CT evaluation of bone fragility 2 years after bariatric surgery: an observational study.

INTRODUCTION: The objectives were to evaluate bone fragility on computed tomography (CT) in patients with obesity before and 2 years after bariatric surgery and to identify risk factors for a decrease in the scanographic bone attenuation coefficient of the first lumbar vertebra (SBAC-L1). MATERIALS AND METHODS: Patients with obesity who underwent bariatric surgery and CT before and 2 years (± 6 months) after bariatric surgery were included. SBAC-L1 was measured on CT with a fracture threshold at 145 HU. RESULTS: 78 patients were included, 85.9% women, mean age of 48.5 years (± 11.4); the mean BMI was 46.2 kg/m2 (± 7) before surgery and 29.8 kg/m2 (± 6.7) 2 years after surgery. There was a significant change in SBAC-L1 2 years after surgery (p = 0.037). In multivariate analysis, the risk factors for having an SBAC-L1 ≤ 145HU 2 years after bariatric surgery in those with an SBAC-L1 > 145HU before surgery were age and sex, with men and older patients having a higher risk (OR 32.6, CI 95% [1.86-568.77], and OR 0.85, CI 95% [0.74-0.98], respectively). CONCLUSION: SBAC-L1 was significantly lower two years after bariatric surgery. Men sex and older patients were the risk factors for having an SBAC-L1 below the fracture threshold 2 years after surgery.

Development of a new ultrasound scoring system to evaluate glandular inflammation in Sjögren's syndrome: an OMERACT reliability exercise.

OBJECTIVE: The aim of this exercise from the OMERACT Ultrasound subgroup on Sjögren's syndrome was to develop and assess the reliability of a consensus-based semiquantitative colour Doppler US scoring system for pathologic salivary gland vascularization in patients with primary Sjögren's syndrome (pSS). METHODS: Using the Delphi method, a colour Doppler semiquantitative scoring system for vascularization of bilateral parotid and submandibular glands was developed and tested in static images and on patients (9 pSS patients and 9 sonographers). Intra-reader and inter-reader reliability of grading the salivary glands were computed by weighted Cohen and Light's kappa analysis, respectively. RESULTS: The consensus-based semiquantitative score was: grade 0, no visible vascular signals; grade 1, focal, dispersed vascular signals; grade 2, diffuse vascular signals detected in <50% of the gland; grade 3, diffuse vascular signals in >50% of the gland. In static images, the intra- and inter-reader reliability showed excellent kappa values (95% CI) of 0.90 (0.87, 0.93) and 0.80 (0.74, 0.84), respectively, for all four salivary glands together. In patients, the intra- and inter-reader reliability for all four salivary glands together was kappa = 0.84 (0.73, 0.92) and 0.70 (0.64, 0.76), respectively. CONCLUSION: The consensus-based colour Doppler US scoring for the evaluation of salivary gland vascularization in pSS showed a good inter-reader reliability and excellent intra-reader reliability in static images and in patients. The clinical application of the developed scoring system should be tested in clinical settings.

Characteristics of patients with knee and/or hip osteoarthritis undergoing spa treatment: the prospective KHOALA cohort study.

Knee and hip osteoarthritis (KHOA) are a source of functional impairment. With aging, the management of osteoarthritis (OA) is a major issue in the search for improved quality of life. Spa treatment provides short- and mid-term symptom relief without serious side effects. This study aimed to identify characteristics of patients with KHOA associated with use of spa treatment. The prospective KHOALA cohort included 878 adults aged 40 to 75 years with symptomatic KHOA. We separately analyzed knee and hip OA data and compared patients who never had spa treatment with those who had at least one or multiple treatments during 5 years of follow-up in terms of socio-demographic characteristics, clinical data, quality of life (OAKHQOL, SF-36), physical activity (MAQ), functional impairment (WOMAC), and health care consumption (pharmacological and non-pharmacological treatments). Factors associated with at least one or multiple spa treatments were evaluated with regression logistic models. In all, 607 (69.1%) patients had knee OA (KOA), 222 (25.3%) hip OA (HOA) and 49 (5.6%) both, 91 (13.9%) with KOA, and 33 (12.2%) with HOA had at least one spa treatment. In the KOA cohort, the probability of at least one, two, or three spa treatments was increased with older age (odds ratio = 1.6 [95% confidence interval 1.2-2.2], 1.8 [1.2-2.8], 2.4 [1.4-4.2], respectively), greater use of physiotherapy (OR = 3.9 [2.1-7.1], 2.7 [1.3-5.6], 2.5 [1.1-5.9]), having a prosthesis (OR = 2.1 [1.2-3.8], 2.2 [1.1-4.3], 2.5 [1.1-5.5]), and low MAQ score (OR = 0.7 [0.6-0.9], 0.7 [0.5-1.0], 0.7 [0.5-1.0]). In the HOA cohort, female sex was associated with at least one (OR = 3.0 [1.1-8.0]) or two (OR = 5.1 [1.2-22.5]) spa treatments. In this cohort of KHOA, repeated spa treatment over 5 years was strongly associated with older age, greater use of physiotherapy and presence of a prothesis with KOA and female sex with HOA. This study may help to better understand spa treatment determinants in OA.

Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial.

Importance: Few treatments are available for patients with glucocorticoid-dependent polymyalgia rheumatica. IL-6 antagonists may reduce disease activity in patients with active glucocorticoid-dependent polymyalgia rheumatica. Objective: To compare the efficacy of tocilizumab vs placebo in patients with glucocorticoid-dependent polymyalgia rheumatica. Design, Setting, and Participants: This double-blind, parallel-group, placebo-controlled randomized clinical trial enrolled 101 patients with polymyalgia rheumatica at 17 hospitals in France from February 2017 to October 2019. Final follow-up occurred in November 2020. Inclusion criteria were persistent disease activity (polymyalgia rheumatica activity score computed using the C-reactive protein level [CRP PMR-AS] >10) and prednisone dose greater than or equal to 10 mg per day. Interventions: Patients were randomly assigned to receive intravenous tocilizumab (8 mg/kg; n = 51) or placebo (n = 50) every 4 weeks for 24 weeks, combined with predefined standardized tapering of oral prednisone. Main Outcomes and Measures: The primary efficacy end point was CRP PMR-AS less than 10 (range, 0-100; higher values indicate greater activity; no minimal clinically important difference defined) combined with either prednisone dose less than or equal to 5 mg per day or a decrease in prednisone dose greater than or equal to 10 mg from baseline at week 24. There were 11 secondary outcomes assessed at week 24 included in this report, including disease activity (measured by CRP PMR-AS) and the proportion of patients no longer taking prednisone. Results: Of the 101 randomized patients (mean age, 67.2 years; 68 [67.3%] women), 100 (99%) received at least 1 infusion and 100 completed the trial. The primary end point was achieved in 67.3% of patients in the tocilizumab group and 31.4% of patients in the placebo group (adjusted difference, 36.0% [95% CI, 19.4%-52.6%]; adjusted relative risk, 2.3 [95% CI, 1.5-3.6]; P < .001). Of 11 reported secondary end points at 24 weeks, 7 showed significant differences favoring tocilizumab, including mean CRP PMR-AS score (7.5 [95% CI, 5.4-9.6] vs 14.9 [95% CI, 11.4-18.4]; adjusted difference, -7.5 [95% CI, -11.2 to -3.8]; P < .001) and the percentage of patients no longer receiving prednisone (49.0% vs 19.6%; adjusted difference, 29.3% [95% CI, 18.9%-39.7%]; adjusted relative risk, 2.5 [95% CI, 1.8-3.5]; P < .001). The most frequent adverse events were infections, experienced by 23 patients (46.9%) in the tocilizumab group and 20 (39.2%) in the placebo group. Conclusions and Relevance: Among patients with active polymyalgia rheumatica despite prednisone therapy, tocilizumab, compared with placebo, resulted in a significantly greater percentage of patients with a CRP PMR-AS less than 10 with reduced prednisone requirements at week 24. Further research is needed to confirm efficacy and to determine the balance of potential benefits and harms. Trial Registration: ClinicalTrials.gov Identifier: NCT02908217.

Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA).

OBJECTIVE: To evaluate the impact of a nurse-led program of self-management and self-assessment of disease activity in axial spondyloarthritis. METHODS: Prospective, randomized, controlled, open, 12-month trial (NCT02374749). Participants were consecutive axial spondyloarthritis patients (according to the rheumatologist) and nurses having participated in a 1-day training meeting. The program included self-management: educational video and specific video of graduated, home-based exercises for patients; and self-assessment: video presenting the rationale of tight monitoring of disease activity with composite scores (Ankylosing Spondylitis Disease activity Score, ASDAS/Bath Ankyslosing Spondylitis Disease Activity Index, BASDAI). The nurse trained patients to collect, calculate and report (monthly) ASDAS/BASDAI. Treatment allocation was by random allocation to this program or a comorbidities assessment (not presented here and considered here as the control group). RESULTS: A total of 502 patients (250 and 252 in the active and control groups, respectively) were enrolled (age: 46.7 (12.2) years, male gender: 62.7%, disease duration: 13.7 (11.0) years). After the one-year follow-up period, the adherence to the self-assessment program was considered good (i.e. 79% reported scores >6 times). Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ). CONCLUSION: This study suggests a short-term benefit of a nurse-led program on self-management and self-assessment for disease activity in a young axial spondyloarthritis population in terms of disease activity, exercises and physical activity.

