Success Predictors of Endoscopic Sleeve Gastroplasty.

OBJECTIVE: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive procedure that proved to be safe and effective in obesity treatment. However, not all subjects respond to treatment in the same way, and, with a view to personalized care, it is essential to identify predictors of success or failure. METHODS: A retrospective 2-year followed-up cohort of ESG subjects was analyzed to investigate the presence of any baseline or early indicators of long-term optimal or suboptimal ESG outcomes. RESULTS: A total of 315 subjects (73% women) were included, with 73% of patients exhibiting an Excess weight loss percentage (%EWL) >25% at the 24 months. Neither demographic parameters (age and sex), smoking habits, and menopause in women nor the presence of comorbidities proved potential predictive value. Interestingly, the %EWL at 1 month after ESG was the strongest predictor of 24-month therapeutic success. Subsequently, we estimated an "early threshold for success" for 1 month-%EWL by employing Youden's index method. CONCLUSIONS: ESG is a safe and effective bariatric treatment that can be offered to a wide range of subjects. Early weight loss seems to impact long-term ESG results significantly and may allow proper early post-operative care optimization.

Management of psoriatic arthritis: a consensus opinion by expert rheumatologists.

Background: Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease involving several articular and extra-articular structures. Despite the important progresses recently made in all of the aspects of this disease, its management is still burdened by unresolved issues. The aim of this exercise was to provide a set of statements that may be helpful for the management of PsA. Methods: A group of 38 Italian rheumatologists with recognized expertise in PsA selected and addressed the following four topics: "early PsA," "axial-PsA," "extra-articular manifestations and comorbidities," "therapeutic goals." Relevant articles from the literature (2016-2022) were selected by the experts based on a PubMed search. A number of statements for each topic were elaborated. Results: Ninety-four articles were selected and evaluated, 68 out of the 1,114 yielded by the literature search and 26 added by the Authors. Each of the four topic was subdivided in themes as follows: transition from psoriasis to PsA, imaging vs. CASPAR criteria in early diagnosis, early treatment for "early PsA"; axial-PsA vs. axialspondyloarthritis, diagnosis, clinical evaluation, treatment, standard radiography vs. magnetic resonance imaging for "axial PsA"; influence of inflammatory bowel disease on the therapeutic choice, cardiovascular comorbidity, bone damage, risk of infection for "comorbidities and extra-articular manifestations"; target and tools, treat-to-target strategy, role of imaging for "therapeutic goals." The final document consisted of 49 statements. Discussion: The final product of this exercise is a set of statements concerning the main issues of PsA management offering an expert opinion for some unmet needs of this complex disease.

Impact of Pregnancy on Weight Loss After Endoscopic Sleeve Gastroplasty.

PURPOSE: Obesity and pregnancy are strictly related: on the one hand, obesity-one of the most common comorbidities in women of reproductive age-contributes to infertility and obesity-related pregnancy complications, whereas pregnancy is a condition in which, physiologically, the pregnant woman undergoes weight gain. Endoscopic sleeve gastroplasty (ESG) may be used for the treatment of obesity in women of childbearing age. MATERIALS AND METHODS: A retrospective analysis was conducted to evaluate weight trajectories, the evolution of obesity-related comorbidities, and lifestyle modification in women who became pregnant after ESG. A comparison was made between childbearing-age women who became pregnant after ESG and non-pregnant women. RESULTS: A total of 150 childbearing-age women underwent ESG at a large tertiary medical center. Of these, 11 patients (33.4 ± 6.2 years) became pregnant after the procedure, following a mean time interval of 5.5 ± 3.9 months. Three women (two affected by polycystic ovary syndrome) reported difficulty getting pregnant before undergoing ESG. The mean preconception BMI was 31.9±4.0 kg/m2 (-7.24 ± 4.0 kg/m2 after ESG). Total body weight loss (TBWL, %) was 18.08 ± 8.00, 11.00 ± 11.08, and 12.08 ± 8.49, at the beginning of pregnancy, at the delivery, and at the first follow-up (19.6 ± 7.8 months after ESG). TBWL of at least 5% was achieved before pregnancy in all patients (73% reached a TBWL ≥ 10%). No significant differences in weight loss and QoL were found between the pregnancy and non-pregnancy groups up to 24 months after ESG. CONCLUSIONS: Endoscopic sleeve gastroplasty allows for adequate weight loss before and after pregnancy in patients with obesity.

