Maternal autoimmune rheumatic diseases can influence the outcomes of children through several life stages. During pregnancy, maternal inflammation and autoantibodies can hinder fetal development and lead to growth restriction, preterm birth, and low birth weight; prematurity, especially at extreme gestational ages, can in turn impair future child health. Treatment with compatible immunomodulatory drugs and preventive medications aims to keep maternal disease under control and minimise the risk of adverse pregnancy outcomes. However, concerns have been raised about the effects of immunomodulatory drugs on neonatal conditions (ie, the risk of serious infections, inadequate responses to vaccinations, and organ toxicity) and long-term outcomes (metabolic and cardiovascular problems and neurodevelopmental disorders). Among the unmet needs of parents with autoimmune rheumatic diseases, there is the estimation of risk for the children to develop autoimmune disorders and the need for reassurance about parenting capacity while living with a chronic condition. This Series paper provides a comprehensive overview of the literature and guidance on discussing these topics with patients.

Systemic Lupus Erythematosus (SLE) imposes a great burden on the lives of patients. Patients' and physicians' concerns about the disease diverge considerably. Physicians focus on controlling disease activity to prevent damage accrual, while patients focus on symptoms that impact on Health-Related Quality of Life (HRQoL). We explored the physicians' and patients' perspective and the potential role of Patient Reported Outcomes (PROs). Physicians are aware of the theoretical usefulness of PROs to collect information deriving from the patients' perspective. However, they often do not know how to interpret and use these questionnaires in a real shared therapeutic strategy. For the patients, it's important to be seen as a whole person with a true consideration of how they feel and function. Strategies to help bridge the communication gap could include: better use of time during visits, preparing for the consultation, a more understandable lay language used by the doctor, a dedicated nurse.

OBJECTIVES:To develop evidenced recommendations to allow the global systemic lupus erythematosus (SLE) advocacy community to effectively advocate for change and improve care for patients with SLE. METHODS:A Global Working Group consisting of representatives from patient advocacy groups, professional organisations, and the SLE healthcare community defined key areas of unmet need in patients with SLE. Targeted principles for each area of unmet need guided a literature review to investigate the current global situation, pre-existing advocacy efforts, and best practices from other therapy areas. The results from this literature review allowed the Working Group to develop recommendations to improve care for patients with SLE. RESULTS:Barriers faced by patients with SLE can stem from poor recognition of symptoms, which leads to delays in accurate diagnosis, cycling between different healthcare professionals, and inconsistencies in receiving optimal care. Patient access to approved treatments for SLE also remains limited. This Patient Charter, co-developed with a group of internationally recognised clinicians and patient advocates, sets out the minimum standard of care people living with SLE should expect and receive under 4 principles with distinct recommendations for change. CONCLUSIONS:The intention is to improve health outcomes by uniting and empowering patients, caregivers, patient groups, and healthcare professionals to advocate for reforms to healthcare practices for people living with SLE.

SLE presents significant challenges for patients and health-care professionals (HCPs), both across Europe and worldwide. Improving health-care outcomes for patients with SLE requires a comprehensive understanding of patient disease pathways. In particular, the geographical distance between SLE patients and specialized care centres, combined with the scarcity of rheumatologists, exacerbates delays in diagnosis and management. Also, the initial SLE symptoms can often be non-specific, and providing guidelines for primary HCPs and other non-specialists is extremely important. Improvement in access to treatment is also important, with several recently approved therapies for SLE not being available in several European countries and many low- and middle-income countries (LMICs). Furthermore, in the LMICs in which these treatments are available, they are not always covered by the health-care system, making their access almost impossible for those of lower socio-economic status. A number of provisions are already in place within the European Union, to improve access to care for patients with rare and complex diseases, including those with SLE. In particular, European Reference Networks (ERNs), such the ERN for Autoimmune Diseases ReCONNET, are virtual networks involving HCPs across Europe with the aim of improving the care of patients with rare and complex diseases that require highly specialized treatment and a concentration of knowledge and resources. In addition, lupus patient organizations such as Lupus Europe play a crucial role in raising awareness of SLE and advocating for improved access to care. Together, we can work towards a future where all people living with lupus receive the comprehensive and timely care they deserve.

