Publications by authors named "Alberto Lo Gullo"

Objective: To evaluate upadacitinib (UPA) effectiveness on axial and peripheral manifestations of psoriatic arthritis (PsA) by assessing the proportion of patients achieving low disease activity (LDA) and inactive disease (ID) status for axial involvement, and MDA and DAPSA-defined remission/LDA for peripheral domain.

Methods: This retrospective study included PsA patients from 27 Italian rheumatology centers. Demographic, clinical, and outcome data were collected at baseline, 6, and 12 months.

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Objective: To assess the contribution of Systemic sclerosis (SSc)-specific features on type II diabetes mellitus (T2D) in a large cohort of Italian SSc patients.

Methods: A total of 613 SSc patients from 11 tertiary Rheumatology Units across Italy were included. All patients underwent full history taking, clinical examination, and relevant laboratory and radiological evaluations.

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Unlabelled: IXE (Ixekizumab) is a monoclonal antibody targeting interleukin-17A (IL17A) which has demonstrated significant efficacy and safety in the management of psoriatic arthritis (PsA) in randomized controlled trials (RCTs). However, available data on long-term persistence of therapy are scarce.

Methods: This multi-center study aimed to evaluate the drug retention rate (DRR) of IXE in a real-world setting and to identify key factors influencing treatment persistence.

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Objectives: To prospectively evaluate the impact and the rapidity of the effect of mepolizumab on the ANCA-associated vasculitis patient-reported outcomes (AAV-PRO) questionnaire and patient global assessment (PtGA) in an international, multicentre cohort of patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Methods: Patients with active EGPA initiating treatment with mepolizumab were included. PtGA and the AAV-PRO score were assessed at baseline and after 7, 14, 30, 90 and 180 days.

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Background: Following the results of the MANDARA trial, this real-life study aimed at comparing the effectiveness and safety profile of mepolizumab versus benralizumab in a European EGPA cohort.

Methods: We conducted a retrospective observational comparative study including EGPA patients, who received mepolizumab or benralizumab at the asthma dose. Patients were matched 1:1 by sex, age, BVAS and oral corticosteroid (OCS) dosage at the treatment initiation (T0).

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: Sepsis is a critical condition characterized by severe immune dysregulation, ranking among the leading causes of morbidity and mortality in intensive care and internal medicine units. Nutritional status plays a pivotal role in modulating these responses, as when inadequate it can compromise immune defenses, the body's ability to handle stress and inflammation, and the clinical course. Malnutrition is frequently observed in septic patients and is strongly associated with worse clinical outcomes, including increased mortality, prolonged hospital stays, and greater complication rates.

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Objectives: To assess the lung involvement in patients with Still's disease, an inflammatory disease assessing both children and adults. To exploit possible associated factors for parenchymal lung involvement in these patients.

Methods: A multicentre observational study was arranged assessing consecutive patients with Still's disease characterized by the lung involvement among those included in the AIDA (AutoInflammatory Disease Alliance) Network Still's Disease Registry.

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The treatment landscape for Rheumatoid Arthritis (RA) has evolved significantly with the introduction of Janus kinase inhibitors (JAKi), such as Tofacitinib (TOFA), which offer a new therapeutic option for patients who have failed or are intolerant to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Safety concerns, particularly related to cardiovascular and cancer risks, prompted a need for additional investigation in real-world clinical settings. This study aimed to evaluate the long-term effectiveness and predictors of response to TOFA in two subpopulations of RA patients, categorized by differing cardiovascular risk profiles.

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Article Synopsis
  • The study aimed to explore gender differences in the phenotypical expression of Behçet's disease (BD) using data from the International AIDA Network Registry, focusing on damage index, disease manifestations, and cardiovascular risk.
  • A total of 1024 patients (567 males and 457 females) were examined, revealing that males had a significantly higher overall damage index and more frequent occurrences of uveitis and vascular involvement, while females showed higher instances of arthralgia, arthritis, and CNS involvement.
  • Key factors associated with major organ involvement included male gender, treatment with biologic agents, origin from endemic regions, and longer disease duration, indicating a more severe course of BD in males compared to females.
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Background: Upadacitinib (UPA) is a selective, reversible Janus kinase inhibitor (JAKi) approved for the treatment of RA. However, there is still no solid evidence on the long-term efficacy of UPA in treated patients. The purpose of this study was to determine the efficacy of UPA to obtain remission or low disease activity (LDA) in a series of UPA patients in patients with RA after 6 and 12 months of treatment in a real-world setting.

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Background: Geographic origin may represent a variable capable of influencing health status. This study aims to investigate the presence of differences of disease severity in Italian patients with fibromyalgia from different macro-regions.

Methods: This retrospective, cross-sectional study involved patients included in the Italian Fibromyalgia Registry.

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Objectives: Conflicting results about clinical and subclinical atherosclerosis in systemic sclerosis (SSc) and the associated risk factors have been reported. Hence, we aimed to determine the prevalence of clinical and subclinical atherosclerosis in a large number of Italian SSc patients and the associated risk factors.

Methods: This study included 613 SSc patients from 11 Italian tertiary Rheumatologic Units.