Long-term Outcomes of Transoral Outlet Reduction (TORe) for Dumping Syndrome and Weight Regain After Roux-en-Y Gastric Bypass.

BACKGROUND: Both weight regain and dumping syndrome (DS) after Roux-en-Y gastric bypass (RYGB) have been related to the dilation of gastro-jejunal anastomosis. The aim of this study is to assess the safety and long-term efficacy of endoscopic transoral outlet reduction (TORe) for DS and/or weight regain after RYBG. MATERIALS AND METHODS: A retrospective analysis was performed on a prospective database. Sigstad's score, early and late Arts Dumping Score (ADS) questionnaires, absolute weight loss (AWL), percentage of total body weight loss (%TBWL), and percentage of excess weight loss (%EWL) were assessed at baseline and at 6, 12, and 24 months after TORe. RESULTS: Eighty-seven patients (median age 46 years, 79% female) underwent TORe. The median baseline BMI was 36.2 kg/m2. Out of 87 patients, 58 were classified as "dumpers" due to Sigstad's score ≥ 7. The resolution rate of DS (Sigstad's score < 7) was 68.9%, 66.7%, and 57.2% at 6, 12, and 24 months after TORe, respectively. A significant decrease in Sigstad's score as well as in early and late ADS questionnaires was observed (p < 0.001). The median Sigstad's score dropped from 15 (11-8.5) pre-operatively to 2 (0-12) at 24 months. The %TBWL was 10.5%, 9.9%, and 8.1% at 6, 12, and 24 months, respectively. Further, "dumpers" with resolution of DS showed better weight loss results compared with those with persistent DS (p < 0.001). The only adverse event observed was a perigastric fluid collection successfully managed conservatively. CONCLUSION: TORe is a minimally invasive treatment for DS and/or weight regain after RYGB, with evidence of long-term efficacy.

Weight Recidivism and Dumping Syndrome after Roux-En-Y Gastric Bypass: Exploring the Therapeutic Role of Transoral Outlet Reduction.

Obesity is a chronic, relapsing disease representing a global epidemic. To date, bariatric surgery is the most effective treatment for morbid obesity in the long-term. Roux-en-Y gastric bypass (RYGB) is one of the most performed bariatric interventions, with excellent long-term outcomes. However, about one-third of patients may experience weight regain over time, as well as dumping syndrome. Both these conditions are challenging to manage and require a multidisciplinary and personalized approach. The dilation of the gastro-jejunal anastomosis is a recognized etiological factor for both weight regain and dumping syndrome. Dietary modifications, behavioral interventions, and medications represent the first therapeutic step. Revisional surgery is the traditional approach when non-invasive treatments fail. However, re-interventions may be technically difficult and are associated with increased morbidity and mortality. Transoral outlet reduction (TORe) is an endoscopic procedure aimed at reducing the size of the anastomosis and is proposed as a minimally invasive treatment of weight regain and/or dumping syndrome refractory to conservative therapies. This review is aimed at providing a narrative overview of the role of TORe as part of the multidisciplinary therapeutic toolkit nowadays available to approach weight regain and dumping syndrome after RYGB.

Outcomes of Endoscopic Sleeve Gastroplasty in the Elder Population.

PURPOSE: With the aging of the population and the epidemic spread of obesity, the frequency of older individuals with obesity is steadily growing. To date, no data evaluating the use of endoscopic sleeve gastroplasty (ESG) in the elderly have been published. In this case series, we evaluate the short- and medium-term outcomes of ESG in patients with obesity aged 65 years and older. MATERIALS AND METHODS: A retrospective analysis was done on a prospective database; patients aged 65 years and older were included in our analysis. EWL%, TBWL%, the Bariatric Analysis and Reporting Outcome System (BAROS) questionnaire, and the presence of comorbidities were assessed. RESULTS: Eighteen patients aged 65 years and older underwent ESG between November 2017 and July 2021. The median age was 67 years and the mean baseline BMI was 41.2 kg/m2. After ESG, the median TBWL% was 15.1%, 15.5%, and 15.5% at 6, 12, and 24 months, while the median %EWL was 39%, 37%, and 41% at 6, 12, and 24 months, respectively. The median BAROS score was 3.0, 3.4, and 2.5 at 6, 12, and 24 months, respectively. Six out of twelve patients with hypertension and 3/4 diabetic patients reduced or removed their medications within 12 months following ESG. Two out of six patients with OSA stopped therapy with CPAP. No adverse events were recorded. CONCLUSION: According to our experience, ESG is a promising therapeutic option for elder individuals with obesity who fail non-invasive methods, and who refuse or are deemed not suitable for bariatric surgery because of age and comorbidities.

