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Systemic Lupus Erythematosus: HELP
Articles by Luca Iaccarino
Based on 32 articles published since 2008
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Between 2008 and 2019, L. Iaccarino wrote the following 32 articles about Lupus Erythematosus, Systemic.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Editorial When to use belimumab in SLE. 2017

Gatto, Mariele / Iaccarino, Luca / Zen, Margherita / Doria, Andrea. ·a Division of Rheumatology , University of Padova , Padova , Italy. ·Expert Rev Clin Immunol · Pubmed #28463023.

ABSTRACT: -- No abstract --

2 Review Effectiveness, Tolerability, and Safety of Belimumab in Patients with Refractory SLE: a Review of Observational Clinical-Practice-Based Studies. 2018

Trentin, Francesca / Gatto, Mariele / Zen, Margherita / Larosa, Maddalena / Maddalena, Larosa / Nalotto, Linda / Saccon, Francesca / Zanatta, Elisabetta / Iaccarino, Luca / Doria, Andrea. ·Division of Rheumatology, University of Padova, Via Giustiniani, 2, 35128, Padova, Italy. · Division of Rheumatology, University of Padova, Via Giustiniani, 2, 35128, Padova, Italy. adoria@unipd.it. ·Clin Rev Allergy Immunol · Pubmed #29512034.

ABSTRACT: To date, belimumab is the only biological drug approved for the treatment of patients with active refractory SLE. We compared and critically analyzed the results of 11 observational clinical-practice-based studies, conducted in SLE referral centers. Despite the differences in endpoints and follow-up duration, all studies remarked that belimumab provides additional benefits when used as an add-on to existing treatment, allowing a higher rate of patients to reach remission and to taper or discontinue corticosteroids. In the OBSErve studies, 2-9.6% of patients discontinued corticosteroids and 72-88.4% achieved a ≥ 20% improvement by physician's judgment at 6 months. In Hui-Yuen's study, 51% of patients attained response by simplified SRI at month 6. In Sthoeger's study, 72.3% of patients discontinued corticosteroids and 69.4% achieved clinical remission by PGA after a median follow-up of 2.3 years. In the multicentric Italian study, 77 and 68.7% of patients reached SRI-4 response at months 6 and 12, respectively. In all the studies, disease activity indices decreased over time. Retention rates at 6, 9, and 12 months were 82-94.1, 61.2-83.3, and 56.7-79.2%, respectively. The main limitations of these studies include the lack of a control group, the short period of observation (6-24 months) and the lack of precise restrictions regarding concomitant medication management. This notwithstanding, these experiences provide a more realistic picture of real-life effectiveness of the drug compared with the randomized controlled clinical trials, where stringent inclusion/exclusion criteria and changes in background therapy could limit the inference of data to the routine clinical care.

3 Review Rheumatic diseases and autoimmune vascular dementia. 2017

Atzeni, Fabiola / Pipitone, Nicolò / Iaccarino, Luca / Masala, Ignazio Francesco / Weiss, Ronen / Alciati, Alessandra / Doria, Andrea / Chapmanand, Joab / Sarzi-Puttini, Piercarlo. ·IRCCS Orthopedic Institute of Galeazzi, Milan, Italy. Electronic address: atzenifabiola@hotmail.com. · Rheumatology Department, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy. · Division of Rheumatology, University of Padoa, Italy. · Orthopedic and Trauma Unit, Santissima Trinità Hospital, Cagliari, Italy. · Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Chaim Sheba Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Hashomer, Israel. · Department of Clinical Neurosciences, Villa San Benedetto Menni, Hermanas Hospitalarias, FoRiPsi, Albese con Cassano, Como, Italy. · Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Robert and Martha Harden Chair in Mental and Neurological Diseases, Sackler Faculty of Medicine, Tel Aviv University, Israel. · Rheumatology Unit, L. Sacco University Hospital, Milan, Italy. ·Autoimmun Rev · Pubmed #29037904.

ABSTRACT: Vascular dementia (VD) comes second after Alzheimer's disease (AD) as a cause of impaired cognition. VD is not a specific nosological entity, but rather a syndrome encompassing a number of diseases caused by impaired supply of blood to the brain. Systemic autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis and antiphospholipid syndrome (APS) can be associated with dementia. VD is often related to the presence of traditional cardiovascular risk factors, but it may also be associated with a host of disorders affecting the brain blood vessels, neuronal cells, or both. It is important to entertain in the differential diagnosis of VD, to recognize and to cure them accurately in order to preserve life's quality of our patients.

4 Review The Management of Systemic Lupus Erythematosus (SLE) Patients in Remission. 2017

Zen, Margherita / Gatto, Mariele / Nalotto, Linda / Larosa, Maddalena / Iaccarino, Luca / Doria, Andrea. ·Division of Rheumatology, Department of Medicine, DIMED, University of Padua, Italy. ·Isr Med Assoc J · Pubmed #28786263.

ABSTRACT: -- No abstract --

5 Review Role of galectin-3 in autoimmune and non-autoimmune nephropathies. 2017

Saccon, Francesca / Gatto, Mariele / Ghirardello, Anna / Iaccarino, Luca / Punzi, Leonardo / Doria, Andrea. ·Division of Rheumatology, Department of Medicine (DIMED), University of Padova, Italy. · Division of Rheumatology, Department of Medicine (DIMED), University of Padova, Italy. Electronic address: adoria@unipd.it. ·Autoimmun Rev · Pubmed #27666815.

