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Objective To identify determinants of neuropsychiatric (NP) flares in patients with systemic lupus erythematosus (SLE) treated for active SLE yet no ongoing severe NPSLE with non-biologic standard therapy plus belimumab or placebo. Methods We analysed data from five phase III trials (BLISS-52, BLISS-76, BLISS-NEA, BLISS-SC, EMBRACE; N = 3638) after exclusion of patients with baseline NP BILAG A. Factors associated with NPSLE flare, defined as a new NP BILAG A or B, were investigated using Cox regression. In a subgroup analysis, we studied patients with baseline NP BILAG E for determinants of de novo NPSLE flare. Organ damage was assessed using the SLICC/ACR Damage Index (SDI). Results We documented 105 (2.9%) NPSLE flares. In multivariable analysis, male sex (HR = 2.37; 95% CI: 1.31–4.28; p = 0.004), baseline NP BILAG B–D (HR = 5.91; 95% CI: 3.86–9.06; p Conclusion Male sex, NPSLE history, and NP damage were strong determinants of impending NPSLE flare. No clear protection or predisposition was conferred from add-on belimumab.

Research data should be managed, curated, stored and shared in a way that lives up to the expectations regarding trustworthiness and quality, provides sustainability and preserves the investments. The Trustworthy Digital Repository standards which have emerged from the Open Archival Information System (OAIS) reference model offer a certification solution for repositories. CoreTrustSeal (CTS) offers baseline certification and supports the concept of outsourcing. Adopting workflows and guidelines from CoreTrustSeal is also a way to assure that the data published by the repository follow the FAIR principles. Even outside of the formal certification framework the CoreTrustSeal criteria provide a demonstrable approach to internal and external review, supporting a benchmark for comparison and a means to determine the strengths and weaknesses of data repositories. This deliverable is the final deliverable of the SSHOC Task 8.2 Trust & Quality Assurance. It will describe the certification standards of Trustworthy Digital Repositories (TDRs) from the perspective of the SSH domain and summarise the certification support activities provided to the SSHOC community. The experiences gained from the support process will be considered in addition to the results of the examination of the trust in the domain of Social Sciences and Humanities (SSH) and the certification landscape. The support activities are based on the earlier work of T8.2 outlined in the Deliverable 8.1 Certification plan for SSHOC repositories, which laid the ground for the SSHOC trust work to facilitate the adoption of TDR standards and the FAIR principles in SSH data repositories. In this deliverable, ‘trust’ refers to the myriad of issues, standards and processes related to the level of trustworthiness of digital repositories. The deliverable will also discuss possible certification solutions for SSH repositories, consider the complex partnership models of TDRs and outsourcing of their services, and examine how trust can be sustainably managed after the SSHOC project. The experiences and feedback gained from the trust support work demonstrate that the support process has been beneficial for the repositories involved and allowed them to improve their procedures. While certification can be resource-intensive for certain repositories, there are few alternatives for a lighter certification beyond the core certification. The diversity of the SSH repository and data service landscape means that there is no certification solution suitable for all. Complex partnership models and outsourcing of services should also be considered when seeking certification. In some cases, organisations may opt for an assessment instead of formal certification. This has proven beneficial and useful for certain data services in improving their practices. Ensuring the sustainable management of trust is not solely dependent on assessment or certification, as trust goes beyond the technical aspects of repositories and also involves people. Therefore, future endeavours to manage trust should make use of the existing and planned networks of trustworthyrepositories that can share both expertise and responsibility, while recognising the need for more enduring sources of funding for managing trust sustainably.