Personalized Approach for Obese Patients Undergoing Endoscopic Sleeve Gastroplasty.

Obesity is a chronic, relapsing disease representing a major global health problem in the 21st century. Several etiologic factors are involved in its pathogenesis, including a Western hypercaloric diet, sedentariness, metabolic imbalances, genetics, and gut microbiota modification. Lifestyle modifications and drugs often fail to obtain an adequate and sustained weight loss. To date, bariatric surgery (BS) is the most effective treatment, but only about 1% of eligible patients undergo BS, partly because of its negligible morbidity and mortality. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive, endoscopic, bariatric procedure, which proved to be safe and effective. In this review, we aim to examine evidence supporting the role of a personalized and multidisciplinary approach, guided by a multidisciplinary team (MDT), for obese patients undergoing ESG, from patient selection to long-term follow-up. The cooperation of different health professionals, including an endocrinologist and/or obesity medicine physician, a bariatric surgeon, an endoscopist experienced in bariatrics, a registered dietitian, an exercise specialist, a behaviour coach, a psychologist, and a nurse or physician extender, aims to induce radical and sustained lifestyle changes. We also discussed the relationship between gut microbiota and outcomes after bariatric procedures, speculating that the characterization of gut microbiota before and after ESG may help develop new tools, including probiotics, to optimize weight loss outcomes.

Retrospective evaluation of patient profiling and effectiveness of apremilast in an Italian multicentric cohort of psoriatic arthritis patients.

OBJECTIVES: We aimed to evaluate the baseline characteristics, the reasons for prescription, and the effectiveness/safety profile of real-life apremilast for the treatment of psoriatic arthritis (PsA). METHODS: PsA patients treated with apremilast were retrospectively extracted from an Italian multicentric cohort. Baseline population characteristics and reasons for apremilast prescription were analysed. Clinical response was defined as the proportion of patients achieving Disease Activity in PSoriatic Arthritis (DAPSA) remission/low disease activity (LDA), minimal disease activity (MDA), and very low disease activity (VLDA). Six-month retention rate was computed by the Kaplan-Meier method, with a detailed analysis of reasons for discontinuation. Univariate and multivariate models were developed to examine predictors of clinical response and persistence. RESULTS: The study population included 131 patients mainly with oligoarticular PsA (58%), carrying at least one comorbidity (64.1%, in particular history of malignancies [25.9%] and latent tuberculosis [16.3%]) treated with apremilast as first-line targeted therapy (47.7%) or in biologics failures (52.3%). Contraindication to biologics (60.3%) and lack of poor prognostic factors (27.5%) were the most frequent reason for apremilast prescription. The 6-month retention rate was 72.1%. Inefficacy (n=7), diarrhoea (n=10), nausea (n=3), and headache (n=7) were the most frequent reasons for discontinuation. At 3 months DAPSA LDA/remission, MDA, and VLDA were observed in 40.3, 6.7, and 5.6% of patients, respectively. Female sex was a negative predictor of both retention rate and clinical response. CONCLUSIONS: In our real-life analysis apremilast was mainly used in oligoarticular PsA carrying comorbidities leading to contraindications to biologics. Effectiveness and safety profiles were consistent with clinical trials.

Anti-interleukin-1 treatment in patients with rheumatoid arthritis and type 2 diabetes (TRACK): A multicentre, open-label, randomised controlled trial.

