Real-life association between inhaler technique, patient preference and asthma control in patients with uncontrolled asthma switched to budesonide/formoterol DuoResp® Spiromax® combination.

Objective: In asthma, treatment effectiveness is strongly influenced by the quality of inhaler use. New devices such as Spiromax® have been specifically developed to improve ease of use. It is crucial to determine whether switching to such a device improves inhaler technique and clinical outcomes, and to identify factors associated with handling errors.Methods: This observational study assessed inhaler device handling errors in 1435 asthma patients recruited via 135 participating physicians in France, before and after switching therapy from the Symbicort Turbuhaler® or Seretide® Diskus® to DuoResp® Spiromax®. Patients received training in the use of their new device at baseline and were re-assessed after three months.Results: After three months of use, 67% of patients were using the DuoResp® Spiromax® with no handling errors, and 88% with no critical errors. The presence of comorbidities was associated with handling errors overall. Concurrent illness potentially affecting device handling and previous training were associated with critical device handling errors. Most patients (85.4%) preferred DuoResp® Spiromax® over their previous device. Levels of inadequately controlled or uncontrolled asthma were reduced from baseline among patients using DuoResp® Spiromax® (8.6% versus 64.6%), and were higher in patients with critical handling errors.Conclusions: Effective patient education, correct inhaler technique, treatment adherence and devices associated with high patient satisfaction are interrelated factors key to the successful delivery of inhaled asthma therapy. Inhaler technique and patient device satisfaction should be routinely assessed in treated patients with uncontrolled asthma. Supplemental data for this article can be accessed at publisher's website.

Vitamin D, disease activity and comorbidities in early spondyloarthritis.

OBJECTIVES: To assess the vitamin D status in patients presenting inflammatory back pain suggestive of axial spondyloarthritis and to assess the relationship between vitamin D status and disease activity/severity; comorbidities at baseline and during the first two years of follow-up. METHODS: DESIR is a prospective, multicentre, observational study. Vitamin D deficiency was defined as <50 nmol/L and severe deficiency less than 25 nmol/L. Clinical variables were collected at each six month interval visits during the two-year follow-up. RESULTS: A total of 700 patients were analysed. The mean vitamin D was 54.2±28.7 nmol/L. Severe deficiency were observed in 11.7% versus 5% in the DESIR cohort versus the French population respectively. In the DESIR cohort, after adjusting for season and ethnicity, vitamin D deficiency remained significantly associated with presence of radiological sacroiliitis, higher ASDAS score and elevated BASDAI. Such association was also found between vitamin D deficiency and the mean value of disease activity/severity parameters during the two-year follow-up. Otherwise, vitamin D deficiency was significantly associated with the presence of baseline abdominal obesity (OR=1.65 [1.05-2.61], p=0.03), low HDL (OR=1.71 [1.14-2.55], p=0.01) and presence of metabolic syndrome (OR=2.20 [1.04-4.64], p=0.03) at baseline. CONCLUSIONS: We found a higher percentage of patients with severe vitamin D deficiency in early axial spondyloarthritis. Vitamin D deficiency was associated with higher disease activity and severity and presence of metabolic syndrome. Further longitudinal studies are required to evaluate the interest of vitamin D supplementation on the long-term outcome of the disease.

Evaluation of serum interleukin-6 level as a surrogate marker of synovial inflammation and as a factor of structural progression in early rheumatoid arthritis: results from a French national multicenter cohort.

OBJECTIVE: Interleukin-6 (IL-6) is a key cytokine in rheumatoid arthritis pathogenesis. We aimed to analyze the association between IL-6 serum levels and joint inflammation at baseline and the correlation of time-integrated IL-6 values with structural damage during the first 36 months of early arthritis. METHODS: IL-6 was assessed by 2 different methods in 813 patients of the French early arthritis cohort ESPOIR (Etude et Suivi des Polyarthrites Indifférenciées Récentes) over 36 months. IL-6 and C-reactive protein (CRP) changes were correlated to radiographic progression assessed by the total Sharp/van der Heijde score (SHS). Synovium inflammation was assessed in a subgroup of 126 patients by ultrasonography (US). The relationship between SHS change and IL-6 or CRP levels at baseline was investigated by a univariate regression and a multivariable analysis. A longitudinal model nested by visit and patient was conducted to assess the role of IL-6 on SHS at each visit. RESULTS: At baseline, IL-6 was more strongly correlated with the swollen joint count than CRP level. In the univariate analysis, the time-integrated value of IL-6 was more strongly correlated with the swollen joint count and the variation of SHS than time-integrated CRP level. Baseline IL-6 was not independently associated with SHS change. Longitudinal models nested by patient showed that IL-6 levels were associated with structural damage independently from the Disease Activity Score in 28 joints, smoking status, rheumatoid factor, and anti-citrullinated protein peptide antibody serology, treatments, and CRP levels. CONCLUSION: IL-6 level was a marker of US synovitis at baseline. Repeated measurements of IL-6 are associated with structural damage.

