Disease activity in patients with immune-mediated inflammatory diseases after SARS-CoV-2 vaccinations

the T2B! Immunity against SARS-CoV-2 study group, Koos P.J. van Dam, Luuk Wieske, Eileen W. Stalman, Laura Y.L. Kummer, Jesse Roosen, Zoé L.E. van Kempen, Joep Killestein, Adriaan G. Volkers, Laura Boekel, Gerrit J. Wolbink, Anneke J. van der Kooi, Joost Raaphorst, Mark Löwenberg, R. Bart Takkenberg, Geert R.A.M. D'Haens, Phyllis I. Spuls, Marcel W. Bekkenk, Annelie H. Musters, Nicoline F. PostAngela L. Bosma, Marc L. Hilhorst, Yosta Vegting, Frederike J. Bemelman, Alexandre E. Voskuyl, Bo Broens, Agner Parra Sanchez, Cécile A.C.M. van Els, Jelle de Wit, Abraham Rutgers, Karina de Leeuw, Barbara Horváth, Jan J.G.M. Verschuuren, Annabel M. Ruiter, Lotte van Ouwerkerk, Diane van der Woude, Renée C.F. Allaart, Y. K.Onno Teng, Pieter van Paassen, Matthias H. Busch, Papay B.P. Jallah, Esther Brusse, Pieter A. van Doorn, Adája E. Baars, Dirk Jan Hijnen, Corine R.G. Schreurs, W. Ludo van der Pol, H. Stephan Goedee, Maurice Steenhuis, Sofie Keijzer, Olvi Cristianawati

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8 Citations (Scopus)


For patients with immune-mediated inflammatory diseases (IMIDs), concerns exist about increased disease activity after vaccination. We aimed to assess changes in disease activity after SARS-CoV-2 vaccination in patients with IMIDs, and determine risk factors for increased disease activity. In this substudy of a prospective observational cohort study (Target-to-B!), we included patients with IMIDs who received a SARS-CoV-2 vaccine. Patients reported changes in disease activity on a five-point Likert scale every 60 days for up to twelve months after first vaccination. In case of self-reported increased activity, hospital records were screened whether the treating physician reported increased activity, and for potential intensification of immunosuppressive (ISP) treatment. Mixed models were used to study determinants for self-reported increased disease activity. In total, 2111 patients were included for analysis after primary immunization (mean age 49.7 years [SD 13.7], 1329/2111 (63.0%) female), from which 1266 patients for analysis after first additional vaccination. Increased disease activity at 60 days after start of primary immunization was reported by 223/2111 (10.6%). In 96/223 (43.0%) the increase was confirmed by the treating physician and in 36/223 (16.1%) ISP treatment was intensified. Increased disease activity at seven to 60 days after additional vaccination, was reported by 139/1266 (11.0%). Vaccinations were not temporally associated with self-reported increased disease activity. Conversely, increased disease activity before first vaccination, neuromuscular disease, and multiple sclerosis were associated. Altogether, self-reported increased disease activity after vaccination against SARS-CoV-2 was recorded in a minority of patients and was generally mild. Moreover, multivariate analyses suggest that disease related factors, but not vaccinations are the major determinants for self-reported increased disease activity.

Original languageEnglish
Article number102984
JournalJournal of Autoimmunity
Publication statusPublished - Feb 2023

Bibliographical note

Funding Information:
This study was supported by ZonMw (The Netherlands Organization for Health Research and Development; project number 10430012010009 ). The sponsor had no role in the design, analysis or reporting of the study.

Publisher Copyright: © 2022


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