학술논문
Disease activity in patients with immune-mediated inflammatory diseases after SARS-CoV-2 vaccinations.
Document Type
Academic Journal
Author
van Dam KPJ; Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands.; Wieske L; Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Clinical Neurophysiology, St Antonius Hospital, Nieuwegein, the Netherlands.; Stalman EW; Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands.; Kummer LYL; Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands.; Roosen J; Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands.; van Kempen ZLE; Department of Neurology, Amsterdam UMC, VU University Medical Center, Amsterdam, the Netherlands.; Killestein J; Department of Neurology, Amsterdam UMC, VU University Medical Center, Amsterdam, the Netherlands.; Volkers AG; Department of Gastroenterology and Hepatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Boekel L; Amsterdam Rheumatology and Immunology Center, Location Reade, Department of Rheumatology, Amsterdam, the Netherlands.; Wolbink GJ; Amsterdam Rheumatology and Immunology Center, Location Reade, Department of Rheumatology, Amsterdam, the Netherlands.; van der Kooi AJ; Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands.; Raaphorst J; Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands.; Löwenberg M; Department of Gastroenterology and Hepatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Takkenberg RB; Department of Gastroenterology and Hepatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; D'Haens GRAM; Department of Gastroenterology and Hepatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Spuls PI; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Bekkenk MW; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Musters AH; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Post NF; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Bosma AL; Department of Dermatology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Hilhorst ML; Department of Internal Medicine, Section of Nephrology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Vegting Y; Department of Internal Medicine, Section of Nephrology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Bemelman FJ; Department of Internal Medicine, Section of Nephrology, Amsterdam UMC, Location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.; Voskuyl AE; Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands.; Broens B; Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands.; Sanchez AP; Department of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Department of Rheumatology and Clinical Immunology, University of Amsterdam, Amsterdam, the Netherlands.; van Els CACM; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands; Faculty of Veterinary Medicine, Utrecht University, Utrecht, the Netherlands.; de Wit J; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.; Rutgers A; Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands.; de Leeuw K; Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands.; Horváth B; Department of Dermatology, Center for Blistering Diseases, University Medical Center Groningen, University Groningen, Groningen, the Netherlands.; Verschuuren JJGM; Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.; Ruiter AM; Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.; van Ouwerkerk L; Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.; van der Woude D; Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.; Allaart RCF; Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.; Teng YKO; Centre of Expertise for Lupus, Vasculitis- and Complement-mediated Systemic Diseases, Department of Internal Medicine - Nephrology Section, Leiden University Medical Centre, Leiden, the Netherlands.; van Paassen P; Department of Nephrology and Clinical Immunology, Maastricht University Medical Center, Maastricht, the Netherlands.; Busch MH; Department of Nephrology and Clinical Immunology, Maastricht University Medical Center, Maastricht, the Netherlands.; Jallah PBP; Department of Nephrology and Clinical Immunology, Maastricht University Medical Center, Maastricht, the Netherlands.; Brusse E; Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.; van Doorn PA; Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.; Baars AE; Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.; Hijnen DJ; Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.; Schreurs CRG; Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.; van der Pol WL; Brain Center UMC Utrecht, Department of Neurology and Neurosurgery, Utrecht, the Netherlands.; Goedee HS; Brain Center UMC Utrecht, Department of Neurology and Neurosurgery, Utrecht, the Netherlands.; Steenhuis M; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands.; Keijzer S; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands.; Keijser JBD; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands.; Cristianawati O; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands.; Rispens T; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands.; Brinke AT; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands.; Verstegen NJM; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands.; Marieke van Ham S; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, the Netherlands; Swammerdam Institute for Life Sciences, University of Amsterdam, the Netherlands.; Tas SW; Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Department of Rheumatology and Clinical Immunology, University of Amsterdam, Amsterdam, the Netherlands.; Kuijpers TW; Department of Pediatric Immunology, Rheumatology and Infectious Disease, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands.; Eftimov F; Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: f.eftimov@amsterdamumc.nl.
Source
Publisher: Academic Press Country of Publication: England NLM ID: 8812164 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-9157 (Electronic) Linking ISSN: 08968411 NLM ISO Abbreviation: J Autoimmun Subsets: MEDLINE
Subject
Language
English
Abstract
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.