Secukinumab and ustekinumab treatment in psoriatic arthritis: results of a direct comparison.

OBJECTIVES: To evaluate the characteristics of patients (pts) with PsA treated by ustekinumab (UST) or secukinumab (SEK) and to compare real-world persistence of UST and SEK in PsA. METHODS: In this retrospective, national, multicentre cohort study, pts with PsA (CASPAR criteria or diagnosis confirmed by the rheumatologist) initiating UST or SEK with a follow-up ≥6 months were included from January 2011 to April 2019. The persistence between SEK and UST was assessed after considering the potential confounding factors by using pre-specified propensity-score methods. Causes of discontinuation and tolerance were also collected. RESULTS: A total of 406 pts were included: 245 with UST and 161 with SEK. The persistence rate was lower in the UST group compared with the SEK group [median persistence 9.4 vs 14.7 months; 26.4% vs 38.0% at 2 years; weighted hazard ratio (HR) = 1.42; 95% CI: 1.07, 1.92; P =0.015]. In subgroup analysis, the persistence rate of SEK associated with MTX was significantly higher than that of UST associated with MTX: HR = 2.20; 95% CI: 1.30, 3.51; P =0.001, in contrast to SEK vs UST monotherapy: HR = 1.06; 95% CI: 0.74, 1.53; P =0.75. Discontinuation due to inefficacy was reported in 91.7% (SEK) and 82.4% (UST) of pts. Discontinuation due to an adverse event was reported in 12.2% (SEK) and 7.7% (UST) of pts. CONCLUSION: In this first study comparing UST and SEK, the persistence of SEK was higher than that of UST in PsA. In subgroup analysis, this difference was only found in association with MTX.

Topographical analysis of structural lesions between dominant and non-dominant hands in erosive osteoarthritis.

KEY MESSAGES: No difference between both hands was observed for clinical and radiographical presentations in EHOA patients. A bilateral and symmetrical relationship was found between hand joints. HIGHLIGHTS: EHOA have symmetrical distribution and specific association in structural lesions. This study aims to analyse the preferential topographical distribution of clinical and structural lesions between the dominant and non-dominant hands in erosive hand osteoarthritis (EHOA) patients. Both hands were assessed via radiography in EHOA patients. A comparative analysis of the clinical features and structural lesions between the dominant and non-dominant hands was performed. The structural lesions were assessed according to the anatomical radiographic score of Verbruggen-Veys (VV). Next, a principal component analysis was performed to describe and highlight the relationships observed between the joints. Sixty patients were included in this study: there were 57 women, and the mean age was 66.1 (± 7.6) years. For the distal interphalangeal (DIP) joints, nodes were observed more frequently on the dominant hand (4 vs 3; p = 0.005). No difference in structural lesions was observed between the two hands except for the 2nd proximal interphalangeal (PIP) (p = 0.045). A principal component analysis with varimax rotation described relationships between the 2nd PIP, 3rd PIP, 4th PIP, 4th DIP and 5th DIP joints in both hands. No significant differences between dominant and non-dominant hands were observed for clinical and structural lesions in our sample of EHOA patients. A bilateral and symmetrical injury was observed in most EHOA joints. Trial registration Clinical trial registration number: NCT01068405.

ACPA-positive versus ACPA-negative rheumatoid arthritis: two distinct erosive disease entities on radiography and ultrasonography.

The objective of this study is to assess the prevalence, localization, and severity of bone erosions on radiography (RX) and ultrasonography (US) according to ACPA status in patients with rheumatoid arthritis (RA). 78 patients with ACPA-positive (ACPA+) RA and 30 patients with ACPA-negative (ACPA-) RA fulfilling the ACR 1987 and/or ACR/EULAR 2010 criteria were consecutively included. On RX, a modified Sharp erosion score (SHSe) was evaluated by two blinded readers and one adjudicator for discordant cases (number of eroded joints ≤ three). On US, erosions were scored on six bilateral joints (MCP2, 3, 5; MTP2, 3, 5) with a four-point scale to calculate the total US score for erosions (USSe). The mean total SHSe and USSe were 3.7 and 4.4 times higher in the ACPA+ group than in the ACPA- group, respectively (P < 0.001). On both RX and US, the most discriminating joint between the two groups was MTP5, especially in cases with bilateral erosion. Based on multivariate analyses, ACPA + status was associated with erosive RA on RX according to the EULAR 2013 definition criteria [OR 4.4 (95% CI 1.2-16.4)], and on US according to the following two definitions: the presence of at least two eroded joint facets [OR 3.7 (95% CI 1.4-9.9)] or at least one grade 2 joint facet erosion [OR 9.0 (95% CI 2.8-28.4)]. Compared to ACPA- RA, ACPA + RA is associated independently with more severe erosive disease on RX and US. Both US and RX bilateral erosions in MTP5 joints are highly discriminant for ACPA + RA patients (97.8% in US and 100% in RX).

