patients had BME on the post-Gd-DTPA sequence without BME on the STIR sequence. These 2 patients already fulfilled the mNY criteria at baseline. In this cohort of patients with early IBP, the post-Gd-DTPA sequence of the MRI-SIJ did not have an incremental value in the detection of sacroiliitis compared with the STIR sequence plus pelvic radiographs.
    Clinical and experimental rheumatology 01/2014; · 2.66 Impact Factor
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    ABSTRACT: To update the evidence for the safety of synthetic disease-modifying antirheumatic drugs (sDMARDs), glucocorticoids (GC) and biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism (EULAR) recommendations for the management of RA. Systematic literature review (SLR) of observational studies (including registries). Interventions were any bDMARD (anakinra, infliximab, etanercept, adalimumab, rituximab, abatacept, tocilizumab, golimumab or certolizumab pegol) or sDMARD (methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, gold/auranofin, azathioprine, chlorambucil, chloroquine, cyclosporin, cyclophosphamide, mycophenolate, minocycline, penicillamine, tacrolimus or tofacitinib) and a comparator was required. Information on GCs was collected from the included studies. All safety outcomes were included. Forty-nine observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria. Substantial heterogeneity precluded meta-analysis of any of the outcomes. Patients on tumour necrosis factor inhibitors (TNFi) compared to patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1-1.8), a higher risk of tuberculosis, and an increased risk of infection by herpes zoster cannot be excluded. Patients on TNFi did not have an increased risk for malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5). From the studies identified on conventional sDMARDs, no new safety signals were found. The findings from this SLR confirm the known safety pattern of sDMARDs and bDMARDs for the treatment of RA.
    Annals of the rheumatic diseases 01/2014; · 8.11 Impact Factor
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    ABSTRACT: The burden of disease in patients with ankylosing spondylitis (AS) can be considerable. However, no agreement has been reached among expert members of Assessment of SpondyloArthritis International Society (ASAS) to define severity of AS. Based on the International Classification of Functioning, Disability and Health (ICF), a core set of items for AS has been selected to represent the entire spectrum of possible problems in functioning. Based on this, the objective of this study was to develop a tool to quantify health in AS, the ASAS Health Index. First, based on a literature search, experts' and patients' opinion, a large item pool covering the categories of the ICF core set was generated. In several steps this item pool was reduced based on reliability, Rasch analysis and consensus building after two cross-sectional surveys to come up with the best fitting items representing most categories of the ICF core set for AS. After the first survey with 1754 patients, the item pool of 251 items was reduced to 82. After selection by an expert committee, 50 items remained which were tested in a second cross-sectional survey. The results were used to reduce the number of items to a final set of 17 items. This selection showed the best reliability and fit to the Rasch model, no residual correlation, and absence of consistent differential item function and a Person Separation Index of 0.82. In this long sequential study, 17 items which cover most of the ICF core set were identified that showed the best representation of the health status of patients with AS. The ASAS Health Index is a linear composite measure which differs from other measures in the public domain.
    Annals of the rheumatic diseases 01/2014; · 8.11 Impact Factor
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    ABSTRACT: The Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis (SpA) allows classification of patients with ('imaging' arm) and without ('clinical' arm) imaging abnormalities of the sacroiliac joints. To compare the phenotype of early axial SpA with regard to the two arms of the ASAS axial SpA criteria. Demographics, clinical and biological features of SpA, disease activity, severity parameters, and imaging abnormalities at the sacroiliac and spine levels were compared, in the two arms of the ASAS axial SpA criteria, in the patients of the French cohort of early SpA. Of the 615 patients analysed, 435 (70.7%) met the ASAS criteria (262 (60.2%) and 173 (39.8%) in the imaging and clinical arms, respectively). There were no major differences in the characteristics of the two groups except that those in the imaging arm were more likely to be younger, male and have higher concentrations of C-reactive protein. Imaging abnormalities other than those meeting the ASAS criteria for the imaging arm (ie, x-ray-determined structural damage or MRI-revealed inflammatory changes in the sacroiliac joint (SIJ)) were observed (MRI-SIJ structural damage (55.0% vs 3.5%), MRI-spine inflammatory changes (35.1% vs 12.9%), MRI-spine structural damage (10.3% vs 5.3%) and x-ray-syndesmophytes (11.8% vs 5.3%)) in the imaging versus clinical arm, respectively. Our study confirms the external validity of the clinical arm of the ASAS criteria. It is notable that many patients in the clinical arm showed other imaging changes in SIJs and spine.
