Publications by authors named "Larosa Maddalena"

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: Data about hydroxychloroquine (HCQ) levels during pregnancy are sparse. We assessed HCQ whole blood levels at first trimester of pregnancy as a potential predictor of maternal and obstetric/fetal outcomes in patients with systemic lupus erythematosus (SLE).

Methods: We included pregnant SLE patients enrolled in the prospective GR2 study receiving HCQ, with at least one available first-trimester whole-blood HCQ assay.

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Article Synopsis
  • The study examined pregnancy outcomes in women with autoimmune rheumatic diseases (ARD) enrolled in the Italian P-RHEUM.it cohort from 2018 to 2023, focusing on maternal and infant health.
  • Results showed that out of 866 pregnancies, 15.6% experienced maternal disease flares, 30.1% had obstetrical complications, and 91.7% resulted in live births, with a relatively low rate of perinatal deaths and complications.
  • The research concluded that effective preconception counseling and proper medication management during pregnancy may help reduce disease-related risks, suggesting that outcomes for women with ARD were comparable to those in the general obstetric population.
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Article Synopsis
  • The study explored the role of complement levels (C3 and C4) as potential biomarkers for monitoring disease activity and risks during pregnancies in women with systemic lupus erythematosus (SLE).
  • Data from 532 lupus patients showed that complement levels generally rise during pregnancy but are notably lower in those with prior lupus nephritis and flares, particularly in the first trimester.
  • Lower or minimal increases in C3 and C4 levels during early pregnancy were linked to higher rates of complications and gestational flares, suggesting these complement levels could help predict risks for SLE patients.
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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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Article Synopsis
  • A task force, including rheumatologists, healthcare professionals, and patients, was created to develop non-drug management recommendations for systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) through a systematic literature review.
  • They established 4 overarching principles and 12 tailored recommendations focused on patient education, physical activity, and lifestyle changes, with varying strengths of recommendation (A-D) and strong agreement among members.
  • The goal is to enhance the holistic care of SLE and SSc, encouraging collaboration between patients and healthcare providers while integrating non-pharmacological strategies alongside traditional therapies.
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Article Synopsis
  • The study evaluated the effectiveness of belimumab for treating joint and skin symptoms in patients with systemic lupus erythematosus (SLE) using specific metrics like DAS28 and CLASI.
  • Results showed notable improvements, with increasing percentages of patients achieving remission in joint (DAS28) and skin (CLASI) symptoms over 24 months.
  • Belimumab was also found to reduce the need for glucocorticoids, and early responders (by 6 months) had a higher chance of achieving remission later in the treatment.
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Background: Prospective data about the risks of thrombotic and severe haemorrhagic complications during pregnancy and post partum are unavailable for women with antiphospholipid syndrome. We aimed to assess thrombotic and haemorrhagic events in a prospective cohort of pregnant women with antiphospholipid syndrome.

Methods: This multicentre, prospective, observational study was done at 76 centres in France.

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Objectives: To demonstrate that unsuccessful treatment optimization in early disease is associated with difficult-to-treat RA (D2T-RA).

Methods: In this retrospective multicentre cohort study conducted from 09/2021-03/2022, we enrolled individuals fulfilling the 2010 ACR/EULAR RA criteria diagnosed 2000-2019. The outcome was D2T-RA by the EULAR definition.

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Article Synopsis
  • This study investigates whether low-dose acetylsalicylic acid (LDASA) should be given to pregnant patients with Systemic Lupus Erythematosus (SLE) who have no history of kidney issues or positive antiphospholipid antibodies.
  • Researchers analyzed 216 pregnancies from 187 patients, comparing outcomes between those treated with LDASA and those who were not; they found no significant differences in adverse pregnancy outcomes (APOs) between the two groups.
  • While LDASA treatment did show a lower incidence of pre-eclampsia (2.4% vs 8.3%), the overall conclusion is that LDASA does not significantly reduce severe obstetric complications,
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Article Synopsis
  • - The study aimed to assess the consensus among experts on defining antiphospholipid antibody (aPL) negativization in patients with antiphospholipid syndrome (APS) through a survey conducted by the Italian Society for Rheumatology (SIR-APS).
  • - Results showed strong agreement (up to 90%) among a group of 30 experts on the definition of aPL negativization as having two negative tests one year apart, and on specific management approaches for patients with aPL negativity after experiencing thrombotic events.
  • - Experts advised cautious suspension of vitamin K antagonists (VKAs) in patients with a history of thrombosis or triple aPL positivity, emphasizing that VKA cessation may be considered only when risks
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Objectives: The specific roles of remission status, lupus low disease activity state (LLDAS), and damage accrual on the prognosis of pregnancies in women with SLE are unknown. We analysed their impact on maternal flares and adverse pregnancy outcomes (APOs).