Objective:To optimise the organisation of care and encourage the adoption of good clinical practices, the RarERN Path© methodology was designed within ERN ReCONNET. The aim of our work was to report the application of RarERN Path© on systemic sclerosis within the ERN ReCONNET centres, providing a feasible and flexible organisational reference model for optimising the systemic sclerosis care pathway in different countries. Methods:RarERN Path© is a six-phase methodology which enables the creation of a reference organisational model co-designed on the basis of the expertise of different stakeholders. It foresees six phases, ranging from the map of existing patients' care pathways and patients' stories, to the consensus on a common organisational patient care pathways, and its key performance indicators definition. Results:The agreed reference model highlights the importance of having an organisational flow for referrals that foresees how patients may access directly the specialised unit from the different referrals. Specific specialised visits were considered as mandatory to be organised and they included cardiologist, pneumologist, gastroenterologist, psychologist, nephrologist, dermatologist, wound care specialist/nurses and other healthcare professionals (such as nurses, social workers and nutritional counselling). Moreover, specific services related to therapy were highlighted as strongly recommended to be organised, mainly represented by infusion therapy and wound care, as well as occupation therapy and physiotherapy. Conclusion:The organisational model emerged from our investigation emphasises that the organisation of specific services for systemic sclerosis treatment should be organised as a solid support for implementing the existing recommendations on systemic sclerosis management in real life.

Background: Many patient organisations are increasingly struggling to attract and retain volunteers to work on the organisation's key missions. Understanding what motivates them is a first step to better meet their aspirations and retain them to support our important roles. Objectives: To identify relevant drivers of volunteers' motivations across Lupus Europe's member organisations. Methods: A short survey has been distributed through Lupus Europe's volunteers and members networks asking for a short free-text description of what motivate(d) them to volunteer for a lupus patient organisation, as well as their role and level of volunteering work. Answers were manually categorised to the different Clary et al. (1998) functional motivators of engagement and frequency was analysed. Results: 111 individual statements were obtained allowing the identification of 214 underlying individual motivation drivers. -The "Values" dimension unsurprisingly topped the list with 56.8% of participants highlighting it, most often in the generic form of "a desire to help others". While it is the top driver of all roles (except Patient Advisory Network (PAN), it has a higher impact on Advocacy roles (88.9%), Peer-to-peer (P2P) (65%) and leadership roles (62.1%). -The "Social" dimension (being part of a group, connecting with people) comes second with 32.4%, mostly due to the PAN where it reaches 55.6%, compared to 21.6% in other roles. -A similar pattern is observed for "Understanding" (having opportunities to grow knowledge) averaging 31.5% across all participants, reaching 50% in the PAN group and 45% for Peer-to-Peer roles, but only averaging 14.8% in other roles. -The overall "Protective dimension" was mentioned by 20.7% of participants, with limited fluctuations by roles. The type of "Protection" considered is however very different between PAN roles where it takes a more physical dimension (growing knowledge to better fight my lupus, 25%) compared, at the other end of the spectrum to advocates that view it under a more psychological dimension (turning my disease's negative into positive, 22.2%). The other roles have a close to 50/50 split between these 2 extremes. -Enhancement (feeling better about myself, self-esteem) is only mentioned by 12.6% of participants. It has low appeal to most roles, but is present in 33.3% of Advocates, and 16.7% of PAN members. -Finally, the Career dimension (acquiring new skills that I can possibly use elsewhere) were also mentioned by 12.6% of participants, but this was more in Board and organisation support (Administrative, organising events, …) roles. The volunteers' motivation types also impact their level of engagement, measured in reported estimated hours of volunteering per month (averaging 25.4hrs amongst participants): People motivated by "values" volunteer 32hrs/month vs. 14 for those that aren't; Volunteers with "physical protective" motivation volunteer 31hrs vs. an average 15 for those with "Psychological protective" function". Volunteers displaying "Social, Career or Enhancement" motivations perform 15-17hrs/month on average vs. 27 for those less affected by such motivators. From those volunteers that deliver most hours, all are motivated by values, and none mentioned career or enhancement. Conclusion: This analysis of (lupus) volunteers motivation highlights opportunities to tailor Motivation talks to volunteering types to maximise their engagement. The findings also support the development of targeted motivational support structures, potentially augmenting volunteer satisfaction and commitment. REFERENCES: [1] Clary et al. (1998). Understanding and assessing the motivations of volunteers: A functional approach. Journal of Personality and Social Psychology, 74(6), 1516-1530. https://doi.org/10.1037/0022-3514.74.6.1516. Acknowledgements: None of the authors has direct conflict of Interest. However, LUPUS EUROPE is funded mostly by grants or donations from Pharmaceutical Companies (Astra Zeneca, Biogen, BMS, Boehringer-Ingelheim, Galapagos, GSK, Idorsia, Janssen, Merck, Novartis, Otsuka, Roche, UCB), none of which exceeds 20% of total funds collected, and none having a say on the content of our studies. Disclosure of Interests: None declared.

