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M M Schoels,
J Braun, M Dougados,
P Emery,
O Fitzgerald,
A Kavanaugh,
T K Kvien,
R Landewé,
T Luger,
P Mease,
I Olivieri,
J Reveille,
C Ritchlin,
M Rudwaleit,
J Sieper,
J S Smolen,
M de Wit,
D van der Heijde
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ABSTRACT: BACKGROUND: Current recommendations for the management of axial spondyloarthritis (SpA) and psoriatic arthritis are to monitor disease activity and adjust therapy accordingly. However, treatment targets and timeframes of change have not been defined. An international expert panel has been convened to develop 'treat-to-target' recommendations, based on published evidence and expert opinion. OBJECTIVE: To review evidence on targeted treatment for axial and peripheral SpA, as well as for psoriatic skin disease. METHODS: We performed a systematic literature search covering Medline, Embase and Cochrane, conference abstracts and studies in http://www.clinicaltrials.gov. RESULTS: Randomised comparisons of targeted versus routine treatment are lacking. Some studies implemented treatment targets before escalating therapy: in ankylosing spondylitis, most trials used a decrease in Bath Ankylosing Spondylitis Disease Activity Index; in psoriatic arthritis, protocols primarily considered a reduction in swollen and tender joints; in psoriasis, the Modified Psoriasis Severity Score and the Psoriasis Area and Severity Index were used. Complementary evidence correlating these factors with function and radiographic damage at follow-up is sparse and equivocal. CONCLUSIONS: There is a need for randomised trials that investigate the value of treat-to-target recommendations in SpA and psoriasis. Several trials have used thresholds of disease activity measures to guide treatment decisions. However, evidence on the effect of these data on long-term outcome is scarce. The search data informed the expert committee regarding the formulation of recommendations and a research agenda.
Annals of the rheumatic diseases 06/2013; · 8.11 Impact Factor
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ABSTRACT: OBJECTIVES: To evaluate the performances (sensitivity, specificity, positive and negative predictive values) at diagnosis and study visit of the ASAS criteria in axial spondyloarthritis in patients with for chronic back pain (CBP). Secondary objective: identifying the most contributory item to diagnosis/classify spondyloarthritis. METHODS: Multi-centre, cross-sectional study. Patients: history of CBP under 45years visiting a rheumatologist in France. Data: a) items of the different sets of criteria, checking if present at diagnosis ('diagnosis')/after diagnosis but at study visit ('classification'); b) Rheumatologist diagnosis at study visit. Statistical analysis: descriptive characteristics and performances for diagnosis and classification. The diagnosis of the rheumatologist was considered as the "gold standard". RESULTS: 1210 patients were eligible for our analysis. Sensitivity and Specificity for ASAS axial criteria were 0.76 and 0.94, and 0.87 and 0.92 for diagnostic and classification purposes, respectively. LR+ of the ASAS axial criteria was 13.6 and 10.30 for diagnostic and classification purposes, respectively. The most contributory items to diagnosis and classification were X-ray sacroiliitis, followed by MRI sacroiliitis for diagnosis and history of uveitis for classification. CONCLUSION: we confirm the validity of the ASAS criteria for both diagnostic and classification purposes, in a clinical setting of patients with CBP. © 2013 by the American College of Rheumatology.
Arthritis care & research. 04/2013;
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ABSTRACT: OBJECTIVE: To clarify gender differences in early axial spondyloarthritis (SpA). METHODS: 475 patients included in the DESIR cohort, a prospective multicenter French cohort of patients with early inflammatory back pain suggestive of SpA, and fulfilling the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA were studied. The clinical and imaging features were compared between genders and according to the "clinical" or the "imaging" arm of the ASAS criteria, using univariate and multivariate analysis. RESULTS: Comparisons between the 239 men and the 236 women showed higher disease activity when measured by BASDAI and BASG, higher fatigue and functional scores in women despite less radiographic sacroiliitis and MRI inflammation of sacroiliac joints and spine. Disease activity measured by ASDAS-CRP was not different between men and women. In contrast to patients classified with the "clinical" arm, disease activity and functional scores did not differ between women and men with sacroiliitis on imaging except for the fatigue and the AS-Qol. Women with sacroiliitis had more peripheral involvement and more family history whereas HLAB27 positivity, elevated CRP and MRI inflammation of spine were associated with male gender. CONCLUSIONS: Women with early axial SpA according to ASAS criteria had greater disease activity when measured by BASDAI and worse functioning despite less radiological abnormalities than men. Differences in the disease expression may be confounding factors to establish the diagnosis of SpA and to assess the disease activity in women, suggesting that the "imaging arm" is a pivotal measure in the ASAS criteria. © 2013 by the American College of Rheumatology.