ABSTRACT: Galectins are evolutionary conserved β-galactoside binding proteins with a carbohydrate-recognition domain (CRD) of approximately 130 amino acids. In mammals, 15 members of the galectin family have been identified and classified into three subtypes according to CRD organization: prototype, tandem repeat-type and chimera-type galectins. Galectin-3 (gal-3) is the only chimera type galectin in vertebrates containing one CRD linked to an unusual long N-terminal domain which displays non-lectin dependent activities. Although recent studies revealed unique, pleiotropic and context-dependent functions of gal-3 in both extracellular and intracellular space, gal-3 specific pathways and its ligands have not been clearly defined yet. In the kidney gal-3 is involved in later stages of nephrogenesis as well as in renal cell cancer. However, gal-3 has recently been associated with lupus glomerulonephritis, with Familial Mediterranean Fever-induced proteinuria and renal amyloidosis. Gal-3 has been studied in experimental acute kidney damage and in the subsequent regeneration phase as well as in several models of chronic kidney disease, including nephropathies induced by aging, ischemia, hypertension, diabetes, hyperlipidemia, unilateral ureteral obstruction and chronic allograft injury. Because of the pivotal role of gal-3 in the modulation of immune system, wound repair, fibrosis and tumorigenesis, it is not surprising that gal-3 can be an intriguing prognostic biomarker as well as a promising therapeutic target in a great variety of diseases, including chronic kidney disease, chronic heart failure and cardio-renal syndrome. This review summarizes the functions of gal-3 in kidney pathophysiology focusing on the reported role of gal-3 in autoimmune diseases.

6 Review Success and failure of biological treatment in systemic lupus erythematosus: A critical analysis. 2016

Gatto, Mariele / Saccon, Francesca / Zen, Margherita / Bettio, Silvano / Iaccarino, Luca / Punzi, Leonardo / Doria, Andrea. ·Division of Rheumatology, Department of Medicine, University of Padova, Via Giustiniani 2, 35123, Padova, Italy. · Division of Rheumatology, Department of Medicine, University of Padova, Via Giustiniani 2, 35123, Padova, Italy. Electronic address: adoria@unipd.it. ·J Autoimmun · Pubmed #27373904.

ABSTRACT: Patients affected with systemic lupus erythematosus (SLE) still display increased mortality and decreased quality of life in respect to general population. The major determinant of poor long term prognosis is organ damage, which is predictive of more damage and death. Damage is in turn triggered by uncontrolled disease activity and especially by the long-standing corticosteroid use which often accompanies SLE patients over their disease course, owing both to the need of reaching disease remission and to the habit of keeping patients on a small steroid dose for an indefinite period of time. Hence, the need for new drugs and therapeutic strategies aiming at minimizing damage accrual through a better control of disease activity and a steroid-sparing potential is paramount. So far, however, the therapeutic strategy in SLE requires a multitarget approach which is not devoid of widespread immunesuppression. In fact, several studies have been carried out in recent years targeting both the adaptive and the innate immune system, the majority of which did not achieve their primary endpoint, being often divergent from successful clinical experience and thereby committing physician to off-label use of targeted therapies in face of refractory SLE manifestations. The study designs and the chosen endpoints were often blamed for inadequacy, being at least in part responsible for study failures. In this review, we go over major clinical trials conducted in SLE by analyzing any critical aspects related to study design, predefined endpoints and biological activity of novel compounds that may have hampered study outcome, despite the great effort of providing less toxic drugs within a targeted, pathogenic-based approach.

7 Review Advances in the diagnosis and classification of systemic lupus erythematosus. 2016

Larosa, Maddalena / Iaccarino, Luca / Gatto, Mariele / Punzi, Leonardo / Doria, Andrea. ·a Department of Medicine - DIMED, Division of Rheumatology , University of Padova , Padova , Italy. ·Expert Rev Clin Immunol · Pubmed #27362864.

ABSTRACT: INTRODUCTION: Systemic lupus erythematosus (SLE) is the prototype of systemic autoimmune diseases. Patients with SLE display a wide spectrum of clinical and serological findings that can mislead and delay the diagnosis. Diagnostic criteria have not been developed yet, whereas several sets of classification criteria are available; however, none of them has 100% sensitivity and 100% specificity, i.e. the hallmark of diagnostic criteria. Nevertheless, classification criteria are often misused as diagnostic criteria, which may affect earliness of diagnosis and lead to more misdiagnosed cases. Areas covered: In this review, we compare old and new classification criteria, discussing their application and pinpointing their limitations in the management of patients. Moreover, we will focus on current and novel biomarkers for SLE diagnosis, highlighting their predictive value and applicability in clinical practice. Expert commentary: SLE diagnosis still represents a challenge, remaining largely based on a clinical judgment. Besides SLE diagnosis, even its classification is still challenging to date. Indeed, although classification of SLE seems to be achieved more frequently with the 2012 SLICC criteria than with the previous 1997 ACR criteria, this last-updated 2012 set might be improved. Notably, diagnostic and classification criteria should be applied to any subject in the world, and consequently they should include immunological variables validated in different populations, which is still an unmet need.

8 Review Clinical and pathologic considerations of the qualitative and quantitative aspects of lupus nephritogenic autoantibodies: A comprehensive review. 2016

Gatto, Mariele / Iaccarino, Luca / Ghirardello, Anna / Punzi, Leonardo / Doria, Andrea. ·Division of Rheumatology, Department of Medicine, University of Padova, Via Giustiniani 2, 35123 Padova, Italy. · Division of Rheumatology, Department of Medicine, University of Padova, Via Giustiniani 2, 35123 Padova, Italy. Electronic address: adoria@unipd.it. ·J Autoimmun · Pubmed #26879422.

ABSTRACT: Autoantibodies are key mediators in determining the clinical manifestations of systemic lupus erythematosus (SLE). The mechanisms by which antibodies may be harmful to self tissues encompass complement mediated inflammation, cell apoptosis and immune-complexes mediated damage, however the precise cooperation of antibodies in SLE have not been unravelled so far. Lupus nephritis (LN) is a protean feature of SLE resulting in wide variety of symptoms including asymptomatic proteinuria, mild renal disease until end-stage renal failure which are triggered by complex autoantibody interactions. Novel clues concerning development and self-maintenance of LN have come to light in recent times, pointing straight to a multistep inflammatory process which is incited by anti-chromatin antibodies, the best known being anti-DNA and anti-nucleosome antibodies, culminating in a self-maintaining inflammatory loop with spreading of glomerular inflammation. In the maintenance of the inflammatory process pro-inflammatory antibodies are involved, among which anti-C1q are thought to play a major role, whereas hindrance of the nephritic process could be actively mediated by protective autoantibodies. Despite being so relevant in occurrence of LN, nor anti-chromatin neither anti-C1q antibodies have been precisely characterized in terms of origin, antigen specificity and mechanisms of action. Moreover, novel autoantibodies are emerging in LN which can modify disease course, whereas the pathogenic value of a myriad of cross-reactive antibodies has been progressively challenged. The aim of this review is to give a comprehensive view of known and emerging autoantibody reactivities involved in renal inflammation and damage going over their origin, mechanisms of action and interactions in determining LN course.