Background: Systemic lupus erythematosus (SLE) is a complex and heterogenous autoimmune disease characterised by periods of worsening symptoms, known as flares. Flares and long-term glucocorticoid (GC) therapy are both associated with increased risk of long-term damage. This significantly impacts health-related quality of life and increases emergency hospital visits and healthcare costs. The challenges facing SLE patients worldwide have garnered significant attention from patient groups and clinical experts, driving robust consensus work on their unmet needs [1,2,3]. Key challenges include poor recognition of symptoms, leading to delays in diagnosis, cycling between healthcare professionals, and receiving suboptimal care. Patient access to approved treatments for SLE also remains limited. The publication of updated EULAR recommendations for the management of SLE provides an opportunity for the lupus community to advocate for improved standards of care by championing their implementation. Key recommendations include GC-sparing approaches and early use of biological therapies to achieve remission or lower disease activity, preserve renal function, and reduce flares and organ damage. Objectives: To unite and empower patients, patient groups and healthcare professionals to advocate for improvements in the care and treatment received by people with SLE. Methods: Representatives from patient groups, professional organisations and the treatment community came together to develop a Patient Charter. Results: The Patient Charter identifies four principles of care and associated recommendations to improve care:Principle 1: I deserve recognition and understanding of early symptoms of SLE to drive timely, accurate diagnosis and assessment so that I can receive the best care available as soon as possible.Recommendations: Improve public, patient and clinical education on SLE; develop a standard list of diagnostic criteria and clinical investigation tools; implement referral pathways.Principle 2: I deserve access to information about my SLE, so I can play an active role in the management of my condition, minimise flares and reduce the impact of SLE on my life.Recommendations: Improve access to patient information and self-management tools; co-create interventions with SLE patients to improve their uptake.Principle 3: I deserve access to a coordinated multi-disciplinary care team who fully understands my condition and my experience, regardless of who am I or where I live.Recommendations: Ensure patient access to multi-disciplinary teams; implement personalised care plans for every patient; establish shared care infrastructure; adopt telehealth solutions.Principle 4: I deserve access to appropriate and comprehensive pharmacological and non-pharmacological care, which reduces the burden of my SLE and allows me to have a high quality of life for as long as possible.Recommendations: Encourage clinical