Arthritis care & research. 03/2013;
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P Mandl,
Pv Balint,
Y Brault,
M Backhaus,
Ma D'Agostino,
W Grassi,
D van der Heijde,
E de Miguel,
Rj Wakefield,
I Logeart, M Dougados
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ABSTRACT: OBJECTIVES: To evaluate the metrological properties of composite disease activity indices in rheumatoid arthritis (RA), utilizing information derived from clinical, grey-scale (GS) and Power Doppler (PD) ultrasound examination. To assess the classification of patients according to disease activity using such indices. METHODS: This ancillary study utilized data from a prospective, randomized, parallel-group, multicenter study conducted in subjects with moderate RA, randomized to receive etanercept and methotrexate (ETN+MTX) or usual care (various DMARDs). In multimodal indices the 28-swollen joint count (SJC) was either supplemented or replaced by clinically non-swollen joints in which the presence of synovitis was detected either by GS and/or PD and were calculated according to the DAS28 or SDAI indices. Reliability, external validity and discriminative capacity were calculated at baseline/screening by intraclass correlation coefficient, Pearson's correlation and standardized response mean respectively. RESULTS: Data from 62 patients (age: 53.8±13.2 years; disease duration: 8.8±7.7 years; disease activity: 4.6± 0.5 (DAS28), 20.9± 5.9 (SDAI)) were analyzed, 32 receiving ETN+MTX and 30 receiving DMARDs. The metrological properties were at least as good for GS and/or PD-based indices as for their clinical counterparts. Using GS and PD supplemented indices an additional 67.8% and 32.3% (DAS28-derived and SDAI-derived indices respectively) of patients could be classified as having high disease activity at the screening visit. CONCLUSION: Multimodal indices incorporating ultrasound and clinical data had similar metrological properties as their clinical counterparts; certain indices allowed for a significantly larger number of patients to be classified to either high or moderate disease activity at the screening visit. © 2012 by the American College of Rheumatology.
Arthritis care & research. 12/2012;
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F Tubach,
P Ravaud,
E Martin-Mola,
H Awada,
N Bellamy,
C Bombardier,
Dt Felson,
N Hassouni,
M Hochberg,
I Logeart,
M Matucci-Cerinic,
M van de Laar,
D van der Heijde, M Dougados
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ABSTRACT: OBJECTIVE: To estimate the Minimum Clinically Important Improvement (MCII) and Patient Acceptable Symptomatic State (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries. METHODS: We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, The Netherlands), 4-week cohort study involving 1,532 patients which were prescribed NSAISDs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis or rheumatoid arthritis. The MCII and PASS values were estimated with the 75(th) percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability and physician global assessment, all normalized to a 0-100 score. RESULTSA: For the whole sample, the estimated MCII values for absolute change at 4 weeks (95% confidence interval [95% CI]) were -17 (-18, -15) for pain; -15 (-16, -14) for patient global assessment; -12 (-13, -11) for functional disability assessment; and -14 (-15, -14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (40, 44) for pain; 43 (41, 45) for patient global assessment; 43 (41, 44) for functional disability assessment; and 39 (37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients). CONCLUSION: This work allows for promoting the use of values of MCII (15/100 for absolute improvement, 20% for relative improvement) and PASS (40/100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function or physician global assessment used as outcome criteria. © 2012 by the American College of Rheumatology.
Arthritis care & research. 06/2012;
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J E Gottenberg,
P Ravaud,
A Cantagrel,
B Combe,
R M Flipo,
T Schaeverbeke,
E Houvenagel,
P Gaudin,
D Loeuille,
S Rist, M Dougados,
J Sibilia,
X Le Loët,
C Marcelli,
T Bardin,
I Pane,
G Baron,
X Mariette
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ABSTRACT: Very limited data are available regarding the efficacy of abatacept (ABA) in real life. The aims of this study were to determine the efficacy of ABA in rheumatoid arthritis and predicting factors of efficacy in common practice.