    Annals of the rheumatic diseases 01/2014; · 8.11 Impact Factor
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    ABSTRACT: MRI is increasingly used to measure inflammation in rheumatoid arthritis (RA) research, but the correlation to clinical assessment is unexplored. This study determined the association and concordance between inflammation of small joints measured with MRI and physical examination. 179 patients with early arthritis underwent a 68 tender joint count and 66 swollen joint count and 1.5T MRI of MCP (2-5), wrist and MTP (1-5) joints at the most painful side. Two readers scored synovitis and bone marrow oedema (BME) according to the OMERACT RA MRI scoring method and assessed tenosynovitis. The MRI data were first analysed continuously and then dichotomised to analyse the concordance with inflammation at joint examination. 1790 joints of 179 patients were studied. Synovitis and tenosynovitis on MRI were independently associated with clinical swelling, in contrast to BME. In 86% of the swollen MCP joints and in 92% of the swollen wrist joints any inflammation on MRI was present. In 27% of the non-swollen MCP joints and in 66% of the non-swollen wrist joints any MRI inflammation was present. Vice versa, of all MCP, wrist and MTP joints with inflammation on MRI 64%, 61% and 77%, respectively, were not swollen. BME, also in case of severe lesions, occurred frequently in clinically non-swollen joints. Similar results were observed for joint tenderness. Inflammation on MRI is not only present in clinically swollen but also in non-swollen joints. In particular BME occurred in clinically non-inflamed joints. The relevance of subclinical inflammation for the disease course is a subject for further studies.
    Annals of the rheumatic diseases 12/2013; · 8.11 Impact Factor
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    ABSTRACT: Objectives. This 24-week, multicenter, double-blind, randomized, placebo-controlled study (NCT00791999) compared efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) vs placebo plus MTX in Japanese rheumatoid arthritis (RA) patients with inadequate response to MTX. Methods. In total, 316 patients were randomized 1:1:1:1 to subcutaneous CZP 100, 200, or 400 mg (induction dose: 200 mg or 400 mg CZP at Weeks 0, 2, and 4) plus MTX or placebo plus MTX every 2 weeks. Primary endpoint was ACR20 response at Week 12. Results. ACR20 response rates were 62.5%, 76.8%, 77.6%, and 28.6% at Week 12, and 61.1%, 73.2%, 71.8%, and 24.7% at Week 24 for CZP 100, 200, and 400 mg, and placebo groups, respectively, with statistical significance between each CZP group and placebo. Change in Total Sharp Score over 24 weeks was significantly smaller in CZP 200 and 400 mg groups vs placebo. Improvements in health-related quality of life (HRQoL) were observed in all three CZP groups vs placebo. Incidence of adverse events was similar between CZP groups. Conclusions. CZP plus MTX resulted in rapid, sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX, with significant inhibition of radiographic progression and improved HRQoL.
    Modern Rheumatology 12/2013; · 1.72 Impact Factor
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    Rheumatology (Oxford, England) 11/2013; · 4.24 Impact Factor
  • Annals of the rheumatic diseases 11/2013; · 8.11 Impact Factor
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    ABSTRACT: Objectives. To evaluate criterion and construct validity of the self-administered comorbidity questionnaire (SCQ) in patients with AS.Methods. The SCQ and indices of disease activity, physical function, health-related quality of life (HRQoL) and work disability were administered to 98 patients with AS. Criterion validity was assessed by the agreement between the SCQ answers and comorbidities identified in medical records. Construct validity was assessed by correlating the SCQ with the Charlson index and Michaud-Wolfe index; by correlating the SCQ with demographics, physical function, HRQoL and AS-related disease activity; and by exploring the contribution of comorbidity to these outcomes while adjusting for clinical-demographic characteristics. Furthermore, a modified version of the SCQ (mSCQ) was evaluated for the same aspects of validity, after removing rheumatic conditions.Results. Agreement was moderate to perfect for most conditions (κ 0.47-1.00), except for ulcer disease, depression and OA (κ 0.14-0.15). The correlation between the SCQ and Charlson and Michaud-Wolfe indices was 0.24 and 0.39 respectively, and between the mSCQ and both indices 0.36 and 0.53. Both SCQ and mSCQ correlated weakly to moderately with age, physical function and HRQoL (0.24-0.45). The SCQ also correlated weakly with disease activity (0.27) while the mSCQ did not (0.17). In multivariable analysis, both SCQ and mSCQ contributed independently to physical function, HRQoL and work disability, while the Michaud-Wolfe and Charlson indices did not.Conclusion. The SCQ is a promising instrument to determine comorbidities and to understand the impact on health outcomes in patients with AS. Excluding rheumatic conditions from the SCQ (mSCQ) improved validity.
