Randomised, controlled trial of avocado-soybean unsaponifiable (Piascledine) effect on structure modification in hip osteoarthritis: the ERADIAS study.

OBJECTIVE: To assess the ability of avocado-soybean unsaponifiable-Expanscience (ASU-E) to slow radiographic progression in symptomatic hip osteoarthritis (OA). METHODS: Prospective, randomised, double blind, parallel group, placebo controlled 3 year trial. Patients with symptomatic (painful ≥1 year, Lequesne Index between 3 and 10) hip OA (American College of Rheumatology criteria) and a minimum joint space width (JSW) of the target hip between 1 and 4 mm on a pelvic radiograph were randomly assigned to 300 mg/day ASU-E or placebo. Standing pelvis, target hip anteroposterior (AP) and oblique views were taken annually. The primary outcome was JSW change at year 3, measured at the narrowest point on pelvic or target hip AP view (manual measure using a 0.1 mm graduated magnifying glass). The full analysis dataset (FAS) included all patients having at least two successive radiographs. An analysis of covariance Mixed Model for Repeated Measurements with Missing at Random (for missing data) was performed to compare adjusted 3 year JSW changes (primary outcome) and the percentages of 'progressors' (JSW loss≥0.5 mm) between groups. RESULTS: 399 patients were randomised (345 kept in the FAS), aged 62 (35-84) years, 54% women, mean body mass index 27 (SD 4) kg/m(2), mean symptom duration 4 (SD 5) years, 0-100 normalised Lequesne Index 30 (SD 9) and global pain visual analogue scale 37 (SD 23) mm. Mean baseline JSW was 2.8 (0.9) mm. There was no significant difference on mean JSW loss (-0.638 mm vs -0.672 mm, p=0.72, in the ASU-E and placebo groups, respectively) but there were 20% less progressors in the ASU-E than in the placebo group (40% vs 50%, respectively, p=0.040). No difference was observed on clinical outcomes. Safety was excellent. CONCLUSIONS: 3 year treatment with ASU-E reduces the percentage of JSW progressors, indicating a potential structure modifying effect in hip OA to be confirmed, and the clinical relevance requires further assessment.

Efficacy and safety of rituximab in the treatment of refractory inflammatory myopathies in adults: results from the AIR registry.

OBJECTIVES: To assess the efficacy and safety of rituximab (RTX) in patients with refractory idiopathic inflammatory myopathies (IIMs). METHODS: RTX efficacy was based on improvement in three criteria: creatine phosphokinase (CPK) level, daily CS dose and physicians' opinion. A decrease in CPK level or CS dose was significant if it was >25%. RESULTS: Thirty patients were studied (21 women; age 52.5 years, disease duration 6.1 years). All had previously received immunosuppressors (ISs). Twenty-five patients received 1 g of RTX twice 2 weeks apart and five received 4 weekly RTX infusions (375 mg/m(2)). RTX was given in association with IS in 21 patients. Twenty-eight patients received CS (mean dose 21.2 mg/day). Mean follow-up was 17.2 months. Thirteen adverse events were reported, including seven infections and one serious infection (pyelonephritis). RTX was effective in 16 patients. Duration of efficacy was 15.5 months. Of the 20 patients with baseline CPK level ≥2 × upper limit of normal (ULN), 11 (55%) improved. The main level fell from 20.7 to 11 × ULN. CS decreased in 15 patients, stopped in 4, remained stable in 8 and increased in the remaining 3. The CS dose decreased from 21.2 to 9.9 mg/day. The physicians' opinion was favourable in 21 patients. Manual muscle testing was performed in only five patients: it increased from 87 to 91/100 at 6 months. CONCLUSIONS: RTX was well tolerated and had some beneficial effects on patients with IIM, the main limitation of this study resulted in a lack of manual muscle testing.

Chondrocalcinosis of the Knee and the Risk of Osteoarthritis Progression: Data From the Knee and Hip Osteoarthritis Long-term Assessment Cohort.

