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

K.P.J. van Dam; L. Wieske; E.W. Stalman; L.Y.L. Kummer; J. Roosen; Z.L.E. van Kempen; J. Killestein; A.G. Volkers; L. Boekel; G.J. Wolbink; A.J. van der Kooi; J. Raaphorst; M. Lowenberg; R.B. Takkenberg; G.R.A.M. D'Haens; P.I. Spuls; M.W. Bekkenk; A.H. Musters; N.F. Post; A.L. Bosma; M.L. Hilhorst; Y. Vegting; F.J. Bemelman; A.E. Voskuyl; B. Broens; A.P. Sanchez; C.A.C.M. van Els; J. de Wit; A. Rutgers; K. de Leeuw; B. Horvath; J.J.G.M. Verschuuren; A.M. Ruiter; L. van Ouwerkerk; D. van der Woude; R.C.F. Allaart; Y.K.O. Teng; P. van Paassen; M.H. Busch; P.B.P. Jallah; E. Brusse; P.A. van Doorn; A.E. Baars; D.J. Hijnen; C.R.G. Schreurs; W.L. van der Pol; H.S. Goedee; M. Steenhuis; S. Keijzer; J.B.D. Keijser; Filip Eftimov; T2B! immunity against SARS-CoV-2 study group

doi:10.1016/j.jaut.2022.102984

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

K.P.J. van Dam, L. Wieske, E.W. Stalman, L.Y.L. Kummer, J. Roosen, Z.L.E. van Kempen, J. Killestein, A.G. Volkers, L. Boekel, G.J. Wolbink, A.J. van der Kooi, J. Raaphorst, M. Lowenberg, R.B. Takkenberg, G.R.A.M. D'Haens, P.I. Spuls, M.W. Bekkenk, A.H. Musters, N.F. Post, A.L. BosmaM.L. Hilhorst, Y. Vegting, F.J. Bemelman, A.E. Voskuyl, B. Broens, A.P. Sanchez, C.A.C.M. van Els, J. de Wit, A. Rutgers, K. de Leeuw, B. Horvath, J.J.G.M. Verschuuren, A.M. Ruiter, L. van Ouwerkerk, D. van der Woude, R.C.F. Allaart, Y.K.O. Teng, P. van Paassen, M.H. Busch, P.B.P. Jallah, E. Brusse, P.A. van Doorn, A.E. Baars, D.J. Hijnen, C.R.G. Schreurs, W.L. van der Pol, H.S. Goedee, M. Steenhuis, S. Keijzer, J.B.D. Keijser, Filip Eftimov^*, T2B! immunity against SARS-CoV-2 study group

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

For patients with immune-mediated inflammatory diseases (IMIDs), concerns exist about increased disease ac-tivity 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 obser-vational 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. Alto-gether, 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 language	English
Article number	102984
Number of pages	9
Journal	Journal of Autoimmunity
Volume	135
Issue number	1
DOIs	https://doi.org/10.1016/j.jaut.2022.102984
Publication status	Published - 1 Feb 2023

Keywords

SARS-CoV-2
COVID-19
Vaccination
Autoimmune disease
Disease activity
Flare

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van Dam, K. P. J., Wieske, L., Stalman, E. W., Kummer, L. Y. L., Roosen, J., van Kempen, Z. L. E., Killestein, J., Volkers, A. G., Boekel, L., Wolbink, G. J., van der Kooi, A. J., Raaphorst, J., Lowenberg, M., Takkenberg, R. B., D'Haens, G. R. A. M., Spuls, P. I., Bekkenk, M. W., Musters, A. H., Post, N. F., ... T2B! immunity against SARS-CoV-2 study group (2023). Disease activity in patients with immune-mediated inflammatory diseases after SARS-CoV-2 vaccinations. Journal of Autoimmunity, 135(1), Article 102984. https://doi.org/10.1016/j.jaut.2022.102984

@article{5141c1721c60405b88540c8c0202ef18,

title = "Disease activity in patients with immune-mediated inflammatory diseases after SARS-CoV-2 vaccinations",

abstract = "For patients with immune-mediated inflammatory diseases (IMIDs), concerns exist about increased disease ac-tivity 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 obser-vational 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. Alto-gether, 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.",

keywords = "SARS-CoV-2, COVID-19, Vaccination, Autoimmune disease, Disease activity, Flare",

author = "\{van Dam\}, K.P.J. and L. Wieske and E.W. Stalman and L.Y.L. Kummer and J. Roosen and \{van Kempen\}, Z.L.E. and J. Killestein and A.G. Volkers and L. Boekel and G.J. Wolbink and \{van der Kooi\}, A.J. and J. Raaphorst and M. Lowenberg and R.B. Takkenberg and G.R.A.M. D'Haens and P.I. Spuls and M.W. Bekkenk and A.H. Musters and N.F. Post and A.L. Bosma and M.L. Hilhorst and Y. Vegting and F.J. Bemelman and A.E. Voskuyl and B. Broens and A.P. Sanchez and \{van Els\}, C.A.C.M. and \{de Wit\}, J. and A. Rutgers and \{de Leeuw\}, K. and B. Horvath and J.J.G.M. Verschuuren and A.M. Ruiter and \{van Ouwerkerk\}, L. and \{van der Woude\}, D. and R.C.F. Allaart and Y.K.O. Teng and \{van Paassen\}, P. and M.H. Busch and P.B.P. Jallah and E. Brusse and \{van Doorn\}, P.A. and A.E. Baars and D.J. Hijnen and C.R.G. Schreurs and \{van der Pol\}, W.L. and H.S. Goedee and M. Steenhuis and S. Keijzer and J.B.D. Keijser and Filip Eftimov and \{T2B! immunity against SARS-CoV-2 study group\}",

