Journal of Translational Autoimmunity (Dec 2023)
Long-term outcomes of COVID-19 vaccination in patients with rare and complex connective tissue diseases: The ERN-ReCONNET VACCINATE study
- Chiara Tani,
- Chiara Cardelli,
- Roberto Depascale,
- Anna Gamba,
- Luca Iaccarino,
- Andrea Doria,
- Matilde Bandeira,
- Sara Paiva Dinis,
- Vasco C. Romão,
- Emanuele Gotelli,
- Sabrina Paolino,
- Maurizio Cutolo,
- Niccolò Di Giosaffatte,
- Alessandro Ferraris,
- Paola Grammatico,
- Lorenzo Cavagna,
- Veronica Codullo,
- Carlomaurizio Montecucco,
- Valentina Longo,
- Lorenzo Beretta,
- Ilaria Cavazzana,
- Micaela Fredi,
- Silvia Peretti,
- Serena Guiducci,
- Marco Matucci-Cerinic,
- Stefano Bombardieri,
- Gerd R. Burmester,
- João E. Fonseca,
- Charissa Frank,
- Ilaria Galetti,
- Eric Hachulla,
- Ulf Müller-Ladner,
- Matthias Schneider,
- Vanessa Smith,
- Farah Tamirou,
- Jacob M. Van Laar,
- Ana Vieira,
- Rossella D'Urzo,
- Sara Cannizzo,
- Andrea Gaglioti,
- Diana Marinello,
- Rosaria Talarico,
- Marta Mosca
Affiliations
- Chiara Tani
- Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
- Chiara Cardelli
- Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; Department of Medical Biotechnologies, University of Siena, Siena, Italy
- Roberto Depascale
- Rheumatology Unit, Department of Medicine - DIMED, University of Padua, Padua, Italy
- Anna Gamba
- Rheumatology Unit, Department of Medicine - DIMED, University of Padua, Padua, Italy
- Luca Iaccarino
- Rheumatology Unit, Department of Medicine - DIMED, University of Padua, Padua, Italy
- Andrea Doria
- Rheumatology Unit, Department of Medicine - DIMED, University of Padua, Padua, Italy
- Matilde Bandeira
- Rheumatology Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte & Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon Academic Medical Centre, Lisbon, Portugal
- Sara Paiva Dinis
- Rheumatology Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte & Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon Academic Medical Centre, Lisbon, Portugal
- Vasco C. Romão
- Rheumatology Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte & Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon Academic Medical Centre, Lisbon, Portugal
- Emanuele Gotelli
- Research Laboratory and Academic Division of Clinical Rheumatology, Internal Medicine Department, University of Genoa, Genoa, Italy
- Sabrina Paolino
- Research Laboratory and Academic Division of Clinical Rheumatology, Internal Medicine Department, University of Genoa, Genoa, Italy
- Maurizio Cutolo
- Research Laboratory and Academic Division of Clinical Rheumatology, Internal Medicine Department, University of Genoa, Genoa, Italy
- Niccolò Di Giosaffatte
- Laboratory of Medical Genetics, Department of Experimental Medicine, Sapienza University and San Camillo Forlanini Hospital, Rome, Italy
- Alessandro Ferraris
- Laboratory of Medical Genetics, Department of Experimental Medicine, Sapienza University and San Camillo Forlanini Hospital, Rome, Italy
- Paola Grammatico
- Laboratory of Medical Genetics, Department of Experimental Medicine, Sapienza University and San Camillo Forlanini Hospital, Rome, Italy
- Lorenzo Cavagna
- Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
- Veronica Codullo
- Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
- Carlomaurizio Montecucco
- Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; Division of Rheumatology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
- Valentina Longo
- Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Referral Center for Systemic Autoimmune Diseases, Milan, Italy
- Lorenzo Beretta
- Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Referral Center for Systemic Autoimmune Diseases, Milan, Italy
- Ilaria Cavazzana
- Rheumatology and Clinical Immunology Unit, ASST-Spedali Civili and University of Brescia, Brescia, Italy
- Micaela Fredi
- Rheumatology and Clinical Immunology Unit, ASST-Spedali Civili and University of Brescia, Brescia, Italy
- Silvia Peretti
- Division of Rheumatology and Scleroderma Unit, Department of Clinical and Experimental Medicine, AOU Careggi, University of Florence, Florence, Italy
- Serena Guiducci
- Division of Rheumatology and Scleroderma Unit, Department of Clinical and Experimental Medicine, AOU Careggi, University of Florence, Florence, Italy