The Orencia and Rheumatoid Arthritis" (ORA) prospective registry, promoted by the French Society of Rheumatology, has included 1003 patients with RA.
773 patients had already fulfilled the 6-month follow-up visit. Only 21.3% of patients would have fulfilled inclusion criteria used in pivotal controlled trials. The European League Against Rheumatism (EULAR) response, was observed in 330 (59.1%) of the 558 assessed patients (good response: 20.4%, moderate response: 38.7%) and was similar in patients who did and in patients who did not fulfill inclusion criteria of controlled trials. Among EULAR responders, initial 28-joint disease activity score (5.4 (4.7-6.5) in responders vs 4.9 (4.0-6.0) in non responders, p< 0.0001), the proportion of rheumatoid factor (75.6% vs 66.7%, p= 0.03) and the proportion of anti-cyclic citrullinated peptide antibody (anti-CCP)-positivity (75.9% vs 62.2%, p= 0.001) were significantly higher. In multivariate analysis adjusted on initial 28-joint disease activity score and CRP, anti-CCP positivity was associated with EULAR response (OR=1.9;95% CI=1.2 to 2.9, p=0.007), but not rheumatoid factor (OR=1.0;95% CI=0.6 to 1.6, p=0.9). Anti-CCP positivity was also significantly associated with a higher ABA retention rate at 6 months.
Real life efficacy of ABA in the ORA registry was similar as that reported in clinical trials. Anti-CCP positivity was associated with a better response to ABA, independently from disease activity.
Annals of the rheumatic diseases 05/2012; 71(11):1815-9. · 8.11 Impact Factor
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P. Mandl,
P. V. Balint,
Y. Brault,
M. Backhaus,
M.-A. D'Agostino,
W. Grassi,
D. van der Heijde,
E. de Miguel,
R. J. Wakefield,
I. Logeart, M. Dougados
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ABSTRACT: Objective
To evaluate the intraobserver reliability, face validity, and discriminant capacity of different global ultrasound (US) scoring systems for measuring synovitis in rheumatoid arthritis (RA).Methods
This study was ancillary to a 52-week, multicenter, prospective, randomized, open-label, parallel-group outpatient study conducted in patients with moderate RA who were randomized to receive either etanercept combined with methotrexate or various disease-modifying antirheumatic drugs. A total of 66 different synovitis scoring systems were constructed and evaluated, including 11 different joint combinations; data derived from clinical findings, gray-scale US, and power Doppler US (PDUS); and both binary counts and semiquantitative scores.ResultsDue to discontinuation of the trial, only 62 patients, a subset of the initially planned number of patients, were included in this study. Reliability was found to be better for gray-scale US and PDUS than for clinical evaluation of synovitis in patients with stable disease between the screening and baseline visits (range for intraclass correlation coefficient 0.6, 0.95 for gray-scale US and 0.56, 0.93 for PDUS versus 0.31, 0.75 for clinical indices). The median (range) difference in the discriminant capacities of clinical indices versus gray-scale US and versus PDUS was 0.25 (−0.64, 0.96) and −0.025 (−0.59, 0.53), respectively, in the period from baseline to 12 weeks. No relevant differences in metrologic properties were observed regarding the number and composition of joints between the different scoring systems. Our findings suggested that a simplified scoring system referring to gray-scale US and PDUS findings might be sufficient.Conclusion
Our findings indicate that gray-scale US and PDUS have better reliability than generally used clinical indices for evaluating synovitis in RA. PDUS has at least as good discriminant capacity as clinical assessment of synovitis for distinguishing between treatment arms.
Arthritis & Rheumatism 03/2012; 64(4):1272 - 1282. · 7.87 Impact Factor
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ABSTRACT: In 2010, new classification criteria for rheumatoid arthritis (RA) were developed.
To assess agreement between 1987 American College of Rheumatology (ACR) and 2010 ACR/European League Against Rheumatism (EULAR) criteria and the potential source of discordance, based on ESPOIR cohort data.
813 early arthritis patients were included in ESPOIR between 2002 and 2005. Between-criteria agreement was based on the κ coefficient. Discordance was explored by logistic regression.