trial participation; minimise or monitor GC use to the lowest possible dose; update and implement clinical guidelines. Conclusion: SLE places a significant burden on the lives of millions of people worldwide, significantly impacting a patient’s quality of life, mental health and relationships. It has a substantial impact on healthcare systems due to suboptimal disease management, and on society, through the loss of productivity caused by the debilitating long-term symptoms and impact of SLE. The principles and recommendations we have set out in this charter demonstrate the core elements of quality care that all people living with SLE should receive, regardless of health system or geography. We urge healthcare professionals, providers, health systems and policymakers around the world to swiftly implement SLE diagnosis and care guidelines which reflect these principles and ensure that the latest advancements and current approaches in SLE care reach the patients who need them. REFERENCES: [1] Cornet A et al. Lupus Science & Medicine. 2021 8(1), e000469[2] Tse, K et al. Lupus Science & Medicine. 2021 8(1), e000433[3] European Reference Network. 2018 https://reconnet.ern-net.eu/ Acknowledgements: The Patient Charter was initiated by AstraZeneca to inform a discussion about what quality care should look like in the provision of SLE services. These principles were debated and refined during a discussion held on Thursday 7 July 2022, organised and funded by AstraZeneca. Nine experts from academic and patient organisations and a professional group discussed the value of establishing a Patient Charter as a potential starting point for discussions on how to improve SLE care. Writing and editing assistance, including preparation of a draft manuscript under the direction and guidance of the authors, incorporating author feedback, and manuscript submission, was provided by MHP Group and Fishawack Health. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Disclosure of Interests: Marta Mosca AbbVie, AstraZeneca, Bristol Myers Squibb, Janssen and Lilly, AstraZeneca, AbbVie, GSK, Idorsia, Lilly and UCB, Idorsia, Jeanette Andersen AstraZeneca, Bristol Myers Squibb and Roche, AstraZeneca, Bayer, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, GSK, Idorsia, Janssen, Lilly, Merck, Novartis, Roche and UCB, Patrick Wildman: None declared, Susan Manzi AstraZeneca, Exagen Diagnostics Inc, GSK, Lilly, Novartis, UCB, AbbVie, AstraZeneca and GSK, Zahir Amoura AstraZeneca, GSK, Novartis, and Roche, AstraZeneca, GSK, Novartis, Roche; Amgen, Kezar and Otsuka, Irene Bultink GSK and UCB, Odirlei André Monticielo AbbVie, Apsen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, GSK, Janssen, Novartis and UCB, AstraZeneca, GSK and Janssen, Sandra Navarra Astellas, AstraZeneca, Boehringer Ingelheim, GSK, Janssen, Novartis and Pfizer, Biogen, Biogen, GSK, Idorsia, Lilly and Novartis, Susanne Pettersson Novartis.

