The Impact of Anti-SARS-CoV-2 Vaccine in Patients with Systemic Lupus Erythematosus: A Multicentre Cohort Study

Abstract

Vulnerable subjects, including systemic lupus erythematosus (SLE) patients, have been prioritised to receive anti-SARS-CoV-2 vaccines. Few data about the safety of these vaccines in SLE are available. The aim of our study is to investigate the safety of anti-SARS-CoV-2 vaccines in SLE. We included 452 SLE patients, referring to seven tertiary centres, who were immunised. A total of 119 (26%) reported side effects (SE) after the first and/or the second shot (the most frequent SE were fever, local reaction, fatigue, and arthralgia). Patients with constitutional symptoms and those on an immunosuppressive regimen (especially belimumab) showed more SE. In addition, 19 (4%) had a flare after the immunisation (flares classified by organ involvement: six musculoskeletal with constitutional symptoms, four renal, three cardio-respiratory, three haematological, two mucocutaneous). None of the patients needed hospitalisation and none died. Moreover, 15 required a transient increase in corticosteroids and four were treated with steroid pulses. One patient required an additional rituximab course. Anti-dsDNA, moderate/high DAS before vaccine, and belimumab were found more frequently in patients with disease flare. Anti-SARS-CoV-2 vaccines are safe in SLE patients, and they should be recommended in these patients, as the potential benefits widely outweigh the risk of SE. Treatment adjustment might be considered with the aim of minimising SE risk and flare.

Latent Class Analysis Identifies Distinct Phenotypes of Systemic Lupus Erythematosus Predictive of Flares after mRNA COVID-19 Vaccination: Results from the Coronavirus National Vaccine Registry for ImmuNe Diseases SINGapore (CONVIN-SING)

“…Various studies have reported associations between lupus disease flares and mRNA COVID-19 vaccination ( Supplementary Table S3 ) [ 25 , 26 , 27 , 28 , 29 ] and two have focused on SLE patients [ 25 , 26 ]. A study involving 183 SLE patients reported that 11 (6%) patients experienced flares following vaccination, most of which were mild and constituted symptoms such as joint pain, skin rash, fatigue, muscle aches and mouth ulcers [ 25 ].…”

“…A study involving 183 SLE patients reported that 11 (6%) patients experienced flares following vaccination, most of which were mild and constituted symptoms such as joint pain, skin rash, fatigue, muscle aches and mouth ulcers [ 25 ]. A multicentre cohort study of 452 SLE patients who had received COVID-19 vaccination found that 4% of patients flared after immunisation, with musculoskeletal, constitutional symptoms and renal being the most common types of flare; however, none of the disease flares required hospitalisation [ 26 ]. It is worth noting that new-onset SLE after mRNA COVID-19 vaccination has been described in various case reports, raising the plausibility of an association between induced autoimmunity and mRNA vaccination [ 30 , 31 ].…”

Efficacy, Immunogenicity, and Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases: A Systematic Review and Meta-Analysis

“…Autoimmune medications given to the patients included alemtuzumab [29,34,48,66], abatacept [8,33,35,39,47,57,58,63,[72][73][74][75]94,98], anti-CD20/-B cell depleting therapy [8,29,[32][33][34][35]37,[39][40][41]43,45,[47][48][49][52][53][54][55]57,60,[62][63][64][65][66]72,74,75,87,89,92,94,[96]…”

Vaccination updates and special considerations for systemic lupus erythematosus patients

“…Initial studies on the 2021 original COVID vaccine series administered to SLE patients demonstrated clinical efficacy with impaired but generally sufficient immunogenicity [11,12 ▪ ]. Despite theoretical risks, patient concerns, and case reports, vaccination rarely precipitated severe flares in larger studies [12 ▪ ,13–18].…”