Background: The recently published 2019 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for systemic lupus erythematosus (SLE) were developed to increase the reliability and identification of SLE, especially in early disease. With the emergence of several new drugs for SLE, identifying and treating patients early are more important than ever. Methods: Data of 446 SLE patients evaluated in our center between 1996–2019 and 226 controls with other autoimmune diseases evaluated between 2001–2022 were retrospectively analyzed. The sensitivity and specificity of the 2019 ACR/EULAR criteria were compared to the 2012 SLICC and the 1997 ACR criteria. Results: The 2019 ACR/EULAR criteria showed very good sensitivity (86.6%) compared to the 1997 ACR criteria (76.7%), p < 0.001, with a trend toward significance compared to the 2012 SLICC criteria (83.6%), p = 0.072. Their sensitivity remained high (87.6%) in patients with a short disease duration. The specificity of the 2019 ACR/EULAR criteria (91.2%) was statistically lower than the 2012 SLICC (96.0%) and 1997 ACR criteria (95.1%), p = 0.007 and p = 0.012, respectively, but still had a very high value. A total of 22 controls (9.7%) fulfilled at least one set of criteria (15 patients with MCTD, 5 with UCTD, and 2 with SSc). Conclusion: In this large real-life cohort, the 2019 ACR/EULAR criteria had very good performance compared to the 2012 SLICC and 1997 ACR criteria.

Background:Systemic lupus erythematosus (SLE) is a heterogenous autoimmune disease, with increased morbidity and mortality, often diagnosed in advanced stages. The recently published 2019 American College Of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for SLE are weighted, hierarchically clustered criteria developed to increase reliability and the identification of early SLE.Objectives:To compare the sensitivity and specificity of the 2019 ACR/EULAR criteria with the 2012 SLICC criteria in a large single-centre cohort of patients with SLE, diagnosed according to expert oppinion.Methods:Data of SLE patients evaluated in our centre between 1996-2019 have been retrospectively analyzed. The control cohort included patients with positive antinuclear antibodies of other ethiology than SLE, evaluated between 2001-2019. The sensitivity and specificity of the 2019 ACR/EULAR and 2012 SLICC criteria were tested using the McNemar test for correlated proportions.Results:Four hundred and forty-six patients with SLE (413 women, mean±SD age 40.5±12.7 years, disease duration 10.1±9.2 years) and 67 controls (63 women, mean±SD age 50.4±12.6 years, disease duration 7.6±6.9 years; 29 systemic sclerosis (SSc), 18 mixed connective tissue dissease (MCTD), 15 undifferentiated CTD, 2 rheumatoid arthritis (RA), 2 SSc – RA overlaps and 1 dermatomyositis) were included. The sensitivity of the 2019 ACR/EULAR and 2012 SLICC criteria were similar 85.4% and 83.6 %, respectively (p=0.3). The specificity of the 2019 ACR/EULAR and 2012 SLICC criteria were 70.2 % and 86.6%, respectively (p=0.007). In the SLE group, patients missclassified according to the new 2019 ACR/EULAR criteria were 65, whereas according to the 2012 SLICC criteria were 73; of them, 44 patients did not fulfill any criteria. In the control group, patients misclassified had mainly MCTD (13/20 patients according to the new 2019 ACR/EULAR, and 8/9 according to the 2012 SLICC criteria).Conclusion:In this real-life cohort, the 2019 ACR/EULAR criteria have a similar sensitivity and lower specificity than the 2012 SLICC criteria, misclassifying especially MCTD patients. These results might be due to the long disease duration in our cohort.References:[1] Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019;71(9):1400–1412. doi:10.1002/art.40930Disclosure of Interests:None declared

