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 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.

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.

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.

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.

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.

Assessment of work instability in spondyloarthritis: a cross-sectional study using the ankylosing spondylitis work instability scale.

OBJECTIVES: Work status is an important outcome in SpA. The objective was to assess work instability and its determinants in a cohort of patients with SpA, using the AS-work instability scale (AS-WIS). METHODS: We performed a cross-sectional monocentre study. Patients were definite SpA patients with paid work. Work instability was measured by the AS-WIS. Its determinants were assessed by correlations with SpA scores (BASDAI, BASFI and patient's global assessment) and patients with low work instability (AS-WIS score < 11) were compared with those with moderate to high instability, through backward logistic regression. RESULTS: In all, 156 patients were assessed: mean (s.d.) age 41 (11) years, mean disease duration 15 (11) years; 71 (45.5%) were on TNF blockers. The mean AS-WIS score was 9.5 (5.5); 55 (35%) patients had moderate and 8 (5%) patients had high work instability. Correlations of the AS-WIS score with SpA scores were significant but moderate (BASDAI R = 0.42, BASFI R = 0.41, patient's global assessment R = 0.53; P < 0.0001). In multivariate analysis, high patient's global assessment was the only element associated with moderate to high work instability; demographic characteristics and treatments were not significant elements. CONCLUSION: Work instability was found to be high and its main determinant was patient's global assessment. The predictive validity of the AS-WIS in terms of job retention should be further assessed.

Prevalence and clinical characteristics of dactylitis in spondylarthritis: a descriptive analysis of 275 patients.

OBJECTIVES: Dactylitis is a common but little studied feature of spondylarthritis (SpA). Our objective was to assess the prevalence of dactylitis among a cohort of patients with spondylarthritis in a tertiary care centre and to describe the clinical characteristics of dactylitis. METHODS: This was a prospective single centre observational study carried out in 2010. The patients included had been diagnosed as having definite SpA based on Amo's criteria. Each patient was interviewed by a physician. The data collected included prevalence of dactylitis and its clinical characteristics, effectiveness of the different treatments, and association with severe manifestations of SpA, and analysed by descriptive analysis. RESULTS: 275 consecutive SpA patients were assessed: mean age 43.2±13.5 years, mean disease duration 14.0±11.8 years, 169 (61.4%) were men. In all, 59 patients (21.5%) suffered from SpA-associated dactylitis. The localisation of dactylitis was toes in 46 patients (78.0%) and/or fingers in 25 patients (42.4%). The most frequent localisations were the second toe and the second finger. Dactylitis was the first symptom of SpA in 14 patients (5.1%), and 28.8% (n=17) of dactylitis appeared within the first 5 years of disease. Dactylitis was present in 35.1% (n=13) of patients with undifferenciated SpA and in 30.6% (n=15) of patients with psoriatic arthritis. It was significantly associated with history of peripheral arthritis or heel pain. In our population, there was no correlation between dactylitis and HLA B27 status or sex and it was not a marker of severity of disease. CONCLUSIONS: Dactylitis is a frequent manifestation in SpA (21.5%) particularly in peripheral disease and it may be the first manifestation of the disease with localisation being more frequent in the toes.

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.

Heel pain in spondyloarthritis: results of a cross-sectional study of 275 patients.

OBJECTIVES: Heel pain is a common but poorly studied feature of spondyloarthritis (SpA). The aims of this study were to assess the prevalence and clinical features of heel pain in a cohort of patients with SpA. METHODS: This was a retrolective single centre observational study in 2010. Patients with SpA as defined by Amor's criteria were recruited. The data collected were: demographic and disease characteristics, history of heel pain, age at first heel pain, localisation, nature and intensity of pain and treatments. The analyses were descriptive. RESULTS: A total of 275 SpA patients (mean age 44.6±13.5 yrs, mean disease duration 16.7±11.8 yrs, 61.5% men) were assessed. A history of heel pain was reported in 130 patients (47.1%), and was the first symptom of SpA in 15.7% of all patients. Heel pain was frequent in both axial (89/201, 44.3%) and peripheral disease (27/56, 48.2%). Distribution was more frequently inferior (88, 69.3%) than posterior (61, 48.0%) (p<0.0001), and frequently bilateral: simultaneously (41.9%) rather than alternatively (29.1%) (p=0.03). Main clinical symptoms were: morning pain on weight bearing (83.6%), but also night pain (34.4%), and/or patient-described swelling (24.2%). Heel pain was frequently recurrent (74.2%), intense (70.3%), source of a limp (71.6%), and often resistant to non-steroidal anti-inflammatory drugs (NSAIDs) (54/108, 50%). Tumour necrosis factor blockers were efficacious on heel pain in 72/94 (76.6%) of cases. CONCLUSIONS: This study confirmed heel pain as a frequent symptom in both axial and peripheral SpA. It occurred early in the disease course and it was frequently recurrent and resistant to NSAIDs.

