To evaluate the efficacy and safety of rituximab in patients with primary Sjögren's syndrome (pSS).
The AutoImmune and Rituximab registry has included 86 patients with pSS treated with rituximab, ...prospectivey followed up every 6 months for 5 years.
Seventy-eight patients with pSS (11 men, 67 women), who already had at least one follow-up visit, were analysed. Median age was 59.8 years (29-83), median duration of disease was 11.9 years (3-32). Indications for treatment were systemic involvement for 74 patients and only severe glandular involvement in four patients. The median European Sjögren's Syndrome disease activity index (ESSDAI) was 11 (2-31). 17 patients were concomitantly treated with another immunosuppressant agent. Median follow-up was 34.9 months (6-81.4) (226 patient-years). Overall efficacy according to the treating physician was observed in 47 patients (60%) after the first cycle of rituximab. Median ESSDAI decreased from 11 (2-31) to 7.5 (0-26) (p<0.0001). Median dosage of corticosteroid decreased from 17.6 mg/day (3-60) to 10.8 mg/day (p=0.1). Forty-one patients were retreated with rituximab. Four infusion reactions and one delayed serum sickness-like disease resulted in rituximab discontinuation. Three serious infections (1.3/100 patient-years) and two cancer-related deaths occurred.
In common practice, the use of rituximab in pSS is mostly restricted to patients with systemic involvement. This prospective study shows good efficacy and tolerance of rituximab in patients with pSS and systemic involvement.
The aim of this study was (1) to evaluate the relative and absolute reliability of gait parameters during walking in single- and dual-task conditions in patients with axial spondyloarthritis (axSpA), ...(2) to evaluate the absolute and relative reliability of dual task effects (DTE) parameters, and (3) to determine the number of trials required to ensure reliable gait assessment, in patients with axSpA. Twenty patients with axSpa performed a 10-m walk test in single- and dual-task conditions, three times for each condition. Spatiotemporal, symmetry, and DTE gait parameters were calculated from foot-worn inertial sensors. The relative reliability (intraclass correlation coefficients-ICC) and absolute reliability (standard error of measurement-SEM and minimum detectable change-MDC) were calculated for these parameters in each condition. Spatiotemporal gait parameters showed good to excellent reliability in both conditions (0.59 < ICC < 0.90). The reliability of symmetry and DTE parameters was low. ICC, SEM, and MDC were better when using the mean of the second and the third trials. Spatiotemporal gait parameters obtained from foot-worn inertial sensors assessed in patients with axSpA in single- and dual-task conditions are reliable. However, symmetry and DTE parameters seem less reliable and need to be interpreted with caution. Finally, better reliability of gait parameters was found when using the mean of the 2nd and the 3rd trials.
Studies on the effects of dual tasking in patients with chronic inflammatory rheumatic diseases are limited. The aim of this study was to assess dual tasking while walking in patients with axial ...spondyloarthritis (axSpA) in comparison to healthy controls. Thirty patients with axSpA and thirty healthy controls underwent a 10-m walk test at a self-selected comfortable walking speed in single- and dual-task conditions. Foot-worn inertial sensors were used to compute spatiotemporal gait parameters. Analysis of spatiotemporal gait parameters showed that the secondary manual task negatively affected walking performance in terms of significantly decreased mean speed (p < 0.001), stride length (p < 0.001) and swing time (p = 0.008) and increased double support (p = 0.002) and stance time (p = 0.008). No significant interaction of group and condition was observed. Both groups showed lower gait performance in dual task condition by reducing speed, swing time and stride length, and increasing double support and stance time. Patients with axSpA were not more affected by the dual task than matched healthy controls, suggesting that the secondary manual task did not require greater attention in patients with axSpA. Increasing the complexity of the walking and/or secondary task may increase the sensitivity of the dual-task design to axial spondyloarthritis.
Abstract Objectives Complex Regional Pain Syndrome Type 1 is a severely disabling pain syndrome with no definite established treatment. We have performed a systematic literature review and ...meta-analysis of all randomized controlled trials to assess the benefit of bisphosphonates on pain and function in patients with Complex Regional Pain Syndrome Type 1. Methods A systematic literature search was performed in the Medline, Embase and Cochrane databases. Two authors selected independently blinded randomized trials comparing bisphosphonates to placebo on short-term (J30 to J40) and medium term pain (M2–M3), safety and function in patients with CRPS 1. The methodological quality of the studies was analyzed. Data were aggregated using the method of the inverse of the variance. Results 258 articles were identified. Four trials of moderate to good quality comprising 181 patients (90 in the bisphosphonate group and 91 in the placebo group) were included in this meta-analysis. Short-term pain Visual Analog Scale was significantly lower in the bisphosphonate group versus the placebo group (SMD = −2.6, 95%CI −1.8, −3.4, P < 0.001), as well as the medium term Visual Analog Scale pain (SMD = −2.5, 95%CI −1.4, −3.6, P < 0.001). There were more adverse events in the bisphosphonate group (35.5%) than in the placebo group (16.4%) with a relative risk of 2.1 (95%CI 1.3, 3.5, P = 0.004) and a number needed to harm of 4.6, (95%CI 2.4, 168.0) but no serious side effects. Conclusions Our results suggest that bisphosphonates reduce pain in patients with Complex Regional Pain Syndrome type 1. Other studies are needed to determine their effectiveness.