Evaluation of the validity of the different arms of the ASAS set of criteria for axial spondyloarthritis and description of the different imaging abnormalities suggestive of spondyloarthritis: data from the DESIR cohort.

BACKGROUND: 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. OBJECTIVE: To compare the phenotype of early axial SpA with regard to the two arms of the ASAS axial SpA criteria. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Early increase of abdominal adiposity in patients with spondyloarthritis receiving anti-tumor necrosis factor-α treatment.

OBJECTIVE: Patients with spondyloarthritis (SpA) receiving anti-TNF-α treatment have an increase in fat mass. This may be relevant to cardiovascular risk. The aim of this study was to estimate visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) changes by dual-energy x-ray absorptiometry (DEXA) in patients with SpA under anti-TNF-α therapy. METHODS: We used an ancillary protocol to an open, prospective 2-year followup study of patients with SpA. Waist circumference (WC), body weight, body mass index, VAT, and SAT were measured at baseline, 6 months, and 1 and 2 years. Univariate and multivariate analyses were performed to assess variables associated with VAT and SAT changes. RESULTS: A total of 85 patients were analyzed. Patients were 39.3 ± 11.4 years old and mean baseline Bath Ankylosing Spondylitis Disease Activity Index was 55.0 ± 20.2. Treatment was effective according to clinical and biological variables, and body weight increased by 0.9 ± 1.7 kg over 2 years. There was a significant gain in VAT after 6 months (13.7 ± 20.6 cm(2), p < 0.0001), 1 year (21.0 ± 26.6 cm(2), p < 0.0001), and after 2 years (29.1 ± 33.4 cm(2), p < 0.0001); and in SAT after 6 months (12.5 ± 27.4 cm(2), p < 0.0001), 1 year (27.1 ± 38.2 cm(2), p < 0.0001), and after 2 years (31.9 ± 53.2 cm(2), p < 0.0001). We could not find any determinant of these changes by multivariate analysis. CONCLUSION: In patients with SpA receiving anti-TNF-α therapy, there is an early significant increase in abdominal obesity with significant increase in both VAT and SAT after 1 and 2 years of treatment. Prospective studies are required to investigate the relationship between these changes and cardiovascular risk.

Assessing structural changes in axial spondyloarthritis using a low-dose biplanar imaging system.

OBJECTIVES: Patients with axial SpA experience repeated spine imaging. EOS is a new low-dose imaging system with significantly lower irradiation than conventional radiography (CR). The objective was to explore the EOS performances compared with CR for the classification and follow-up of SpA. METHODS: We performed an observational, cross-sectional, single-centre study including SpA patients (definite diagnosis by expert opinion) and control patients [definite chronic mechanical low back pain (cLBP)]. All patients underwent pelvic and frontal and lateral CR of the entire spine and two-dimensional (2D) EOS imaging on the same day. Images were blindly assessed for sacroiliitis [modified New York criteria (mNY)] and for ankylosis of the spine [modified Stoke AS Spine Score (mSASSS)]. Global ease of interpretation was rated on a scale of 0-10. The primary outcome was intermodality agreement, with an a priori defined non-inferiority limit of 0.7. Interobserver, intra-observer and intermodality agreement were measured by kappa, weighted kappa, intraclass correlation coefficient and Bland-Altman plots. RESULTS: Forty-eight SpA patients [mean age 47.6 years (s.d. 14.9), symptom duration 21.4 years (s.d. 13.3), 35 (70%) men] and 48 cLBP controls [mean age 49.1 years (s.d. 10.7), 9 (22.5%) men] were included. Intermodality agreement between EOS and CR was 0.50 (95% CI 0.26, 0.75) and 0.97 (95% CI 0.95, 0.98) for sacroiliitis and mSASSS, respectively. Ease of interpretation was greater for CR [8.2 (s.d. 0.9)] compared with EOS [7.2 (s.d. 0.8), P < 0.0001). CONCLUSION: Our results suggest that EOS could replace CR for the follow-up of structural damage of the spine, but its place in the classification of sacroiliitis needs to be further explored.