Prevalence and characteristics of hip involvement in spondyloarthritis: a single-centre observational study of 275 patients.

OBJECTIVES: Hip involvement is a classic feature of spondyloarthritis (SpA). The aim of the present paper is to study the prevalence, clinical and radiological features of hip involvement, and the association with criteria for severity, in a cohort of patients with SpA in a tertiary care centre. DESIGN: retrospective single centre observational study in 2010 of patients with definite SpA who underwent direct interview by a physician. Hip involvement was defined as hip pain considered related to SpA inflammation and confirmed radiographically. Other data collection: demographic data, SpA characteristics, treatments performed for hip involvement. ANALYSIS: prevalence of hip involvement was analysed according to disease duration (Kaplan-Meyer). Multivariate Cox analysis compared patients with vs. without hip involvement over time. RESULTS: In all, 275 SpA patients were assessed. The median age was 45 (IQR 35-55) years, the median SpA symptom duration 14 (7-25) years, 61% (169) were men, and 79% were HLA-B27 positive. Hip involvement was found in 18% (49) SpA patients, with already 13% after 5 years of disease duration and with frequent bilateral involvement (61%). Hip involvement was associated with non-Caucasian origin (p=0.05). Thirty-three percent (16/49) needed surgery (23 total joint replacements in all) with good functional results. CONCLUSIONS: Hip involvement is a frequent manifestation in SpA (18%), often bilateral, and associated with non-Caucasian origin. One third of the patients needed total joint replacement. Physicians should be wary of hip pain in SpA patients and implement rapid diagnostic procedures in such cases.

Identification of rheumatoid arthritis patients with vertebral fractures using bone mineral density and trabecular bone score.

The aim of this study was to test bone mineral density (BMD), trabecular bone score (TBS), and their combination, for detection of rheumatoid arthritis (RA) patients with vertebral fractures (VFs). One hundred eighty-five women aged 56.0 ± 13.5 yr, with RA since 15.5 ± 9.9 yr were studied. Lumbar spine, total hip, and femoral neck BMD were assessed by dual-energy X-ray absorptiometry (DXA). TBS was calculated from anteroposterior image of lumbar spine BMD. VFs from T4 to L4 were evaluated using Vertebral Fracture Assessment software on DXA device. The proportions of patients with VF and T-scores ≤-2.5 were only 24.2%, 21.2%, and 33.3% at lumbar spine, total hip, and femoral neck, respectively. T-scores were significantly lower in patients with VF than in patients without VF, the largest difference being observed at femoral neck (p=0.0001). TBS was significantly lower in patients with VF vs without VF (p=0.0001). The areas under the curves were 0.621, 0.704, 0.703, 0.719, and 0.727 for lumbar spine BMD, TBS, lumbar spine BMD+TBS, total hip BMD, and femoral neck BMD, respectively. The threshold of 1.173 for TBS had the best sensitivity (63%) and specificity (74%). TBS measured at the lumbar spine has a better discrimination value than lumbar spine BMD, and similar to femoral neck BMD, for prediction of presence of VF in patients with RA. In RA subjects with osteopenia, the proportion of patients with VF was higher in the lowest tertile of TBS when compared with the highest tertile. In this population, at low risk according to BMD, TBS could help to detect patients with VF.

Validation of a numerical rating scale to assess functional impairment in hip and knee osteoarthritis: comparison with the WOMAC function scale.

