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293 result(s) for "Bellis, E."
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AB1120 REAL-LIFE EFFICACY AND SAFETY OF IXEKIZUMAB IN A COHORT OF PATIENTS WITH PSORIATIC ARTHRITIS: A SINGLE-CENTER RETROSPECTIVE STUDY
BackgroundIxekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is indicated for psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis.Literature highlights efficacy and safety in real life in patients affected by psoriasis[1], instead little are data concerning PsA.[2]ObjectivesTo retrospectively evaluate the effectiveness and safety of ixekizumab, in a cohort of patients with PsA.MethodsPatients with a diagnosis of PsA and treated with ixekizumab who visited our outpatient clinic from October 2019 to December 2022 were included in the study. Clinical data were recorded since the first prescription of ixekizumab and at 6-month follow-up visit. Demographic, clinical and laboratory characteristics, treatment, and causes of discontinuation were analyzed. Differences between baseline and 6-months erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender joint count (TJC) and swollen joint count (SJC) were analysed.ResultsMain results are reported on Table 1. 76 patients were included in the study, with an average age at the prescription of ixekizumab (T0) of 57.1±13.0 years.Main comorbidities were: hypertension (44.7%), obesity and overweight (44.7%), cardiopathy (19.7%), hepatic steatosis (21.0%), diabetes (13.2%), and hyperlipemia (3.9%). 93.42% of patients presented peripheral arthritis, 30.6% axial involvement, and 42.1 % enthesitis.28,9% of patients were biologic-naïve, 34,0% received one biologic agent before, and 31.5% two or more biologic agents. 88,2% of patients initiated ixekizumab in combination with a csDMARDs, mainly methotrexate.The indications for the prescription of ixekizumab as a first biologic agent were: multiple comorbidities, severe psoriasis, and intolerance to csDMARDs.28.9% of patients stopped ixekizumab because of primary failure (31.8%), secondary failure (22.7%), or adverse events (45.5%). 40% of the adverse events were relevant skin reactions at the injection site. No severe adverse events were registered.60 patients completed 6 months of treatment (T6). In those patients, a statistically significant decrease between the SJC and TJC at baseline and T6 was found (p-value 0.0011 and 0.0006 respectively). No difference in the values of ESR and CRP values between T0 and T6 was present.ConclusionThere are few data in real life concerning efficacy and safety in patients affected by PsA. In our cohort, ixekizumab significantly improved peripheral arthritis, and it revealed a good safety profile, without severe adverse events during the follow up. Further real-life evaluations on axial involvement, which was not included in this study, are warranted.References[1]Malagoli P. et al. Real life long-term efficacy and safety of ixekizumab in moderate-to-severe psoriasis: A 192 weeks multicentric retrospective study-IL PSO (Italian landscape psoriasis). Dermatol Ther. 2022[2]Manfreda V. et al. Efficacy and safety of ixekizumab in psoriatic arthritis: a retrospective, single-centre, observational study in a real-life clinical setting. Clin Exp Rheumatol. 2020Table 1.General characteristics of our cohort and clinical and laboratory findings at baseline and follow-up for patients who completed 6 months of treatment with ixekizumab.Male/female n. (%)22 (28.9%)/54 (71.1%)Mean age at diagnosis (years)50.0Years from diagnosis at the first prescription of ixekizumab (years)6.7Patients: n. 60T0T6p-valueESR (mm/h)27.44±23.327.56±22.20.9741CRP (mg/dl)1.58±2.470.98±1.70.1569TJC9.17±6.985.02±6.650.0011SJC1.57±2.750.28±0.640.0006Acknowledgements:NIL.Disclosure of InterestsElisa Bellis Consultant of: Bristol-myers Squibb Srl - Temas, Grant/research support from: Pfizer, DENISE DONZELLA: None declared, Gloria Crepaldi Speakers bureau: Eli-Lilly, BMS, Consultant of: Galapagos, Janssen, Valeria Data: None declared, Marinella Gammino: None declared, Valeria Guardo: None declared, Claudia Lomater Speakers bureau: Eli-Lilly, Janssen, Formedica, Bristol-myers, Elena Marucco: None declared, Marta Saracco: None declared, Annamaria Iagnocco Speakers bureau: Abbvie, MSD, Alfasigma, Celltrion, BMS, Celgene, Eli-Lilly, -Sanofi Genzyme, Pfizer, Galapagos, Gilead, Novartis, SOBI, Janssen, Consultant of: Abbvie, MSD, Alfasigma, Celltrion, BMS, Celgene, Eli-Lilly, -Sanofi Genzyme, Pfizer, Galapagos, Gilead, Novartis, SOBI, Janssen, Grant/research support from: Pfizer, Abbvie.