Competing Interests: Declaration of competing interest F Eftimov and T Kuijpers report (governmental) grants from ZonMw to study immune response after SARS-Cov-2 vaccination in auto-immune diseases. F Eftimov also reports grants from Prinses Beatrix Spierfonds, CSL Behring, Kedrion, Terumo BCT, Grifols, Takeda Pharmaceutical Company, and GBS-CIDP Foundation; consulting fees from UCB Pharma and CSL Behring; honoraria from Grifols. AJ van der Kooi reports grants from CSL Behring and participation on an advisory board for Argen-X. M Löwenberg reports a grant from Galapagos not related to this study, and honoraria from Bristol Myers Squibb, Pfizer, Takeda, and Tillotts. Ph I Spuls is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and is a chief investigator of the TREAT NL registry taskforce and SECURE-AD registry. M.W. Bekkenk is a secretary for Dutch Experimental Dermatology Board and head of the pigmentary disorders group within the Dutch Dermatology Board, and reports honoraria from Pfizer, Sanofi, Novartis and Fondation René Touraine. J Killestein has speaking relationships with Merck Serono, Biogen Idec, TEVA, Sanofi, Genzyme, Roche and Novartis; Amsterdam UMC, location VUmc, MS Center Amsterdam has received financial support for research activities from Merck Serono, Bayer Shcering Pharma, Biogen Idec, GlaxoSmithKline, Roche, Teva, Sanofi, Genzyme, GlaxoSmithKline, and Novartis. B Horváth reports unpaid positions as medical advisor for several patient groups, a board position for ERN-SKIN, and associate editor for The British Journal of Dermatology; reports grants from Abbvie, Akari Therapeutics, Celgene, and Novartis; consulting fees from UCB Pharma, Novartis and Janssen-Cilag; honoraria from Abbvie. J.J.G.M. Verschuuren reports consulting fees from Argenx, Alexion and NMD Pharma; is coinventor on patent applications based on MuSK-related research. DJ Hijnen reports grants from Abbvie, AstraZeneca, Janssen, LEO Pharma and UCB Pharma, and honoraria from Abbvie, Galderma, Janssen, Lilly, Pfizer, Sanofi and UCB Pharma, and a paid position in an advisory board for BIOMAP IMI. P.A. van Doorn participated on an advisory board for Octapharma. P. van Paassen reports grants from Alexion Pharma and GSK; and participation on GSK and Vifor Pharma advisory boards. G.R.A.M. D'Haens reports consulting fees from Abbvie, Agomab, AstraZeneca, AM Pharma, AMT, Arena Pharmaceuticals, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Exo Biologics, Galapagos, Index Pharmaceuticals, Kaleido, Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Origo, Polpharma, Procise Diagnostics, Prometheus laboratories, Prometheus Biosciences, Progenity, and Protagonist; honoraria from Abbvie, Arena, Galapagos, Gilead, Pfizer, BMS, Takeda; participation on advisory boards for Abbvie, Seres Health, Galapagos, and AstraZeneca. R.B. Takkenberg reports honoraria from Sobi and Norgine and participation in an advisory board for Norgine. SH Goedee is a board member of the Dutch Society of Clinical Neurophysiology (unpaid), reports grants from Prinses Beatrix Spierfonds, and received speaker fees from Shire/Takeda. AH Zwinderman reports paid data safety monitoring board positions for Torrent Ltd and Foresee Pharmaceuticals Co. No other disclosures were reported. Bar plot showing proportions of self-reported increased disease activity (with corresponding 95% CI's), physician confirmed increased disease activity, and treatment intensification, within each IMID group at 60 days after start of primary immunization. IBD: inflammatory bowel disease; IMID: immune-mediated inflammatory disease; ISP: immunosuppressant; MS: multiple sclerosis; NMO: neuromyelitis optica; SLE: systemic lupus erythematosus. Bar plot showing incidence of self-reported increased disease activity at different timepoints. A) self-reported increased disease activity within 60 days after vaccination: at 60 days after start of primary immunization (prim. imm.), seven to 60 days after first additional vaccination (add. vacc.), and at other follow-up moments within seven to 60 days after a vaccination other than the moments mentioned before (e.g. second vaccination of primary immunization or second additional vaccination). B) self-reported increased disease activity not within 60 days after vaccination, in the two-monthly follow-up surveys starting at first vaccination. Figure showing the results of the multivariate mixed model on determinants of self-reported increased disease activity. RR's with corresponding 95% CI for age, female sex, BMI, IMID group (with gastro-intestinal disease as reference group), recent increased disease activity (self-reported increased disease activity in the three months preceding enrollment), ISP use, and any SARS-CoV-2 vaccination in 60 days before the survey. BMI: body mass index; CI: confidence interval; IMID: immune-mediated inflammatory disease; ISP: immunosuppressant; MS: multiple sclerosis; NMO: neuromyelitis optica; RR: relative risk; SARS-CoV-2: severe acute respiratory syndrome coronavirus 2.
(Copyright © 2022. Published by Elsevier Ltd.)
