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Introduction The first biologic authorized for systemic lupus erythematosus (SLE) up to this date, belimumab, is currently not recommended for use during pregnancy due to lack of data. Provided that the health of the child begins with the health of the mother, pregnant patients face the dilemma of cessation or continuation of belimumab. If belimumab is stopped, there will be a risk of SLE flare and its consequences for the mother and the foetus. Continuation is also not optimal because of the lack of knowledge on safety for use during pregnancy. Aim To compare the reported foetal outcomes in SLE patients who stopped scheduled belimumab within the first trimester (group A) and those who continued scheduled belimumab during the first trimester or thereafter (group B). Material and method All belimumab-exposed pregnancy-related reports were extracted from the EudraVigilance (EV) database until March 11th, 2021. After case review, repeated cases, uninformative reports, non-medical elective abortions and foetal chromosomal abnormalities were excluded. Included pregnancies were divided into two groups (group A and B, as described above). Foetal outcomes were divided into live birth or foetal death (due to miscarriage or stillbirth) and were compared between both groups. Furthermore, neonatal outcomes, such as reporting rates of preterm birth, low birth weight and major congenital malformations were compared. Results No statistical difference in foetal death was observed between group A and B (reported numbers (%) = 32 (46.4) and 11 (52.4), respectively). Odds ratio (OR, [95% Confidence Intervals (CIs)]) of foetal death in group B compared to group A was 1.27 [0.48, 3.32]. Reporting rates of preterm birth and low birth weight were higher – though not statistically different – in group A. Conclusion The positive results of our study are supportive for the continuation of belimumab during pregnancy. Since the analysis is based on spontaneous reports/retrospective data, additional studies are needed to confirm the results.

Background: Increasing evidence suggests that TNF inhibitors (TNFi) are safe to use during pregnancy1. A drawback of TNFi use during pregnancy is active transport across the placenta, which is affected by the structure of the TNFi1. The European League Against Rheumatism (EULAR) defined points to consider (PtC) on the use of TNFi during pregnancy2: to prevent placental transfer, etanercept should be discontinued at gestational age (GA) 30-32 weeks, and both adalimumab and infliximab should be discontinued at GA 20 weeks. Certolizumab pegol can be conditionally continued throughout pregnancy. Objectives: The aim of this research is to validate the EULAR PtC by measuring the level of TNFi in cord blood. Methods: Patients were derived from the PreCARA study, an ongoing prospective cohort study on inflammatory rheumatic diseases and pregnancy in the Netherlands. Patients were treated according to a treat-to-target approach, which included the use of TNFi. TNFi were, if possible, discontinued at recommended stop time points. Maternal blood samples were collected in each trimester. Cord blood was analyzed for the presence of certolizumab pegol, etanercept, adalimumab and infliximab. Levels of TNFi in the cord blood were compared between patients that stopped at the advised GA and patients who did not. Results: Data from 111 patients with inflammatory rheumatic diseases were used for the current analysis. Most patients stopped treatment before the recommended GA (table 1). Certolizumab pegol (n = 68) was measured in a low number of cord blood samples (5.9%) and in low concentrations (median, (IQR): 0.25 µg/ml (0.15 – 1.3)). Etanercept was not detected in any cord blood samples (n = 28). Adalimumab (n = 24) and infliximab (n = 13) were measured more often in cord blood (in 50.0% and 61.5% of patients, respectively), this also was observed in patients that stopped before the recommended GA (in 47.7% for adalimumab and 60.0% for infliximab). However, the observed concentrations were low: the maximum observed concentrations in cord blood were 2.1 µg/ml (stopped at GA 19.4 weeks) for adalimumab and 4.5 µg/ml (stopped at GA 21.1 weeks) for infliximab. Conclusion: Stopping TNFi around the GA recommended by the EULAR PtC resulted in no measurable levels or low concentrations of TNF inhibitor in the cord blood in a majority of patients. References: [1]Smeele HTW, Dolhain RJEM. Current perspectives on fertility, pregnancy and childbirth in patients with Rheumatoid Arthritis. Semin Arthritis Rheum. 2019;49(3S):S32-S35. doi:10.1016/j.semarthrit.2019.09.010 [2]Gotestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795-810. doi:10.1136/annrheumdis-2015-208840 Disclosure of Interests: Erik Kemper: None declared, Nafise Ghalandari: None declared, Hubertina Johanna Maria Josephina Crijns: None declared, Hieronymus TW Smeele: None declared, Radboud Dolhain Speakers bureau: UCB, Roche, Abbvie, Genzyme, Novartis, Consultant of: Galapagos, Grant/research support from: UCB