Effectiveness of tumor necrosis factor α blockers in early axial spondyloarthritis: data from the DESIR cohort.

OBJECTIVE: To estimate the frequency of use and effectiveness in daily practice of tumor necrosis factor α (TNFα) blockers in a population with inflammatory back pain suggestive of early axial spondyloarthritis (SpA). METHODS: The Devenir des Spondylarthropathies Indifférenciées Récentes (DESIR) cohort is a prospective, multicenter, observational cohort of 708 patients with early (<3 years' duration) inflammatory back pain suggestive of axial SpA. The percentage of patients receiving TNFα blockers over the first 2 years of followup was estimated by survival analysis. To evaluate effectiveness, the primary outcome (40% improvement in disease activity according to the Assessment of SpondyloArthritis international Society criteria [ASAS40]) was compared in patients who received TNFα blockers versus control patients who received any other treatment (usual care). Controls were matched to the patients based on a propensity score method. RESULTS: A total of 30.2% (95% confidence interval [95% CI] 26.7-33.7) patients received at least 1 TNFα blocker during the 24 months of followup. The percentage of ASAS40 responders was 31.5% (62 of 197 patients) in the group receiving TNFα blockers versus 13.2% (26 of 197) in the control group (OR 2.99 [95% CI 1.80-4.99], P = 0.0002). This effectiveness was more pronounced in the subgroup of patients with sacroiliitis identified on magnetic resonance imaging, with 46% of ASAS40 responders receiving TNFα blockers versus 15% of ASAS40 responders receiving usual care (OR 4.99 [95% CI 2.17-11.51]). CONCLUSION: Our study shows that TNFα blockers are frequently used in daily practice to treat patients with early axial SpA. Our findings confirm the effectiveness of TNFα blockers as compared to any other treatment, especially in the subgroup of patients with sacroiliitis on MRI.

Difficulties in the diagnosis of vertebral fracture in men: agreement between doctors.

UNLABELLED: The agreement for vertebral fracture (VF) diagnosis in men, between doctors is poor. OBJECTIVES: To assess the agreement for VF diagnosis, in men, on standard radiographs, between experts, before and after consensual workshop and establishing an algorithm. METHODS: The agreement between thirteen experimented rheumatologists has been calculated in thirty osteoporotic men. Then, the group discussed in a workshop and 28 other radiograph sets of osteoporotic men with follow-up radiographs and incident confirmed VF, have been reviewed. The experts identified and hierarchised 18 pathological features of vertebral deformation and established an algorithm of VF diagnosis. Eleven experts have realized a second reading of the first set of radiographs. We compared the agreement between the 2 readings without and with the algorithm. RESULTS: After consensus and the use of the algorithm the results are: number of fractured patients (with at least 1 VF) according to the experts varies from 13 to 26 patients out of 30 (13 to 28 during the first reading). The agreement between the experts at the patient level is 75% (70% at the first reading). Among the 390 vertebrae analyzed by the experts, the number of VF detected varies from 18 to 59 (18 to 98 at the first reading). The agreement between the experts at the vertebral level is 92% (89% at the first reading). The algorithm allows a good improvement of the agreement, especially for 8 of the 11 experts. Discrepancies for the VF diagnosis between experts exist. The algorithm improves the agreement.

Rapidly destructive tibiofemoral knee osteoarthritis: clinicoradiological presentation and outcome after global medical treatment including non-arthroscopic joint lavage plus corticosteroid injection. A single center retrolective study.