Systemic lupus erythematosus (SLE) is a disease of high unmet therapeutic need. The challenge of accurately measuring clinically meaningful responses to treatment has hindered progress towards positive outcomes in SLE trials, impeding the approval of potential new therapies. Current primary end points used in SLE trials are based on legacy disease activity measures that were neither specifically designed for the clinical trial context, nor developed according to contemporary recommendations for clinical outcome assessments (COAs), such as that substantial patient input should be incorporated into their design. The Treatment Response Measure for SLE (TRM-SLE) Taskforce is a global collaboration of SLE clinician-academics, patients and patient representatives, industry partners and regulatory experts, established to realize the goal of developing a new COA for SLE clinical trials. The aim of this project is a novel COA designed specifically to measure treatment effects that are clinically meaningful to patients and clinicians, and intended for implementation in a trial end point that supports regulatory approval of novel therapeutic agents in SLE. This Consensus Statement reports the first outcomes of the TRM-SLE project, including a structured process for TRM-SLE development.

Systemic lupus erythematosus (SLE) is a very complicated and heterogeneous disease, and the popular saying is that no two lupus patients are the same. This of course also means that the treatment and planning of care can be very complicated and needs to be adjusted to the individual patient. One of the best ways to achieve this goal is through shared decision making. If the patient feels like they have a voice in the treatment plans the probability of treatment adherence increases substantially. On average the SLE patient is more aware of their own symptoms, disease progression and medication than patients with less complicated or less heterogeneous diseases. They need to become experts in their disease because they are the ones living with the symptoms and can often 'feel' a flare coming on before the laboratory results show it. Health-related-quality of life (HRQoL) when living with a chronic disease like SLE very much depends on how you self-manage; living a healthy life, keeping active, prioritising everyday tasks according to energy-level etc. The engaged and informed patient can be both a help and a burden when it comes to the physican's disease management. It helps if the patient has the right medical information and respects that the physician has the expertise to decide what is best for them.1 A patient needs to know that not every symptom is because of lupus and that they might not be flaring, even though they feel like they are. This 'complicated' care of an SLE patient often takes more than one health care professional. Apart from a multidisciplinary team of physicians each specialised in their own manifestations (like kidneys, lungs, heart etc.) it is often beneficial to involve other areas such as specialised nurses, physiotherapists, psychologists, occupational therapists etc. This multidisciplinary team of course requires a good coordination, which should not be put exclusively on the patient.

Systemic lupus erythematosus (SLE) imposes a great burden on the lives of patients. Patients' and physicians' concerns about the disease diverge considerably. Physicians focus on controlling disease activity to prevent damage accrual, while patients focus on symptoms that impact on health-related quality of life (HRQoL). The existing clinician reported outcomes (ClinRO), such as disease activity indices, remission, low disease activity (LLDAS), response (SRI and BICLA) do not include the patient perspective. Several investigations show that patients judged in remission by the treating physician, still report the presence of relevant clinical symptoms.1 2 Patients and physicians assess the disease differently (discordance up to 58% of cases) Patients tend to score disease activity higher than physicians Patients consider subjective manifestations as more relevant than physicians Physicians consider laboratory abnormalities as more relevant It seems there is a discordance between patients and physicians when it comes to prioritising outcomes. The best way to identify the patients' priorities is through Patient Reported Outcomes (PROs). PROs allow us to capture aspects of the disease which have an impact on patients and constitute their burden of the disease. Ideally, the dialogue between doctor and patient should address the most bothersome symptoms for the individual patient. What is most bothersome for one might not be the same as for someone else and it most likely won´t be the same priority as the doctor has. At the same time, some of the most bothersome symptoms are difficult (if not impossible) to manage with traditional SLE treatments. In these cases, the communication becomes even more important, and a communication gap can be detrimental to the HRQoL and overall care.3 References Yen JC, et al. Discordance between patients and their physicians in the assessment of lupus disease activity: relevance for clinical trials. Lupus. 1999;8(8):660–70. doi: 10.1191/096120399680411362. Cornet A, et al. Living with systemic lupus erythematosus in 2020: a European patient survey. Lupus Sci Med. 2021 Apr;8(1):e000469. doi: 10.1136/lupus-2020-000469. PMID: 33849920; PMCID: PMC8051432. Cornet A, et al. Patient-doctor communication gap - results of a speed-shop on 'lupus flare' at lupus 2022 meetings. Ann Rheum Dis. 2023;82:309. POS0171. Learning Objectives Describe the burden of the disease from the patient´s perspective Explain the importance of patient-physician communication Distinguish between patient and physician priorities