9 Review Cardiovascular risk factors, burden of disease and preventive strategies in patients with systemic lupus erythematosus: a literature review. 2015

Benvenuti, Francesco / Gatto, Mariele / Larosa, Maddalena / Iaccarino, Luca / Punzi, Leonardo / Doria, Andrea. ·a 1 University of Padova, Division of Rheumatology, Department of Medicine , Via Giustiniani 2, 35128 Padova, Italy +390 498 212 202, +393 388 072 644 ; +390 498 212 191 ; adoria@unipd.it. ·Expert Opin Drug Saf · Pubmed #26212119.

ABSTRACT: INTRODUCTION: Risk of developing cardiovascular disease (CVD) is increased in systemic lupus erythematosus (SLE) compared with the general population. Traditional risk factors cannot account for the totality of CV events and adequate prevention may be challenging. AREAS COVERED: This review summarizes traditional and emerging risk factors of CVD in SLE patients and goes over potential pathogenic mechanisms involved in CVD development. Role of commonly used drugs and preventive strategies exploitable in everyday clinical practice are also discussed. EXPERT OPINION: SLE-related risk factors involve both disease- and treatment-related features, including disease activity, disease phenotype, corticosteroid misuse and alterations of innate and adaptive immunity. Primary prevention is mandatory in management of lupus patients through appropriate disease control, corticosteroid tapering, use of antimalarials and eventually vitamin D supplementation.

10 Review Value and goals of treat-to-target in systemic lupus erythematosus: knowledge and foresight. 2015

Doria, A / Gatto, M / Iaccarino, L / Punzi, L. ·Division of Rheumatology, Department of Medicine, University of Padova, Padova, Italy adoria@unipd.it. · Division of Rheumatology, Department of Medicine, University of Padova, Padova, Italy. ·Lupus · Pubmed #25801894.

ABSTRACT: Treat-to-target is a therapeutic strategy aimed at improving disease outcome through the achievement of shared treatment goals, which has dramatically ameliorated the prognosis of widespread disorders, such as hypertension or diabetes. Conversely, efforts to delineate treat-to-target in systemic lupus erythematosus (SLE) have failed in pinpointing common goals and treatment strategies, probably because of disease heterogeneity and lack of measurable biomarkers predicting disease course and ensuring a safe treatment tapering during quiescence. Given the detrimental effects of persistent disease activity and protracted corticosteroid therapy on patients' outcome in lupus, disease remission should be pursued whenever possible. Fortunately, clinical remission is currently realistic for a greater number of patients than it was in the past, yet tight monitoring is required in order for patients to benefit from disease- and corticosteroid-free intervals, while minimizing the risk of disease flares. In everyday practice, patients should be brought to the lowest level of disease activity ensuring a significant benefit over a persistently active disease, being either clinical remission or low disease activity.

11 Review Optimizing outcome in SLE: treating-to-target and definition of treatment goals. 2014

Doria, Andrea / Gatto, Mariele / Zen, Margherita / Iaccarino, Luca / Punzi, Leonardo. ·Division of Rheumatology, University of Padova, Padua, Italy. Electronic address: adoria@unipd.it. · Division of Rheumatology, University of Padova, Padua, Italy. ·Autoimmun Rev · Pubmed #24480071.

ABSTRACT: Patients affected with systemic lupus erythematosus (SLE) display poor-long term prognosis and increased mortality in respect of general population. This may be due to continuous organ damage accrual which is fostered both by persistent disease activity (mainly in the short term) and prolonged corticosteroid exposure (mainly in the long term). The effort of defining novel therapeutic goals to which patients should be treated in order to have their prognosis improved is named treat-to-target. Remission in SLE was shown to be associated with better outcome and prolonged survival; in clinical practice, patients may experience either complete or clinical remission, which are defined as complete clinical/serological healing or no clinical signs of lupus with active serology, respectively. The main treat-to-target in SLE is complete remission, however since longitudinal observations suggest that clinical remission or low disease activity even with minimal corticosteroid intake do improve patients prognosis and survival as well, they may be assumed as acceptable alternative targets. Suitable therapeutic strategies have to be defined in order for these goals to be achieved including early diagnosis, effective treatment and proper corticosteroid tapering which in turn require development of more reliable serum biomarkers for early disease detection and less toxic targeted therapies with a steroid-sparing potential.

12 Review Serpins, immunity and autoimmunity: old molecules, new functions. 2013

Gatto, Mariele / Iaccarino, Luca / Ghirardello, Anna / Bassi, Nicola / Pontisso, Patrizia / Punzi, Leonardo / Shoenfeld, Yehuda / Doria, Andrea. ·Division of Rheumatology, Department of Medicine, University of Padua, Via Giustiniani 2, 35128, Padua, Italy. ·Clin Rev Allergy Immunol · Pubmed #23325331.

ABSTRACT: Serine protease inhibitors (serpins) are evolutionary old, structurally conserved molecules which encompass nearly all branches of life. More than 1,000 serpins were characterized to date which are subdivided into 16 subgroups (A-P) according to their common ancestry; among them, 37 are found in humans. Serpins were termed after their capability to inhibit serine proteases, but mounting evidence suggests that they may achieve a greater deal of functions, ranging from embryological growth to synaptic plasticity, development of both myeloid and lymphoid immune cells, and modulation of apoptosis. Serpins are mainly extracellular molecules, although some of them (namely, ov-serpins or clade B serpins) mostly act inside the cells, being either ubiquitously or tissue-specifically expressed. Among newly characterized serpin functions, regulation of cellular proliferation through apoptosis modulation and proteasome disturbance seems to play a major role. Accordingly, several serpins were found to be hyperexpressed in tumor cells. Indeed, apoptosis dysregulation is likely to be a cornerstone in both tumorigenesis and autoimmunity, since uncontrolled cellular viability results in tumor proliferation, while inefficient disposal of apoptotic debris may favor the rescue of autoreactive immune cells. Such a process was widely documented in systemic lupus erythematosus (SLE). Interestingly, alterations in the expression of some serpins, e.g., the ov-serpin SERPINB3, are being unraveled in patients affected with SLE and other autoimmune disorders, suggesting that a failure in serpin function might affect immune homeostasis and self-tolerance, thereby contributing to autoimmunity. Here, we provide an overview of serpin origin, function, and dysfunction, focusing on human serpins and ov-serpins, with a hub on SERPINB3.