ObjectivesPrevious research has demonstrated that patients with rheumatoid arthritis (RA) are less likely to breast feed their offspring. Treatment options for RA during lactation have expanded and the importance of counselling is recognised. The aim of the current research was to study breast feeding among women with RA who benefit from these developments.MethodsPatients were derived from the Preconceptional Counselling in Active Rheumatoid Arthritis (PreCARA) cohort. Patients were treated according to a modified treat-to-target approach aimed at remission and received pregnancy counselling, including counselling on breast feeding. Postpartum visits were scheduled at 4–6, 12 and 26 weeks post partum. Prevalence of breast feeding at each postpartum visit was compared with a historical reference cohort (Pregnancy-induced Amelioration of Rheumatoid Arthritis cohort) and the general population.ResultsData on 171 pregnancies were available for the current analysis. 120 (70.2%) patients with RA initiated breast feeding. 103/171 (60.2%), 68/171 (39.8%) and 45/171 (26.3%) patients with RA breast fed their offspring at 4–6, 12 and 26 weeks post partum, respectively. These percentages were higher at all postpartum visits compared with the historical reference cohort (pConclusionPatients with RA in the PreCARA cohort were more likely to breast feed their offspring compared with patients with RA in the historical reference cohort. The breastfeeding rates observed were similar to breastfeeding rates among women in the general population. The increase in breast feeding among patients with RA may be due to the extension of lactation-compatible medication and pregnancy counselling.

Aim To evaluate the number and nature of reported congenital malformations (CMs) after intrauterine exposure to non-tumour necrosis factor inhibitors (non-TNFis) compared to certolizumab pegol (CZP) Material and methods A retrospective comparative study was conducted in the EudraVigilance (EV) database. EV is a pharmacovigilance database, which can be used for detecting safety signals and generating hypotheses on possible relations between drugs and adverse events. A supposedly safe biologic (CZP) was considered as the reference group. Pregnancy-reports of non-TNFis and CZP were extracted. Odds ratios (ORs) for CMs were calculated for each non-TNFi, versus CZP (quantitative assessment). Then, CM patterns were compared to CZP in consultation with a clinical geneticist (qualitative assessment). Results ORs were not statistically significant except for belimumab and vedolizumab (similar in magnitude). Although qualitative analyses did not show any specific patterns for belimumab but three cases of corpus callosum agenesis (CCA) were identified for vedolizumab (versus null in CZP and other investigated non-TNFis). Two of the CCA cases were associated with other neurological CMs (one cerebral ventriculomegaly with microcephaly and one polymicrogyria). This may indicate that these CCAs are related to undiagnosed genetic alterations or are associated with the underlying maternal disease, although a definite relationship with vedolizumab exposure cannot be ruled out. Conclusion No special safety signal was identified regarding the occurrence of CMs after exposure to non-TNFis, except for vedolizumab. Based on available information, no firm conclusions can be made regarding observed CCAs in the vedolizumab group (it warrants further research)