Neuropsychological findings in childhood neglect and their relationships to pediatric PTSD
Although child neglect is the most prevalent form of child maltreatment, the neurocognitive effects of neglect are understudied. We examined IQ, reading, mathematics, and neurocognitive domains of fine-motor skills, language, visual-spatial, memory/learning, and attention/executive functions in two groups of nonsexually abused medically healthy neglected children, one with DSM-IV posttraumatic stress disorder (PTSD) and one without, and a demographically similar healthy nonmaltreated control group. Significantly lower IQ, reading, mathematics, and selected differences in complex visual attention, visual memory, language, verbal memory and learning, planning, problem solving, and speeded naming were seen in Neglect Groups. The Neglect with PTSD Group performed worse than controls on NEPSY Design Copying, NEPSY Tower, and Mathematics; and performed worse than controls and Neglect without PTSD on NEPSY Memory for Faces-Delayed. Negative correlations were seen between PTSD symptoms, PTSD severity, and maltreatment variables, and IQ, Academic Achievement, and neurocognitive domains. Neglected children demonstrated significantly lower neurocognitive outcomes and academic achievement than controls. Lower IQ, neurocognitive functions, and achievement may be associated with more PTSD symptoms (particularly re-experiencing symptoms), greater PTSD severity, and a greater number of maltreatment experiences. Trauma experiences may additionally contribute to subsequent neurodevelopmental risk in neglected children. (JINS, 2009, 15, 868–878.)
AB0918 RETENTION RATE OF SECUKINUMAB IN SPONDYLOARTHRITIS: INSIGHTS FROM A REAL-WORLD STUDY
Background:Secukinumab is a human monoclonal antibody that selectively binds interleukin 17A, inhibiting its interaction with the interleukin 17 receptor and is prescribed for the treatment of psoriatic arthritis (PsA), plaque psoriasis, ankylosing spondylitis, axial spondyloarthritis, and juvenile idiopathic arthritis.Objectives:To retrospectively evaluate the drug retention rate (DRR) of secukinumab in a monocentric cohort of patients affected by spondyloarthritis.Methods:Patients with a diagnosis of spondyloarthritis and treated with secukinumab who were evaluated at our outpatient clinic from January 2017 to February 2023 were included in the study. Demographic, clinical characteristics, and comorbidities were recorded. DRR was evaluated by Kaplan-Meier method as time to drug discontinuation, and baseline factors predicting drug discontinuation were investigated through Cox regression after adjusting for baseline confounders.Results:One-hundred-seventy-eight patients were included in the study, with a median follow-up of 20.5 (IQR 10-39) months. Among these, 64.6% of patients were female, and 9.7% tested positive for HLAB27. 69.7% of patients presented peripheral involvement, 52.2% axial involvement, 40.4% enthesitis, and 52% psoriasis. Comorbidities were observed in 65.2% of patients, with the most common being hypertension (34.8%), cardiovascular diseases (18.5%), hepatic steatosis (22.5%), diabetes (11.8%), hyperlipemia (23%), kidney disease (6.2%), and a personal history of cancer (10.1%). The multivariable analysis identified the number of previous targeted synthetic or biological DMARD (ts/b DMARDs) (HR 1.44, 95% CI 1.01-2.06), hypertension at baseline (HR 2.56, 95% CI 1.08-6.11), and body mass index (BMI) (HR 1.08, 95% CI 1.01-1.17) as independent predictors of drug discontinuation. In contrast, old age at diagnosis was associated with a lower risk of discontinuation (HR 0.96, 95% CI 0.92-0.99) (Table 1). The drug retention rate at 12, 24 and 48 months was 79.4%, 69.3%, 55% respectively (Figure 1, panels A and B).Conclusion:In our cohort, secukinumab revealed a good DRR. An old age at diagnosis seemed to be protective against withdrawal, whereas the number of previous ts/b DMARDs, hypertension at baseline, and BMI were identified as predictors of drug discontinuation. Further studies are needed to confirm our findings.Table 1.Predictors of secukinumab withdrawal (Cox regression)VariableHR (95%CI)P valueNumber of previous ts/b DMARDs1.44 (1.01-2.06)0.045Hypertension2.56 (1.08-6.11)0.033BMI1.08 (1.01-1.17)0.036Age at diagnosis0.96 (0.92-0.99)0.038Variables in the model: gender, age at diagnosis, BMI, disease duration before secukinumab, number of previous ts/b DMARDs, psoriasis, SPA phenotype.Figure 1.Secukinumab retention rate.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:Elisa Bellis BMS, Mariele Gatto GSK, Astrazeneca, Janssen, GSK, Denise Donzella Janssen, Gloria Crepaldi Janssen, Galapagos, Eli Lilly, BMS, Novartis, Abbvie, Alfasigma, Valeria Data: None declared, Silvia Di Gregorio: None declared, Marinella Gammino: None declared, Valeria Guardo: None declared, Claudia Lomater Abbvie, BMS, Janssen, Eli Lilly, Novartis, Pfizer, Gaetano Liperoti: None declared, Elena Marucco: None declared, Ginevra Pastorin: None declared, Silvia Perrone: None declared, Marta Saracco: None declared, Annamaria Iagnocco Abbvie, Alfasigma, BMS, Celgene, Celltrion, Eli Lilly, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofy Genzyme, SOBI, Abbvie, Pfizer, Novartis.