Systemic lupus erythematosus (SLE) is a very complicated and heterogeneous disease, and the popular saying is that no two lupus patients are the same. This of course also means that the treatment and planning of care can be very complicated and needs to be adjusted to the individual patient. One of the best ways to achieve this goal is through shared decision making. If the patient feels like they have a voice in the treatment plans the probability of treatment adherence increases substantially. On average the SLE patient is more aware of their own symptoms, disease progression and medication than patients with less complicated or less heterogeneous diseases. They need to become experts in their disease because they are the ones living with the symptoms and can often 'feel' a flare coming on before the laboratory results show it. Health-related-quality of life (HRQoL) when living with a chronic disease like SLE very much depends on how you self-manage; living a healthy life, keeping active, prioritising everyday tasks according to energy-level etc. The engaged and informed patient can be both a help and a burden when it comes to the physican´s disease management. It helps if the patient has the right medical information and respects that the physician has the expertise to decide what is best for them.1 A patient needs to know that not every symptom is because of lupus and that they might not be flaring, even though they feel like they are. This 'complicated' care of an SLE patient often takes more than one health care professional. Apart from a multidisciplinary team of physicians each specialised in their own manifestations (like kidneys, lungs, heart etc.) it is often beneficial to involve other areas such as specialised nurses, physiotherapists, psychologists, occupational therapists etc. This multidisciplinary team of course requires a good coordination, which should not be put exclusively on the patient. Reference Cornet A, et al. Patients expectations, and what we (can) do about it. Lupus Sci Med.2020;7:doi:10.1136/lupus-2020-eurolupus.7. Learning Objectives Explain the importance of involving patients in shared-decision-making Describe how a multidisciplinary team can be used in the SLE care Describe the role of the informed patient in their own care

ABSTRACTObjectiveDespite significant improvements in diagnosis delay and treatment strategies, the burden of Systemic Lupus Erythematosus (SLE) remains high. The objective of the study was to assess the association between diagnosis delay, disease activity and burden on daily life (BoDL) in a large sample of European patients with SLE.MethodsIn May 2020, Lupus Europe, the European umbrella patient association for SLE, conducted a multilingual anonymous online cross-sectional study to individuals with a self-reported physician’s diagnosis of SLE living in Europe. The BoDL score was computed using 1 to 5 Likert scales on 5 domains (mobility, anxiety/depression, self-care, daily activities and pain/discomfort) and the sum was rescaled on a 0 (minimum Burden on daily life) to 100 (maximum BoDL) scale. Comparisons between independent groups were made using the Mann-Whitney test for continuous outcomes and the Chi-2 test (or Fisher’s exact test) for quantitative data.ResultsData of 4,150 SLE patients from 35 European countries were analysed. Those with a diagnosis of SLE within 2 years of first symptoms had significantly lower mean BoDL scores than those diagnosed after 5 years (33.6 versus 44.0, p<0.001). The BoDL score was better in SLE patients feeling that their lupus had been under control during the last 3 months versus the others (34.0% versus 47.6%, p<0.001).ConclusionThis large international study highlights the association between diagnosis delay and self-perceived disease activity with the burden of the disease on the daily life of people living with SLE. Healthcare pathways, which may accelerate diagnosis and optimize therapeutic management, are necessary to improve patients’ outcomes in SLE.

Objective Previous research on coping strategies of patients with SLE showed that there are no absolute adaptive or maladaptive strategies and that the range of potential coping strategies is large and heterogeneous. In this paper, we aimed to identify, in a large sample of patients with SLE (N=3222), the most frequent words used by patients to describe their coping strategies, to group them into significant themes and to test their possible association with specific patient characteristics. Methods Our analyses were based on the data set of the European survey ‘Living with Lupus in 2020’ (N=3222). Through the T-LAB software, we analysed the answers that adult participants gave to an open-ended question about how they cope with the disease. We identified the most frequent words, and with hierarchical cluster analysis we grouped them into semantic clusters (ie, themes) that were characterised by specific patterns of words. Finally, we tested the possible association between clusters and illustrative variables (sociodemographics, disease characteristics, quality of life). Results Five coping strategies were identified, each of them constituting an important percentage of the total word occurrences: positive attitude (22.58%), social support (25.46%), medical treatments (10.77%), healthy habits (20.74%) and avoid stress (20.45%). Each strategy was statistically associated with specific patient characteristics, such as age and organ involvement. Conclusions Learning to adapt to a lifetime of having SLE may require replacing old coping strategies with more effective ones. Investigating patients’ coping strategies in relation to different patient characteristics represents a useful starting point for developing more targeted and efficacious interventions.