Data for 811 patients were available, with their main characteristics as follows: women 77%, swollen joint count 7.2, tender joint count 8.4, disease activity score in 28 joints 5.2, rheumatoid factor 46%, anticitrullinated protein antibody (ACPA) 39%, structural damage 22%. At baseline, 579 (71.4%) patients met the 1987 ACR criteria and 641 (79.0%) the 2010 criteria. Agreement at baseline was discordant for 168 patients: 115 satisfied the 2010 criteria and 53 the 1987 criteria. Concordance between the two sets was fair, with a κ coefficient of 0.45 and 0.42 at baseline and year 2, respectively. The main sources of discordance were the number and symmetry of joint involvement, as well as ACPA status.
2010 ACR/EULAR criteria identified more patients with RA than did 1987 criteria. The 2010 criteria failed to identify RA patients with symmetrical seronegative arthritis and limited joint involvement.
Annals of the rheumatic diseases 03/2012; 71(3):386-9. · 8.11 Impact Factor
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ABSTRACT: To assess the association between a single nucleotide polymorphism in the gene of FCGR3A and the response to treatment with rituximab (RTX) in rheumatoid arthritis (RA).
SMART is a randomised open trial assessing two strategies of re-treatment in patients responding to 1 g infusion of RTX with methotrexate on days 1 and 15 after failure, intolerance or contraindication to tumour necrosis factor (TNF) blockers. Among the 224 patients included, 111 could be genotyped and were included in an ancillary study of SMART. Univariate and multivariate analyses adjusted on disease activity score on 28 joints were performed to assess whether FCGR3A-158V/F polymorphism was associated with European League Against Rheumatism response at week 24.
Among the 111 patients, 90 (81%) were responders of whom 30 (27%) were good responders. V allele carriage was significantly associated with a higher response rate (91% of responders vs 70%, OR 4.6 (95% CI 1.5 to 13.6), p=0.006). These results were also confirmed in rheumatoid factor-positive patients (93% vs 74%, p=0.025). In multivariate analysis, V allele carriage was independently associated with response to RTX (OR 3.8 (95% CI 1.2 to 11.7), p=0.023).
The 158V/F polymorphism of FCGR3A seems to influence the response to RTX in patients with RA after failure, intolerance or contraindication to TNF blockers.
Annals of the rheumatic diseases 02/2012; 71(6):875-7. · 8.11 Impact Factor
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ABSTRACT: To determine the prevalence of uveitis in patients with recent inflammatory back pain (IBP) suggestive of spondylarthritis (SpA), and to investigate the impact of uveitis on the overall features of these patients.
The Devenir des Spondylarthropathies Indifférenciées Récentes (DESIR; Outcome of Recent Undifferentiated Spondylarthropathies) cohort is a prospective multicenter French cohort of 708 patients with early IBP suggestive of SpA. Uveitis was defined by an ophthalmologic episode diagnosed as uveitis by an ophthalmologist, or history of a medical diagnosis of uveitis given to the patient. Data on the baseline demographic characteristics, functional status and quality of life, imaging features, bone mineral density (BMD), and blood tests were compared in patients with and without uveitis. Factors associated with the presence of uveitis were identified both by univariate and multivariate analysis (logistic regression).
The prevalence of uveitis at inclusion in the DESIR cohort was 8.5%. Uveitis occurred after the first symptoms of IBP in 45% of patients. The presence of uveitis was significantly associated (univariate) with pain in the cervical spine, infection preceding inflammatory disease, a previous diagnosis of inflammatory bowel disease (IBD), the Short Form 36 (SF-36; mental and physical health and social relationship subscales), Achilles enthesitis, elevated leukocyte count, and radiologic hip involvement, but not with fulfillment of classification criteria, HLA-B27, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Disease Activity Score, and BMD. Stepwise multivariate analysis found an association between uveitis and pain in the cervical spine, infection preceding inflammatory disease, a previous diagnosis of IBD, and the physical health limitation of the SF-36 (P < 0.05).
In recent IBP suggestive of SpA, uveitis is associated with IBD and infection. This might suggest a role of environmental factors in the incidence of uveitis in SpA.
Arthritis care & research. 02/2012; 64(7):1089-93.
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ABSTRACT: Many outcomes have been proposed in the assessment of psoriatic arthritis (PsA). The Outcome Measures in Rheumatology (OMERACT) core set for PsA evaluation comprises 6 domains: joints, skin, function, pain, patient's global assessment, and quality of life. The objective of this work was to assess reporting of outcomes in PsA, including patient-reported outcomes (PROs) in recent publications.
