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    Can the dose of belimumab be reduced in patients with systemic lupus erythematosus?

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    The aims of this study were to investigate the prevalence of dose reduction in patients with SLE treated with belimumab (BEL) in Spain, analyse treatment modalities, and determine impact on control of disease activity. Retrospective longitudinal and multicentre study of SLE patients treated with BEL. Data on disease activity, treatments and outcomes were recorded before and after reduction (6-12 months), and they were compared. A total of 324 patients were included. The dose was reduced in 29 patients (8.9%). The dosing interval was increased in nine patients receiving subcutaneous BEL and in six patients receiving intravenous BEL. The dose per administration was reduced in 16 patients. Pre-reduction status was remission (2021 DORIS) in 15/26 patients (57.7%) and LLDAS in 23/26 patients (88.5%). After reduction, 2/24 patients (8.3%) and 3/22 patients (13.6%) lost remission at 6 months and 12 months, respectively [not statistically significant (NS)]. As for LLDAS, 2/23 patients (8.7%) and 2/21 patients (9.5%) lost their status at 6 and 12 months, respectively (NS). Significantly fewer patients were taking glucocorticoids (GCs) at their 12-month visit, although the median dose of GCs was higher at the 12-month visit (5 [0.62-8.75] vs 2.5 [0-5] at baseline). Doses of BEL can be reduced with no relevant changes in disease activity-at least in the short term-in a significant percentage of patients, and most maintain the reduced dose. However, increased clinical or serologic activity may be observed in some patients. Consequently, tighter post-reduction follow-up is advisable

    Sustained drug-free remission in giant cell arteritis.

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    The objectives of this study were to evaluate the frequency and timing of sustained drug-free remission (SDFR) in patients with GCA and to identify potential predictive factors of this outcome. A retrospective review of all patients included in the large Spanish multicentre registry for GCA (ARTESER) with at least 2 years of follow-up was undertaken. SDFR was defined as the absence of typical signs, symptoms, or other features of active GCA for ≥12 months after discontinuation of treatment. We included 872 patients. Forty-seven percent had received concomitant treatment with tocilizumab and/or immunosuppressants, mainly MTX. SDFR was achieved in 21.2% (185/872) of the patients. The cumulative rates of patients achieving SDFR at 2, 3 and 4 years were 6.3%, 20.5% and 25.3%, respectively. Patients who achieved SDFR could reduce their prednisone dosage to 10 mg/day (P = 0.090) and 5 mg/day (P = 0.002) more quickly than those who did not. Relapses were less frequent in patients with SDFR (P = 0.006). The presence of relapses [incident rate ratio (IRR): 0.492, P  Within 3-4 years of diagnosis, only one-quarter of patients with GCA successfully reached the SDFR. Once the SDFR was achieved, the likelihood of experiencing recurrence was low. Relapses and the need for glucocorticoid boluses appear to have been predictors of the need for long-term glucocorticoids

    Tuberculosis in adult migrants in Europe: a TBnet consensus statement.

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    20.500.12530/87908Global migration has increased in recent decades owing to war, conflict, persecution and natural disasters, but also secondary to increased opportunities related to work or study. Migrants' risk of tuberculosis (TB) differs depending on migration, socioeconomic status, mode of travel and TB risk in transit, TB incidence and healthcare provision in country of origin. Despite advances in TB care for migrants and new treatment strategies, decisions for managing migrants at risk of TB often rely on expert opinions, rather than clinical evidence. A systematic literature search was conducted, studies were mapped to different recommendation groups and included studies were synthesised by meta-analysis where appropriate. Current evidence on the diagnosis of active TB in migrants entering the European Union/European Economic Area and UK, including clinical presentation and diagnostic delay, treatment outcomes of drug-susceptible TB, prevalence, and treatment outcomes of multidrug-resistant/rifampicin-resistant TB and TB/HIV co-infection, was summarised. A consensus process was used based on the evidence. We documented that migrants had higher vulnerability for TB, including an increased risk of extrapulmonary TB, multidrug-resistant/rifampicin-resistant TB, TB/HIV co-infection and worse TB treatment outcomes compared to host populations. Consensus recommendations include screening migrants for TB/latent TB infection according to country data, a minimal package for TB care in drug-susceptible and multidrug-resistant/rifampicin-resistant TB, implementation of migrant-sensitive strategies and free healthcare and preventive treatment for migrants with HIV co-infection. Dedicated care for TB prevention and treatment in migrant populations within the European Union/European Economic Area and UK is essential

    Predicting Time in Range Without Hypoglycaemia Using a Risk Calculator for Intermittently Scanned CGM in Type 1 Diabetes

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    20.500.12530/87873Purpose: To investigate the impact of clinical and socio-economic factors on glycaemic control and construct statistical models to predict optimal glycaemic control (OGC) after implementing intermittently scanned continuous glucose monitoring (isCGM) systems. Methods: This retrospective study included 1072 type 1 diabetes patients (49.0% female) from three centres using isCGM systems. Clinical data and net income from the census tract were collected for each individual. OGC was defined as time in range > 70%, with time below 70 mg/dL 70%, with time below 70 mg/d

    Hydrosalpinx treatment before in-vitro fertilization: systematic review and network meta-analysis.