- Marco Matucci-Cerinic
- Division of Rheumatology and Scleroderma Unit, Department of Clinical and Experimental Medicine, AOU Careggi, University of Florence, Florence, Italy
- Stefano Bombardieri
- University of Pisa, Pisa, Italy
- Gerd R. Burmester
- Department of Rheumatology and Clinical Immunology, Charité University Medicine Berlin, Berlin, Germany
- João E. Fonseca
- Rheumatology Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte & Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon Academic Medical Centre, Lisbon, Portugal
- Charissa Frank
- Flemish Association for Hereditary Connective Tissue Disorders, Koersel, Belgium
- Ilaria Galetti
- Federation of European Scleroderma Associations (FESCA), Milan, Italy
- Eric Hachulla
- Département de Médecine Interne et Immunologie Clinique, Centre de Référence des Maladies Systémiques et Auto-Immunes Rares du Nord-Ouest (CERAINO), LIRIC, INSERM, Univ. Lille, CHU Lille, Lille, France
- Ulf Müller-Ladner
- Department of Rheumatology and Clinical Immunology, Kerckhoff-Klinik GmbH, Justus-Liebig University of Giessen, Bad Nauheim, Germany
- Matthias Schneider
- Department of Rheumatology, University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany
- Vanessa Smith
- Department of Rheumatology and Department of Internal Medicine, Ghent University Hospital, Ghent, Belgium; Unit for Molecular Immunology and Inflammation, VIB Inflammation Research Center (IRC), Ghent, Belgium
- Farah Tamirou
- Department of Rheumatology, Cliniques Universitaires Saint-Luc, Université Catholique De Louvain, Louvain, Belgium
- Jacob M. Van Laar
- Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
- Ana Vieira
- Liga Portuguesa Contra as Doenças Reumáticas, Núcleo Síndrome de Sjögren, Lisbon, Portugal
- Rossella D'Urzo
- Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
- Sara Cannizzo
- Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
- Andrea Gaglioti
- Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
- Diana Marinello
- Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
- Rosaria Talarico
- Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
- Marta Mosca
- Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; Corresponding author. Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa Via Roma 67, 56126, Pisa, Italy.
- Journal volume & issue
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Vol. 7
p. 100221
Abstract
Background: Vaccination is one of the most important measures to contain the COVID-19 pandemic, especially for frail patients. VACCINATE is a multicentre prospective observational study promoted by the European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ERN ReCONNET) aimed at assessing the long-term outcomes of COVID-19 vaccination in patients with rare and complex connective tissue diseases (rcCTDs) in terms of efficacy and safety. Methods: Adult rcCTDs patients were eligible for recruitment. Demographic, clinical and vaccination data were collected at enrolment. Follow-up visits were scheduled 4, 12, 24, 36 and 48 weeks after completion of the first vaccination cycle; data on adverse events, disease exacerbations and the occurrence of new SARS-CoV-2 infections were collected at these time-points. Findings: 365 rcCTDs patients (87 % female, mean age 51.8 ± 14.6 years) were recruited. Overall, 200 patients (54.8 %) experienced at least one adverse event, generally mild and in most cases occurring early after the vaccination. During follow-up, 55 disease exacerbations were recorded in 39 patients (10.7 %), distributed over the entire observation period, although most frequently within 4 weeks after completion of the vaccination cycle. The incidence of new SARS-CoV-2 infections was 8.9 per 1000 person-months, with no cases within 12 weeks from vaccine administration and an increasing trend of infections moving away from the primary vaccination cycle. Only one case of severe COVID-19 was reported during the study period. Interpretation: COVID-19 vaccination seems effective and safe in rcCTDs patients. The rate of new infections was rather low and serious infections were uncommon in our cohort. No increased risk of disease flares was observed compared to previous disease history; however, such exacerbations may be potentially severe, emphasising the need for close monitoring of our patients.