A systematic literature search of clinical trials related to PsA and reporting at least 1 clinical outcome between 2006 and 2010 was performed in PubMed, i.e., just before to just after publication of the OMERACT core set. All clinical outcomes were noted and subdivided into domains of health. Data analysis was descriptive.
Fifty-eight articles (12,405 patients) were included in the analysis: 17 (29%) were randomized clinical trials; the patients' mean ± SD age was 48.2 ± 5.4 years and the mean ± SD disease duration was 9.0 ± 3.1 years. Eighty-four different outcomes were reported, with a mean ± SD of 6.9 ± 4.3 per study. Patients were mainly assessed using the 6 core set domains, reported in 37.9% (quality of life) to 55.2% (skin) of articles; however, the core set was rarely completely reported since only 10.3% of the studies reported all 6 core domains. PROs were heterogeneous and in particular there was no consensus regarding the number of joints to assess and instruments for dactylitis and enthesitis. PROs were assessed in more than 75% of publications using 28 different instruments.
There is great heterogeneity in PsA assessment, even since publication of the OMERACT core set. Better consensus on instruments to assess each domain of health and better insight into which outcomes are important for patients is needed.
Arthritis care & research. 12/2011; 64(3):397-406.
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R L Manno,
C O Bingham,
S Paternotte,
L Gossec,
H Halhol,
G Giacovelli,
L Rovati,
S A Mazzuca,
D O Clegg,
H Shi,
E Tajana Messi,
A Lanzarotti, M Dougados
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ABSTRACT: Total joint replacement has been proposed as an endpoint in disease modifying osteoarthritis drug (DMOAD) randomized clinical trials (RCTs); however, disparities have generated concerns regarding this outcome. A combined Osteoarthritis Research Society International (OARSI)/Outcome Measures in Rheumatology (OMERACT) initiative was launched in 2004 to develop a composite index ['virtual total joint replacement' (VJR)] as a surrogate outcome for osteoarthritis (OA) progression in DMOAD RCTs. Our objective was to evaluate the prevalence of patients fulfilling different thresholds of sustained pain, reduced function, and X-ray change in existing DMOAD RCTs.
Post hoc analysis of summary data from the placebo arm of eight DMOAD RCTs.
Eight OA RCTs representing 1379 patients were included. Pain was assessed by WOMAC and/or VAS and function by WOMAC and/or Lequesne. Among six knee and two hip studies, 248 (22%) and 132 (51%) patients respectively had X-ray progression [decrease joint space width (JSW) ≥0.5 mm]. The prevalence of patients fulfilling clinical and radiographic criteria was highest (n = 163, 12%) in the least stringent scenario (pain + function ≥80 at ≥2 visits); with few patients (n = 129, 2%) in the most stringent scenario (pain + function ≥80 at ≥4 visits). Using these prevalence data, a sample size of 352-2144 per group would be needed to demonstrate a 50% difference between groups.
The prevalence of patients with sustained symptomatic OA of at least a moderate degree with X-ray progression is low. Even using lenient criteria to define VJR, large patient numbers would be required to detect differences between groups in DMOAD RCTs. Investigation of the optimal cutoff threshold and combination of symptoms and radiographic change should be pursued.
Osteoarthritis and Cartilage 11/2011; 20(2):93-101. · 3.90 Impact Factor
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L Gossec,
J S Smolen,
C Gaujoux-Viala,
Z Ash,
H Marzo-Ortega,
D van der Heijde,
O FitzGerald,
D Aletaha,
P Balint,
D Boumpas, [......],
N McHugh,
I B McInnes,
C Ritchlin,
J Sieper,
P P Tak,
G Valesini,
J Vencovsky,
K L Winthrop,
A Zink,
P Emery
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ABSTRACT: Psoriatic arthritis (PsA) is a clinically heterogeneous disease. Clear consensual treatment guidance focused on the musculoskeletal manifestations of PsA would be advantageous. The authors present European League Against Rheumatism (EULAR) recommendations for the treatment of PsA with systemic or local (non-topical) symptomatic and disease-modifying antirheumatic drugs (DMARD).
The recommendations are based on evidence from systematic literature reviews performed for non-steroidal anti-inflammatory drugs (NSAID), glucocorticoids, synthetic DMARD and biological DMARD. This evidence was discussed, summarised and recommendations were formulated by a task force comprising 35 representatives, and providing levels of evidence, strength of recommendations and levels of agreement.