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Article Synopsis
  • The Janus kinase inhibitors (JAKi) like tofacitinib, baricitinib, upadacitinib, and filgotinib are effective in treating rheumatoid arthritis but faced safety concerns from the FDA and EMA, particularly about serious adverse events (SAEs) such as thrombosis and cancer.
  • The study aimed to analyze the impact of the EMA's first two safety warnings on how rheumatologists in Italy prescribed JAKi from July 2019 to June 2022, using data from 29 rheumatology centers.
  • Results showed a significant reduction (32%) in JAKi prescriptions after the first warning, with a smaller decrease (16%) observed after the second warning, although there
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Objectives: The primary objective of this study was the translation and validation of the ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire into Italian, denoted as AAV-PRO_ita. The secondary objective was to evaluate the impact of ANCA-associated vasculitis (AAV) on quality of life (QoL) and work impairment in a large cohort of Italian patients.

Methods: The study design took a prospective cohort study approach.

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  • This study evaluated the effectiveness of a systemic score in predicting severe outcomes in patients with Still disease, including the risk of mortality and severe complications like macrophage activation syndrome.
  • Involving 597 patients, the study found that a higher systemic score significantly correlated with life-threatening outcomes, with scores of 7 or above indicating a greater risk.
  • Key components that were most predictive of severe outcomes included liver and lung involvement, emphasizing the importance of these factors in managing Still disease.
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Objectives: The persistence in therapy of rheumatoid arthritis drugs and particularly bDMARD is a limiting factor for their long-term use. The randomized controlled trials (RCTs) may not reflect real-world contexts due to strict inclusion and exclusion criteria. Baricitinib, which targets both JAK1 and JAK2, has been used in Italy for several years.

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  • This study evaluated the effectiveness and safety of the IL-5 receptor inhibitor benralizumab for treating patients with eosinophilic granulomatosis with polyangiitis (EGPA) across 28 European centers.
  • Out of 121 patients treated, complete responses increased from 12.4% at 3 months to 46.4% at 12 months, while partial responses decreased over the same period.
  • Notable improvements were seen in disease activity, as measured by the Birmingham Vasculitis Activity Score (BVAS), and a reduction in various disease manifestations, alongside better lung function.
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Objectives: We investigated the effectiveness and safety of filgotinib in a real-life multicentre cohort of rheumatoid arthritis (RA) patients.

Methods: RA patients were evaluated at baseline and after 12 and 24 weeks and were stratified based on previous treatments as biologic disease-modifying anti-rheumatic drug (bDMARD)-naive and bDMARD-insufficient responders (IR). Concomitant usage of methotrexate (MTX) and oral glucocorticoids (GC) was recorded.

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Article Synopsis
  • - This study investigates whether pediatric-onset, adult-onset, and elderly-onset Still's disease are the same condition or different diseases by comparing demographic, clinical, and treatment response data across these age groups.
  • - Out of 411 patients surveyed, most were adults (76.4%), while 15.8% were pediatric and 7.8% were elderly, with significant differences found in symptoms like skin rash and arthritis being more prevalent in children, and pleuritis in the elderly.
  • - Overall, while some minor differences in symptoms and lab results were noted among the age groups, the study concludes that Still's disease has similar demographic and treatment characteristics across pediatric, adult, and elderly patients.
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Background: Different patient clusters were preliminarily suggested to dissect the clinical heterogeneity in Still's disease. Thus, we aimed at deriving and validating disease clusters in a multicentre, observational, prospective study to stratify these patients.

Methods: Patients included in GIRRCS AOSD-study group and AIDA Network Still Disease Registry were assessed if variables for cluster analysis were available (age, systemic score, erythrocyte sedimentation rate (ESR), C reactive protein (CRP) and ferritin).

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Article Synopsis
  • The study focuses on patients with Still's disease to identify clinical and laboratory signs associated with macrophage activation syndrome (MAS), a serious complication.
  • Out of 414 patients examined, 39 (9.4%) developed MAS, with several significant variables like liver involvement and high ferritin levels linked to its occurrence.
  • Multivariate analysis revealed that having hepatomegaly and monoarthritis were directly associated with MAS, while factors like a normal platelet count were protective against its development.
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: Tofacitinib (TOFA) was the first Janus kinase inhibitor (JAKi) to be approved for the treatment of rheumatoid arthritis (RA). However, data on the retention rate of TOFA therapy are still far from definitive. : The goal of this study is to add new real-world data on the TOFA retention rate in a cohort of RA patients followed for a long period of time.

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  • A study assessed the clinical characteristics and treatment effectiveness of methotrexate (MTX) in patients with Still's disease, focusing on changes in disease activity and inflammatory markers.
  • Among the 171 patients studied, MTX was commonly used with glucocorticoids (GCs), and many showed significant improvement, with 38.6% achieving clinical remission and reduced inflammation.
  • The results suggest that MTX is effective in managing Still's disease symptoms, reducing the need for GCs, though some patients discontinued MTX due to side effects or lack of efficacy.
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Background: Inflammatory bowel diseases (IBDs), including ulcerative colitis (UC) and Crohn's disease (CD), are chronic and disabling diseases that affect patient health-related quality of life (HRQoL). IBD patients are frequently exposed to high levels of stress and psychological distress. Biological drugs have been proven to reduce inflammation, hospitalization, and most of the complications that characterize IBDs; their potential contribution to patients' HRQoL remains to be explored.

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