    Rheumatology (Oxford, England) 11/2013; · 4.24 Impact Factor
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    ABSTRACT: To evaluate the longterm safety of adalimumab administered with or without methotrexate (MTX) and compare the efficacy of combination therapy initialization to adalimumab or MTX monotherapy initialization during the open-label extension (OLE) of the PREMIER trial (ClinicalTrials.gov Identifier:NCT00195663). Patients with early rheumatoid arthritis (RA) were randomized to receive blinded adalimumab + MTX, adalimumab alone, or MTX alone for 2 years. Following the double-blinded period, patients enrolling in the OLE were given adalimumab for up to 8 additional years, beginning as monotherapy; investigators could add MTX at their discretion. Results for clinical, functional, and radiographic progression were collected for up to 10 years of treatment. During the PREMIER OLE, 250/497 patients (50.3%) completed the trial without new safety signals arising. Similar proportions of patients discontinued the trial early, although lack of efficacy was reported less often for patients initially randomized to the adalimumab + MTX arm (9.3%; 21.2%, and 23.7% for adalimumab and MTX monotherapies, respectively). Clinical and functional disease control was maintained throughout the trial. Patients initially randomized to adalimumab + MTX displayed better outcomes, particularly in prevention of radiographic progression (modified total Sharp score change = 4.0, 8.8, 11.0 at Year 10 for the initial adalimumab + MTX, adalimumab, and MTX arms, respectively). Intensive therapy with adalimumab + MTX combination in patients with early RA has longterm benefits compared to patients initiating with 2-year adalimumab or MTX monotherapy that persists up to 10 years following adalimumab OLE. No new safety findings were observed following longterm adalimumab treatment.
    The Journal of Rheumatology 11/2013; · 3.26 Impact Factor
  • D van der Heijde, D Zack, J Wajdula, S Sridharan, As Koenig
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    ABSTRACT: Objectives: Therapies involving anti-tumour necrosis factor are associated with increased risk of serious infections, opportunistic infections, and some types of malignancies in subjects with rheumatic diseases. However, limited data have been collected for subjects with ankylosing spondylitis (AS). The aim of this retrospective analysis of all sponsor-conducted trials was to examine the rates of serious infections, inflammatory bowel disease (IBD), malignancies, and non-malignant skin cancers during treatment in subjects with AS. Method: Data from five randomized controlled trials (one sulfasalazine-controlled, four placebo-controlled) and four open-label studies evaluating etanercept were pooled for analyses. All randomized subjects who received at least one dose of treatment were included in the study. Results: Analyses included 1323 subjects (> 1500 subject-years of treatment). Rate ratios of serious infections and IBD events for etanercept vs. placebo/sulfasalazine during the double-blind studies were 2.19 [95% confidence interval (CI) 0.22-107.79] and 1.09 (95% CI 0.06-64.56), respectively. There were no reports of opportunistic infections. Using the Surveillance, Epidemiology and End Results database, the standardized incidence ratio for malignancies was 1.47 (95% CI 0.54-3.21). Conclusions: These data suggest that etanercept is well tolerated in subjects with AS. Despite the large number of patients, the 95% CI data all cross 1.0, limiting possible conclusions. No new safety signals were observed.