Ten recommendations were developed for treatment from NSAID through synthetic DMARD to biological agents, accounting for articular and extra-articular manifestations of PsA. Five overarching principles and a research agenda were defined.
These recommendations are intended to provide rheumatologists, patients and other stakeholders with a consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes, based on combining evidence and expert opinion. The research agenda informs directions within EULAR and other communities interested in PsA.
Annals of the rheumatic diseases 09/2011; 71(1):4-12. · 8.11 Impact Factor
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J Braun,
R van den Berg,
X Baraliakos,
H Boehm,
R Burgos-Vargas,
E Collantes-Estevez,
H Dagfinrud,
B Dijkmans, M Dougados,
P Emery, [......],
W P Maksymowych,
I Olivieri,
K Pavelka,
J Sieper,
E Stanislawska-Biernat,
D Wendling,
S Ozgocmen,
C van Drogen,
Bj van Royen,
D van der Heijde
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ABSTRACT: This first update of the ASAS/EULAR recommendations on the management of ankylosing spondylitis (AS) is based on the original paper, a systematic review of existing recommendations and the literature since 2005 and the discussion and agreement among 21 international experts, 2 patients and 2 physiotherapists in a meeting in February 2010. Each original bullet point was discussed in detail and reworded if necessary. Decisions on new recommendations were made - if necessary after voting. The strength of the recommendations (SOR) was scored on an 11-point numerical rating scale after the meeting by email. These recommendations apply to patients of all ages that fulfill the modified NY criteria for AS, independent of extra-articular manifestations, and they take into account all drug and non-drug interventions related to AS. Four overarching principles were introduced, implying that one bullet has been moved to this section. There are now 11 bullet points including 2 new ones, one related to extra-articular manifestations and one to changes in the disease course. With a mean score of 9.1 (range 8-10) the SOR was generally very good.
Annals of the rheumatic diseases 06/2011; 70(6):896-904. · 8.11 Impact Factor
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L Gossec,
S Paternotte,
G J Aanerud,
A Balanescu,
D T Boumpas,
L Carmona,
M de Wit,
B A C Dijkmans, M Dougados,
M Englbrecht, [......],
J R Kirwan,
E Martin Mola,
M Matucci Cerinic,
K Otsa,
G Schett,
M Scholte-Voshaar,
T Sokka,
G von Krause,
G A Wells,
T K Kvien
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ABSTRACT: A patient-derived composite measure of the impact of rheumatoid arthritis (RA), the rheumatoid arthritis impact of disease (RAID) score, takes into account pain, functional capacity, fatigue, physical and emotional wellbeing, quality of sleep and coping. The objectives were to finalise the RAID and examine its psychometric properties.
An international multicentre cross-sectional and longitudinal study of consecutive RA patients from 12 European countries was conducted to examine the psychometric properties of the different combinations of instruments that might be included within the RAID combinations scale (numeric rating scales (NRS) or various questionnaires). Construct validity was assessed cross-sectionally by Spearman correlation, reliability by intraclass correlation coefficient (ICC) in 50 stable patients, and sensitivity to change by standardised response means (SRM) in 88 patients whose treatment was intensified.
570 patients (79% women, mean ± SD age 56 ± 13 years, disease duration 12.5 ± 10.3 years, disease activity score (DAS28) 4.1 ± 1.6) participated in the validation study. NRS questions performed as well as longer combinations of questionnaires: the final RAID score is composed of seven NRS questions. The final RAID correlated strongly with patient global (R=0.76) and significantly also with other outcomes (DAS28 R=0.69, short form 36 physical -0.59 and mental -0.55, p<0.0001 for all). Reliability was high (ICC 0.90; 95% CI 0.84 to 0.94) and sensitivity to change was good (SRM 0.98 (0.96 to 1.00) compared with DAS28 SRM 1.06 (1.01 to 1.11)).
The RAID score is a patient-derived composite score assessing the seven most important domains of impact of RA. This score is now validated; sensitivity to change should be further examined in larger studies.
Annals of the rheumatic diseases 06/2011; 70(6):935-42. · 8.11 Impact Factor
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ABSTRACT: Patients with advanced ankylosing spondylitis (AS) experience disability because of reduced spinal mobility and pulmonary function impairment. This placebo-controlled study evaluated the effect of etanercept (ETN) in patients with advanced AS.