OBJECTIVE: To assess the impact of knee chondrocalcinosis (CC) on the 5-year risk of joint replacement and disease progression in patients with knee osteoarthritis (OA). METHODS: Patients with symptomatic knee OA without previous total joint (knee or hip) replacement (TJR) were recruited from the Knee and Hip Osteoarthritis Long-term Assessment cohort. Cox proportional hazards regression and generalized estimating equation models were used to compare the time from inclusion or OA diagnosis to total knee replacement (TKR) or TJR between patients with and those without knee CC at inclusion. In patients without incident TKR, logistic regression was performed to examine the association between CC and radiographic progression (Kellgren/Lawrence [K/L] grade) or worsening of Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscores for OA pain or function between years 0 and 5. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) were estimated. Analyses were adjusted for age, sex, body mass index, WOMAC subscores, and K/L grade. RESULTS: Among the 656 patients included, 93 (14.2%) had knee CC, and 91 (13.9%) underwent TKR during the follow-up. Risk of TKR was not affected by the presence of knee CC (HR 1.26 [95% CI 0.74-2.17]). Similar results were obtained for the risk of incident TJR. For patients without incident TKR, knee CC did not affect the risk of worsening of K/L grade (odds ratio [OR] 0.9 [95% CI 0.4-1.7]), WOMAC pain subscore (OR 1.1 [95% CI 0.7-1.4]), or WOMAC function subscore (OR 0.9 [95% CI 0.4-2.0]). CONCLUSION: In patients with symptomatic knee OA, the presence of knee CC did not affect the risk of arthroplasty or disease progression at 5 years.

Body composition and clinical symptoms in patients with hip or knee osteoarthritis: Results from the KHOALA cohort.

OBJECTIVE: To analyze the associations between body composition, notably low lean mass, and clinical symptoms [pain, physical function, quality of life (QoL)] in patients with symptomatic hip and/or knee OA. METHODS: Cross-sectional study using data from the 3-year follow-up visit of the Knee and Hip OsteoArthritis Long-term assessment (KHOALA) cohort. Skeletal muscle and fat mass were measured by dual X-ray absorptiometry (DXA). Fat mass index (FMI) was defined as total fat mass/height2. Appendicular lean mass was adjusted on body mass index (ALM/BMI), and low lean mass was defined according to the definition of FNIH Sarcopenia Project recommendations. Pain and function were measured by the WOMAC index and QoL by the SF-36. RESULTS: In total, 358 patients underwent DXA (67% women, mean [SD] age 63.4 [8.4] years, mean BMI 29.5 [5.6]kg/m2). The visual analog scale (0-100) pain score was 38.0 [24.7] and 25.4% had hip and 74.6% knee OA. Low lean mass and ALM/BMI were associated with impaired QoL and WOMAC scores on bivariate analysis (all p ≤ 0.001) but not on multivariate analysis after adjustment for FMI. For patients with normal BMI, mean [SD] WOMAC scores were higher (greater impairment) with low lean mass than normal body composition (WOMAC function 33.4 [23.3] and 24.0 [17.4], p = 0.02), and mean SF-36 physical component score was lower (greater impairment) 40.3 [10.2] and (44.3 [8.4], p = 0.04). Among patients with obesity, low lean mass had no additional effect. CONCLUSION: For patients with OA and normal BMI, QoL and function were more impaired for those with than without low lean mass. Conserving muscle mass in people with OA could have functional and antalgic benefits especially for those with normal BMI.

Remitting seronegative symmetrical synovitis pitting oedema after BCG instillation.

Remitting seronegative symmetrical synovitis pitting oedema (RS3PE) is a distinct form of seronegative rheumatoid arthritis like polyarthritis. It is characterized by late onset symmetrical joint involvement and pitting oedema of hands and feet (JAMA 254(19):2763-2767, [1]). Polyarthritis secondary to intravesical Bacillus Calmette Guerin (BCG) therapy has been reported (Clin Rheumatol 21:536-537, [2]). To our knowledge, about 0.5% of patients receiving BCG instillation presented polyarthritis, but only one case of RS3PE has been reported (J Rheumatol 28:1699-1701, [3]). We described the second case of RS3PE following intravesical BCG instillation of bladder carcinoma.

Systemic vasculitis revealing a benign tumor: a paraneoplastic syndrome?

Systemic vasculitis is a rare event in the course of malignant tumors and has not been described in association with benign tumors. We report a case of renal oncocytoma in a patient who presented with digital necrosis, arthralgia, myalgia, and a decline in general health. The symptoms resolved fully after tumor excision, supporting a diagnosis of paraneoplastic syndrome.

Femoro-tibial knee osteoarthritis: One or two X-rays? Results from a population-based study.