BACKGROUND: The inflammatory contribution to type 2 diabetes (T2D) has suggested new therapeutic targets using biologic drugs designed for rheumatoid arthritis (RA). On this basis, we aimed at investigating whether interleukin-1 (IL-1) inhibition with anakinra, a recombinant human IL-1 receptor antagonist, could improve both glycaemic and inflammatory parameters in participants with RA and T2D compared with tumour necrosis factor (TNF) inhibitors (TNFis). METHODS AND FINDINGS: This study, designed as a multicentre, open-label, randomised controlled trial, enrolled participants, followed up for 6 months, with RA and T2D in 12 Italian rheumatologic units between 2013 and 2016. Participants were randomised to anakinra or to a TNFi (i.e., adalimumab, certolizumab pegol, etanercept, infliximab, or golimumab), and the primary end point was the change in percentage of glycated haemoglobin (HbA1c%) (EudraCT: 2012-005370-62 ClinicalTrial.gov: NCT02236481). In total, 41 participants with RA and T2D were randomised, and 39 eligible participants were treated (age 62.72 ± 9.97 years, 74.4% female sex). The majority of participants had seropositive RA disease (rheumatoid factor and/or anticyclic citrullinated peptide antibody [ACPA] 70.2%) with active disease (Disease Activity Score-28 [DAS28]: 5.54 ± 1.03; C-reactive protein 11.84 ± 9.67 mg/L, respectively). All participants had T2D (HbA1c%: 7.77 ± 0.70, fasting plasma glucose: 139.13 ± 42.17 mg). When all the enrolled participants reached 6 months of follow-up, the important crude difference in the main end point, confirmed by an unplanned ad interim analysis showing the significant effects of anakinra, which were not observed in the other group, led to the study being stopped for early benefit. Participants in the anakinra group had a significant reduction of HbA1c%, in an unadjusted linear mixed model, after 3 months (ß: -0.85, p < 0.001, 95% CI -1.28 to -0.42) and 6 months (ß: -1.05, p < 0.001, 95% CI -1.50 to -0.59). Similar results were observed adjusting the model for relevant RA and T2D clinical confounders (male sex, age, ACPA positivity, use of corticosteroids, RA duration, T2D duration, use of oral antidiabetic drug, body mass index [BMI]) after 3 months (ß: -1.04, p < 0.001, 95% CI -1.52 to -0.55) and 6 months (ß: -1.24, p < 0.001, 95% CI -1.75 to -0.72). Participants in the TNFi group had a nonsignificant slight decrease of HbA1c%. Assuming the success threshold to be HbA1c% ≤ 7, we considered an absolute risk reduction (ARR) = 0.42 (experimental event rate = 0.54, control event rate = 0.12); thus, we estimated, rounding up, a number needed to treat (NNT) = 3. Concerning RA, a progressive reduction of disease activity was observed in both groups. No severe adverse events, hypoglycaemic episodes, or deaths were observed. Urticarial lesions at the injection site led to discontinuation in 4 (18%) anakinra-treated participants. Additionally, we observed nonsevere infections, including influenza, nasopharyngitis, upper respiratory tract infection, urinary tract infection, and diarrhoea in both groups. Our study has some limitations, including open-label design and previously unplanned ad interim analysis, small size, lack of some laboratory evaluations, and ongoing use of other drugs. CONCLUSIONS: In this study, we observed an apparent benefit of IL-1 inhibition in participants with RA and T2D, reaching the therapeutic targets of both diseases. Our results suggest the concept that IL-1 inhibition may be considered a targeted treatment for RA and T2D. TRIAL REGISTRATION: The trial is registered with EU Clinical Trials Register, EudraCT Number: 2012-005370-62 and with ClinicalTrial.gov, number NCT02236481.

Effectiveness of Certolizumab-Pegol in Rheumatoid Arthritis, Spondyloarthritis, and Psoriatic Arthritis Based on the BIOPURE Registry: Can Early Response Predict Late Outcomes?