Objectives Clinical difficulty to discriminate between the Alzheimer disease (AD) and dementia with Lewy bodies (DLB) has led researchers to focus on highly sensitive functional imaging modalities. The aim of the present study was to assess 131I-MIBG cardiac imaging to distinguish between AD and DLB. Patients and methods Seventeen patients who were known cases of dementia underwent 131I-MIBG myocardial scintigraphy to differentiate AD from DLB. Planar and 131I-MIBG SPECT were obtained 2 h after the injection of 1 mCi 131I-MIBG on a dual head gamma camera. The visual assessment of the heart uptake compared with lungs and the quantification based on the heart to mediastinal ratio (HMR) were done. The cardiac receiver operating characteristic (ROC) curve was designed for the optimal HMR cut-off values to predict the diagnoses of the patients. The diagnoses were clinically confirmed during the follow up of 14 ± 8.2 months. Results Out of 17 patients (13 males; 76.5%), 10 patients had AD (7 males; 70%) and 7 patients had DLB (6 males; 85%). The pooled HMR was 1.74 ± 0.33 in the study population; with 1.95 ± 0.22 in the AD group and 1.43 ± 0.20 in the DLB group to demonstrate significantly different HMR scores between patients with AD and DLB (p value = 0.001). The visual interpretation was positive in 10 patients (accuracy of 88.2%). The shortest distance on the ROC curve to the optimal value corresponding to HMR = 1.57 identified 10 patients with a high HMR (positive cardiac uptake) and 7 patients with a low HMR (negative cardiac uptake), the accuracy calculated at 88.2%. Conclusion 131I-MIBG myocardial scintigraphy is a potential alternative diagnostic modality for discrimination between AD and DLB when 123I is not available.

Background The effects of biologicals on reproduction are unknown. Therefore pregnancy during biologicals use is discouraged. However biologicals are frequently prescribed in patients of childbearing potential and many patients become pregnant while using these drugs. Objectives In 2015 EULAR published a broad review article on this matter. Our aim was to update the data based on newly published articles. Methods A search was conducted at 18/10/2017 and then 21/11/2018 in Embase, Medline Ovid, Web Of Science, Cochrane CENTRAL and Google Scholar with specific search terms for each database. Articles were excluded based on title/abstract (double blind, two researchers, NG and HJMJC) and then full text (one researcher, NG). A chart was made based on outcomes of interest(see Table1). The references of included articles were reviewed to include and minimize the missing articles. Results Totally 137 articles were included (79 articles at first round, 51 articles at second round and 7 found after screening the references of the included articles). A descriptive analysis was performed to sum up the data on each separate biological and all the biologicals together. The results are shown in Table1. It should be notified that due to heterogeneity of the data the calculated percentages are up to individual interpretations and cannot be compared to each other. Conclusion From 2015 onwards, there have been many articles published regarding use of biologicals during pregnancy. Despite limitations of our study, such as heterogeneity in being prospective or retrospective and quality of the included articles, no alarm is raised concerning safety issues. Disclosure of Interests Nafise Ghalandari: None declared, Radboud Dolhain Grant/research support from: UCB Pharma B.V, Johanna Hazes: None declared, Eugene van Puijenbroek: None declared, Manavi Kapur: None declared, Hubertina Johanna Maria Josephina Crijns: None declared

Clinical difficulty to discriminate between the Alzheimer disease (AD) and dementia with Lewy bodies (DLB) has led researchers to focus on highly sensitive functional imaging modalities. The aim of the present study was to assessSeventeen patients who were known cases of dementia underwentOut of 17 patients (13 males; 76.5%), 10 patients had AD (7 males; 70%) and 7 patients had DLB (6 males; 85%). The pooled HMR was 1.74±0.33 in the study population; with 1.95±0.22 in the AD group and 1.43±0.20 in the DLB group to demonstrate significantly different HMR scores between patients with AD and DLB (p value=0.001). The visual interpretation was positive in 10 patients (accuracy of 88.2%). The shortest distance on the ROC curve to the optimal value corresponding to HMR=1.57 identified 10 patients with a high HMR (positive cardiac uptake) and 7 patients with a low HMR (negative cardiac uptake), the accuracy calculated at 88.2%.