13 Review Emerging and critical issues in the pathogenesis of lupus. 2013

Gatto, Mariele / Zen, Margherita / Ghirardello, Anna / Bettio, Silvano / Bassi, Nicola / Iaccarino, Luca / Punzi, Leonardo / Doria, Andrea. ·Division of Rheumatology, Department of Medicine, University of Padova, Via Giustiniani 2, 35128 Padova, Italy. ·Autoimmun Rev · Pubmed #23000207.

ABSTRACT: Systemic lupus erythematosus (SLE) is a multisystemic, autoimmune disease, encompassing either mild or severe manifestations. SLE was originally labeled as being an immune complex-mediated disease, but further knowledge suggested its pathogenesis is motlier than that, involving complex interactions between predisposed individuals and their environment. People affected with SLE have their immune system skewed toward aberrant self-recognition usually after encountering a triggering agent. Defeats in early and late immune checkpoints contribute to tolerance breakdown and further generation and expansion of autoreactive cell-clones. B and T cells play a master role in SLE, however clues are emerging about other cell types and new light is being shed on SLE autoantibodies, since some of them display really harmful potential (pathogenic antibodies), while others are just connected with disease development (pathological antibodies) and may even be protective. Autoantibody generation is elicited by abnormal apoptosis and inefficient clearance of cellular debris causing intracellular autoantigens (e.g. nucleosomes) to persist in the extracellular environment, being further recognized by autoreactive cells. Here we explore the complexity of SLE pathogenesis through five core issues, i.e. genetic predisposition, B and T cell abnormalities, abnormal autoantigen availability, autoantibody generation and organ damage, relying on current knowledge and recent insights into SLE development.

14 Review SLE diagnosis and treatment: when early is early. 2010

Doria, Andrea / Zen, Margherita / Canova, Mariagrazia / Bettio, Silvano / Bassi, Nicola / Nalotto, Linda / Rampudda, Mariaelisa / Ghirardello, Anna / Iaccarino, Luca. ·Division of Rheumatology, Department of Clinical and Experimental Medicine, University of Padova, Italy. adoria@unipd.it ·Autoimmun Rev · Pubmed #20813207.

ABSTRACT: Around 1980 antinuclear antibody testing became widely used in routine laboratory practice leading to a tapering in the lag time between SLE onset and diagnosis. Since then nothing relevant has been introduced which could help us in making the diagnosis of SLE earlier than now. Notably, there is increasing evidence that early diagnosis and treatment could increase SLE remission rate and improve patient prognosis. Although it has been shown that autoantibodies appear before clinical manifestations in SLE patients, currently we cannot predict which autoantibody positive subjects will eventually develop the disease. Thus, great effort should be made in order to identify new biomarkers able to improve our diagnostic potential. B lymphocyte stimulator (BLyS), anti-ribosomal P protein and anti-C1q antibodies are among the most promising. In recent years, some therapeutic options have emerged as appropriate interventions for early SLE treatment, including antimalarials, vitamin D, statins and vaccination with self-derived peptides. All these immune modulators seem to be particularly useful when introduced in an early stage of the disease.

15 Review Hormones, immune response, and pregnancy in healthy women and SLE patients. 2010

Zen, Margherita / Ghirardello, Anna / Iaccarino, Luca / Tonon, Michele / Campana, Carla / Arienti, Silvia / Rampudda, Mariaelisa / Canova, Mariagrazia / Doria, Andrea. ·Division of Rheumatology, Clinical and Experimental Medicine, University of Padova, Padova, Italy. adoria@unipd.it ·Swiss Med Wkly · Pubmed #20175004.

ABSTRACT: During pregnancy the maternal immune system is modified in order to achieve immune tolerance toward paternal antigen expressed on foetal cells. These modifications, which occur both at the foeto-maternal interface and in the systemic circulation, are driven by oestrogens and progesterone whose blood concentrations increase during pregnancy. The cytokine profile is also modified. Th2 cytokines are enhanced while the Th1 response is inhibited. This could explain why Th1-mediated autoimmune diseases tend to improve and Th2-mediated diseases, such as systemic lupus erythematosus (SLE), tend to worsen during pregnancy. However, whether or not SLE relapses more frequently during pregnancy is still a matter of debate. Steroid hormone and cytokine profiles differ in SLE patients compared with healthy subjects during pregnancy leading to a dysregulation of the balance between cell-mediated and humoral immune response, which, in turn, could explain the variability of the SLE course during gestation. This review focuses on hormonal-related cytokine changes observed during pregnancy in healthy subjects and SLE patients.

16 Clinical Trial Effects of Belimumab on Flare Rate and Expected Damage Progression in Patients With Active Systemic Lupus Erythematosus. 2017

Iaccarino, Luca / Bettio, Silvano / Reggia, Rossella / Zen, Margherita / Frassi, Micol / Andreoli, Laura / Gatto, Mariele / Piantoni, Silvia / Nalotto, Linda / Franceschini, Franco / Larosa, Maddalena / Fredi, Micaela / Punzi, Leonardo / Tincani, Angela / Doria, Andrea. ·University of Padova, Padova, Italy. · Spedali Civili and University of Brescia, Brescia, Italy. ·Arthritis Care Res (Hoboken) · Pubmed #27390293.