OBJECTIVE: Our objective was to compare the use of both anteroposterior (AP) extended-knee X-ray and semi-flexed X-ray (current gold standard) versus the use of semi-flexed X-ray alone to detect femoro-tibial osteoarthritis (OA). METHODS: Individuals 40 to 75 years of age with symptomatic hip and/or knee OA (Kellgren/Lawrence [KL] score≥2) were recruited using a multiregional prevalence survey in France. Both AP and schuss X-rays were performed and read; two years later, the same examiner, blinded to the results of the first reading, performed a second reading of the schuss X-ray. We compared the KL stages of each knee and analyzed osteophyte detection and localization, joint space narrowing (JSN), and the relationship to obesity. RESULTS: The analysis included 350 participants with OA of various stages. Comparing the two readings showed that a higher proportion of patients had KL≥2 when the two X-ray views were combined (right knee: P<0.0001; left knee: P<0.001). There were no differences when using the schuss X-ray alone versus in combination with an AP X-ray in terms of detecting JSN, osteophytes. A comparison of schuss X-ray alone versus AP X-ray alone demonstrated the superiority of the schuss view for evaluating JSN (P=0.0001 and P=0.0001) and no difference in osteophyte detection. CONCLUSION: Our study shows that the schuss view alone was sufficient for detecting knee osteophytes and JSN. Using one X-ray rather than two will reduce medical costs and irradiation burden. Using two views seems preferable for epidemiological studies.

Association between hip morphology and prevalence, clinical severity and progression of hip osteoarthritis over 3 years: The knee and hip osteoarthritis long-term assessment cohort results.

OBJECTIVE: To assess the effects of variations in hip morphology on prevalence, clinical severity and progression of hip osteoarthritis. METHODS: From 2007 to 2009, we conducted a study of 242 patients aged between 40 and 75 years with symptomatic lower limb osteoarthritis, as part of a population-based osteoarthritis cohort study in France. Standard radiographs of both hips were obtained at baseline and at three years. The progression of hip osteoarthritis was evaluated according to the radiological Kellgren-Lawrence score (KL) and clinical severity from the scores on a Visual Analogic Scale (VAS) for pain recorded yearly. Five measures were used to describe hip morphology: centre edge angle, acetabular index (AI), vertical centre anterior angle, acetabular depth and neck-shaft angle. RESULTS: Of the 484 hips studied, 205 (42%) showed osteoarthritis at baseline and 16 (11 right and 5 left) underwent joint replacement during the follow-up. AI was the morphological measure most consistently and strongly associated with radiographic osteoarthritis at baseline (odds-ratio=1.05, 95% CI: 1.01-1.08 per degree of angle change), clinical severity (correlation coefficient with VAS during 3 years=0.15, P=0.004), radiological progression (odds-ratio=1.05, 95% CI: 1.00-1.10 per degree) and joint replacement (hazard ratio=1.18, 95% CI: 1.07-1.29 per degree). CONCLUSIONS: Acetabular obliquity and especially AI is strongly, and likely causally, associated with the existence, severity and progression of hip osteoarthritis.

Topical ketoprofen patch (100 mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study.

BACKGROUND: Topical nonsteroidal anti-inflammatory drugs offer the advantage of enhanced drug delivery to local affected tissues with low plasma levels and an expected reduced incidence of systemic adverse events (mainly peptic ulcer disease and gastrointestinal hemorrhage). HYPOTHESIS: To test the efficacy and tolerability of a 100-mg patch of ketoprofen applied once a day. STUDY DESIGN: Randomized controlled clinical trial; Level of evidence, 1. METHODS: The 2-week trial included patients suffering painful (spontaneous pain >or=50 mm on a 0- to 100-mm visual analog scale), benign (grade I or II), recent (<2 days) ankle sprains as a model of general traumatic soft tissue injuries. The primary efficacy criterion was spontaneous pain change after 7 days of treatment in the intention-to-treat population. One hundred sixty-three patients were randomized (ketoprofen, 81; placebo, 82). RESULTS: After 1 week of treatment, the decrease in spontaneous pain was -50+/-20 mm for ketoprofen and -38+/-24 mm for the placebo, showing a statistically significant intergroup difference (P=.0007). The majority of the secondary criteria were also statistically significant in favor of the ketoprofen patch. Tolerance was good in both groups, adverse events being mostly local. CONCLUSION: This trial suggested that a 7-day course of treatment with a ketoprofen patch is useful in benign ankle sprain, without revealing unexpected adverse events.

