COVID-19 vaccination in autoimmune diseases (COVAD) study: vaccine safety and tolerance in rheumatoid arthritis
R Naveen, Ioannis Parodis, Mrudula Joshi, Parikshit Sen, Julius Lindblom, Vishwesh Agarwal, James B Lilleker, Ai Lyn Tan, Arvind Nune, Samuel Katsuyuki Shinjo, Babur Salim, Nelly Ziadé, Tsvetelina Velikova, Abraham Edgar Gracia‐Ramos, Miguel Ángel Saavedra, Jessica Day, Ashima Makol, Oliver Distler, Hector Chinoy, Vikas Agarwal, Rohit Aggarwal, Latika Gupta, Elena Nikiphorou, COVAD Study Group, Bhupen Barman, Yogesh Preet Singh, Rajiv Ranjan, Avinash Jain, Sapan C Pandya, Rakesh Kumar Pilania, Aman Sharma, Matthew Antony Manoj, Vikas Gupta, Chengappa Kavadichanda, Pradeepta Sekhar Patro, Sajal Ajmani, Sanat Phatak, Rudra Prosad Goswami, Abhra Chandra Chowdhury, Ashish Jacob Mathew, Padnamabha Shenoy, Ajay Asranna, Keerthi Talari Bommakanti, Anuj Shukla, Arun Kumar R Pandey, Kunal Chandwar, Sinan Kardeş, Döndü Üsküdar Cansu, Min‐Chul Kim, Ashima Makol, Tulika Chatterjee, John D Pauling, Chris Wincup, Lorenzo Cavagna, Nicoletta Del Papa, Gianluca Sambataro, Fabiola Atzeni, Marcello Govoni, Simone Parisi, Elena Bartoloni Bocci, Gian Domenico Sebastiani, Enrico Fusaro, Marco Sebastiani, Luca Quartuccio, Franco Franceschini, Pier Paolo Sainaghi, Giovanni Orsolini, Rossella De Angelis, Maria Giovanna Danielli, Vincenzo Venerito, Marcin Milchert, Lisa S Traboco, Suryo Anggoro Kusumo Wibowo, Erick Adrian Zamora Tehozol, Jorge Rojas‐Serrano, Ignacio García‐De La Torre, Jesus Loarce‐Martos, Sergio Prieto‐González, Albert Gil‐Vila, Raquel González, Masataka Kuwana, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Johannes Knitza, Stylianos Tomaras, Margarita Aleksandrovna Gromova, Or Aharonov, Tamer A. Gheita, Ihsane Hmamouchi, Leonardo Santos Hoff, Margherita Giannini, F. Maurier, Julien Campagne, Alain Meyer, Melinda Nagy‐Vincze, Daman Langguth, Vidya Limaye
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.