note = "Funding Information: We would like to thank ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007 ) for the funding of the study and the T2B partners, including the patient groups and Health Holland for the support in this study. This collaboration project is financed by the PPP Allowance made available by Top Sector Life Sciences \& Health to Samenwerkende Gezondheidsfondsen ( SGF ) under project number LSHM18055-SGF to stimulate public-private partnerships and co-financing by health foundations that are part of the SGF. Also, we would like to thank E.P. Moll van Charante, J.A Bogaards and R.A. Scholte for their guidance in the data safety monitoring board. 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: {\textcopyright} 2022",

year = "2023",

month = feb,

day = "1",

doi = "10.1016/j.jaut.2022.102984",

language = "English",

volume = "135",

journal = "Journal of Autoimmunity",

issn = "0896-8411",

publisher = "Academic Press",

number = "1",

}

van Dam, KPJ, Wieske, L, Stalman, EW, Kummer, LYL, Roosen, J, van Kempen, ZLE, Killestein, J, Volkers, AG, Boekel, L, Wolbink, GJ, van der Kooi, AJ, Raaphorst, J, Lowenberg, M, Takkenberg, RB, D'Haens, GRAM, Spuls, PI, Bekkenk, MW, Musters, AH, Post, NF, Bosma, AL, Hilhorst, ML, Vegting, Y, Bemelman, FJ, Voskuyl, AE, Broens, B, Sanchez, AP, van Els, CACM, de Wit, J, Rutgers, A, de Leeuw, K, Horvath, B, Verschuuren, JJGM, Ruiter, AM, van Ouwerkerk, L, van der Woude, D, Allaart, RCF, Teng, YKO, van Paassen, P, Busch, MH, Jallah, PBP, Brusse, E, van Doorn, PA, Baars, AE, Hijnen, DJ, Schreurs, CRG, van der Pol, WL, Goedee, HS, Steenhuis, M, Keijzer, S, Keijser, JBD, Eftimov, F & T2B! immunity against SARS-CoV-2 study group 2023, 'Disease activity in patients with immune-mediated inflammatory diseases after SARS-CoV-2 vaccinations', Journal of Autoimmunity, vol. 135, no. 1, 102984. https://doi.org/10.1016/j.jaut.2022.102984

TY - JOUR

T1 - Disease activity in patients with immune-mediated inflammatory diseases after SARS-CoV-2 vaccinations

AU - van Dam, K.P.J.

AU - Wieske, L.

AU - Stalman, E.W.

AU - Kummer, L.Y.L.

AU - Roosen, J.

AU - van Kempen, Z.L.E.

AU - Killestein, J.

AU - Volkers, A.G.

AU - Boekel, L.

AU - Wolbink, G.J.

AU - van der Kooi, A.J.

AU - Raaphorst, J.

AU - Lowenberg, M.

AU - Takkenberg, R.B.

AU - D'Haens, G.R.A.M.

AU - Spuls, P.I.

AU - Bekkenk, M.W.

AU - Musters, A.H.

AU - Post, N.F.

AU - Bosma, A.L.

AU - Hilhorst, M.L.

AU - Vegting, Y.

AU - Bemelman, F.J.

AU - Voskuyl, A.E.

AU - Broens, B.

AU - Sanchez, A.P.

AU - van Els, C.A.C.M.

AU - de Wit, J.

AU - Rutgers, A.

AU - de Leeuw, K.

AU - Horvath, B.

AU - Verschuuren, J.J.G.M.

AU - Ruiter, A.M.

AU - van Ouwerkerk, L.

AU - van der Woude, D.

AU - Allaart, R.C.F.

AU - Teng, Y.K.O.

AU - van Paassen, P.

AU - Busch, M.H.

AU - Jallah, P.B.P.

AU - Brusse, E.

AU - van Doorn, P.A.

AU - Baars, A.E.

AU - Hijnen, D.J.

AU - Schreurs, C.R.G.

AU - van der Pol, W.L.

AU - Goedee, H.S.

AU - Steenhuis, M.

AU - Keijzer, S.

AU - Keijser, J.B.D.

AU - Eftimov, Filip

AU - T2B! immunity against SARS-CoV-2 study group

N1 - Funding Information: We would like to thank ZonMw (The Netherlands Organization for Health Research and Development, grant 10430072010007 ) for the funding of the study and the T2B partners, including the patient groups and Health Holland for the support in this study. This collaboration project is financed by the PPP Allowance made available by Top Sector Life Sciences & Health to Samenwerkende Gezondheidsfondsen ( SGF ) under project number LSHM18055-SGF to stimulate public-private partnerships and co-financing by health foundations that are part of the SGF. Also, we would like to thank E.P. Moll van Charante, J.A Bogaards and R.A. Scholte for their guidance in the data safety monitoring board. 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

PY - 2023/2/1

Y1 - 2023/2/1

N2 - For patients with immune-mediated inflammatory diseases (IMIDs), concerns exist about increased disease ac-tivity 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 obser-vational 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. Alto-gether, 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.

AB - For patients with immune-mediated inflammatory diseases (IMIDs), concerns exist about increased disease ac-tivity 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 obser-vational 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. Alto-gether, 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.

KW - SARS-CoV-2

KW - COVID-19

KW - Vaccination

KW - Autoimmune disease

KW - Disease activity

KW - Flare

U2 - 10.1016/j.jaut.2022.102984

DO - 10.1016/j.jaut.2022.102984

M3 - Article

C2 - 36621174

SN - 0896-8411

VL - 135

JO - Journal of Autoimmunity

JF - Journal of Autoimmunity

IS - 1

M1 - 102984

ER -

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

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Keywords

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