POS1025 ADMINISTRATION OF BELIMUMAB IN EARLY ACTIVE LUPUS PATIENTS HINDERS ACCRUAL OF EULAR/ACR CRITERIA WITHIN THE FIRST 12 MONTHS OF TREATMENT
Background:Addition of biologic drugs to standard of care (SoC) in systemic lupus erythematosus (SLE) is advised in refractory patients. Evidence is needed on the effectiveness of early biologic use in influencing SLE course.Objectives:To assess the effect of belimumab administration on disease progression in early active lupus patients.Methods:We performed a multicentric observational study on patients with early SLE receiving either belimumab or SoC alone and compared the rate of EULAR/ACR 2019 criteria [1] accrual between the two groups as a measure of lupus progression over time. Patients were defined as early active if they were diagnosed within 12 months from treatment initiation and displayed up to two EULAR/ACR clinical criteria, excluding major organ involvement, with active serology (i.e. positive anti-dsDNA antibodies and/or decreased serum complement). Clinical, demographic and serological data were collected in an anonymized fashion at baseline and at 3, 6, and 12 months. Kaplan-Meier curves with log-rank comparison were used to assess criteria accrual throughout the first 12 month of follow-up.Results:We included 57 early active SLE patients, 24 (42.1%) receiving SoC alone and 33 (57.9%) receiving add on belimumab to SoC and followed up for at least 12 months from baseline. The groups were comparable in terms of age, gender, disease duration, background immunosuppression and overall disease activity at baseline. Patients doomed to early belimumab displayed higher mean SLICC and prednisone daily dosage (Table 1).Overall, 8.7 events/100-patients years occurred in our cohort. Twenty-five percent of patients on SoC versus 3.2% of patients on early belimumab accrued at least one EULAR/ACR criterion throughout the follow-up (p=0.035). Patients on SoC displayed development of skin rash (2 cases), arthritis (1 case), lupus nephritis (1 case), while one case of pericarditis occurred in the belimumab group.Criteria-free survival was significantly longer in patients receiving belimumab early as compared to those receiving SoC alone (log-rank 5.78, p=0.016) Figure 1. Mean time-to-event (months) was shorter in patients on SoC alone (10.3± 3.33 vs. 11.8±1.07, p=0.027).Conclusion:Timely use of belimumab in patients with early active SLE can significantly delay disease progression, potentially preventing development of severe manifestations.REFERENCES:[1] Aringer M, et al. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol 2019;71:1400-1412. doi: 10.1002/art.40930.Table 1.Baseline clinical and demographic features of early SLE patientsBelimumabSoCPAge34.05±11.6038.65±11.120.141Gender, F (%)29 (87.9)23 (95.8)0.385HCQ n (%)30 (90.9)17 (70.8)0.077IS n (%)26 (78.8)21 (87.5)0.494Prednisone mg/d8.75±6.675.00±10.610.054Anti-dsDNA titers (kU/L)201.04±282.9588.91±46.860.020C3 mg/dl79.54±27.4182.48±23.910.348C4 mg/dl12.00±5.1210.77±3.530.180cSLEDAI-2K5.42±1.765.75±1.330.227SLICC-DI0.12±0.420.00±0.000.052Continuous variables expressed as mean±SD. HCQ, hydroxycholoroquine; IS, immunosuppressants; cSLEDAI-2K, clinical SLE-activity index 2000; SLICC-DI, SLICC damage indexFigure 1.Kaplan-Meier curves depicting criteria-free survival in patient groupsAcknowledgements:NIL.Disclosure of Interests:Mariele Gatto GSK, AstraZeneca, Janssen, Matilde Caria: None declared, Claudio Cruciani: None declared, Pietro Francesco Gavino Pilo: None declared, Elisa Bellis BMS, Denise Donzella Janssen, Roberto Depascale: None declared, Daniela Rossi: None declared, Dario Roccatello: None declared, Andrea Doria GSK, AstraZeneca, Pfizer, Celgene, Eli Lilly, BMS, Roche, Annamaria Iagnocco Abbvie, Alfasigma, BMS, Celgene, Celltrion, Eli Lilly, Galapagos, Gilead,Janssen, MSD, Novartis, Pfizer, Sanofy Genzyme, SOBI, Abbvie, Pfizer, Novartis, Savino Sciascia: None declared.