ABSTRACT: OBJECTIVE: To investigate effectiveness and safety of belimumab in patients with active systemic lupus erythematosus (SLE) in a clinical practice setting. METHODS: Sixty-seven patients with active SLE, mean ± SD age 39.3 ± 10.2 years, from 2 Italian prospective cohorts were treated with belimumab (10 mg/kg on day 0, 14, 28, and then every 28 days) added to background therapy. The Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, the Disease Activity Score in 28 joints (DAS28), 24-hour proteinuria, the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score, anti-double-stranded DNA (anti-dsDNA), C3 and C4 levels, and prednisone daily dose were recorded at baseline, month 3, 6, 9, 12, 18, and 24. Arthritis was subdivided into "classical" (CLP) and "rheumatoid-like"; skin manifestations into acute (ACLE), subacute (SCLE), and chronic. SLE flares, defined according to the SLEDAI Flare Index, were calculated before and after belimumab initiation. Adverse events were carefully evaluated during treatment. Statistics were performed by the SPSS package (version 21.0). RESULTS: Mean ± SD followup was 16.2 ± 9.5 months. Main refractory manifestations treated with belimumab were musculoskeletal (37.3%), mucocutaneous (22.4%), and renal (23.9%). SLEDAI-2K, prednisone daily dose, anti-dsDNA, DAS28, CLASI, and 24-hour proteinuria decreased during treatment. DAS28 score decreased in patients with polyarthritis (P < 0.001), particularly in those with CLP (P < 0.001), and CLASI decreased in patients with skin manifestation (P = 0.003), either ACLE (P = 0.051) or SCLE (P = 0.047). Flare rate was lower 1 and 2 years after belimumab initiation than in the periods before (P = 0.001). Belimumab was well-tolerated and no damage accrual was observed after initiation. CONCLUSION: Belimumab was effective and safe in a clinical practice setting; it decreased the number of flares and hindered damage progression in patients with active SLE.

17 Clinical Trial Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry. 2015

Iaccarino, Luca / Bartoloni, Elena / Carli, Linda / Ceccarelli, Fulvia / Conti, Fabrizio / De Vita, Salvatore / Ferraccioli, Gianfranco / Galeazzi, Mauro / Gatto, Mariele / Gerli, Roberto / Govoni, Marcello / Gremese, Elisa / Iuliano, Annamaria / Mansutti, Elena / Moroni, Gabriella / Mosca, Marta / Nalli, Cecilia / Naretto, Carla / Padovan, Melissa / Palma, Lavinia / Raffiotta, Francesca / Roccatello, Dario / Tincani, Angela / Valesini, Guido / Zen, Margherita / Doria, Andrea. ·Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy. · Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. · Department of Internal Medicine and Medical Specialities, Rheumatology, La Sapienza University, Roma, Italy. · Department of Medical and Biological Sciences, Rheumatology Clinic, University Hospital Santa Maria della Misericordia, Udine, Italy. · Institute of Rheumatology and Affine Sciences, School of Medicine, Catholic University of the Sacred Heart, Rome, Italy. · Research Centre of Systemic Autoimmune and Autoinflammatory Diseases, Rheumatology Unit, Policlinico Le Scotte, University of Siena, Siena, Italy. · Department of Medical Sciences, University of Ferrara, Italy. · Division of Nephrology, Fondazione Ca' Granda Ospedale Maggiore IRCCS, Milano, Italy. · Rheumatology and Clinical Immunology, Department of Clinical and Experimental Sciences, Spedali Civili and University of Brescia, Italy. · Department of Rare Disease, Immunology, Haematology and Immunohaematology, Research Centre of Immunopathology of Rare Diseases (CMID), Hospital Torino Nord Emergenza San G. Bosco and University of Torino, Italy. ·Clin Exp Rheumatol · Pubmed #26053285.

ABSTRACT: OBJECTIVES: To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting. METHODS: 145 SLE patients (ACR criteria) were treated with RTX in 11 Italian Centres: 118 with two infusions (1 g), two weeks apart; 27 with 4 infusions (375 mg/m2), one week apart, followed in 10 cases by two further doses, after 1 and 2 months. Systemic complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as 1< ECLAM ≤3. Renal CR (RCR) and renal PR (RPR) were defined according to EULAR recommendations for management of lupus nephritis. RESULTS: Data from 134 (92.4%) patients were available. The mean±SD follow-up was 27.3±18.5 months. After the first course of RTX, CR or PR were observed in 85.8% and CR in 45.5% of cases; RCR or RPR in 94.1% and RCR in 30.9% of patients after 12-month follow-up. Disease flares occurred in 35.1% and renal flares in 31.2% of patients during observational period. Among patients retreated, CR or PR were observed in 84.4% and CR in 57.8% of cases. Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8%, 16.4%, and 3.8% of patients and after retreatment in 33.3%, 22.2% and 11.1%, respectively. No severe infusion reactions or deaths occurred. CONCLUSIONS: Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.

18 Article Early Lupus Project: one-year follow-up of an Italian cohort of patients with systemic lupus erythematosus of recent onset. 2018

Sebastiani, G D / Prevete, I / Iuliano, A / Piga, M / Iannone, F / Coladonato, L / Govoni, M / Bortoluzzi, A / Mosca, M / Tani, C / Doria, A / Iaccarino, L / Tincani, A / Fredi, M / Conti, F / Spinelli, F R / Galeazzi, M / Bellisai, F / Zanetti, A / Carrara, G / Scirè, C A / Mathieu, A. ·1 UOC Reumatologia, Azienda Ospedaliera San Camillo-Forlanini, Roma, Italy. · 2 Cattedra e Struttura Complessa di Reumatologia, Università degli Studi e AOU di Cagliari, Italy. · 3 Dipartimento Interdisciplinare di Medicina - Sezione di Reumatologia, Universita' di Bari, Italy. · 4 UO e Sezione di Reumatologia - Dipartimento di Scienze Mediche, Università degli Studi di Ferrara, Italy. · 5 UO Reumatologia, Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa, Italy. · 6 Rheumatology Unit, Department of Medicine, University of Padova, Italy. · 7 UOC Reumatologia e Immunologia Clinica, Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia, ASST Spedali Civili - Brescia, Italy. · 8 Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Italy. · 9 UOC di Reumatologia, Azienda Ospedaliera Universitaria Senese, Italy. · 10 Centro Studi SIR (Società Italiana di Reumatologia), Italy. ·Lupus · Pubmed #29779436.