    Scandinavian journal of rheumatology 11/2013; · 2.51 Impact Factor

Publication Stats

20k Citations
3,356.36 Total Impact Points

Institutions

  • 2005–2014
    • Leiden University Medical Centre
      • Department of Rheumatology
      Leyden, South Holland, Netherlands
    • Nambour General Hospital
      Намбор, Queensland, Australia
    • University of the Pacific (California - USA)
      Stockton, California, United States
    • French Institute of Health and Medical Research
      Lutetia Parisorum, Île-de-France, France
  • 2013
    • Autonomous University of Barcelona
      Cerdanyola del Vallès, Catalonia, Spain
    • University of Amsterdam
      Amsterdamo, North Holland, Netherlands
    • Academisch Medisch Centrum Universiteit van Amsterdam
      • Department of Clinical Immunology and Rheumatology
      Amsterdam, North Holland, Netherlands
    • University of Southampton
      Southampton, England, United Kingdom
    • Hospital General Universitario de Elda
      Elda, Valencia, Spain
  • 2007–2013
    • Diakonhjemmet Hospital (Norway)
      Kristiania (historical), Oslo County, Norway
    • Ludwig-Maximilian-University of Munich
      • Department of Physical Medicine and Rehabilitation
      München, Bavaria, Germany
    • Toronto Western Hospital
      Toronto, Ontario, Canada
    • Hôpital Bichat - Claude-Bernard (Hôpitaux Universitaires Paris Nord Val de Seine)
      Lutetia Parisorum, Île-de-France, France
  • 2005–2013
    • Medical University of Vienna
      Linz, Upper Austria, Austria
    • Ruhr-Universität Bochum
      Bochum, North Rhine-Westphalia, Germany
  • 2004–2013
    • University of Washington Seattle
      Seattle, Washington, United States
    • Carol Davila University of Medicine and Pharmacy
      • Department of Internal Medicine and Rheumatology
      Bucharest, Bucuresti, Romania
  • 1997–2013
    • University of Leeds
      • • Leeds Institute of Molecular Medicine (LIMM)
      • • School of Medicine
      Leeds, England, United Kingdom
  • 2012
    • Royal Prince Alfred Hospital
      Camperdown, New South Wales, Australia
    • National Institute Of Rheumatology And Physiotherapy
      Budapeŝto, Budapest, Hungary
    • The Queen Elizabeth Hospital
      Tarndarnya, South Australia, Australia
    • Paris Diderot University
      Lutetia Parisorum, Île-de-France, France
    • Mount Sinai Hospital, Toronto
      Toronto, Ontario, Canada
    • Centre Hospitalier Universitaire de Québec (CHUQ)
      Québec, Quebec, Canada
  • 2008–2012
    • Université Paris Descartes
      • Faculté de Médecine
      Lutetia Parisorum, Île-de-France, France
    • The University of Edinburgh
      Edinburgh, Scotland, United Kingdom
    • Johnson & Johnson
      New Brunswick, New Jersey, United States
    • Menzies Research Institute
      Hobart Town, Tasmania, Australia
  • 2004–2012
    • Charité Universitätsmedizin Berlin
      • • Department of Gastroenterology, Infectiology and Rheumatology
      • • Institute of Health Sciences Education and Nursing Science
      Berlín, Berlin, Germany
  • 1999–2012
    • Maastricht Universitair Medisch Centrum
      Maestricht, Limburg, Netherlands
  • 1995–2012
    • Maastricht University
      • • Department of Social Medicine
      • • Interne Geneeskunde
      Maastricht, Provincie Limburg, Netherlands
  • 2011
    • Government of Quebec
      Québec, Quebec, Canada
    • Merck
      Whitehouse Station, New Jersey, United States
    • Centre Hospitalier Universitaire de Montpellier
      Montpelhièr, Languedoc-Roussillon, France
    • Abbott Laboratories
      • Abbott Laboratories
      North Chicago, IL, United States
  • 2008–2011
    • Norwegian University of Science and Technology
      Nidaros, Sør-Trøndelag, Norway
  • 2007–2011
    • University of Toronto
      • Division of Rheumatology
      Toronto, Ontario, Canada
  • 2001–2011
    • Stanford University
      • • Division of Rheumatology
      • • Division of Immunology
      Palo Alto, CA, United States
  • 2010
    • University of Coimbra
      Coímbra, Coimbra, Portugal
    • University of Alabama at Birmingham
      • Division of Clinical Immunology and Rheumatology
      Birmingham, AL, United States
    • Oslo University Hospital
      Kristiania (historical), Oslo County, Norway
    • Oregon Health and Science University
      Portland, Oregon, United States
    • Medisch Centrum Haaglanden
      's-Gravenhage, South Holland, Netherlands
  • 2007–2010
    • University of Alberta
      Edmonton, Alberta, Canada
  • 1989–2010
    • Radboud University Medical Centre (Radboudumc)
      • Department of Human Genetics
      Nymegen, Gelderland, Netherlands
  • 2002–2009
    • Université René Descartes - Paris 5
      • Faculté de Médecine
      Paris, Ile-de-France, France
  • 2005–2008
    • Hôpital Cochin (Hôpitaux Universitaires Paris Centre)
      Lutetia Parisorum, Île-de-France, France
  • 2006
    • Aix-Marseille Université
      Marsiglia, Provence-Alpes-Côte d'Azur, France
    • University of California, San Francisco
      • Division of Rheumatology
      San Francisco, CA, United States
    • University of California, San Diego
      San Diego, California, United States
  • 2000–2002
    • Freie Universität Berlin
      • Institute of Social and Cultural Anthropology
      Berlín, Berlin, Germany
    • VU University Amsterdam
      Amsterdamo, North Holland, Netherlands