TY - JOUR
T1 - Long-term outcomes of COVID-19 vaccination in patients with rare and complex connective tissue diseases
T2 - The ERN-ReCONNET VACCINATE study
AU - Tani, Chiara
AU - Cardelli, Chiara
AU - Depascale, Roberto
AU - Gamba, Anna
AU - Iaccarino, Luca
AU - Doria, Andrea
AU - Bandeira, Matilde
AU - Dinis, Sara Paiva
AU - Romão, Vasco C.
AU - Gotelli, Emanuele
AU - Paolino, Sabrina
AU - Cutolo, Maurizio
AU - Di Giosaffatte, Niccolò
AU - Ferraris, Alessandro
AU - Grammatico, Paola
AU - Cavagna, Lorenzo
AU - Codullo, Veronica
AU - Montecucco, Carlomaurizio
AU - Longo, Valentina
AU - Beretta, Lorenzo
AU - Cavazzana, Ilaria
AU - Fredi, Micaela
AU - Peretti, Silvia
AU - Guiducci, Serena
AU - Matucci-Cerinic, Marco
AU - Bombardieri, Stefano
AU - Burmester, Gerd R.
AU - Fonseca, João E.
AU - Frank, Charissa
AU - Galetti, Ilaria
AU - Hachulla, Eric
AU - Müller-Ladner, Ulf
AU - Schneider, Matthias
AU - Smith, Vanessa
AU - Tamirou, Farah
AU - Van Laar, Jacob M.
AU - Vieira, Ana
AU - D'Urzo, Rossella
AU - Cannizzo, Sara
AU - Gaglioti, Andrea
AU - Marinello, Diana
AU - Talarico, Rosaria
AU - Mosca, Marta
N1 - Publisher Copyright:
© 2023
PY - 2023/12
Y1 - 2023/12
N2 - 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.
AB - 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.
KW - Breakthrough infection
KW - COVID-19
KW - Flare
KW - SARS-CoV-2
KW - Vaccination
KW - ystemic autoimmune disease
UR - https://www.scopus.com/pages/publications/85179043737
U2 - 10.1016/j.jtauto.2023.100221
DO - 10.1016/j.jtauto.2023.100221
M3 - Article
AN - SCOPUS:85179043737
SN - 2589-9090
VL - 7
JO - Journal of translational autoimmunity
JF - Journal of translational autoimmunity
M1 - 100221
ER -