ABSTRACT: Objective To describe the clinical and serological features of a prospectively followed cohort of early diagnosed systemic lupus erythematosus (SLE) patients during a one-year follow-up period. Methods SLE patients with disease duration less than 12 months were consecutively enrolled in a multicentre, prospective study. At study entry and then every 6 months, a large panel of data was recorded. Results Of 260 patients enrolled, 185 had at least 12 months of follow-up; of these, 84.3% were female, 92.4% were Caucasians. Mean diagnostic delay was about 20 months; higher values of European Consensus Lupus Activity Measurement (ECLAM) and of organs/systems involved were both associated with shorter diagnostic delay. Clinical and serological parameters improved after study entry. However, patients' quality of life deteriorated and cardiovascular risk factors significantly increased. About one-third of patients with active disease at study entry went into remission (ECLAM = 0). Negative predictors for remission were: oral ulcers, arthritis, low C4, anti-SSB (Ro) antibodies and therapy with mycophenolate. There was a widespread use of glucocorticoids both at baseline and during follow-up. Conclusion Clinical symptoms and serological parameters improve during the first period after diagnosis. However, patients' quality of life deteriorates. The widespread use of glucocorticoids is probably the reason for the early significant increase of some cardiovascular risk factors.

19 Article Lupus low disease activity state is associated with a decrease in damage progression in Caucasian patients with SLE, but overlaps with remission. 2018

Zen, Margherita / Iaccarino, Luca / Gatto, Mariele / Saccon, Francesca / Larosa, Maddalena / Ghirardello, Anna / Punzi, Leonardo / Doria, Andrea. ·Department of Medicine, University of Padova, Division of Rheumatology, Padova, Italy. ·Ann Rheum Dis · Pubmed #28970217.

ABSTRACT: OBJECTIVE: To evaluate the prevalence, duration and effect on damage accrual of the 'Lupus Low Disease Activity State' (LLDAS) in a monocentric cohort of patients with systemic lupus erythematosus (SLE). METHODS: We studied 293 Caucasian patients with SLE during a 7-year follow-up period. Disease activity was assessed by SLE Disease Activity Index 2000 (SLEDAI-2K) and SELENA-SLEDAI physician global assessment (PGA), and damage by Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). We considered the following definition of LLDAS: SLEDAI-2K ≤4 without major organ activity, no new disease activity, PGA (0-3)≤1, prednisone ≤7.5 mg/day and well-tolerated immunosuppressant dosages. The effect of LLDAS on SDI was evaluated by multivariate regression analysis. We also evaluated remission defined as clinical SLEDAI-2K=0 and prednisone ≤5 mg/day in patients treated with/without stable immunosuppressants and/or antimalarials. RESULTS: LLDAS lasting 1, 2, 3, 4 or ≥5 consecutive years was achieved by 33 (11.3%), 43 (14.7%), 39 (13.3%), 31 (10.6%) and 109 (37.2%) patients, respectively. Patients who spent at least two consecutive years in LLDAS had significantly less damage accrual compared with patients never in LLDAS (p=0.001), and they were significantly less likely to have an increase in SDI (OR 0.160, 95% CI 0.060 to 0.426, p<0.001). On average, 84% of patients in LLDAS also fulfilled the criteria for remission. CONCLUSIONS: LLDAS was associated with a decrease in damage progression in Caucasian patients with SLE. The majority of patients in LLDAS were in remission, which can largely contribute to the protective effect of LLDAS on damage accrual.

20 Article Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. Results of a large, multicentric, nationwide study. 2018

Iaccarino, Luca / Andreoli, Laura / Bocci, Elena Bartoloni / Bortoluzzi, Alessandra / Ceccarelli, Fulvia / Conti, Fabrizio / De Angelis, Rossella / De Marchi, Ginevra / De Vita, Salvatore / Di Matteo, Andrea / Emmi, Giacomo / Emmi, Lorenzo / Gatto, Mariele / Gerli, Roberto / Gerosa, Maria / Govoni, Marcello / Larosa, Maddalena / Meroni, Pier Luigi / Mosca, Marta / Pazzola, Giulia / Reggia, Rossella / Saccon, Francesca / Salvarani, Carlo / Tani, Chiara / Zen, Margherita / Frigo, Anna Chiara / Tincani, Angela / Doria, Andrea. ·Division of Rheumatology, Department of Medicine-DIMED, University of Padova, Padova, Italy. · Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia, Italy. · Rheumatology Unit, Department of Medicine, University of Perugia, Perugia, Italy. · Medical Sciences, UOC of Rheumatology, University Hospital S. Anna, Ferrara, Italy. · Rheumatology Unit, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy. · Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy. · Clinic of Rheumatology, Department of Medical and Biological Sciences, University Hospital "Santa Maria della Misericordia", Udine, Italy. · Internal Interdisciplinary Medicine, Centre for Rare Cardiovascular and Immunological Diseases, Lupus Clinic, AOU Careggi, Florence, Italy. · Department of Surgery and Translational Medicine, University of Florence, Italy. · Rheumatology Department, University of Milan, Istituto Ortopedico Gaetano Pini, Milano, Italy. · Rheumatology Unit, University of Pisa, Pisa, Italy. · Rheumatology Unit, Internal Medicine Department, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy. · Biostatistics, Epidemiology and Public Health Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy. · Division of Rheumatology, Department of Medicine-DIMED, University of Padova, Padova, Italy. Electronic address: adoria@unipd.it. ·J Autoimmun · Pubmed #28935492.

ABSTRACT: OBJECTIVE: To investigate efficacy, safety and survival of belimumab and to identify predictors of drug response and drug discontinuation in patients with active SLE in clinical practice. PATIENTS AND METHODS: Data of SLE patients, treated with belimumab, from 11 Italian prospective cohorts were analyzed. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24-h proteinuria, CLASIa (Cutaneous LE Disease Area and Severity Index Activity) were recorded at baseline and every 6 months. SLE Responder Index-4 (SRI-4) was calculated at 12 and 24 months. Demographic and clinical features and comorbidities were included in the univariate and multivariate analysis. Adverse events were recorded at each visit. Statistics was performed using the SPSS software. RESULTS: We studied 188 SLE patients, mean follow-up 17.5 ± 10.6 months. The most frequent manifestations, which required the use of belimumab, were polyarthritis (45.2%) and skin rashes (25.5%). SRI-4 was achieved by 77.0% and 68.7% of patients at 12 and 24-months. Independent predictors of 12-month response were SLEDAI-2K ≥ 10 (OR 40.46, p = 0.001) and polyarthritis (OR 12.64, p = 0.001) and of 24-month response were SLEDAI-2K ≥ 10 (OR 15.97, p = 0.008), polyarthritis (OR 32.36, p = 0.006), and prednisone ≥7.5 mg/day (OR 9.94, p = 0.026). We observed a low rate of severe adverse events. Fifty-eight patients (30.8%) discontinued belimumab after a mean follow-up of 10.4 ± 7.5 months. The drug survival was 86.9%, 76.9%, 69.4%, 67.1%, and 61.9% at 6, 12, 18, 24, and 30 months, respectively. No factors associated with drug discontinuation were found. CONCLUSION: Belimumab is effective and safe when used in clinical practice setting.