Video clip assessment of a salivary gland ultrasound scoring system in Sjögren's syndrome using consensual definitions: an OMERACT ultrasound working group reliability exercise.

OBJECTIVE: To develop ultrasound (US) definitions and a US novel scoring system for major salivary gland (SG) lesions in patients with primary Sjögren's syndrome (pSS) and to test their intrareader and inter-reader reliability using US video clips. METHODS: Twenty-five rheumatologists were subjected to a three-round, web-based Delphi process in order to agree on (1) definitions and scanning procedure of salivary gland ultrasonography (SGUS): parotid, submandibular and sublingual glands (PG, SMG and SLG); (2) definitions for the elementary SGUS lesions in patients with Sjögren's syndrome; (3) scoring system for grading changes. The experts rated the statements on a 1-5 Likert scale. In the second step, SGUS video clips of patients with pSS and non-pSS sicca cases were collected containing various spectrums of disease severity followed by an intrareader and inter-reader reliability exercise. Each video clip was evaluated according to the agreed definitions. RESULTS: Consensual definitions were developed after three Delphi rounds. Among the three selected SGs, US assessment of PGs and SMGs was agreed on. Agreement was reached to score only greyscale lesions and to focus on anechoic/hypoechoic foci in a semiquantitative matter or, if not possible on a qualitatively (present/absent) evaluation of fatty or fibrous lesions. Intrareader reliability for detecting and scoring these lesions was excellent (Cohen's kappa 0.81) and inter-reader reliability was good (Light's kappa 0.66). CONCLUSION: New definitions for developing a novel semiquantitative US score in patients with pSS were developed and tested on video clips. Inter-reader and intrareader reliabilities were good and excellent, respectively.

Performance of 18F-sodium fluoride positron emission tomography with computed tomography to assess inflammatory and structural sacroiliitis on magnetic resonance imaging in axial spondyloarthritis.

OBJECTIVES: To assess increased sacroiliac joint (SIJ) uptake on 18F-NaF PET/CT according to a qualitative and quantitative approach and to compare with MRI SIJ assessments for structural and inflammatory sacroiliitis in a population of 23 patients with spondyloarthritis (SpA) (IDRCB: 2012-A00568-35; ClinicalTrials.gov: NCT 02869100). METHODS: This single-center prospective study included 23 patients with active SpA according to the ASAS and/or modified NY criteria. All patients had a pelvic AP-view radiograph, MRI of the SIJ and 18F-NaF PET/CT examinations within a month, which were analysed by three blinded readers. For MRI data, the SIJs were assessed according to the ASAS criteria and SPARCC method for scoring structural lesions (erosion, sclerosis, fat metaplasia, backfill and ankylosis) and inflammation. On the 18F-NaF PET, the SIJs were scored according to a slice-by-slice approach. Abnormal uptake was assessed using a qualitative method inspired by the ASAS criteria and two quantitative approaches (the PET-activity score according to the SPARCC method and the maximum standardised uptake value (SUVmax) for each SIJ). RESULTS: Structural sacroiliitis was observed on 7 radiographs and 15 MRIs. 10 MRIs showed inflammatory sacroiliitis (mean SPARCC 18.7). Twenty patients had a positive PET with a mean PET-activity score of 18.2 (±8.7). The mean SUVmax for a positive PET was 1.78 vs. 1.45 for a negative one. The inter-reader reliability was good for the PET activity score (ICC= 0.56 [IC-95: 0.32; 0.76]) and good to excellent for the SUVmax (ICC=0.70-0.90 [IC-95: 0.41; 0.96]). According to a binary approach, a positive PET was not correlated with a positive MRI for structural sacroiliitis. The PET-activity score (r=0.61, p=0.001) and SUVmax (r=0.56, p=0.004) were correlated with the SPARCC inflammation score but not with structural sacroiliitis or for SPARCC structural lesions. CONCLUSIONS: Abnormal uptake by the SIJ on 18F-NaF PET is more frequent (87.0%) than inflammatory (43.5%) and structural sacroiliitis (65.2%) on MRI in a population of SpA patients. The PET activity score and SUVmax had good correlations with inflammatory sacroiliitis but not with structural lesions on MRI.