OBJECTIVE: To determine (i) clinicoradiological presentation and outcome of rapidly destructive knee osteoarthritis (RDKOA) after global medical treatment including knee lavage plus corticosteroid injection, (ii) predisposing factors of subsequent requirement to knee surgery. METHODS: Retrolective monocenter study with tibiofemoral RDKOA, defined as a loss of at least 50% of joint space width within 1 year, with a post lavage follow-up of at least 1 year. RESULTS: One hundred and eleven patients were enrolled, age 64.1 years, BMI: 28.9, 70.3% female. VAS pain was 56.1mm, Lequesne index: 11.9, WOMAC function score: 51.9. Chronic mechanical effusion (216 white cells/mm3) was aspirated in 102 patients (91.9%), lasting more than 6 months in 71.4%. Medial tibiofemoral compartment was concerned in 79.3%. Joint space loss reached 52.2% in extension and 71.0% in semi-flexed position within a mean 7.3-month period. Radiological chondrocalcinosis was present in 13.5% and osteonecrosis in 12.6%. Lavage (one liter, two 14-gauge cannulae) plus corticosteroid was completed by hyaluronic acid injections in 71.2% of patients. Eighty-nine patients were reviewed with a mean follow-up period of 55.0 months. Thirty-seven (41.6%) required surgery. Mean delay between lavage and surgery was 16.1 months. Pain was acceptable in 100.0% of operated patients and 87.8% of non-operated patients. Multivariate regression analysis determined that functional impairment, assessed by the maximal walking time, and radiological severity in extension were baseline predisposing factors of subsequent requirement to surgery. CONCLUSION: The outcome of RDKOA seems less severe than expected after global medical treatment.

Repeated anticitrullinated protein antibody and rheumatoid factor assessment is not necessary in early arthritis: results from the ESPOIR cohort.

OBJECTIVE: Presence and levels of anticyclic citrullinated peptide antibodies (anti-CCP) and rheumatoid factor (RF) contribute to the classification and prognosis of rheumatoid arthritis (RA). The objective was to determine the usefulness of repeating anti-CCP/RF measurements during the first 2 years of followup in patients with early arthritis. METHODS: In patients with early undifferentiated arthritis, serial anti-CCP and RF were measured using automated second-generation assays every 6 months for 2 years. Frequencies of seroconversions (from negative to positive or the reverse) and changes in antibody levels during followup were determined. RESULTS: In all, 775 patients, mean (SD) age 48.2 (12.5) years, mean symptom duration 3.4 (1.7) months, 76.6% female, were analyzed; 614 (79.2%) satisfied the American College of Rheumatology/European League Against Rheumatism 2010 classification criteria for RA at baseline. At baseline, respectively for anti-CCP and RF, 318 (41.0%) and 181 (23.4%) patients were positive, of whom 298 (93.7% of the positive) and 111 (61.3% of the positive) were highly positive (above 3 × upper limit of the norm). There were only 12 anti-CCP seroconversions toward the positive (i.e., 2.6% of the anti-CCP-negative), 21 seroconversions toward the negative (6.6% of the anti-CCP-positive), and 8 (1.0%) changes to a higher anti-CCP level category during the 2-year followup; respectively for RF, 27 (4.6%), 95 (52.5%), and 13 (1.7%). CONCLUSION: In this cohort of patients with early arthritis, including in the subset of patients who did not fulfill the RA criteria, antibody status showed little increase over a 2-year period. Repeated measurements of anti-CCP/RF very infrequently offer significant additional information.

Fatigue in spondyloarthritis: a marker of disease activity. A cross-sectional study of 266 patients.

OBJECTIVES: Fatigue is an important aspect of spondyloarthritis (SpA). However the influencing factors of fatigue in SpA are unclear. The objective of this study was to explore if fatigue is related to disease activity or to patient characteristics. METHODS: This was a retroelective observational study (Cochin COSPA study) in one tertiary-referral centre. The primary outcome was fatigue, evaluated on a 0-100mm Visual Analogue Scale (VAS). The covariates were demographic characteristics, disease subtype (axial vs. peripheral) and disease-related factors, e.g. Bath Disease Activity Index (BASDAI), patient global assessment (VAS), Bath Functional Index (BASFI). To explain fatigue, univariate then multivariate logistic regressions were conducted (with fatigue analysed as above or below 50 mm), as well as multiple linear regressions with the different covariates. RESULTS: Two hundred and sixty-six SpA patients were analysed. Sixty-one percent were male; mean age and disease duration were 44.5±13.5 years and 16.8±11.7 years, respectively. Mean VAS fatigue was 49.3±32.7mm; 49.6% of patients had fatigue VAS>50mm. Logistic regression showed high fatigue was associated with disease: BASDAI and BASFI (p<0.0001), as well as female gender (p=0.025) and aerobic exercise (p=0.005), but there was no difference in the subtypes of SpA. In multivariate analysis, the single factor explaining fatigue was patient global assessment (p<0.001 and odds ratio =1.35). By linear regression, demographic variables explained 2.8% of the variance, whereas disease characteristics and activity explained 44.6%. CONCLUSIONS: Fatigue levels were high in SpA patients whatever the subtype and appeared more strongly related to the disease than to patient-related variables, thus confirming its usefulness as an outcome measure.

