Abstract Objective It has been suggested that SARS-CoV-2 infections prior to primary vaccination are associated with increased disease activity of underlying immune-mediated inflammatory diseases (IMIDs). Our primary objective was to assess the incidence of increased disease activity after SARS-CoV-2 breakthrough infections in patients with IMIDs, and study risk factors associated with increased disease activity. Methods IMID patients, enrolled in the prospective Target-to-B! (T2B!) study, who completed primary vaccination and reported a positive SARS-CoV-2 test between 1 July 2021 and 1 April 2022 were included. Patients reported increased disease activity (yes/no) in surveys at 7 and 28 days after a positive test. Also, proportions of patients who consulted their treating physician, confirmation of increased disease activity by the treating physician, and intensification of immunosuppressive (ISP) treatment were analyzed. Multivariate models were used to identify determinants associated with increased disease activity. Results We included 457 IMID patients who reported a breakthrough infection. Increased disease activity at 7 and/or 28 days was reported by 148/457 (32.4%; 95% CI 28.3-36.8) patients. Of these, 35/148 (23.6%) consulted their treating physician. Treating physicians confirmed increased disease activity in 20/148 (13.5%) and intensified ISP treatment in 11/148 (7.4%). Factors associated with increased disease activity were ‘recent increase in disease activity prior to the breakthrough infection’, ‘increased disease activity after SARS-CoV-2 vaccination’, and ‘neurological IMIDs’. Conclusions Approximately one third of the IMID patients reported increased disease activity after SARS-CoV-2 breakthrough infection, but treatment was rarely intensified. These results are reassuring for IMID patients and their treating physicians.
Note:
Funding Information: This study was supported by ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007). The sponsor had no role in the design, analyses or reporting of the study.
Declaration of Interests: None.
Ethics Approval Statement: This is a substudy of a prospective multicenter cohort study, the Target-to-B! (T2B!) study (Trial ID: NL8900; Dutch Trial Register) which was approved by the medical ethical committee of the Amsterdam UMC (2020.194). Signed informed consent was obtained from all participants.
Stalman, Eileen and van Dam, Koos and Kummer, Laura and van Kempen, Zoé and Killestein, Joep and Volkers, Adriaan G. and Tas, Sander and van der Kooi, Anneke J. and Raaphorst, Joost and Boekel, Laura and Wolbink, Gertjan and Löwenberg, Mark and Takkenberg, R. Bart and D'Haens, Geert R.A.M. and Spuls, Phyllis I. and Bekkenk, Marcel W. and Musters, Annelie H. and Post, Nicoline F. and Bosma, Angela L. and Hilhorst, Marc L. and Vegting, Yosta and Bemelman, Frederike J. and Voskuyl, Alexandre and Broens, Bo and Sanchez, Agner Parra and van Els, Cecile and de Wit, Jelle and Rutgers, Abraham and de Leeuw, Karina and Horváth, Barbara and Verschuuren, Jan J.G.M. and Ruiter, Annabel M. and van Ouwerkerk, Lotte and van der Woude, Diane and Allaart, Cornelia F. and Teng, Onno YK and van Paassen, Pieter and Busch, Matthias and Brusse, Esther and van Doorn, Pieter and Baars, Adája E. and Hijnen, Dirk Jan and Schreurs, Corine R.G. and van der Pol, Ludo and Goedee, H. Stephan and Steenhuis, Maurice and Keijser, Jim and Keijzer, Sofie and Cristianawati, Olvi and ten Brinke, Anja and Verstegen, Niels and Zwinderman, Aeilko H. and van Ham, Marieke and Rispens, Theo and Kuijpers, Taco and Eftimov, Filip and Wieske, Luuk and Study Group, T2B! Immunity Against SARS-CoV-2, Disease Activity after Sars-Cov-2 Delta and Omicron Breakthrough Infections in Patients with Immune-Mediated Inflammatory Diseases. Available at SSRN: https://ssrn.com/abstract=4885476 or http://dx.doi.org/10.2139/ssrn.4885476
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