21 Article The effect of different durations of remission on damage accrual: results from a prospective monocentric cohort of Caucasian patients. 2017

Zen, Margherita / Iaccarino, Luca / Gatto, Mariele / Bettio, Silvano / Saccon, Francesca / Ghirardello, Anna / Punzi, Leonardo / Doria, Andrea. ·Division of Rheumatology, Department of Medicine, University of Padova, Padova, Italy. ·Ann Rheum Dis · Pubmed #27884821.

ABSTRACT: AIM: To identify the shortest duration of remission associated with improved outcomes in systemic lupus erythematosus (SLE). METHODS: We studied 293 Caucasian patients with SLE during 7-year follow-up. Disease activity was assessed by SLE Disease Activity Index 2000 and damage by Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). We defined three remission levels: complete, clinical off-corticosteroids, clinical on-corticosteroids (prednisone 1-5 mg/day). The effect of different durations of remission (1, 2, 3, 4 and ≥5 consecutive years) on damage was evaluated by multivariate logistic regression analysis. RESULTS: Among patients achieving 1-year (27 patients), 2-year (47 patients), 3-year (45 patients), 4-year (26 patients) remission, damage was similar irrespective of the level of remission achieved, whereas, among patients achieving ≥5-year remission (113 patients), damage was higher in those in clinical remission on-corticosteroids (p<0.001).In multivariate analysis, ≥2 consecutive year remission was protective against damage (OR (95% CI)): 2 years 0.228 (0.061 to 0.850); 3 years 0.116 (0.031 to 0.436); 4 years 0.118 (0.027 to 0.519) and ≥5 years 0.044 (0.012 to 0.159). Predictors of damage were cumulative prednisone dose ≥180 mg/month (3.136 (1.276 to 7.707)), antiphospholipid antibody syndrome (5.517 (2.092 to 14.546)), vasculitis (3.107 (1.030 to 9.307)) and number of flare/year (8.769 (1.692 to 45.449)). CONCLUSIONS: Two consecutive years is the shortest duration of remission associated with a decrease in damage progression in Caucasian patients with SLE.

22 Article Prolonged remission in Caucasian patients with SLE: prevalence and outcomes. 2015

Zen, Margherita / Iaccarino, Luca / Gatto, Mariele / Bettio, Silvano / Nalotto, Linda / Ghirardello, Anna / Punzi, Leonardo / Doria, Andrea. ·Division of Rheumatology, Department of Medicine, University of Padova, Padova, Italy. ·Ann Rheum Dis · Pubmed #26223434.

ABSTRACT: AIM: To assess the prevalence of prolonged remission in Caucasian patients affected with systemic lupus erythematosus (SLE) and its relationship with damage accrual. METHODS: Caucasian patients diagnosed with SLE between 1990 and 2009 and quarterly seen from 2009 to 2013 were included in the study. We defined remission as prolonged when lasting ≥5 consecutive years. Three levels of remission were defined using the SLE Disease Activity Index-2000 (SLEDAI-2K): complete remission: no disease activity in corticosteroid-free and immunosuppressant-free patients; clinical remission off corticosteroids: serologically active clinical quiescent (SACQ) disease in corticosteroid-free patients and clinical remission on corticosteroids: SACQ disease in patients taking prednisone 1-5 mg/day. Damage was measured by the SLICC/American College of Rheumatology Damage Index (SDI). RESULTS: 224 patients fulfilled inclusion criteria: 196 (87.5%) were women, mean±SD disease duration 11.2±6.8 years. During the 5-year follow-up, 16 patients (7.1%) achieved prolonged complete remission, 33 (14.7%) prolonged clinical remission off corticosteroids and 35 (15.6%) prolonged clinical remission on corticosteroids. At the multivariate analysis, vasculitis (OR 4.95), glomerulonephritis (OR 2.38) and haematological manifestations (OR 2.19) over the patients' disease course were associated with an unremitted disease. SDI increased more frequently in unremitted (72/140, 51.4%) than in remitted patients (22/84, 26.2%; p=0.001); SDI median increase was higher in unremitted than in remitted patients: 1 (0-3) vs 0 (0-2), respectively (p<0.001). At multivariate analysis, unremitted disease (OR 2.52) and high-dose corticosteroid intake (OR 2.35) were risk factors for damage accrual. CONCLUSIONS: Thirty-seven percent of our Caucasian patients achieved a prolonged remission, which was associated with a better outcome in terms of damage accrual.

23 Article Clinical profile and direct medical cost of care of adults presenting with systemic lupus erythematosus in Italy. 2015

Doria, Andrea / Iaccarino, Luca / La Montagna, Giovanni / Mathieu, Alessandro / Piga, Matteo / Galeazzi, Mauro / Iuliano, Annamaria / Maurel, Frédérique B / Garofano, Anna M / Perna, Alessandra G / Porcasi, Rolando E. ·Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy. · Rheumatology Unit, Second University of Napoli, Napoli, Italy. · Division of Rheumatology, Department of Medical Sciences, University of Cagliari, Cagliari, Italy. · Department of Rheumatology, Ospedale Santa Maria alle Scotte, University of Siena, Siena, Italy. · HEOR, Real-World Evidence Solutions (RWES) unit, IMS Health, Paris-La Défense, France. · Immuno-Inflammation & Infectious Diseases (II-ID) Global Franchise, GlaxoSmithKline, London, UK. · Speciality Care Medical Department, GlaxoSmithKline, Verona, Italy. ·Clin Exp Rheumatol · Pubmed #26005879.