Added value of trabecular bone score to bone mineral density for prediction of osteoporotic fractures in postmenopausal women: the OPUS study.

UNLABELLED: The objective of this study was to consider whether trabecular bone score (TBS) improves on areal bone mineral density (aBMD) measurement alone for the prediction of incident fractures in postmenopausal women. PATIENTS AND METHODS: The OPUS study was conducted in ambulatory European women aged above 55years, recruited in 5 centers followed over 6years. For the assessment of the performance of TBS, baseline Hologic scans from 3 centers (Kiel, Paris and Sheffield) were available. Follow-up for incident fractures was available for 1007 women (mean age 65.9±6.9years). We compared the performance of TBS, aBMD, and their combination, by using net reclassification improvement (NRI, primary analysis) and receiver operator characteristic (ROC) c-statistical analysis with ORs and areas under the curves (AUCs) (secondary analyses). RESULTS: 82 (8.1%) subjects with incident clinical osteoporotic fractures, and 46 (4.6%) with incident radiographic vertebral fractures were recorded over 6years. Performance of TBS was significantly better than lumbar spine (LS) aBMD for the prediction of incident clinical osteoporotic fractures (NRI=16.3%, p=0.007). For radiographic vertebral fractures, TBS and LS aBMD had similar predictive power but the combination of TBS and LS aBMD increased the performance over LS aBMD alone (NRI=8.6%, p=0.046) but the prediction is similar to hip and femoral neck aBMD. In non osteoporotic women, TBS predicted incident fragility fractures similarly to LS aBMD. CONCLUSIONS: This prospective study shows that in general population, TBS is a useful tool to improve the performance of lumbar spine aBMD for vertebral osteoporotic fractures.

Increase in bone density in patients with spondyloarthritis during anti-tumor necrosis factor therapy: 6-year followup study.

OBJECTIVE: To assess the effects on bone mineral density (BMD) of prolonged anti-tumor necrosis factor (anti-TNF) therapy in patients with spondyloarthritis (SpA); to compare the BMD changes to those observed in SpA patients not treated with anti-TNF; and to identify the predictors of these changes. METHODS: Fifty-nine patients with SpA according to the European Spondylarthropathy Study Group criteria who were treated with anti-TNF therapy for at least 4 years were included. Thirty-four patients with SpA from an international longitudinal observational study (OASIS cohort) were used as a control group. Lumbar spine and hip BMD were measured by dual-energy x-ray absorptiometry at baseline, after 1 year, and after at least 4 years. RESULTS: Over an average 6.5 years' followup, the increase in BMD was 11.8% (± 12.8%) at the lumbar spine (p < 0.0001) and 3.6% (± 9.3%) at the great trochanter (p = 0.0001) in patients treated with anti-TNF. At the lumbar spine, the increase was similar in patients with and those without syndesmophytes. BMD changes were significantly higher in the anti-TNF group than in the control group at lumbar spine (p < 0.0001), at femoral neck (p = 0.002), and at trochanter (p = 0.011), but not at total hip (p = 0.062). Multivariate analysis showed that the predictors of lumbar spine BMD changes in the total population were the use of anti-TNF (p < 0.0001) and, in the anti-TNF therapy group, the 1-year lumbar spine BMD change (p = 0.007). CONCLUSION: This study shows that prolonged anti-TNF therapy increases lumbar spine and trochanter BMD. This effect should be taken into account before introducing antiosteoporotic treatment in these patients.

Lumbar disc degeneration in osteoporotic men: prevalence and assessment of the relation with presence of vertebral fracture.

OBJECTIVE: The relationship between osteoarthritis (OA) and osteoporosis (OP) remains controversial. An inverse relationship between spine OA and the presence of prevalent vertebral fractures has been shown in osteoporotic women. Our objective was to assess this relationship in osteoporotic men. METHODS: All the patients had OP based on densitometric data and were aged ≥ 65 years. Spine radiographs were performed according to a standardized procedure. Vertebral fractures were assessed from T4 to L4 by a semiquantitative method. Disc degenerative changes were assessed by the presence and severity of osteophytes and disc narrowing at levels T12-L1 to L5-S1. Logistic regression was used to study the relationship between the presence of vertebral fracture and lumbar disc degeneration. RESULTS: The study included 261 osteoporotic men. The prevalence of vertebral fractures was 26.4% (69/261). At least 1 osteophyte was found in 91.6% (239/261) of patients, and at least 1 disc space narrowing in 63.5% (165/260). The prevalence of at least 1 osteophyte and/or at least 1 disc space narrowing was similar in patients with and those without vertebral fracture. No relationship was found between the presence and/or the severity of osteophytes and disc narrowings and the presence of prevalent vertebral radiographic fractures. CONCLUSION: In osteoporotic men, the prevalence of lumbar spine degeneration is high. There is no relationship between lumbar disc degeneration and the presence of vertebral fracture in osteoporotic men.