OBJECTIVES: (1) To investigate the psychometric properties of a patient-reported numerical rating scale (NRS) for evaluating functional disability in osteoarthritis (OA), in comparison with the WOMAC function scale and with a physician-reported function NRS; (2) to estimate the patient acceptable symptomatic state (PASS) and the minimal clinically important improvement (MCII) values for treatment with non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: Data were extracted from a prospective multicentre study involving 1186 patients with knee or hip OA. The psychometric properties assessed were feasibility: percentage of responses, floor and ceiling effects; construct validity by examining the correlations with classically used OA outcomes measures; responsiveness by comparing the results of before and 1 month after treatment with NSAIDs using standardised response mean (SRM) and effect size (ES). The MCII and PASS values of each function scale were calculated by an anchoring method. RESULTS: No floor or ceiling effect was observed. High correlations were observed as expected between the patient NRS and WOMAC function, pain visual analogue scale and patient global assessment. The responsiveness was moderate to large, with SRM and ES ranging from 0.6 (hip OA) to 0.9 (knee OA) and higher than that of the WOMAC function scale. The PASS was close to 3 for the NRS scales. The MCII appears to be the change that makes the OA functional disability decrease from baseline to the PASS. CONCLUSION: The patient-reported NRS demonstrated good psychometric properties, similar to the WOMAC function scale and can be regarded as a promising tool in therapeutic evaluation and decision-making in OA.

Switching between tumour necrosis factor blockers in spondyloarthritis: a retrospective monocentre study of 222 patients.

OBJECTIVES: To assess the frequency and effectiveness of switching TNF blockers in spondyloarthritis, and the predisposing factors of this effectiveness. METHODS: This was a retrospective systematic monocentre study; inclusion criteria were definite spondyloarthritis (Amor's criteria) and introduction of a first TNF blocker after January 2004. The retention rate of the first and second TNF blocker (if applicable) was evaluated (Kaplan-Meier technique). Patients' characteristics were compared with regard to requirement for switching. Predisposing factors of retention of the second TNF blocker were analysed (log-rank, Cox). RESULTS: A total of 222 patients started a first TNF blocker; 79% fulfilled the New York modified criteria, with increased CRP (75%) and median BASDAI of 50 (35-61). Mean follow up was 29±20 months (i.e. a total of 538 patient-years). By the end of follow-up, 72 patients (32%) had switched to a second TNF blocker. Patients who switched had more peripheral enthesitic symptoms (p=0.01) and a tendency for more peripheral involvement (p=0.06). Retention of the first and second TNF blocker was similar (p=0.32). No predictive factors were found for retention of the second TNF blocker; including no difference between TNF blockers and between reasons for stopping the first. CONCLUSIONS: The effectiveness of switching TNF blocker in spondyloarthritis appears clinically relevant; no predictive factors of this effectiveness were evidenced.

Risk of infections in bronchiectasis during disease-modifying treatment and biologics for rheumatic diseases.

BACKGROUND: Bronchiectasis is frequently associated (up to 30%) with chronic inflammatory rheumatic diseases and leads to lower respiratory tract infections. Data are lacking on the risk of lower respiratory tract infections in patients treated with biologic agents. METHODS: Monocenter, retrospective systematic study of all patients with a chronic inflammatory rheumatic disease and concomitant bronchiectasis, seen between 2000 and 2009. Univariate and multivariate analyses were performed to evidence predictive factors of the number of infectious respiratory events. RESULTS: 47 patients were included (mean age 64.1±9.1 years, 33 (70.2%) women), with a mean follow-up per patient of 4.3±3.1 years. Rheumatoid arthritis was the main rheumatic disease (90.1%). The mean number of infectious events was 0.8±1.0 event per patient-year. The factors predicting infections were the type of treatment (biologic vs. non biologic disease-modifying treatments), with an odds ratio of 8.7 (95% confidence interval: 1.7-43.4) and sputum colonization by any bacteria (odds ratio 7.4, 2.0-26.8). In multivariate analysis, both factors were independently predictive of infections. CONCLUSION: Lower respiratory tract infectious events are frequent among patients receiving biologics for chronic inflammatory rheumatic disease associated with bronchiectasis. Biologic treatment and pre-existing sputum colonization are independent risk factors of infection occurrence.

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.

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.

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.

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.