Methods: We evaluated all women (≥18 years) with SLE enrolled in the prospective GR2 study with an ongoing singleton pregnancy at 12 weeks (one pregnancy/woman).

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Objectives: To derive and validate a definition of low disease activity (LDA) for SLE based on the SLE Disease Activity Score (SLE-DAS), in a real-life multicentre cohort of SLE patients.

Methods: Derivation was conducted using data from a monocentric cohort of SLE (Portugal), and validation was performed in a multicentre cohort (Italy, France and Spain). The Lupus Low Disease Activity State (LLDAS) was used as comparator.

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Background: Belimumab was recently approved for treatment of lupus glomerulonephritis (LN).

Aim: To evaluate renal response and its predictors in LN patients receiving belimumab in real-life.

Patients And Methods: We considered all patients fulfilling the SLEDAI-2K renal items and/or having estimated glomerular filtration rate (eGFR)≤60 ml/min/1.

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Objectives: There is an unmet need for accurate and user-friendly definitions of systemic lupus erythematosus (SLE) disease activity and remission. We aimed to derive and validate the SLE Disease Activity Score (SLE-DAS) definitions for disease activity categories and clinical remission state.

Methods: Derivation was conducted at Padova Lupus Clinic (Italy).

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Background: The criteria for antiphospholipid syndrome (APS) include severe preeclampsia and/or placental insufficiency leading to preterm delivery before 34 weeks of gestation, but this APS manifestation has been rarely studied. Thus, we report a series of severe preeclampsia occurred in patients with APS.

Methods: We retrospectively analysed data of women with APS (Sydney criteria) who experienced severe preeclampsia with delivery before 34 weeks' gestation between 2000 and 2017 at five French internal medicine departments and one Italian rheumatology unit.

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Systemic Lupus Erythematosus (SLE) mainly occurs during childbearing age. Remission or low disease activity state (LDAS) before conception are recommended by experts to achieve a favourable lupus pregnancy outcome but little is known on the best way to evaluate remission or activity status during pregnancy. We tested SLE-disease activity score (SLE-DAS) in the first trimester as predictor of maternal flares and obstetrical complications in 2nd and 3rd trimester in a cohort of SLE pregnant women.

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Objectives: Whether immunosuppressive therapy may be safely withdrawn in lupus nephritis (LN) is still unclear. We assessed rate and predictors of flare after IS withdrawal in patients with LN in remission.

Methods: Patients with biopsy-proven LN treated with immunosuppressants (IS) between 1980 and 2020 were considered.

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The concern about the offspring's health is one of the reasons for a reduced family size of women with rheumatic diseases (RD). Increased risk of autoimmune diseases (AD) and neurodevelopmental disorders (ND) has been reported in children born to patients with RD. Within a nationwide survey about reproductive issues of women with RD, we aimed at exploring the long-term outcome of their children.

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: Systemic Lupus Erythematosus (SLE) is a chronic B cell-mediated autoimmune disease which can potentially involve several organs and systems. The development of SLE is associated with a complexity of genetic, hormonal and environmental factors leading to immune deregulation and production of autoantibodies. Therefore, novel therapies have focused on B cells as key effectors of SLE pathogenesis.

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Article Synopsis
  • - The study aimed to find out if being in disease remission or a low disease activity state at the start of pregnancy improves outcomes for patients with Systemic Lupus Erythematosus (SLE).
  • - Researchers monitored 347 pregnancies in SLE patients, discovering that a significant portion were in remission at the beginning, and those in remission or on hydroxychloroquine (HCQ) had lower rates of disease flare and adverse pregnancy outcomes (APOs).
  • - The findings suggest that careful prenatal planning focused on achieving disease remission can significantly lower the risk of complications during pregnancy for SLE patients.
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