Objective
Several lines of evidence have emphasized an improvement in aerobic capacity and muscle strength after physical exercise programs in rheumatoid arthritis (RA) patients. Our objective was to ...evaluate the efficacy of aerobic exercises in RA on quality of life, function, and clinical and radiologic outcomes by a systematic literature review and a meta‐analysis.
Methods
A systematic literature search was performed in the Medline, EMBase, and Cochrane databases up to July 2009 and in the s presented at rheumatology scientific meetings during the last 5 years. Randomized controlled trials (RCTs) comparing aerobic exercises with non‐aerobic interventions in RA patients were included. Outcomes studied were postintervention quality of life, function assessed by the Health Assessment Questionnaire (HAQ), a pain visual analog scale (VAS), joint count, the Disease Activity Score in 28 joints (DAS28), and radiologic damage. Efficacy was assessed by standardized mean differences (SMDs; difference between groups of mean outcome variation from baseline/SD at baseline) of aerobic exercises versus non‐aerobic rehabilitation. Heterogeneity was tested. SMDs were pooled by a meta‐analysis using the inverse of variance model.
Results
Fourteen RCTs, including 1,040 patients, met the inclusion criteria. Exercise improved the postintervention quality of life (SMD 0.39, P < 0.0001), HAQ score (SMD 0.24, P = 0.0009), and pain VAS (SMD 0.31, P = 0.02). Exercise in this RA population appeared safe, since global compliance, DAS28, and joint count were similar in both groups.
Conclusion
Cardiorespiratory aerobic conditioning in stable RA appears to be safe and improves some of the most important outcome measures. However, the degree of the effect of aerobic exercise on the abovementioned parameters is small.
IntroductionSubclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with ...patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. This study aims to determine the impact of a GFD on the quality of life of patients with axial SpA.Methods and analysisThe GlutenSpA study is a 24-week, randomised, double-blinded, placebo-controlled, multicentre trial. Patients with axial SpA (n=200) will follow a 16-week GFD and be randomly assigned (1:1) to an experimental or control arm. In the experimental arm with receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavour capsules per day. The control arm will receive at least 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day. The primary end-point is the variation in Assessment of SpondyloArthritis International Society—Health Index (ASAS-HI) questionnaire between week 16 and baseline. A second open-label period of 8 weeks will follow the intervention period, during which the patient will be free to decide whether they will follow the GFD. The secondary outcomes comprise several patient-reported outcomes (SpA activity (Bath Ankylosing Spondylitis Disease Activity Index)), fatigue (Functional Assessment of Chronic Illness Therapy), depression (Hospital Anxiety and Depression Scale), functional disability index (Bath Ankylosing Spondylitis Functional Index)), variations in body mass index and Homeostasis Model Assessment Index and variations in the abundance and type of bacterial species found in the gut microbiota for a subgroup of patients (n=40). The data will be analysed using the intention-to-treat principle.The regional ethics committee (CPP Nord-ouest IV) has approved the study (IDRCB 2018-A00309-46). The results of the trial will be submitted for publication in peer-reviewed journals. The authors have no relationship that may have influenced the submitted work.Trial registration numberNCT04274374.
Abstract
Background
Patients with rheumatoid arthritis (RA) have an increased risk of cardiovascular (CV) disease. Adiponectin is involved in the metabolism of glucose and lipids with favourable ...effects on CV disease, especially its high molecular weight (HMW) isoform. Body composition changes are described in RA with various phenotypes including obesity. The effects of tocilizumab on serum adiponectin and body composition, especially fat mass, in patients with RA are not well determined.
Methods
Patients with active RA despite previous csDMARDs and/or bDMARDs and who were tocilizumab naïve were enrolled in a multicentre open-label study. They were evaluated at baseline, 1, 3, 6 and 12 months. Clinical assessment included body mass index (BMI) and anthropometric measurements. Lipid and metabolic parameters, serum adiponectin (total and HMW), leptin, resistin and ghrelin were measured at each time point. Body composition (lean mass, fat mass, % fat, fat in the android and gynoid regions) was evaluated at baseline, 6 and 12 months.
Results
One hundred seven patients were included. Both total and HMW adiponectin significantly increased from baseline to month 3, peaking respectively at month 3 (
p
= 0.0105) and month 1 (
p
< 0.0001), then declining progressively until month 6 to 12 and returning to baseline values. Significant elevation in HMW adiponectin persisted at month 6 (
p
= 0.001). BMI and waist circumference significantly increased at month 6 and 12, as well as lean mass at month 6 (
p
= 0.0097). Fat mass, percentage fat and android fat did not change over the study period. Lipid parameters (total cholesterol and LDL cholesterol) increased while glycaemia, insulin and HOMA-IR remained stable. Serum leptin, resistin and ghrelin did not change during follow-up.