BACKGROUND: Identification of predictors of clinical response to certolizumab-pegol (certolizumab) may aid the decision-making process for treating patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA). OBJECTIVE: The aim of our study was to evaluate the effectiveness of certolizumab and identify any predictors of favorable outcome in patients with RA, PsA, or SpA. METHODS: We studied 355 RA, SpA, and PsA patients starting treatment with certolizumab. Endpoints of the study were drug survival and identification of predictors of clinical outcome. Drug retention was analyzed via the Kaplan-Meier method, and hazard ratios (HRs) were estimated using Cox regression models. RESULTS: Of 355 certolizumab initiators, 178 had RA, 94 had PsA, and 83 had SpA. Biologic-naïve RA patients had significantly higher survival rates (73.3%) than switchers taking certolizumab as a second-line (49.0%) or third- or next-line biologic agent (51.2%; p = 0.0001). Instead, PsA and SpA patients showed similar drug retention rates regardless of the line of treatment. A significant clinical improvement from baseline was seen at 3 months for RA (28 joint-Disease Activity Score [DAS28]; p = 0.001), PsA (Disease Activity Index for PsA [DAPSA]; p = 0.001), and SpA (Bath Ankylosing Disease Index; p = 0.01). Biologic-naïve patients had the lowest HR (0.31; p = 0.001) of discontinuing certolizumab for RA, and the highest HR (7.94; p = 0.01) of achieving minimal disease activity (MDA) for PsA. For PsA, a predictor of late MDA was the achievement of low/remission DAPSA at 3 months, and 3-month low/remission DAS28 predicted late remission for RA. CONCLUSIONS: Our study revealed that the best predictor of certolizumab effectiveness in unselected patients with RA, PsA, or SpA was a biologic-naïve status and achievement of an early response within 3 months.

Cervical lymphadenopathy: can the histogram analysis of apparent diffusion coefficient help to differentiate between lymphoma and squamous cell carcinoma in patients with unknown clinical primary tumor?

PURPOSE: To retrospectively evaluate the value of whole-lesion histogram analysis of apparent diffusion coefficient (ADC) maps in differentiating between lymphoma and metastatic squamous cell carcinoma (SCC) of unknown clinical primary in neck nodes. METHODS: A total of 39 patients, 20 affected by lymphoma and 19 affected by metastatic non-nasopharyngeal SCC, were included in this retrospective study. All patients underwent MR imaging with a 1.5 T scanner system, including diffusion-weighted imaging (DWI) with three different b values (b = 0, 500 and 800 s/mm2). The entire tumor volume was manually delineated on the ADC maps, using the T2-weighted images and DWIs with b = 800 s/mm2 as a guide to the lesion location. The Mann-Whitney rank-sum test for independent samples was performed to compare the histogram parameters of patients with lymphoma and SCC. RESULTS: The SCCs showed significantly higher median ADC (ADCmedian) and mean ADC (ADCmean) values, compared to lymphomas (p < 0.001), while they exhibited lower kurtosis and skewness without reaching significance (p = 0.066 and 0.148, respectively). The ADCmean and ADCmedian had the best discriminative powers for differentiating lymphoma and SCC, with an area under the curve of 87% and 85%, respectively. The optimal cutoff values for ADCmean and ADCmedian as predictors for lymphoma were ≤ 0.83 × 10-3 mm2/s and ≤ 0.73 × 10-3 mm2/s, respectively. CONCLUSIONS: The whole-lesion ADC histogram analysis of cervical lymphadenopathy may help to discriminate lymphomas from non-nasopharyngeal SCC in patients with unknown clinical primary tumor.

Ultrasound-guided preoperative localization of breast lesions: a good choice.

PURPOSE: The aim of the study was to verify whether ultrasound (US)-guided preoperative localization of breast lesions is an adequate technique for correct and safe surgical resection and to contribute positively and effectively to this topic in the literature with our results. METHODS: From June 2016 to November 2016, 155 patients with both benign and malignant breast lesions were selected from our institute to undergo US localization before surgery. The lesions included were: sonographically visible and nonpalpable lesions; palpable lesions for which a surgeon had requested US localization to better evaluate the site and extension; sonographically visible, multifocal breast lesions, both palpable and nonpalpable. US localization was performed using standard linear transducers (Siemens 18 L6, 5.5-8 MHz, 5.6 cm, ACUSON S2000 System, Siemens Medical Solutions). The radiologist used a skin pen to mark the site of the lesion, and the reported lesion's depth and distance from the nipple and pectoral muscle were recorded. The lesions were completely excised by a team of breast surgeons, and the surgical specimens were sent to the Radiology Department for radiological evaluation and to the Pathology Department for histological assessment. RESULTS: In 155 patients who underwent to preoperative US localization, 188 lesions were found, and the location of each lesion was marked with a skin pen. A total of 181 lesions were confirmed by the final histopathologic exam (96.28%); 132 of them (72.92%) were malignant, and 124 of these (93.93%) showed free margins. CONCLUSIONS: US-guided preoperative localization of sonographically visible breast lesions is a simple and nontraumatic procedure with high specificity and is a useful tool for obtaining accurate surgical margins.