BackgroundPlanning a pregnancy in rheumatoid arthritis (RA) meets several issues, mostly concerning potential drug toxicity and disease flares.ObjectivesThe purpose of this study is to evaluate pregnancy planning, RA activity during pregnancy and postpartum, pregnancy and fetal outcomes in a Romanian cohort of female patients diagnosed with RA.MethodsWe designed an observational ambispective study which included 36 RA Caucasian females with obstetric history after the onset of RA (14 - prospective, 22 - retrospective). The cases were obtained from several Clinics of Rheumatology from Romania.ResultsThe mean age at inclusion is 39.88 years, age at RA diagnosis 24.97 years and mean age at conception 31.03 years.We recorded a total number of 65 pregnancies: 29 deliveries at term, 3 premature births, 12 elective abortions, 20 spontaneous abortions (attributed to trombophilia, methotrexate [MTX], Leflunomide and Toxoplasmosis gondii) and 1 ongoing.24/36 (66.6%) had only one pregnancy after the onset of RA and 7/36 (19.4%) were multipares before the diagnosis. 47.6% had at least one unplanned pregnancy, while being on treatment with DMARDs.Concerning the exposure to synthetical DMARDs during the pregnacy:5 patients received Leflunomide and 2 received MTX during the first trimester, the pregnancy outcomes being: 2 spontaneous abortion, 2 elective abortions, 2 normal birth, 1- premature twin pregnancy.In case of biologic DMARDs: 2 were exposed to Etanercept until weeks 2 and 3 (normal birth), and 1 to Infliximab – week 4 (elective abortion). In patients receiving Rituximab the washout period varied from 4 weeks in 2 pregnancies (1- spontaneous abortion and 1 normal birth) to 48 weeks (2 normal births and 1 premature).We registred 3 patients on biological therapy, which stopped the treatment with 2 years before the planned preganncy (Etanercept), respectivelly 6 months (Etanercept and Adalimumab)66.6 of our patients were in Remission or Low Disease Activity (DAS28CRP) at preconception.Maintaing or improvement of the disease activity during the pregnancy were the principal trend in our population, excepting 2 situations.The average pregnancy length was 35.2 weeks, with 3 preterm deliveries and the mean birthweight was 2624 grams. No fetal abnormality was identifiedFive patients never had a new flare postpartum, while in the others the mean time to flare postpartum was 9 weeksConclusionsPatients with RA can have successful pregnancies. The pregnancy is planned in about half of cases. Pregnancy decreases disease activity, but many deliveries are followed by RA flares. No fetal abnormalities were diagnosed.ReferencesPregnancy in autoimmune rheumatic diseases: The importance of counselling for old and new challengesL.Andreoli, C Bazzani M.Tarabo-relli, R. Reggia, A. Lojacono, A. Brucato, P.L Meroni, A. Tincani, Autoimmunity Reviews 10 (2010) 51–54Disclosure of InterestNone declared

Background. The new therapies have enforced another approach regarding the success of a pregnancy in rheumatoid arthritis, in a sense of a decrease in the number of complications which may interfere with the fetal or maternal outcome. Aims. The study aim is to evaluate fertility among female patients with rheumatoid arthritis, in Romania, having as secondary objectives to appraise the pregnancy outcome, in parallel with monitoring the activity of the disease, the relation with the postpartum flare, as well as following up on the evolution status of the foetuses. Material and method. We have analysed a number of 38 female patients diagnosed with rheumatoid arthritis that have had at least one post-diagnosis obstetrical episode, for 23 of the patients we have done it retrospectively, and for 15 patients, prospectively. The study is multicentric and has been carried out between October 2012 and July 2015. The patient evaluation criteria include: the activity of the disease and the treatment management in the pre-conceptual stage; monitoring of the disease every trimester and adequate therapeutic intervention; postpartum reactivation of the rheumatoid arthritis in connection with the breast feeding and the control of the disease during pregnancy: teratogenicity and autoimmunity bearing risks over the product of conception; outcome of pregnancies and foetuses. Results. The 38 women have had an average age at conception of 31.02 years, at almost 6 years from diagnose and we have obtained a number of 67 pregnancies with the following outcome: 31 births at term, 3 premature births, 12 elective abortions and 21 spontaneous abortions. The pregnancy has been planned in 47.77% of cases. Patients have been exposed during preconception as well as during pregnancy at synthetic and biological disease-modifying antirheumatic drugs. During preconception, the activity of the disease was controlled for half of the patients, status that has been kept or improved during pregnancy and only 3 cases have shown a minimal reactivation. The length of the pregnancies was about 34.94 weeks, the average weight at birth was of 2,668 grams. No foetal anomalies have been identified. The postpartum flare has occurred after 9.7 weeks and in 9 of the patients we have not recorded an increase in the degree of activity of the disease. Conclusions. The rheumatoid arthritis is not a contraindication to pregnancy, as the activity of the disease is controlled or partially controlled during the pregnancy with or without antirheumatic therapies, but the risk of an early postpartum relapse remain possible, the majority of pregnancies have a positive outcome. Discussion. The data obtained in our country are in general superposable to the data found in the specialized literature. Giving good pre-conceptional counselling and having an eficient interdisciplinary management of pregnancies are the key elements for successfully covering this chapter in the life of our female patients.