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    20.500.12530/87854To compare the safety and effectiveness of different methods, both ablative and non-ablative, to treat hydrosalpinx in infertile patients before in-vitro fertilization embryo transfer (IVF-ET) via a systematic review and network meta-analysis (NMA). A structured literature search was conducted in common citation databases. Eligibility criteria included peer-reviewed randomized controlled trials (RCTs) or cohort studies comparing the effectiveness and/or safety of different hydrosalpinx treatments, including salpingectomy, laparoscopic proximal tubal occlusion (LTO), insertion of an intratubal device (ITD), ultrasound-guided aspiration, sclerotherapy and expectant management. Primary outcomes were live birth, ongoing pregnancy and clinical pregnancy. Miscarriage, ectopic pregnancy and procedural complications were considered as secondary outcomes. The main NMA included only RCTs, while observational studies were included in a secondary aggregate NMA. Pooled effects were summarized as odds ratios (ORs) with 95% CI for direct and indirect comparisons, derived from random-effects models. Imprecision of NMA estimates was assessed by comparison of their 95% CIs with predefined thresholds for effect size considered to represent clinical relevance (OR 1.1). Heterogeneity for NMA findings was estimated using the variance of the distribution of the underlying treatment effects (τ2), expressed as a 95% prediction interval. Surface under the cumulative ranking curve (SUCRA) was used to predict relative treatment rankings for each outcome. The main analysis included nine RCTs, while an additional 17 observational studies were incorporated into the aggregate analysis. The NMA of RCTs revealed no significant differences in live birth rate between hydrosalpinx treatment methods, with LTO achieving the highest SUCRA value (0.9). Salpingectomy and ultrasound-guided aspiration significantly increased the ongoing pregnancy rate compared with no treatment (OR, 4.35 (95% CI, 1.70-11.14) and 2.80 (95% CI, 1.03-7.58), respectively), with salpingectomy having the highest SUCRA value (0.9). Clinical pregnancy rate was significantly higher following salpingectomy (OR, 2.24 (95% CI, 1.30-3.86)) and LTO (OR, 2.55 (95% CI, 1.20-5.51)) compared with no treatment, despite some heterogeneity; LTO had the highest SUCRA value (0.8). NMA showed no significant differences in secondary outcomes between treatments. Aggregate NMA indicated that sclerotherapy significantly increased the live birth rate compared with no treatment. Higher ongoing pregnancy rate was observed in patients treated with salpingectomy, ultrasound-guided aspiration and LTO compared to untreated patients, with salpingectomy having the highest SUCRA value (0.9). Except for ITD insertion, all interventions increased the clinical pregnancy rate compared with no treatment. LTO had a greater effect on clinical pregnancy rate compared to ultrasound-guided aspiration, with no significant differences in other pairwise comparisons. NMA ranked LTO as the most effective treatment for increasing the clinical pregnancy rate and reducing the miscarriage rate, while sclerotherapy was deemed safer with regard to the ovarian response to IVF stimulation. This NMA fails to support the effectiveness of any hydrosalpinx treatment to improve the live birth rate following IVF-ET, although the beneficial effect of salpingectomy and ultrasound-guided aspiration on ongoing pregnancy rate and of salpingectomy and LTO on clinical pregnancy rate reinforces current recommendations. Based on the aggregated analysis, sclerotherapy could be an effective alternative to conventional laparoscopic techniques, with a favorable safety profile. © 2024 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology

    Impact of intravascular ultrasound for coronary bifurcations treated with last-generation stents: insights from the ULTRA-BIFURCAT registry.