Topical ketoprofen patch.

Although oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in the treatment of a variety of acute and chronic pain conditions, their use may be associated with serious systemic adverse effects, particularly gastrointestinal disorders. In order to minimise the incidence of systemic events related to such agents, topical NSAIDs have been developed. Topical NSAIDs, applied as gels, creams or sprays, penetrate the skin, subcutaneous fatty tissue and muscle in amounts that are sufficient to exert a therapeutic effect on peripheral and central mechanisms in the absence of high plasma concentrations. Data indicate that topical NSAIDs are effective at relieving pain in a number of acute and chronic pain indications. This review article discusses the pharmacokinetics, efficacy and tolerability of a new formulation of ketoprofen available as a topical patch. The topical patch containing ketoprofen 100mg as the active principle has been developed using a novel delivery system that dispenses therapeutic doses of the drug directly to the site of injury. Pharmacokinetic data indicate that although plasma levels of ketoprofen are higher when the drug is administered as a patch versus a gel, the total systemic bioavailability of ketoprofen 100 mg administered via a patch is no more than 10% of that reported for ketoprofen 100 mg administered orally. Because the patch facilitates ketoprofen delivery over a 24-hour period, the drug remains continually present in the tissue subjacent to the site of application. High tissue but low plasma ketoprofen concentrations mean that while tissue concentrations are high enough to exert a therapeutic effect, plasma concentrations remain low enough to not result in systemic adverse events caused by elevated serum NSAID levels. Phase III clinical trials in patients with non-articular rheumatism and traumatic painful soft tissue injuries showed that the topical ketoprofen patch was significantly more effective than placebo at reducing pain during daily activities and spontaneous pain after 7 days' treatment. Moreover, the topical ketoprofen patch was well tolerated; adverse events were primarily cutaneous in nature and occurred in a similar number of ketoprofen and placebo recipients suggesting that these events were related to the patch itself rather than the active ingredient. The incidence of gastrointestinal adverse events was low (<8% of all patients), and occurred in a similar proportion of patients receiving ketoprofen and placebo. Thus, the topical ketoprofen patch appears to be a simple, effective and safe therapeutic option for the treatment of local painful inflammation.

Can ischemic hip disease cause rapidly destructive hip osteoarthritis? A case report.

Avascular osteonecrosis of the femoral head (AONFH) usually goes through the four stages described by Arlet and Ficat: normal radiographs, heterogeneity and sclerosis of the femoral head, subchondral fracture with an individualized sequestrum, and secondary osteoarthritis. Arlet and Ficat individualized a specific pattern of AONFH which they called ischemic hip disease, in which cartilage damage seen as concentric joint space loss precedes the bony alterations. Although radiological and pathological studies of ischemic hip disease have been published, no clinical data are available. We report the case of a 65-year-old man admitted for a 1-month history of severe hip symptoms with concentric joint space loss but no osteophytes. Laboratory tests and examination of fluid aspirated from the hip ruled out septic arthritis and inflammatory hip disease. Two magnetic resonance imaging (MRI) studies done 1 month apart showed diffuse edema involving not only the femoral head but also the neck and trochanter, as well as major synovial hypertrophy. This atypical MRI appearance prompted synovial membrane and pertrochanteric core biopsies, which showed reactive synovitis and stage IV osteonecrosis, respectively. The pain, disability, and joint space loss worsened. Total hip arthroplasty was performed 1 month after the biopsy. Histological examination of the femoral head showed diffuse necrosis; no evidence of another condition was found on histological sections of the entire synovial membrane. This case corroborates the hypotheses put forward by Lequesne that some cases of rapidly destructive hip osteoarthritis may be ascribable to ischemia.

[Retrospective analysis of adverse effects of infliximab in a hospital rheumatology service]. / Analyse rétrospective des effets indésirables de l'infliximab dans un service hospitalier de rhumatologie.

