High rate of progression to symptomatic multiple myeloma in patients with smoldering myeloma and isolated osteoporotic vertebral fracture.

Multiple myeloma (MM) frequently causes vertebral fractures (VF). Some are lytic lesions and others have the aspect of benign osteoporotic fractures not requiring anti-myeloma treatment. We explored outcome of these patients with smoldering myeloma (SM) and osteoporotic VF. In this retrospective bi-centric study, patients were identified using a systematic keyword search on electronic medical records. Patients with SM and isolated VF of osteoporotic aspect without indications for myeloma-specific therapy were included. Overall, 13 (7 %) of the 184 identified patients had SM and VF confirmed to be osteoporotic (median number of VF was 3). During follow-up, 12 (92 %) patients evolved to symptomatic MM, 7 (54 %) of them within 18 months (early progressors). Myeloma defining events were new lytic bone lesions in 7 patients (53.8 %). The serum calcium level was significantly higher in the early progressor group (median 2.35 IQR [2.31-2.38] and 2.28 IQR [2.21-2.29] respectively, p = 0.003). Early progressors had a higher number of VF at diagnosis (3.0 [2.0-5.5] vs 1.0 [1.0-2.5], p = 0.18) and more frequently evolved to symptomatic MM because of lytic bone lesions (5 [71 %] vs 2 [33 %], p = 0.13) compared to late progressors. VF of osteoporotic appearance in the context of SM is a rare situation but at high risk of rapid progression to symptomatic MM, suggesting that they may represent bone fragility linked to MM infiltration rather than solely osteoporotic fractures. Further studies are needed to assess if earlier treatment might be beneficial in this population.

Prophylaxis with tixagevimab/cilgavimab is associated with lower COVID-19 incidence and severity in patients with autoimmune diseases.

OBJECTIVE: To describe the clinical efficacy of tixagevimab/cilgavimab in pre-exposure prophylaxis in patients at risk of severe COVID-19 and unresponsive to vaccination (anti-SARS-CoV-2 antibodies <260 BAU/mL) in rheumatology. METHODS: In this multicenter observational study we included patients with autoimmune or inflammatory diseases who received a pre-exposure prophylaxis by tixagevimab/cilgavimab between December 2021 and August 2022. The endpoint was incidence and severity of COVID-19. RESULTS: Tixagevimab/cilgavimab was administered to 115 patients, median age 62 years (52-71), with chronic arthritis (n = 53), connective tissue disease (n = 38) or vasculitis (n = 11). Main background immunosuppressants were rituximab (n = 98), corticosteroids (n = 62, median dose 5mg, CI95% 5-8 mg) and methotrexate (n = 48). During a median follow-up of 128 days (93-173), COVID-19 occurred in 23/115patients (20%), Omicron identified for the 8 genotyped patients. During study period, the average weekly incidence was 1071/100.000 inhabitants in Ile-de-France vs. 588/100.000 in our patients. Patients who received a 2-injections regimen had a lower risk of infection than with a single injection (16/49, 33% vs. 5/64, 8%, p = 0.0012). The COVID-19+ patients did not differ from uninfected patients concerning age, comorbidities, underlying rheumatic disease, immunosuppressant. All COVID-19 were non-severe. The tolerance of injections was excellent. CONCLUSION: In a population with autoimmune or inflammatory diseases at risk of severe COVID-19 unresponsive to vaccination, pre-exposure prophylaxis by tixagevimab/cilgavimab was associated with lower incidence of COVID-19 and no severe infection to report.

Fertility and pregnancy outcomes in women with spondyloarthritis: a systematic review and meta-analysis.