A multicentre randomised double-blind placebo-controlled trial of 12 weeks' duration was performed. Patients had definite (modified New York criteria), active (Bath AS Disease Activity Index (BASDAI) ≥40), severe (radiological intervertebral bridges) AS refractory to non-steroidal anti-inflammatory drugs and were antitumour necrosis factor naive. They were treated with ETN 50 mg once weekly or identical placebo (PBO).
Of the 95 patients screened, 82 were randomised to receive ETN (n=39) or PBO (n=43). At baseline the disease was active (mean BASDAI 61.0±13.4, C reactive protein (CRP) 20.7±25.5 mg/l) and severe (mean Bath AS Metrology Index (BASMI) 5.7±1.3, mSASSS 36.5±20.5); forced pulmonary vital capacity (FVC) was 3.3±0.7 l. Improvement in BASDAI (normalised net incremental area under the curve between baseline and week 12, primary end point) was significantly greater in the ETN group than in the PBO group (-19.8±16.5 vs -11.0±16.4, p=0.019). Moreover, at week 12, ETN gave better results than PBO for the BASDAI (-26.4±19.7 vs -14.4±19.7; p=0.008), total back pain (-29.2±24.0 vs -14.9±24.0; p=0.010), BASFI (-21.7±17.6 vs -10.1±17.6; p=0.004), BASMI (-0.6±0.6 vs -0.2±0.6; p=0.011), CRP level (-15.7±14.2 vs -1.3±14.2; p<0.001) and FVC (+160±280 ml vs -20±280 ml; p=0.006).
ETN has short-term efficacy for patients with advanced AS, as was previously reported for less advanced disease. The efficacy is observed for the main symptoms (pain) and on markers of inflammation (CRP), as well as disease severity in terms of spinal mobility and pulmonary function.
Annals of the rheumatic diseases 02/2011; 70(5):799-804. · 8.11 Impact Factor
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M Rudwaleit,
D van der Heijde,
R Landewé,
N Akkoc,
J Brandt,
C T Chou, M Dougados,
F Huang,
J Gu,
Y Kirazli,
F Van den Bosch,
I Olivieri,
E Roussou,
S Scarpato,
I J Sørensen,
R Valle-Oñate,
U Weber,
J Wei,
J Sieper
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ABSTRACT: To evaluate new classification criteria for peripheral spondyloarthritis (SpA) in patients with SpA with peripheral manifestations only.
In this Assessment of SpondyloArthritis international Society (ASAS) study, two prespecified sets of criteria were compared against the European Spondylarthropathy Study Group (ESSG) and Amor criteria in newly referred consecutive patients with undiagnosed peripheral arthritis, and/or enthesitis, and/or dactylitis that usually began before 45 years of age. The clinical diagnosis (SpA vs no SpA) made by the ASAS rheumatologist served as reference standard.
In all, 24 ASAS centres included 266 patients, with a final diagnosis of SpA being made in 66.2%. After adjustments a final set of criteria showed the best balance between sensitivity (77.8%) and specificity (82.9%): arthritis and/or enthesitis and/or dactylitis plus (A) one or more of the following parameters: psoriasis, inflammatory bowel disease, preceding infection, human leucocyte antigen B27, uveitis, sacroiliitis on imaging, or (B) two or more other parameters: arthritis, enthesitis, dactylitis, inflammatory back pain in the past, family history of SpA. The new criteria performed better than modified versions of the ESSG (sensitivity 62.5%, specificity 81.1%) and the Amor criteria (sensitivity 39.8%, specificity 97.8%), particularly regarding sensitivity. In the entire ASAS population of 975 patients the combined use of ASAS criteria for axial SpA and ASAS criteria for peripheral SpA also had a better balance (sensitivity 79.5%, specificity 83.3%) than the modified ESSG (sensitivity 79.1%, specificity 68.8%) and Amor criteria (sensitivity 67.5%, specificity 86.7%), respectively.
The new ASAS classification criteria for peripheral SpA performed well in patients presenting with peripheral arthritis, enthesitis and/or dactylitis.