Prospective assessment of bone texture parameters at the hand in rheumatoid arthritis.

OBJECTIVE: Fractal bone analysis (Hmean) is a texture parameter reflecting bone microarchitecture. The BMA device (D3A™ Medical Systems, Orléans, France) is a high-resolution X-ray device that allows assessment of bone texture analysis. We aimed to measure Hmean in rheumatoid arthritis patients at the second and third metacarpal bones, at baseline and after 1 year of follow-up, and to assess the relationship of Hmean and rheumatoid arthritis disease parameters. METHODS: Patients with rheumatoid arthritis according to ACR criteria were included. They were assessed over 1 year, in the context of a prospective study conducted in Maastricht. For this substudy, activity of the disease was assessed by erythrocyte sedimentation rate, C-reactive protein and Disease Activity Score 28 performed at each visit. Radiographic bone damage was assessed using hand and feet radiographs at baseline and on a 1-year basis. The bone texture parameters were evaluated on the second and third metacarpal heads of the left hand using BMA device. RESULTS: One hundred and sixty-five rheumatoid arthritis patients were included in this study. At baseline, Hmean was negatively correlated with age [r=-0.22 (P=0.013)] and erythrocyte sedimentation rate [r=-0.16 (P=0.039)]. No significant correlation was found between Hmean and Disease Activity Score, disease activity Visual Analog Scale, daily corticosteroid dose and C-reactive protein. There was a significant increase in Hmean of second and third metacarpal bones over 1 year (1.6% and 1.3%, P<0.01) except in patients with local second and third metacarpal bones erosion. CONCLUSION: The bone texture parameter Hmean is influenced by age, inflammation and local erosions in rheumatoid arthritis.

Bone oedema on MRI is highly associated with low bone mineral density in patients with early inflammatory back pain: results from the DESIR cohort.

OBJECTIVES: To assess bone mineral density (BMD) at lumbar spine and hip in a large cohort of patients with early inflammatory back pain (IBP) suggestive of axial spondyloarthritis (SpA), and to assess systemic and bone inflammation (according to MRI) as risk factors of low BMD. PATIENTS AND METHODS: 332 (52.4% male) patients with IBP suggestive of axial SpA defined by Calin or Berlin criteria were recruited; they had lumbar spine and hip BMD and body composition measurements. Low BMD was defined by Z≤-2 (at least one site). Clinical, biological (erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)) and imaging (x-rays, spine and sacroiliac joint MRI) parameters were compared in patients with and without low BMD (Z≤-2). Significant parameters in univariate analysis were tested in multivariate models. RESULTS: Patients (mean age 33.8 years) had a short duration of axial symptoms (mean 1.6 years); 71.4% fulfilled the Assessment of Spondyloarthritis International Society criteria for axial SpA and HLA-B27 was present in 62.1%. 43 (13.0%) had low BMD (88% male). Multivariate logistic regression showed that parameters significantly associated with low BMD (any site) were the presence of bone marrow oedema (inflammatory lesions) on MRI (OR 4.63, p=0.001), either ESR or CRP (OR 2.60, p=0.037) and male gender (OR 9.60, p=0.0004). CONCLUSIONS: This study conducted in a large cohort of young adults with early IBP suggestive of SpA shows that 13.0% of patients have a low BMD and that the main risk factor associated with low BMD was inflammation on MRI.

FRAX®: prediction of major osteoporotic fractures in women from the general population: the OPUS study.