POS0895 FAMILY PLANNING IN WOMEN AFFECTED BY RHEUMATOLOGICAL DISEASES: REAL-LIFE DATA FROM ITALY
Background:Counseling plays a fundamental role in women affected by rheumatic diseases (RMDs) to ensure the best possible outcomes and should be started as early as possible.Objectives:The study aims to give an overview about the management of family counseling in women affected by RMDs in ItalyMethods:Nineteen Italian centers were involved. Women of childbearing age (18 to 50 years) affected by RMDs were included. Data about diagnosis, disease activity, treatment were collected during routine visits. Information about family planning was obtained through a survey including 19 questions. Data were collected from December 2021 to March 2022 and from October to December 2022.Answers from questionnaires collected from women were expressed by absolute numbers and percentage for categorical variables and mean ± deviation standard for continuous variables.To compare the groups in case of categorical variables the Chi square test was used or the Exact Fisher test when there was a limited amount of data. For continuous variables, the Student’s T test was used.Statistical significance was defined as a p value < 0.05.Results:We collected data on 560 patients, mean age 34.2 ± 5.9 years, with a mean disease duration of 8.8 ± 7.6 years. Diagnoses are summarized in Table 1.Three hundred and fifty-four patients (63%) were at their first counseling, while 112 (20%) were already receiving regular counseling. In 22.7% of cases examination was conducted with another specialist, mostly represented by the gynecologist (89.8%).Fifty percent of patients were treated with conventional synthetic disease modifying antirheumatic drugs (DMARDs), with hydroxychloroquine being the most frequently used (30%), while a smaller percentage of patients received biologic DMARDs (39.6%), mostly represented by TNF inhibitors (29.6%). Only 1.8% of patients were treated with JAK inhibitors.At the time of assessment, 135 of patients were planning a pregnancy, 162 were pregnant and 246 were actively avoiding pregnancy. Two hundred-forty-one patients (43%) reported to use a contraceptive method: barrier method in 69%, estroprogestinic in 18% and intra-uterine device in 2.5%; 319 (57%) were not using any contraception. Within this group, 17% were taking medications incompatible with pregnancy.Most patients (72%) were aware of the effects of their disease on pregnancy but only 53% knew about disease impact on the newborn; 74% of patients showed knowledge about the effect of drugs on pregnancy, 59% were aware of the effects of medications on newborns and 40% understood the long-term effects of therapy on their children.Patients who repeatedly underwent counseling over time had a significantly higher awareness of the disease impact on pregnancy and newborns and of the effects of drug therapy on themselves and their infants in both the short and long term. Answers in the two groups are shown in Table 2.Conclusion:This study demonstrates that a high percentage of patients knows the impact of RMD on pregnancy and vice-versa but a lack of knowledge about the effects of therapies on the newborn has emerged and need to be improved. It also demonstrates the importance to repeat counseling over time to improve patients’ empowerment. An effort should be made in informing patients about the risk of the lack of contraception or the use of less effective method of contraception, especially in those undergoing treatment incompatible with pregnancy.REFERENCES: NIL.Acknowledgements:NIL.Disclosure of Interests:Giulia Carrea: None declared, Maria Gerosa UCB, Astrazeneca, Marta Mosca UCB (Advisor), Melissa Padovan: None declared, Sabrina Paolino: None declared, Maria Grazia Anelli: None declared, Roberta Ramonda: None declared, Cecilia Nalli: None declared, Patrizia Rovere-Querini: None declared, Elisa Bellis: None declared, Salvatore D’Angelo: None declared, Enrico Fusaro: None declared, Maria Sole Chimenti Maria Sole Chimenti has received speaker honoraria and/or unrestrictive research grants from Ely, Lilly, Abbvie, Pfizer, UCB, Novartis, Janssen, Leonardo Santo: None declared, Marco Gabini: None declared, Giulia Pazzola: None declared, Francesca Serale: None declared, Carlomaurizio Montecucco: None declared, Fabrizio Conti: None declared, Roberto F. Caporali: None declared.
