Background: There have been concerns over the susceptibility of SLE patients to severe COVID-19 illness since the beginning of the pandemic, and many patients were assigned ‘clinically extremely vulnerable’ according to the UK’s shielding guidance issued in March 2020. Here we report on vaccination and shielding behaviours of a moderate-to-severe SLE cohort with high immunosuppressant burden.

Objectives: To review the shielding behaviours, and the safety and tolerability of COVID-19 vaccines in a real-world cohort of patients with moderate to severe SLE.

Methods: The British Isles Lupus Assessment Group Biologics Registry (BILAG-BR) is a national prospective registry of lupus patients from the UK (2010-21). Patients from the BILAG-BR were invited to complete a paper or online questionnaire which consisted of 17 questions to assess their self-reported shielding behaviour, vaccination status, and any adverse responses following COVID-19 vaccination. Questionnaires were completed between 9 ^th Oct 2021 and 7 ^th Jan 2022. Responses were linked with data collected in the BILAG-BR.

Results: Data were collected from the first 202/1268 patients (186 [92.1%] women) to respond, with a median age of 51 (IQR 38-61) years from 37 UK centres. The majority of patients were Caucasian (78.1%, 150/192). Previous therapy included rituximab (165, 81.7%), belimumab (33, 16.3%) and cyclophosphamide (54, 26.7%). In the past 12 months, over two thirds of patients (138, 68.3%) had received oral prednisolone (current dose median 5mg [IQR 5-8mg, range 2-40mg] daily), and almost a third had received parental steroids (60, 29.7%).

Shielding was reported in the first national lockdown (March-June 2020) by 93.6% (189/202) of patients, and of those in employment at the time, over half (58/100) were unable to work from home. The vast majority of patients complied with the UK government guidance (97.0%, 196/202) and did not socialise with other households indoors during this time period. Fifty-four percent of patients (109/202) reported attending a hospital or GP appointment during the first lockdown, and 24/202 (11.9%) reported regular appointments. During the first lockdown, 13/109 (11.9%) patients reported receiving rituximab infusions and 9/109 (8.3%) belimumab infusions.

Ninety-seven percent (196/202) had received at least 1 COVID-19 vaccination (Oxford AstraZeneca 95/146, 65.1%; Pfizer/ BioNtech 50/146, 34.3%). Approximately half of patients (54.2%, 104/192) reported an adverse reaction to the vaccine (both vaccine doses in 45 (23.9%) patients). The majority of these included lethargy/ flu-like symptoms (82, 78.8%) or local site reactions (32, 30.8%). Six (3.0%) patients reported a lupus flare and 3 (1.5%) patients reported a hospital attendance due to vaccine side effects.

Conclusion: In this cohort of moderate-to-severe SLE patients there was strong engagement with UK shielding guidance, however only half of patients attended a GP or hospital appointment during the earliest peak of the pandemic, highlighting disruptions to routine clinical care. There was high uptake of COVID-19 vaccination, which whilst generally well tolerated in this cohort, may be temporally associated with a flare, albeit in only a small number of patients. We recognise it may be difficult to distinguish between vaccine adverse events and lupus flares in patients with SLE, therefore this may be an overestimation. Of note, three patients reported a hospital attendance post-vaccination which warrants further investigation.

Acknowledgements: Submitted on behalf of the BILAG-biologics register

Disclosure of Interests: Sarah Dyball Grant/research support from: UCB and Eli Lilly, Mia Rodziewicz Grant/research support from: UCB, Emily Sutton: None declared, Ben Parker Speakers bureau: Eli Lilly and Roche, Consultant of: Fresenius-Kabi and AbbVie, Grant/research support from: Genzyme/Sanofi and GSK, Ian N. Bruce Speakers bureau: AstraZeneca, GSK and UCB, Consultant of: AstraZeneca, Eli Lilly, GSK, Merck Serono, UCB and ILTOO, Grant/research support from: Genzyme/Sanofi, GSK, Roche and UCB