Competing Interests: Declaration of competing interest F Eftimov and T Kuijpers report (governmental) grants from ZonMw to study immune response after SARS-Cov-2 vaccination in auto-immune diseases. F Eftimov also reports grants from Prinses Beatrix Spierfonds, CSL Behring, Kedrion, Terumo BCT, Grifols, Takeda Pharmaceutical Company, and GBS-CIDP Foundation; consulting fees from UCB Pharma and CSL Behring; honoraria from Grifols. AJ van der Kooi reports grants from CSL Behring and participation on an advisory board for Argen-X. M Löwenberg reports a grant from Galapagos not related to this study, and honoraria from Bristol Myers Squibb, Pfizer, Takeda, and Tillotts. Ph I Spuls is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital and is a chief investigator of the TREAT NL registry taskforce and SECURE-AD registry. M.W. Bekkenk is a secretary for Dutch Experimental Dermatology Board and head of the pigmentary disorders group within the Dutch Dermatology Board, and reports honoraria from Pfizer, Sanofi, Novartis and Fondation René Touraine. J Killestein has speaking relationships with Merck Serono, Biogen Idec, TEVA, Sanofi, Genzyme, Roche and Novartis; Amsterdam UMC, location VUmc, MS Center Amsterdam has received financial support for research activities from Merck Serono, Bayer Shcering Pharma, Biogen Idec, GlaxoSmithKline, Roche, Teva, Sanofi, Genzyme, GlaxoSmithKline, and Novartis. B Horváth reports unpaid positions as medical advisor for several patient groups, a board position for ERN-SKIN, and associate editor for The British Journal of Dermatology; reports grants from Abbvie, Akari Therapeutics, Celgene, and Novartis; consulting fees from UCB Pharma, Novartis and Janssen-Cilag; honoraria from Abbvie. J.J.G.M. Verschuuren reports consulting fees from Argenx, Alexion and NMD Pharma; is coinventor on patent applications based on MuSK-related research. DJ Hijnen reports grants from Abbvie, AstraZeneca, Janssen, LEO Pharma and UCB Pharma, and honoraria from Abbvie, Galderma, Janssen, Lilly, Pfizer, Sanofi and UCB Pharma, and a paid position in an advisory board for BIOMAP IMI. P.A. van Doorn participated on an advisory board for Octapharma. P. van Paassen reports grants from Alexion Pharma and GSK; and participation on GSK and Vifor Pharma advisory boards. G.R.A.M. D'Haens reports consulting fees from Abbvie, Agomab, AstraZeneca, AM Pharma, AMT, Arena Pharmaceuticals, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Exo Biologics, Galapagos, Index Pharmaceuticals, Kaleido, Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Pfizer, Immunic, Johnson and Johnson, Origo, Polpharma, Procise Diagnostics, Prometheus laboratories, Prometheus Biosciences, Progenity, and Protagonist; honoraria from Abbvie, Arena, Galapagos, Gilead, Pfizer, BMS, Takeda; participation on advisory boards for Abbvie, Seres Health, Galapagos, and AstraZeneca. R.B. Takkenberg reports honoraria from Sobi and Norgine and participation in an advisory board for Norgine. SH Goedee is a board member of the Dutch Society of Clinical Neurophysiology (unpaid), reports grants from Prinses Beatrix Spierfonds, and received speaker fees from Shire/Takeda. AH Zwinderman reports paid data safety monitoring board positions for Torrent Ltd and Foresee Pharmaceuticals Co. No other disclosures were reported. Bar plot showing proportions of self-reported increased disease activity (with corresponding 95% CI's), physician confirmed increased disease activity, and treatment intensification, within each IMID group at 60 days after start of primary immunization. IBD: inflammatory bowel disease; IMID: immune-mediated inflammatory disease; ISP: immunosuppressant; MS: multiple sclerosis; NMO: neuromyelitis optica; SLE: systemic lupus erythematosus. Bar plot showing incidence of self-reported increased disease activity at different timepoints. A) self-reported increased disease activity within 60 days after vaccination: at 60 days after start of primary immunization (prim. imm.), seven to 60 days after first additional vaccination (add. vacc.), and at other follow-up moments within seven to 60 days after a vaccination other than the moments mentioned before (e.g. second vaccination of primary immunization or second additional vaccination). B) self-reported increased disease activity not within 60 days after vaccination, in the two-monthly follow-up surveys starting at first vaccination. Figure showing the results of the multivariate mixed model on determinants of self-reported increased disease activity. RR's with corresponding 95% CI for age, female sex, BMI, IMID group (with gastro-intestinal disease as reference group), recent increased disease activity (self-reported increased disease activity in the three months preceding enrollment), ISP use, and any SARS-CoV-2 vaccination in 60 days before the survey. BMI: body mass index; CI: confidence interval; IMID: immune-mediated inflammatory disease; ISP: immunosuppressant; MS: multiple sclerosis; NMO: neuromyelitis optica; RR: relative risk; SARS-CoV-2: severe acute respiratory syndrome coronavirus 2.
(Copyright © 2022. Published by Elsevier Ltd.)