Annals of the rheumatic diseases 01/2011; 70(1):25-31. · 8.11 Impact Factor
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ABSTRACT: To compare the efficacy of disease activity score in 28 joints (DAS28ESR)-driven therapy with anti-tumour necrosis factor (patients from the GUEPARD trial) and routine care in patients with recent-onset rheumatoid arthritis (patients of the ESPOIR cohort).
After matching GUEPARD and ESPOIR patients on the basis of a propensity score and a 1:2 ratio, at baseline all patients had comparable demographic characteristics, rheumatoid factor, anticyclic citrullinated peptide antibody positivity and clinical disease activity parameters: erythrocyte sedimentation rate, C-reactive protein, mean DAS (6.26±0.87), Sharp/van der Heijde radiographic score (SHS), health assessment questionnaire (HAQ). Disease duration was longer in GUEPARD patients (5.6±4.6 vs 3.5±2.0 months, p<0.001). After 1 year, the percentage of patients in remission with an HAQ (<0.5) and an absence of radiological progression was higher in the tight control group (32.3% vs 10.2%, p=0.011) as well as the percentage of patients in low DAS with an HAQ (<0.5) and an absence of radiological progression (36.1% vs 18.9%, p=0.045). However, there was no difference in the decrease in DAS, nor in the percentage of EULAR (good and moderate), ACR20, ACR50 and ACR70 responses. More patients in the tight control group had an HAQ below 0.5 (70.2% vs 45.2%, p=0.005). Overall, pain, patient and physician assessment and fatigue decreased more in the tight control group. The mean SHS progression was similar in the two groups as was the percentage of patients without progression.
In patients with recent onset active rheumatoid arthritis, a tight control of disease activity allows more patients to achieve remission without disability and radiographic progression.
Annals of the rheumatic diseases 01/2011; 70(4):611-5. · 8.11 Impact Factor
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J-E Gottenberg,
P Ravaud,
T Bardin,
P Cacoub,
A Cantagrel,
B Combe, M Dougados,
R M Flipo,
B Godeau,
L Guillevin,
X Le Loët,
E Hachulla,
T Schaeverbeke,
J Sibilia,
G Baron,
X Mariette
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ABSTRACT: The risk of severe infection is a crucial factor in the assessment of the short-term risk:benefit ratio of biologic drugs in rheumatoid arthritis (RA). There is no increase in severe infections in RA patients treated with rituximab (RTX) in controlled trials, but this has not yet been assessed in daily practice. We undertook this study to investigate the occurrence of and risk factors for severe infections in off-trial patients using data from the AutoImmunity and Rituximab (AIR) registry.
The AIR registry was set up by the French Society of Rheumatology. The charts of patients with severe infections were reviewed.
Of the enrolled patients, 1,303 had at least 1 followup visit at 3 months or later, with a mean ± SD followup period of 1.2 ± 0.8 years (1,629 patient-years). Eighty-two severe infections occurred in 78 patients (5.0 severe infections per 100 patient-years), half of them in the 3 months following the last RTX infusion. Multivariate analysis showed that chronic lung disease and/or cardiac insufficiency (odds ratio 3.0 [95% confidence interval 1.3-7.3], P = 0.01), extraarticular involvement (odds ratio 2.9 [95% confidence interval 1.3-6.7], P = 0.009), and low IgG level (<6 gm/liter) before initiation of RTX treatment (odds ratio 4.9 [95% confidence interval 1.6-15.2], P = 0.005) were significantly associated with increased risk of a severe infection.
The rate of severe infections in current practice is similar to that reported in clinical trials. The risk factors for severe infections include chronic lung and/or cardiac disease, extraarticular involvement, and low IgG before RTX treatment. This suggests that serum IgG should be checked and the risk:benefit ratio of RTX discussed for patients found to have low levels of IgG.
Arthritis & Rheumatism 09/2010; 62(9):2625-32. · 7.87 Impact Factor
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A Feydy,
L Gossec,
R Bazeli,
F Thévenin,
E Pluot,
J Rousseau,
G Lenczner,
R Campagna,
H Guerini,
A Chevrot, M Dougados,
J-L Drapé
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ABSTRACT: The new diagnostic criteria for ankylosing spondylitis include MRI. MRI frequently allows early diagnosis of inflammatory lesions in patients with normal plain films. In addition, MRI is useful for the detection and quantification of inflammatory and structural lesions, and to assess disease activity.
Journal de Radiologie 09/2010; 91(9 Pt 2):1057-67. · 0.42 Impact Factor