AB0462 BEHCET’S DISEASE: CLINICAL FEATURES AND OFF-LABEL BIOLOGIC TREATMENT STRATEGIES
Background:The treatment of Behçet’s disease (BD) is still mainly based on the evidence derived from case reports, case series, retrospective analyses, and few clinical trials suggesting the safety and potential efficacy of off-label use of biologic agents in refractory cases. 1Objectives:To describe clinical manifestations and their management, with particular focus on treatment indications, outcomes and safety of biologic therapy, in a cohort of patients with BD.Methods:Patients with a diagnosis of BD who visited our outpatient clinic until December 2019 were included in the study. Clinical data were recorded since diagnosis until the latest follow-up visit, analyzing clinical features, flares and therapeutic strategies adopted.Results:A total of 95 patients were included in the study with a medium follow-up of 108.54 ± 169.59 months. 20 of them (21. 05%) were treated with biologic agents. Patients treated with biologic therapy compared to those on conventional non-biologic therapies had a higher proportion of musculoskeletal (80% vs 46.67%, p = 0.008), neurological (30% vs 10.67%, p = 0.031), intestinal involvement (40% vs 12%, p = 0.004), and they were treated with a higher dose of glucocorticoids at diagnosis (16.84 mg ±14.01 vs 8.89 mg ± 11.76, p = 0.012). The most frequent indications for biologic step-up therapy were musculoskeletal involvement (40%), eye involvement (25%), neurological involvement (15%) and intestinal involvement (10%). Most patients initiated a biologic treatment within the first year of follow-up. TNF-inhibitor (TNFi) were more frequently prescribed (95%) and one patient was treated with 8 therapeutic cycles of Rituximab (500 mg/weekly for 4 infusions to be repeated after at least 6 months) because of recurrent pancytopenia. All patients experienced non-biologic therapy before starting a TNFi. The preferred first-line TNFi was infliximab (50%), followed by adalimumab (40%) and etanercept (5%). As second line treatment were also prescribed certolizumab (10%) and golimumab (5%). 10 patients switched to a second line treatment because of inefficacy of the first biologic agent, mainly because of refractory arthritis, intestinal and mucocutaneous involvement. One patient switched from infliximab to certolizumab during pregnancy with subsequent worsening of arthritis.85% of patients treated with biologic agents reached a clinical remission by the time of the latest follow up visit without any safety or tolerability issues.Conclusion:A relevant proportion of patients in our BD cohort were treated with biologic therapy, because of severe or refractory manifestations. The most frequent indications were musculoskeletal, neurological or intestinal involvement. Biologic agents were a generally effective and safe therapeutic approach.References:[1]F. Alibaz-Oner, M. H. Sawalha, H. Direskeneli. Management of Behçet disease, Curr. Opin. Rheumatol, 2018Table 1.General characteristics and disease involvement at diagnosisBiologic therapyNo biologic therapyp value20 (21.05%)75 (78.95%)General characteristicsMediaSDMediaSDAge at disease onset (years ± SD)34.5± 10.4938.64± 13.18p = 0.1976Diagnostic delay (months ± SD)45.28± 67.4828.09± 48.42p = 0.1996Glucocorticoids at diagnosis (mg prednisone ± SD)16.84± 14.018.89± 11.76p = 0.0115Glucocorticoids at latest follow up visit (mg prednisone ± SD)6.38± 7.763.83± 4.81p = 0.0707N%N%F / M12 / 860 / 4054 / 4172 / 28p = 0.3030Disease involvement at diagnosisOral ulcers2010075100Genital ulcers11553749,33p = 0.6540Cutaneous lesions15755066,67p = 0.4787Eye involvement6302736p = 0.6184Musculoskeletal involvement16803546,67p = 0.0082Neurological involvement630810,67p = 0.0311Intestinal involvement840912p = 0.0039Thrombosis2101824p = 0.1747Disclosure of Interests:None declared