A new risk stratification score for the management of ultrasound-detected B3 breast lesions.

To develop a predictive scoring system for ultrasound-detected B3 lesions at ultrasound-guided core needle biopsy (US-CNB). A total of 2724 consecutive US-CNBs performed in our Institution (January 2011 to December 2014) were retrospectively reviewed. Inclusion criteria were as follows: (a) histopathological examination of the entire lesion or (b) availability of radiologic follow-up (FUP) ≥24 months. Patient- and lesion-related variables-patients' age, lesion consistency, lesion size, vascularization, BI-RADS category, and US-CNB result-were analyzed. Positive predictive values (PPVs) for malignancy were calculated correlating US-CNB results with excision histology or FUP. A scoring system for underlying malignancy was developed using risk factors weighting. A total of 102 B3 lesions were included: 27 atypical ductal hyperplasia (26.5%), 5 lobular intraepithelial neoplasia (4.9%), 32 radial scar (31.4%), 37 papillary lesions (36.3%), and 1 fibroepithelial lesion (0.9%). Surgery was performed on 71/102 (69.6%) lesions, and 22/71 were malignant; the remaining 31/102 lesions (30.4%) were unchanged at FUP. The overall PPV for malignancy was 21.6%. Patients' age (odds ratio [OR] = 3.63, P = 0.008), lesion consistency (OR = 5.96, P = 0.001), BI-RADS category (OR = 17.52, P < 0.001), and CNB result (OR = 3.6, P = 0.008) were associated with a higher risk of malignancy underestimation and selected as risk factors in the score definition. Two risk groups were identified: low (0-2 points) and high risk (3-5 points), with significantly different risk of malignancy underestimation (8.0% vs 59.3%, P < 0.001). The proposed score helps to predict the risk of malignancy underestimation and choose the management of B3 lesions at US-CNB.

Automated Breast Ultrasonography (ABUS) in the Screening and Diagnostic Setting: Indications and Practical Use.

Automated breast ultrasonography (ABUS) is a new imaging technology for automatic breast scanning through ultrasound. It was first developed to overcome the limitation of operator dependency and lack of standardization and reproducibility of handheld ultrasound. ABUS provides a three-dimensional representation of breast tissue and allows images reformatting in three planes, and the generated coronal plane has been suggested to improve diagnostic accuracy. This technique has been first used in the screening setting to improve breast cancer detection, especially in mammographically dense breasts. In recent years, numerous studies also evaluated its use in the diagnostic setting: they showed its suitability for breast cancer staging, evaluation of tumor response to neoadjuvant chemotherapy, and second-look ultrasound after magnetic resonance imaging. The purpose of this article is to provide a comprehensive review of the current body of literature about the clinical performance of ABUS, summarize available evidence, and identify gaps in knowledge for future research.

Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. Real-life data from the biologic Apulian registry (BIOPURE).

This study aims to evaluate the drug survival and effectiveness of ustekinumab in psoriatic arthritis (PsA) patients naïve to biologics or inadequate responders to tumor necrosis factor (TNF-IR) inhibitors in real life. PsA patients starting ustekinumab were enrolled from 2014 to 2016. Joint involvement, peripheral or axial, Psoriatic Area Severity Index, Disease Activity Psoriatic Arthritis (DAPSA), Lee Enthesitis Index, Health Assessment Questionnaire, body mass index, comorbidities, co-therapies, mechanism of action, and causes of discontinuation of prior TNFi were collected at baseline, and 6 and 12 months. Twelve-month drug survival was evaluated by Kaplan-Meier curves. Hazard ratios (HRs) of drug discontinuation adjusted for baseline factors were estimated by multiple Cox regression analysis. Percentages of DAPSA-based remission, as crude value and adjusted for drug retention (LUNDEX index), were compared by χ2 test. Mean differences of DAPSA from baseline to 6 and 12 months were compared between naïve and TNF-IR patients by ANOVA. Of 160 PsA patients starting ustekinumab, 54 were naïve and 106 were TNF-IR. Twelve-month drug survival was significantly higher in naïve (87%) than in TNF-IR (68%, p = 0.01). Baseline co-therapy with methotrexate did not increase the persistence on ustekinumab. Naïve patients had the lowest risk of ustekinumab discontinuation (HR 0.27, p = 0.01), and the highest DAPSA-based remission (34%, LUNDEX 26%). Mean differences from baseline of DAPSA was significantly greater in naïve than in TNF-IR patients at 12 months (- 14.4 ± 10 vs. - 4.1 ± 17, p = 0.01). Our data showed that ustekinumab has a good effectiveness in real life and the best outcomes are achieved in biologic-naïve PsA patients.

