Breakthrough SARS-CoV-2 infection in fully vaccinated patients with systemic lupus erythematosus: results from the COVID-19 Vaccination in Autoimmune Disease (COVAD) study
Authors: Palazzo Leonardo , Lindblom Julius , Kihlgren Olsson Emelie , Nikiphorou Elena , Wincup Chris , Saha Sreoshy , Shaharir Syahrul Sazliyana , Katchamart Wanruchada , Akarawatcharangura Goo Phonpen , Traboco Lisa , Chen Yi-Ming , Lilleker James B. , Nune Arvind , Pauling John D. , Agarwal Vishwesh , Dzifa Dey , Toro Gutiérrez Carlos Enrique , Caballero-Uribe Carlo V. , Chinoy Hector ,   COVAD Study Group, Barman Bhupen , Singh Yogesh Preet , Ranjan Rajiv , Jain Avinash , Pandya Sapan C. , Pilania Rakesh Kumar , Sharma Aman , M Manesh Manoj , Gupta Vikas , Kavadichanda Chengappa G. , Patro Pradeepta Sekhar , Ajmani Sajal , Phatak Sanat , Goswami Rudra Prosad , Chowdhury Abhra Chandra , Mathew Ashish Jacob , Shenoy Padnamabha , Asranna Ajay , Bommakanti Keerthi Talari , Shukla Anuj , Pandey Arun Kumar R. , Chandwar Kunal , Kardes Sinan , Cansu Döndü Üsküdar , Kim Minchul , Makol Ashima , Chatterjee Tulika , Pauling John D. , Wincup Chris , Cavagna Lorenzo , Del Papa Nicoletta , Sambataro Gianluca , Fabiola Atzeni , Govoni Marcello , Parisi Simone , Bocci Elena Bartoloni , Sebastiani Gian Domenico , Fusaro Enrico , Sebastiani Marco , Quartuccio Luca , Franceschini Franco , Sainaghi Pier Paolo , Orsolini Giovanni , De Angelis Rossella , Danielli Maria Giovanna , Venerito Vincenzo , Milchert Marcin , Traboco Lisa S. , Wibowo Suryo Anggoro Kusumo , Tehozol Erick Adrian Zamora , Serrano Jorge Rojas , García-De La Torre Ignacio , Loarce-Martos Jesús , Prieto-González Sergio , Gil-Vila Albert , Gonzalez Raquel Aranega , Kuwana Masataka , Yoshida Akira , Nakashima Ran , Sato Shinji , Kimura Naoki , Kaneko Yuko , Knitza Johannes , Tomaras Stylianos , Gromova Margarita Aleksandrovna , Aharonov Or , Gheita Tamer A. , Hmamouchi Ihsane , Hoff Leonardo Santos , Giannini Margherita , Maurier Francois , Campagne Julien , Meyer Alain , Nagy-Vincze Melinda , Langguth Daman , Limaye Vidya , Needham Merrilee , Srivastav Nilesh , Hudson Marie , Landon-Cardinal Océane , Shaharir Syahrul Sazliyana , Rojas Zuleta Wilmer Gerardo , Pereira Silva José António , Fonseca João Eurico , Zimba Olena , Agarwal Vikas , Gupta Latika , Parodis Ioannis 
Published: August 2024

Abstract
Objective
To determine the occurrence of breakthrough COVID-19 infections (BIs) in patients with systemic lupus erythematosus (SLE) compared with patients with other rheumatic autoimmune diseases (rAIDs), patients with non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs).

Methods
The study was based on data from 7035 fully vaccinated respondents to the online COVAD questionnaire with SLE (N = 852), rAIDs (N = 3098), or nrAIDs (N = 414), and HCs (N = 2671). BI was defined as COVID-19 infection occurring in individuals vaccinated with ≥ 2 doses (or 1 dose of J&J) ≥ 14 days after vaccination and not after 6 months since the last vaccine dose. Data were analysed using linear and logistic regression models.

Results
A total of 91/852 (10.7%) SLE patients reported at least one BI. The frequency of BIs in SLE patients was comparable to that among HCs (277/2671; p = 0.847) and patients with nrAID (39/414; p = 0.552) but higher than that among patients with other rAIDs (235/3098; p = 0.005). No demographic factors or treatments were associated with BIs in SLE patients (p ≥ 0.05 for all). Joint pain was more frequent in SLE patients than in HCs (odds ratio [OR]: 3.38; 95% confidence interval [CI]: 1.89–6.04; p < 0.001) or nrAID patients (OR: 2.44; 95% CI: 1.04–5.75; p = 0.041). Patient with SLE did not report a higher frequency of hospitalisation or need for advanced treatment for COVID-19 infection compared with disease controls and HCs, respectively.

Conclusion
COVID-19 vaccination conferred similar protection against COVID-19 infection in terms of frequency and severity in patients with SLE to that reported by healthy individuals.