POS1406 DEVELOPMENT OF A DIAGNOSTIC ALGORITHM FOR THE DIFFERENTIAL DIAGNOSIS OF INTERSTITIAL LUNG DISEASE: PRELIMINARY DATA FROM A MULTICENTER RETROSPECTIVE CASE-CONTROL STUDY
Interstitial lung diseases (ILDs) represent a heterogeneous group of disorders with different treatment and prognosis. ILD may be the presenting or the dominant manifestation of a connective tissue disease (CTD). Multidisciplinary team (MDT) discussion is currently the diagnostic standard. However, there is no consensus on how MDT diagnosis is validated and on the core elements of discussion. To explore the performance of a diagnostic algorithm for the differential diagnosis of ILD based on clinical, serological and radiological data, supporting clinician decision-making. In this retrospective study, analysis was performed on clinical, serological and radiological features at diagnosis and 1-year follow-up in 71 patients, including 41 with CTD-ILD and 30 with idiopathic interstitial pneumonias (IIPs). In order to identify robust hallmarks, we conducted the Receiver Operating Characteristic (ROC) curve analyses in logistic regression, to discriminate significantly different features between CTD-ILD and non-CTD-ILD groups. Out of 71 patients 46% were women, with a mean age of 66±11 years. History of smoking (8.8% current and 39.8% former smokers), was more associated with IIPs. 54% of patients had dyspnea on exertion and 39% dry cough, both more frequently associated with IIPs (p = 0.016). Among radiological features, NSIP pattern was more frequent in CTD-ILD, while UIP was associated with IIP. Lung fibrosis extent was greater in IIP (p = 0.063), in which CT is generally performed in symptomatic patients at diagnosis and rarely for screening purpose. Baseline features with good performance (OR p-value ≤ 0.05) were eligible as potential candidate discriminators: age, sex, smoking habit, rheumatological signs and symptoms, autoantibodies, ILD patterns were selected, to build a multivariate model with high discrimination accuracy (AUC 0.971). The model has a sensitivity of 100% and specificity of 89.7%. The most relevant correlations between population features and CTD-ILD are presented in Table 1. Our study shows that the most important variables in the differential diagnosis between CTD-ILD versus IIPs include, as expected, autoimmune features (rheumatological symptoms and serological data). Questionnaire tool containing these specific hallmarks may be relevant during MDT discussion, limiting the number of misdiagnosed CTD-ILDs and potentially avoiding further unnecessary investigations. However, only prospective cohort studies of early onset ILD are needed to fully validate the relative importance of clinical, serological, functional and radiological data. [1]Furini F. et al, The Role of the Multidisciplinary Evaluation of Interstitial Lung Diseases: Systematic Literature Review of the Current Evidence and Future Perspectives. Front Med (Lausanne). 2019; 6: 246. None declared Table 1Correlation analysis of the most significant discriminativefeatures.FeaturesOdds ratioP valueArea under ROC curveSex (female)3.290.019*0.643Age0.910.001*0.736Smoke0.12<0.001*0.738Respiratory symptoms (dyspnea and/or dry cough)0.260.016*0.644Rheumatological symptoms (any)28.8<0.001*0.839• Raynaud's phenomenon15.040.0110.654• Cutaneous manifestations8.160.0530.593Autoantibodies (ANA, ENA, RF, ACPA, myositis-specific antibodies or aPL) positivity33.68<0.001*0.792Lung function test• Forced vital capacity (%FVC)0.970.1750.638• Diffusing capacity of carbon monoxide (%DLCO)0.960.0720.665High-resolution computed tomography (HRCT) imaging• Honeycombing0.340.0680.593• Emphysema0.140.005*0.647• Extent of lung involvement (%)0.970.0630.668HRCT pattern• NSIP vs UIP30.033*0.625Abbreviations: ANA, antinuclear antibody; ENA, extractable nuclear antigen; RF, rheumatoid factor; ACPA, anti-citrullinated peptide antibody; aPL, antiphospholipid antibody; NSIP, nonspecific interstitial pneumonia; UIP, usual interstitial pneumonia.
