COVID-19 vaccination in autoimmune diseases (COVAD) study: vaccine safety and tolerance in rheumatoid arthritis
Authors: Naveen R , Parodis Ioannis , Joshi Mrudula , Sen Parikshit , Lindblom Julius , Agarwal Vishwesh , Lilleker James B , Tan Ai Lyn , Nune Arvind , Shinjo Samuel Katsuyuki , Salim Babur , Ziade Nelly , Velikova Tsvetelina , Edgar Gracia-Ramos Abraham , Saavedra Miguel A , Day Jessica , Makol Ashima , Distler Oliver , Chinoy Hector , Agarwal Vikas , Aggarwal Rohit , Gupta Latika , Nikiphorou Elena ,   COVAD Study Group, Barman Bhupen , Singh Yogesh Preet , Ranjan Rajiv , Jain Avinash , Pandya Sapan C , Pilania Rakesh Kumar , Sharma Aman , M 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 , Kardeş 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 Dr Marcin , Traboco Lisa S , Wibowo Suryo Anggoro Kusumo , Tehozol Erick Adrian Zamora , Serrano Jorge Rojas , De La Torre Ignacio García , 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 François , Campagne Julien , Meyer Alain , Nagy-Vincze Melinda , Langguth Daman , Limaye Vidya , Needham Merrilee , Srivastav Nilesh , Hudson Marie , Landon-Cardinal Océane , Shaharir Syahrul Sazliyana , Zuleta Wilmer Gerardo Rojas , Silva José António Pereira , Fonseca João Eurico , Zimba Olena 
Published: October 2022

Abstract

Objectives
The COVID-19 vaccination in autoimmune diseases (COVAD) study aimed to assess short-term COVID-19 vaccination-related adverse events (AEs) in RA patients.

Methods
An online self-reported questionnaire (March–December 2021) was used to capture data related to COVID-19 vaccination-related AEs in RA, other autoimmune rheumatic diseases (AIRDs) (excluding RA and inflammatory myositis), non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs). Descriptive and multivariable regression analyses were performed.

Results
Of the 9462 complete respondents, 14.2% (n = 1347) had been diagnosed with RA; they had a mean (s.d.) age of 50.7 (13.7) years, 74.2% were women and 49.3% were Caucasian. In total, 76.9% and 4.2% of patients with RA reported minor and major AEs, respectively. Patients with active and inactive RA had similar AE and hospitalization frequencies. Overall, AEs were reported more frequently by BNT162b2 and mRNA-1273 recipients and less frequently by BBV152 recipients compared with the rest. Major AE and hospitalization frequencies were similar across recipients of different vaccines. Patients receiving methotrexate and hydroxychloroquine reported fewer minor AEs than those patients not on them. Compared with HCs and patients with other AIRDs, patients with RA reported similar total AEs, overall minor AEs, and hospitalizations. Compared with nrAIDs, patients with RA reported lower frequencies of overall AEs, minor AEs (both odds ratio [OR] = 0.7; 95% CI: 0.5, 0.9), and injection site pain (OR = 0.6; 95% CI: 0.5, 0.8) with similar major AE and hospitalization frequencies.

Conclusion
Despite the differences in AE frequency across different COVID-19 vaccines, all were well tolerated in patients with RA and were comparable to HCs, providing reassurance as to the safety of COVID-19 vaccination.