Infliximab is a chimeric monoclonal antibody against human tumour necrosis factor-alpha (TNF alpha), and has received marketing authorization for the treatment of both rheumatoid arthritis (RA) and Crohn's disease. The aim of the present survey was to assess retrospectively adverse drug reactions (ADRs) in patients treated with infliximab for RA in a rheumatology department of the Toulouse University Hospital (Rangueil Hospital). Among 32 patients included in 2000 and 2001, 43 "expected" ADRs occurred in 21 patients (65.6%) [mean age 51.4 +/- 14.0 years]. In four patients (12.5%), ADRs were classified as "serious". In five other patients, they required the discontinuation of infliximab. We identified mainly infectious (n = 21), allergic (n = 3) and cardiovascular (n = 3) ADRs. Infectious ADRs were as follows: seven urinary infections, with a positive rechallenge (R+) in five; nine respiratory infections, with R+ in five; and five cutaneous infections. An acute rise in blood pressure occurred in three patients who had already been treated with antihypertensive drugs. The incidence of ADRs was as follows: respiratory 28.0%; urinary 22.0%; cutaneous 15.6%; allergic 9.4%; and cardiovascular 9.4%. In conclusion, our data allowed a quantitative and qualitative assessment of infliximab-induced ADRs. Further studies are required in order to improve knowledge regarding ADRs induced by long-term treatment with infliximab.

Diffuse idiopathic skeletal hyperostosis (Forestier-Rotes-Querol disease): what's new?

Diffuse idiopathic skeletal hyperostosis (DISH), also known as Forestier-Rotes-Querol disease, is characterized by the ossification of the entheses (i.e., enthesopathy). The diagnosis of DISH requires at least two (according to Forestier) or three (according to Resnick) contiguous intervertebral bridges, without severe disk alterations (in contrast to degenerative spinal disease) or ankylosis of the sacroiliac or facet joints (in contrast to spondylarthritis). Although prevalence estimates vary with the number of bridges used to define the disease, the prevalence of DISH is consistently high and increases with age and obesity. Peripheral involvement is common but difficult to ascribe to DISH in the absence of typical spinal changes. Cervical spine ossification is the most extensively studied manifestation, as dysphagia due to esophageal compression may require surgery. As with spondylarthritis, vertebral fractures on a hyperostotic fused spine may escape recognition, placing the patient at risk for complications in the event of subsequent displacement. These fractures are particularly severe, as they often involve the cervical spine and can therefore, cause major neurological impairments. DISH is associated with an increased risk of metabolic syndrome (odds ratio, 3.88). Research into the pathophysiology of DISH has established that serum levels of the natural osteogenesis inhibitor Dickkopf-1 (DKK-1) are low in patients with DISH or spondylarthritis. Although this abnormality might contribute to the entheseal ossification, it has not been found consistently.

Relationship between hip dysplasia, pain, and osteoarthritis in a cohort of patients with hip symptoms.

OBJECTIVE: The relationship between acetabular dysplasia (HD) and hip osteoarthritis (OA) remains unclear, especially for mild forms of dysplasia. Our objectives were to estimate the prevalence of HD in a population-based sample with symptoms and to evaluate potential associations linking HD, hip OA, and hip pain. METHODS: Individuals 40 to 75 years of age with symptoms in 1 or both hips were recruited during a multiregional prevalence survey. All study participants underwent examination and radiographs. Radiographs were evaluated using Kellgren-Lawrence staging (with stages ≥ 2 indicating hip OA) and HD measures [center-edge (CE) angle, acetabular inclination angle (HTE), acetabular depth (AD), and vertical center-anterior margin angle]. RESULTS: We studied both hips of 842 individuals (1684 hips), among whom 203 had hip OA. Compared to left hips, right hips had significantly smaller CE angles and significantly greater AD and HTE values (p ≤ 0.001). Overall, the prevalence of HD ranged from 7.6% to 22.2% of the hips depending on the measure used. The prevalence of HD was higher in individuals with hip OA, with significant differences for abnormal HTE (19.1% vs 11.4%; p < 0.0001) and abnormal CE (11.3% vs 7.5%; p = 0.04). By logistic regression, only abnormal HTE remained associated with OA. Same-side hip pain was not statistically more common in individuals with HD after stratification on OA status (p = 0.12). CONCLUSION: Our study confirms the relationship between OA and HD, particularly as defined based on the HTE angle.

Reproducibility of radiographic hip measurements in adults.