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    Bifurcation lesions are associated with higher rates of major adverse cardiac events (MACE). To investigate the impact of imaging-guided percutaneous coronary intervention (PCI) in a real-world population with coronary bifurcation lesions. From the ULTRA-BIFURCAT registry, we compared intravascular ultrasound (IVUS) vs. angiographic guidance in a cohort of 3486 propensity matched patients. MACE, a composite of all-cause death, myocardial infarction (MI), target-lesion revascularization, and stent thrombosis was the primary endpoint. Subgroup analyses were performed for unprotected left main (ULM) and non-ULM disease. PSM generated 1743 pairs. MACE occurred in 154 (9%) patients in the IVUS-guided group and in 199 (11%) patients in the angio-guided group (P = 0.09). IVUS guidance was associated with lower MACE in the ULM population [hazard ratio (HR) 0.62, 95% confidence internal (CI) 0.46-0.83], but had no impact in the non-ULM population (HR 1.12, 95% CI 0.83-1.51), P for interaction = 0.006. IVUS was associated with a reduction in all-MI (HR 0.32, 95% CI 0.16-0.64) in the ULM population and with lower stent thrombosis (ST) in the non-ULM population (HR 0.24, 95% CI 0.08-0.71). Provisional stenting was associated with lower MACE in the ULM population (HR 0.67, 95% CI 0.45-0.98), whereas kissing balloon (HR 0.75, 95% CI 0.56-0.99) and ultra-thin stents (HR 0.44, 95% CI 0.29-0.67) were protective factors in the non-ULM population. In a real-world scenario, IVUS guidance during drug eluting stent (DES) implantation is associated with a lower rate of MACE in patients with ULM coronary bifurcation lesions. In non-ULM bifurcations, no difference was observed on MACE, while IVUS guidance was associated with a lower rate of ST

    Real-world evaluation of the effectiveness and safety of dupilumab in bullous pemphigoid: an ambispective multicentre case series.

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    20.500.12530/87854Bullous pemphigoid (BP) affects elderly individuals with multiple comorbidities, making conventional treatments unsuitable. Evaluate the effectiveness and safety of dupilumab in the treatment of BP. A multicentre ambispective cohort study was conducted across 34 hospitals. Patients with BP treated with dupilumab were included. Most of the patients (97.1%) received an initial 600-mg dose followed by 300 mg every 2 weeks. The primary outcome was the proportion of patients achieving complete remission (CR) within 4 weeks, defined as an Investigator's Global Assessment score of 0 or 1. CR at weeks 16, 24 and 52, adverse events (AEs), reductions in Peak Pruritus Numerical Rating Scale (PP-NRS) and systemic glucocorticoid use were also assessed. The study included 103 patients with a median age of 77.3 years; 58.3% were male. CR was achieved by 53.4% within 4 weeks and 95.7% by week 52. The PP-NRS score reduced by 70.0% by week 4 and was completely controlled by week 24. Thirteen patients presented with AEs, most of which were mild. Systemic glucocorticoid use reduced by 82.1% by week 52. Shorter disease duration and exclusive cutaneous involvement predicted better response at 16 weeks. No differences in response rates to dupilumab were observed between drug-associated BP and idiopathic cases. No significant difference in response rates was observed between patients treated with dupilumab in monotherapy and those receiving dupilumab with concomitant treatments. Dupilumab is effective, rapid and safe in managing BP, reducing the need for corticosteroids and other treatments. Early initiation and exclusive skin involvement predict better outcomes

    Long-term effectiveness and tolerability of dolutegravir/lamivudine in treatment-naive people with HIV: an analysis of a multicentre cohort at 96 weeks.

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    20.500.12530/87912To evaluate the long-term effectiveness, persistence and tolerability of dolutegravir (DTG)/lamivudine (3TC), compared with the most frequently prescribed first-line treatment regimens, among antiretroviral-naive people with HIV from CoRIS, a multicentre cohort in Spain, in 2018-23. We used multivariable regression models to compare viral suppression (VS) (HIV RNA viral load Of 2359 participants, DTG/3TC was prescribed in 472 (20.0%), bictegravir/tenofovir alafenamide (TAF)/emtricitabine (FTC) in 1134 (48.1%), DTG + tenofovir disoproxil fumarate/FTC in 300 (12.7%), DTG/abacavir/3TC in 273 (11.6%) and darunavir/cobicistat/TAF/FTC in 180 (7.6%). At 96 weeks from treatment initiation, 94.0% of participants initiating with DTG/3TC achieved VS, and the mean increase in CD4 cell counts was 295.5 cells/μL (95% CI: 269.9-321.1). During the first 96 weeks after DTG/3TC initiation, 9.8% and 1.3% discontinued their initial regimen, overall and due to AEs, respectively. In multivariable analyses, we did not find significant differences in VS or increase in CD4 cell counts among participants initiating with DTG/3TC compared with other regimens. Initiating ART with a regimen other than DTG/3TC was associated with a higher risk of treatment discontinuation, overall and due to AEs. Among treatment-naive people with HIV from this large multicentre cohort, DTG/3TC had similar effectiveness and better persistence and tolerability than those of the most frequently prescribed first-line regimens at 96 weeks

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