PURPOSES: The aim of this study was to analyse how well FRAX® predicts the risk of major osteoporotic and vertebral fractures over 6 years in postmenopausal women from general population. PATIENTS AND METHODS: The OPUS study was conducted in European women aged above 55 years, recruited in 5 centers from random population samples and followed over 6 years. The population for this study consisted of 1748 women (mean age 74.2 years) with information on incident fractures. 742 (43.1%) had a prevalent fracture; 769 (44%) and 155 (8.9%) of them received an antiosteoporotic treatment before and during the study respectively. We compared FRAX® performance with and without bone mineral density (BMD) using receiver operator characteristic (ROC) c-statistical analysis with ORs and areas under receiver operating characteristics curves (AUCs) and net reclassification improvement (NRI). RESULTS: 85 (4.9%) patients had incident major fractures over 6 years. FRAX® with and without BMD predicted these fractures with an AUC of 0.66 and 0.62 respectively. The AUC were 0.60, 0.66, 0.69 for history of low trauma fracture alone, age and femoral neck (FN) BMD and combination of the 3 clinical risk factors, respectively. FRAX® with and without BMD predicted incident radiographic vertebral fracture (n = 65) with an AUC of 0.67 and 0.65 respectively. NRI analysis showed a significant improvement in risk assignment when BMD is added to FRAX®. CONCLUSIONS: This study shows that FRAX® with BMD and to a lesser extent also without FN BMD predict major osteoporotic and vertebral fractures in the general population.

Evidence of the symptomatic and structural efficacy of methotrexate in daily practice as the first disease-modifying drug in rheumatoid arthritis despite its suboptimal use: results from the ESPOIR early synovitis cohort.

OBJECTIVE: To describe the use of MTX in early arthritis (EA) in daily clinical practice and to evaluate its 6-month symptomatic efficacy and 12-month structural efficacy. METHODS: Patients included in the French observational ESPOIR cohort were assessed. Evaluation of the symptomatic and structural efficacy was performed by generalized linear regression after adjustment on propensity score (PS) in the group of patients receiving at least 3 months of MTX vs the ones receiving any other treatment except LEF, SSZ or TNF inhibitors. RESULTS: Within the first 6 months of follow-up of 777 EA patients, 59% received a DMARD, which was MTX in 68% (N = 313) of patients. The mean dose of MTX was 12.7 ± 3.8 mg/week. Only 53.7% of the patients received folic acid supplementation. MTX was initiated in patients with more active and severe disease. At 6 months, in unadjusted analysis, patients starting MTX had a significantly higher DAS-28 (3.58 vs 3.23; P = 0.001) and a significantly higher HAQ (0.60 vs. 0.48; P = 0.01) compared with controls. After adjustment by PS, there were no significant differences. Adjustment for the PS also revealed a statistically significant decrease in the radiological progression at 12 months in the MTX group [total Sharp-van der Heijde score (SHS), 1.05 ± 0.29 vs 2.02 ± 0.29, P = 0.025]. CONCLUSION: This study confirms the symptomatic and structural efficacy of MTX in EA in daily practice despite the non-optimal use of MTX, including low doses and infrequent concomitant folic acid supplementation.

Elaboration and validation of a questionnaire (Qualisex) to assess the impact of rheumatoid arthritis on sexuality with patient involvement.

OBJECTIVES: Rheumatoid arthritis (RA) may have consequences on sexual life. The objective was to develop and validate a questionnaire assessing the impact of RA on sexuality. METHODS: First, 6 patients (5 women, 1 man) with RA, 2 rheumatologists and 1 sexologist elaborated during a one-day focus-group type meeting an exhaustive list of issues relating to impact of RA on sexuality. The list was reduced by merging similar issues, then according to the relative importance for patients of each issue. A questionnaire was developed with input from these patients, with particular attention on phrasing. Psychometric properties (missing data, correlations with other disease aspects, reliability) were assessed in a multi-centre study. RESULTS: The list of 33 issues related to impact of RA on sexuality included psychological issues (9), couple/relationship issues (9), physical issues (7), and general aspects (5). A 10-question numeric rating scale questionnaire was constructed. Preliminary validation was obtained on 53 patients (44 women, mean age 50.7 years; mean disease duration 14.4 years). The mean score was 3.3±2.5, missing data were acceptable (13%). Qualisex results were correlated with disease activity and symptoms (r=0.50-0.65, p< 0.001); but not with demographics, depression or coping. Qualisex was reliable in 40 patients: the intra-class correlation coefficient was 0.83 (95% CI: 0.70-0.91). CONCLUSIONS: A simple (10 questions) and valid tool investigating impact of RA on sexuality has been developed with the involvement of patients. This tool can be useful to assess this important aspect of quality of life.