INTRODUCTION: Hip dysplasia may cause pain and premature hip osteoarthritis. Here, our objective was to assess the inter- and intraobserver reproducibility of radiographic hip parameter measurement in adults. METHODS: We used anteroposterior pelvic radiographs and false-profile lateral hip radiographs from 30 individuals (60 hips) enrolled in a prevalence study of hip osteoarthritis. For each hip, two independent observers recorded five parameters twice, at an interval of 1 month. The five parameters were the vertical-center-edge angle (VCE), the anterior center-edge angle (vertical-center-anterior angle, VCA), the acetabular roof angle (HTE), the neck-shaft angle (CC'D), and acetabulum depth (AD). Reproducibility was assessed using Bland-Altman plots, intraclass correlation coefficients (ICCs), and kappa coefficients for the radiographic diagnosis of hip dysplasia using widely accepted cutoffs. RESULTS: Of the 60 hips, 51 were assessable. Intraobserver ICC values ranged from 0.72 to 0.94 and interobserver ICC values from 0.68 to 0.84. Kappa coefficients were between 0.60 and 1.00, except for the VCA angle (κ=0.41). CONCLUSION: In this study, reproducibility of the main radiographic hip parameters was good according to all evaluation methods used. However, CC'D and, to an even greater extent, the VCA angle seemed challenging to measure.

The KHOALA cohort of knee and hip osteoarthritis in France.

OBJECTIVES: This study aimed to describe the prevalence of symptomatic knee and hip osteoarthritis (OA) and its course over time, as well as identify prognostic factors of OA course and determinants of costs and access to care in France in a patient cohort. METHODS: Subjects aged 40 to 75 years, with uni- or bilateral symptomatic hip and/or knee OA (ACR criteria), Kellgren and Lawrence (KL) stage 2 or greater, were recruited from a French national prevalence survey for the multicenter KHOALA cohort study. Data collected at baseline included sociodemographic and clinical data; WOMAC, IKS and Harris scores for pain and function; MAQ score for physical activity; functional comorbidity index; GHQ28 score for psychological status; and SF-36 (generic) and OAKHQOL (specific) scores for quality of life. Blood and urine samples were collected. RESULTS: Eight hundred and seventy-eight subjects were included, 222 with OA of the hip (mean age 61.2±8.8 years), 607 knee (mean age 62.0±8.5 years) and 49 both hip and knee (mean age 64.9±7.9 years). Mean body mass index was 26.9±4.5 for hip OA and 30.3±6.3 for knee OA. Hip and knee OA patients had 1.99 and 2.06 comorbidities, on average, respectively. Disease severity on X-rays for KL stages 2, 3 and 4 for hip OA was 69.8, 26.1 and 4.1%, respectively, and for knee OA, 44.5, 30.3, and 25.2%. As compared with population norms, age- and sex-standardized SF-36 scores were greatly decreased for both knee and hip OA in all dimensions, particularly physical and emotional dimensions. PERSPECTIVES: Patients will be followed up annually, alternately by mail and clinical visit. This cohort of representative patients with knee and hip OA will be an opportunity for future collaborative research.

Rituximab treatment for spondyloarthritis. A nationwide series: data from the AIR registry of the French Society of Rheumatology.

OBJECTIVE: To evaluate the efficacy and safety of rituximab (RTX) in several subsets of spondyloarthritis (SpA) using the data of the AIR (Autoimmunity and Rituximab) registry. METHODS: All patients receiving RTX for SpA, and prospectively included in the AIR registry from September 2005 to September 2010, were retrospectively analyzed. The response to treatment was evaluated by the Bath Ankylosing Spondylitis Disease Activity Index for axial disease, joint count for peripheral disease, and C-reactive protein reduction. RESULTS: Among the 595 patients included in the AIR registry, 26 patients with SpA from 13 centers were reported: ankylosing spondylitis (10), undifferentiated SpA (7), and psoriatic arthritis (9). Mean disease duration was 8.8 years (range 1-40). The extraarticular features found were psoriasis, 12 cases; uveitis, 4 cases; and Crohn's disease, 3 cases. The mean number of disease-modifying antirheumatic drugs before RTX was 2.4; previous anti-tumor necrosis factor (TNF) agents were taken in 23 cases. The mean number of RTX courses was 1.5 (range 1-5), with a total of 35.6 patient-years. Efficacy was noted in 11/23 cases: 3 out of 3 anti-TNF-naive patients and 8 out of 20 anti-TNF nonresponder patients. No predictive factors of response could be identified, particularly in diagnosis subsets or clinical presentation (axial or peripheral). CONCLUSION: In this nationwide study of several subsets of SpA, RTX had only a moderate efficacy that was more marked in patients who were anti-TNF-naive.