ABSTRACT: OBJECTIVES: To determine the clinical profile and estimate the annual direct medical cost of care of adult patients with active, autoantibody positive systemic lupus erythematosus (SLE) in Italy. METHODS: A two-year, retrospective, multicentre, observational study was conducted from January to May 2011. Patients' characteristics, SLE disease activity and severity, rate of flares, healthcare consumption (e.g. medications, etc.) were evaluated. Medical costs were assessed from the Italian National Health Insurance perspective. RESULTS: Four centres enrolled 96 eligible patients, including 85.4% women. Patients were equally stratified per disease severity (severe SLE: 51%). The mean (SD) age was 42.9 (13.8) years. At baseline, SLE duration was 12.6 (7.2) years. The mean (SD) SELENA-SLEDAI score was higher in severe than in non-severe patients 9.2 (6.4) vs. 3.3 (3.1) (p<0.001). The mean (SD) SLICC/ACR index score was similar in the two subgroups: 0.4 (0.8) vs. 0.3 (0.8). Over the study period, severe patients experienced on average 0.73 (0.56) flares/year and non-severe patients 0.57 (0.63). The annual medical cost was 1.6 times higher in severe than in non-severe patients (€2,101 vs. €1,320; p=0.031). The cost of medications was also 2.5 times higher in severe patients (€1101 vs. €445, p=0.007). Low C3/C4 complement levels and each severe flare incremented the annual cost of €550 (p=0.011) and €465 (p=0.02), respectively. CONCLUSIONS: The medical cost of SLE in Italy is related to disease severity and flares. Medications identified as the main cost drivers, and low C3/C4 complement levels and severe flares as the main cost predictors, increased significantly the cost of SLE management.

24 Article PTX3, Anti-PTX3, and Anti-C1q Autoantibodies in Lupus Glomerulonephritis. 2015

Bassi, Nicola / Del Prete, Dorella / Ghirardello, Anna / Gatto, Mariele / Ceol, Monica / Zen, Margherita / Bettio, Silvano / Mantovani, Alberto / Iaccarino, Luca / Punzi, Leonardo / Doria, Andrea. ·Department of Medicine - DIMED, Division of Rheumatology, University of Padova, Via Giustiniani, 2, 35128, Padova, Italy. · Department of Medicine - DIMED, Division of Nephrology, University of Padova, Padova, Italy. · Department of Biotechnology and Translational Medicine, University of Milano, Milano, Italy. · Department of Medicine - DIMED, Division of Rheumatology, University of Padova, Via Giustiniani, 2, 35128, Padova, Italy. adoria@unipd.it. ·Clin Rev Allergy Immunol · Pubmed #25805362.

ABSTRACT: Pentraxin 3 (PTX3) is an acute-phase protein involved in C1q clearance. The presence of anti-C1q and the absence of anti-PTX3 antibodies were associated with lupus glomerulonephritis (LGLN). Our aim was to assess soluble and kidney-expressed PTX3 and their relationships with anti-C1q and anti-PTX3 antibodies in LGLN. Serum PTX3, anti-C1q, anti-dsDNA, and anti-PTX3 antibodies were tested in 130 systemic lupus erythematosus (SLE) patients, 130 healthy and 127 disease controls. Twenty-nine renal biopsies from SLE patients were analyzed and PTX3 immunostaining was quantified by morphometric analysis. Parametric and nonparametric statistics were performed. PTX3 serum levels were lower in SLE versus controls, but they were correlated with proteinuria in LGLN patients (p = 0.001). LGLN patients had higher anti-C1q and lower anti-PTX3 antibody levels than those without (p < 0.0001). LGLN was more prevalent in anti-C1q(+)/anti-PTX3(-) than in anti-C1q(+)/anti-PTX3(+) patients (p < 0.001). No LGLN was observed in anti-C1q(-)/anti-PTX3(+) patients. PTX3 was expressed in glomeruli and renal interstitium. Renal PTX3 was correlated with proteinuria (p = 0.024) and interstitial fibrosis (p = 0.023). PTX3 staining and fibrosis were higher in anti-PTX3(-) than anti-PTX3(+) patients. In conclusion, PTX3 is expressed in glomeruli of LGLN patients, primarily in anti-PTX3(-) patients, where it is correlated with renal fibrosis. Anti-C1q/anti-PTX3 antibody profile seems to be useful in LGLN assessment.

25 Article Predictors of maternal and fetal complications in SLE patients: a prospective study. 2014

Borella, Elisabetta / Lojacono, Andrea / Gatto, Mariele / Andreoli, Laura / Taglietti, Marco / Iaccarino, Luca / Casiglia, Edoardo / Punzi, Leonardo / Tincani, Angela / Doria, Andrea. ·Rheumatology Unit, Department of Medicine, University of Padova, Via Giustiniani, 2, 35128, Padua, Italy. ·Immunol Res · Pubmed #25398639.

ABSTRACT: The aim of the study was to evaluate predictors of disease flares during pregnancy and obstetric and fetal complications in a cohort of systemic lupus erythematosus (SLE) patients. One hundred and thirty-two pregnancies in 96 SLE patients were prospectively followed by monthly clinical and laboratory evaluations. Predictors of lupus flares, fetal and obstetric complications during pregnancy were identified performing stepwise logistic regression analysis. Maternal lupus flares occurred in 57 % of pregnancies and were being best predicted by the number of flares before conception. Manifestations during flares were best predicted by the same features occurred before conception: dermatological flares by skin rash, renal flares by nephritis, and hematological flares by hematological abnormalities. There were 110 live births and 22 fetal losses. Among live newborns, 22 % were premature. Fetal loss was best predicted by hypertension at conception; miscarriages by the amount of steroids taken during the last year before conception; stillbirth by the number of flares during the last year before conception; preterm birth by the coexistence of anti-phospholipid antibody syndrome and anti-double-stranded DNA antibody levels before conception; premature rupture of membranes by high ECLAM score during the 6 months before conception, small for gestation age by hypertension at conception; and preeclampsia by positive lupus anticoagulant. Some independent predictors of lupus flares and fetal and obstetric complications were identified, which can help the risk assessment of pregnancy in SLE patients.

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