Conclusions
Tocilizumab treatment in RA patients was associated with a significant increase in total and HMW adiponectin, especially at the onset of the treatment. Tocilizumab also induced a significant gain in lean mass, while fat mass did not change. These variations in adiponectin levels during tocilizumab treatment could have positive effects on the CV risk of RA patients. In addition, tocilizumab may have an anabolic impact on lean mass/skeletal muscle.
Trial registration
The ADIPRAT study was a phase IV open-label multicentre study retrospectively registered on ClinicalTrials.gov under the number
NCT02843789
(date of registration: July 26, 2016).
To evaluate synovitis (clinical vs ultrasound (US)) to predict structural progression in rheumatoid arthritis (RA).
Patients with RA.
Prospective, 2-year follow-up.
Synovitis (32 joints (2 wrists, 10 ...metacarpophalangeal, 10 proximal interphalangeal, 10 metatarsophalangeal)) at baseline and after 4 months of therapy by clinical, US grey scale (GS-US) and power doppler (PD-US); x-rays at baseline and at year 2.
Measures of association (OR) were tested between structural deterioration and the presence of baseline synovitis, or its persistence, after 4 months of therapy using generalised estimating equation analysis.
Structural deterioration was observed in 9% of the 1888 evaluated joints in 59 patients. Baseline synovitis increased the risk of structural progression: OR=2.01 (1.36-2.98) p<0.001 versus 1.61 (1.06-2.45) p=0.026 versus 1.75 (1.18-2.58) p=0.005 for the clinical versus US-GS versus US-PD evaluation, respectively. In the joints with normal baseline examination (clinical or US), an increased probability for structural progression in the presence of synovitis for the other modality was also observed (OR=2.16 (1.16-4.02) p=0.015 and 3.50 (1.77-6.95) p<0.001 for US-GS and US-PD and 2.79 (1.35-5.76) p=0.002) for clinical examination. Persistent (vs disappearance) synovitis after 4 months of therapy was also predictive of subsequent structural progression.
This study confirms the validity of synovitis for predicting subsequent structural deterioration irrespective of the modality of examination of joints, but also suggests that both clinical and ultrasonographic examinations may be relevant to optimally evaluate the risk of subsequent structural deterioration.
Abstract
Objective
We aimed to determine whether calprotectin and α-defensins could discriminate septic from other inflammatory arthritides.
Methods
Synovial fluids with a predominance of neutrophils ...from patients with septic arthritis, pseudogout and RA were prospectively collected. Neutrophil-related proteins calprotectin and human neutrophil α-defensins levels were assessed in synovial fluids. Demographic parameters and biomarkers with P-value ⩽0.05 for differentiating septic from non-septic arthritis were included in a multivariable model. Multivariable logistic regression with stepwise selection was performed to build the final combined model.
Results
A total of 74 patients were included: septic arthritis (n = 26), pseudogout (n = 28) and RA (n = 20). Patients with septic arthritis were more likely to be male and young, and to display higher synovial neutrophil count. Calprotectin was significantly increased in patients with septic arthritis. The multivariable model included calprotectin, synovial fluid neutrophil count and gender. Calprotectin was the only biomarker that discriminated septic arthritis from non-septic inflammatory arthritides, with 76% sensitivity, 94% specificity and a positive likelihood ratio = 12.2 at the threshold for calprotectin of 150 mg/l.
Conclusion
Synovial fluid calprotectin is a relevant biomarker to discriminate septic arthritis from other inflammatory arthritides. This biomarker should be tested in an independent cohort.
In the Indo-Pacific region, rivers are inhabited by amphidromous gobies. They are often subjected to a heavy fishing pressure, highlighting the urgent need to acquire knowledge on their biology for ...management purposes. This study investigated the reproductive strategy of
Sicyopterus lagocephalus
, a widespread amphidromous goby, in two rivers of La Réunion Island. Histological observations of ovarian samples and oocyte-size frequency distributions revealed that females had a group-synchronous ovarian follicle development (i.e., two cohorts of oocytes were distinguished simultaneously in ovaries). Females laid an entire clutch in a unique event (from 14,304 to 232,475 eggs) and then another batch of oocytes was recruited, showing that the annual fecundity is indeterminate. Ovarian growth was isometric at all oocyte development stages showing that the gonadosomatic index (GSI) is a good proxy of reproductive condition. The main reproductive season of
S. lagocephalus
spanned from early February to May with a narrower range upstream and a wider one downstream. Reproduction activity is mainly restricted by water temperatures in upstream areas, whereas it is likely influenced by female body condition and competition in downstream areas. The variability of reproductive traits leads to size structure variation in stocks of spawning females throughout the year.
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