OBJECTIVE: The aim of this study was to determine the impact of SpA and its treatments on fertility and pregnancy outcomes, as well as the impact of pregnancy on disease activity. METHODS: A systematic review and meta-analyses were performed, including studies in women with SpA [axial (axSpA) and peripheral SpA, including PsA]. The heterogeneity between studies was quantified (I2), and in the case of substantial heterogeneity, the results were reported in a narrative review. RESULTS: Of 4397 eligible studies, 21 articles were included, assessing a total of 3566 patients and 3718 pregnancies, compared with 42 264 controls. There is a lack of data on fertility in the literature. We found an increased risk of preterm birth [pooled odds ratio (OR) 1.64 (1.15-2.33), I2 =24% in axSpA and 1.62 (1.23-2.15), I2 =0.0% in PsA], small for gestational age [pooled OR 2.05 (1.09-3.89), I2 =5.8% in axSpA], preeclampsia [pooled OR 1.59 (1.11-2.27], I2 =0% in axSpA] and caesarean section [pooled OR 1.70 (1.44-2.00), I2 =19.9% in axSpA and 1.71 (1.14-2.55), I2 =74.3% in PsA], without any other unfavourable pregnancy outcome. Further analysis showed a significantly higher risk of elective caesarean section [pooled OR 2.64 (1.92-3.62), I2 =0.0% in axSpA and 1.47 [1.15-1.88], I2 =0,0% in PsA), without increased risk of emergency caesarean section in PsA. During pregnancy, there appears to be a tendency for unchanged or worsened disease activity in axSpA and unchanged or improved disease activity in PsA. Both conditions tend to flare in the postpartum period. CONCLUSION: SpA seems to be associated with an increased risk of preterm birth, small for gestational age, preeclampsia, and caesarean section.

Normal salivary gland ultrasonography could rule out the diagnosis of Sjögren's syndrome in anti-SSA-negative patients with sicca syndrome.

OBJECTIVE: To evaluate the relevance of salivary gland ultrasound (SGUS) and its place in the diagnostic algorithm in patients referred with dry syndrome (DS) for a suspicion of Sjögren's syndrome (SS). METHODS: We included all patients assessed at our dedicated DS clinic from June 2015 to September 2019 for which a SGUS has been carried out. Images were read blindly and the worst salivary gland was scored according to OMERACT classification. Clinical features, disease activity and treatments were collected. RESULTS: 337 patients were seen from June 2015 to September 2019. 269 patients underwent SGUS. 77 patients were diagnosed with SS and 192 did not meet the ACR/EULAR criteria for SS: non-Sjögren's DS (NSDS). Of these 192 patients, 60 had another possible cause of DS, and 132 patients were diagnosed with SAPS (sicca, asthenia, polyalgia syndrome).SGUS abnormalities were significantly higher in patients with SS versus NSDS: 51% vs 8% for a score ≥2 (p<0.0001), and 43% vs 3% for a score ≥3 (p<0.0001). SGUS score ≥2 had a specificity (Sp) of 91%, sensitivity (Se) of 57%, positive predictive value (PPV) of 72% and negative predictive value (NPV) of 82% for SS diagnosis. SGUS's characteristics in SSA-negative patients were similar to the whole population (Se=42%, Sp=91%, PPV=42%, NPV=92%). The high specificity and NPV in this population could avoid labial salivary gland biopsy (LSGB) in SSA-negative patients with normal SGUS (186 patients, 69%). CONCLUSION: SGUS is useful for SS diagnosis. If anti-SSA antibodies are negative and SGUS score <2, the diagnosis of SS is very improbable and LSGB could be avoided.

Global prevalence of spondyloarthritis in low-income and middle-income countries: a systematic review and meta-analysis protocol.

INTRODUCTION: In the past decade, the definition of spondyloarthritis (SpA) has undergone major modifications with respect to new diagnostic tools and classifications. With the advent of biotherapies, treatment possibilities in patients with SpA have substantially improved in the last few years. There is great interest in obtaining accurate data on the disease prevalence, especially in regions where data remains scarce such as low-income and middle-income countries (LMICs), in order to measure and understand the needs of their healthcare systems. Therefore, through a global systematic review and meta-analysis, the current study aims to investigate the prevalence of SpA and human leucocyte antigen B27 (HLAB27) and its association with the risk of SpA in the LMIC population. METHODS AND ANALYSIS: We will include cohort, case-control and cross-sectional studies performed among adults (>15 years) living in LMICs. EMBASE, Medline, Global Index Medicus and Web of Knowledge will be searched for relevant records published until 30 April 2020, without any language restriction. The review will be reported according to the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines. After screening of titles and abstracts, study selection, data extraction and risk of bias assessment by two independent reviewers, we shall assess the studies individually for clinical and statistical heterogeneity. Random-effect meta-analysis will be used to pool studies judged to be clinically homogeneous. Egger's test and visual inspection of funnel plots will be used to assess publication bias. Results will be presented by WHO subregions. ETHICS AND DISSEMINATION: Since primary data is not collected in this study, ethical approval is not required. This review is expected to provide relevant data on the epidemiology of SpA, HLAB27 and their association in the global population of LMICs. The final report will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42020163898.