Effect of Needle Size in Ultrasound-guided Core Needle Breast Biopsy: Comparison of 14-, 16-, and 18-Gauge Needles.

INTRODUCTION: The aim of the present study was to assess the diagnostic accuracy of ultrasound-guided core needle biopsy (US-CNB) of breast lesions, comparing smaller needles (16- and 18-gauge) with the 14-gauge needle, and to analyze the lesion characteristics influencing US-CNB diagnostic performance. PATIENTS AND METHODS: All the patients provided informed consent before the biopsy procedure. The data from breast lesions that had undergone US-CNB in our institution from January 2011 to January 2015 were retrospectively reviewed. The inclusion criterion was the surgical histopathologic examination findings of the entire lesion or radiologic follow-up data for ≥ 24 months. The exclusion criterion was the use of preoperative neoadjuvant therapy. The US-CNB results were compared with the surgical pathologic results or with the follow-up findings in the 3 needle size groups (14-, 16-, and 18-gauge). The needle size- and lesion characteristic-specific diagnostic accuracy parameters were evaluated. Statistical analysis was performed using a dedicated software program, and P ≤ .01 was considered significant. RESULTS: A total of 1118 US-CNB cases (1042 patients) were included. Of the 1118 cases, 630 (56.3%) were in the 14-gauge group, 136 (12.2%) in the 16-gauge, and 352 (31.5%) in the 18-gauge needle group. Surgery was performed on 800 lesions (71.6%). Of these, 619 were malignant, 77 were high risk, and 104 were benign. The remaining 318 lesions (28.4%) underwent follow-up imaging studies. All the lesions were stable and, therefore, were considered benign. No differences were observed in the diagnostic accuracy parameters among the 3 needle size groups (P > .01). The false-negative rate was greater for lesions < 10 mm (7.2%) (P < .01) but without statistically significant differences among the 3 gauges (P > .01). CONCLUSION: US-CNB performed with small needles (16 and 18 gauge) had the same diagnostic accuracy as that performed with 14-gauge needles, regardless of the lesion characteristics.

Golimumab in real-life settings: 2 Years drug survival and predictors of clinical outcomes in rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis.

OBJECTIVES: To assess the drug survival of golimumab, and predictors thereof, in patients affected with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA) in a prospective observational cohort. METHODS: This is a non-interventional, longitudinal study on RA, SpA, and PsA patients starting treatment with golimumab. Endpoints were the 2 years persistence rate of golimumab and predictors of therapy discontinuation. Drug retention was analyzed using Kaplan-Meier and Cox models. Hazard ratios (HR) of golimumab discontinuation were estimated by Cox-regression hazard models. RESULTS: Of 416 patients starting golimumab, 171 biologic-naïve and 245 inadequate responders to prior biologic drugs, 88 had RA, 147 SpA, and 181 PsA. Global 2 years drug retention was 70.2%, with no different hazard of discontinuation among diseases or line of biologic treatment. The strongest predictor of golimumab discontinuation was female gender (HR = 1.95). Golimumab monotherapy was associated with higher risk drug interruption (HR = 1.67). Within SpA, predictors of golimumab discontinuation were female sex (HR = 4.19), and absence of extra-articular manifestations (HR = 4.60). In PsA, duration of disease was negatively associated to drug interruption (HR = 0.93), whereas golimumab monotherapy was positively (HR = 2.21) associated. Interestingly, failing to achieve a good EULAR response at 3 months was the only predictor of golimumab discontinuation for RA patients (HR = 3.03). CONCLUSIONS: This study provided evidence that golimumab has high retention rate in real-life settings. SpA male patients with extra-articular manifestations, PsA patients on co-therapy with DMARDs, and RA patients attaining an early clinical response had the highest probability to continue golimumab over 2 years.