SAT0207 ANTI-SSA/RO POSITIVITY AND CONGENITAL HEART BLOCK: OBSTETRIC AND FETAL OUTCOME IN A COHORT OF ANTI-SSA/RO POSITIVE PREGNANT WOMEN WITH AND WITHOUT AUTO-IMMUNE DISEASES FROM THREE ITALIAN TERTIARY REFERRAL CENTERS
Background:neonatal lupus syndrome (NLS) is an acquired disease caused by the trasplacental passage of anti-SSA antibodies. Congenital heart block (CHB) represents the most serious manifestation of NLS. The rate of CHB in Anti-SSA positive pregnant women ranges from 1 to 5% in different studiesObjectives:to retrospectively assess the prevalence of CHB in a cohort of anti-SSA positive pregnant women followed in 3 Italian tertiary centersMethods:pregnancies of anti-SSA positive women attending the pregnancy clinic of ASST Pini CTO/Policlinico Mangiagalli, Rheumatology Division of Spedali Civili, Brescia and Rheumatology Division of Ospedale S Matteo, Pavia from 2009 to 2019 were included. Patients underwent monthly clinical examination. Fetal heart rate was assessed weekly by Doppler ultrasound from 14th to 26th gestational week. On week 14 and 26, a fetal echocardiography was performed. A EKG was performed at birthResults:351 prospectively followed pregnancies in 292 anti-SSA/Ro positive women were included. Table 1 reports diagnosis. None of the prospectively followed pregnancies were complicated by complete CHB. Seven additional patients were referred to our clinics after diagnosis of CHB and were subsequently found to be anti-SSA positive, reporting no symptoms of diseases. Considering the 7 additional pregnancies, the incidence of CHB was 1.9%. We observed 3 neonates (0.8%) with cutaneous NLS and 1 case of transient increase of liver enzymes. In another neonate, a 1th degree A-V block was found after birth. A complete analysis of maternal and fetal outcome was possible in 244 cases (Table 2) and compared with 3158 unselected healthy controls. Among these 244 cases, 65% were taking hydroxychloroquineTable 1.patients diagnosisn%Sjogren’s Syndrome58`20Systemic lupus erythematosus7626UCTD7425Asymptomatic Ro carriers5619Other2810292100Table 2.maternal and fetal outcomehealthy controls N=3158Anti-SSA/Ro ptsN=244P valuePrevious CHB n (%)2 (0.8)Anti-SSB pos n (%)46 (18.8)aPL pos n (%)49 (20)PregnancyLive births3158241Preeclampsia, n (%)43 (1.1)2 (0.8)nsDeliveryDelivery <37 wks, n (%) / < 34 wks n (%)401 (12.6) /201 (6)35 (15.6) / 14 (6)ns / nsCesarean Section, n (%)897 (29.3)115 (47.5)<0.001Conclusion:none of the patients prospectively followed in our centers before and during pregnancy developed complete CHB. If the 7 cases of anti-SSA positivity diagnosed after CHB detection were included in the analysis, the incidence of CHB was comparable to previous reports. Our data suggest that a strict follow up and proper treatment of anti-SSA positive patients with or without an autoimmune disease before and during pregnancy can reduce the risk of NLS. Further studies are warranted to confirm a possible protective role of anti-rheumatic treatments, including HCQReferences:[1]Fredi M. Front Cardiovasc Med. 2019Disclosure of Interests:Maria Gerosa: None declared, Micaela Fredi: None declared, Laura Andreoli: None declared, Cecilia Chighizola: None declared, Lorenza Maria Argolini: None declared, Davide Donzelli: None declared, Tamara Vojinovic: None declared, Véronique Ramoni: None declared, Elisa Bellis: None declared, Laura Trespidi: None declared, Federica Gazzola: None declared, Enrico Ferrazzi: None declared, Sonia Zatti: None declared, Fausta Benvenuti: None declared, Pier Luigi Meroni: None declared, Franco Franceschini: None declared, Carlomaurizio Montecucco: None declared, Rolando Cimaz: None declared, Roberto Caporali Consultant of: AbbVie; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme; Celgene; Bristol-Myers Squibb; Pfizer; UCB, Speakers bureau: Abbvie; Bristol-Myers Squibb; Celgene; Lilly; Gilead Sciences, Inc; MSD; Pfizer; Roche; UCB, Angela Tincani: None declared