COVID-19 vaccination in autoimmune disease (COVAD) survey protocol

Sen, Parikshit; Gupta, Latika; Lilleker, James B; Agarwal, Vishwesh; Kardeş, Sinan; Milchert, Marcin; Gheita, Tamer A.; Salim, Babur; Velikova, Tsvetelina; Gracia‐Ramos, Abraham Edgar; Parodis, Ioannis; Selva-O’Callaghan, Albert; Nikiphorou, Elena; Tan, Ai Lyn; Cavagna, Lorenzo; Saavedra, Miguel Ángel; Shinjo, Samuel Katsuyuki; Ziadé, Nelly; Knitza, Johannes; Kuwana, Masataka; Cagnotto, Giovanni; Nune, Arvind; Distler, Oliver; Chinoy, Hector; Aggarwal, Rohit; Barman, Bhupen; Singh, Yogesh Preet; Ranjan, Rajiv; Jain, Avinash; Pandya, Sapan C; Malaviya, A. N.; Pilania, Rakesh Kumar; Sharma, Aman; Manoj, Manesh; Gupta, Vikas; Kavadichanda, Chengappa G; Patro, Pradeepta Sekhar; Ajmani, Sajal; Phatak, Sanat; Goswami, Rudra Prosad; Chowdhury, Abhra Chandra; Mathew, Ashish Jacob; Shenoy, Padnamabha; Asranna, Ajay; Bommakanti, Keerthi Talari; Shukla, Anuj; Naveen, R; Pauling, John D; Wincup, Chris; Chatterjee, Tulika; Kim, Min‐Chul; Giannini, Margherita; Papa, Nicoletta Del; Sambataro, Gianluca; Atzeni, Fabiola; Govoni, Marcello; Parisi, Simone; Bocci, Elena Bartoloni; Sebastiani, Gian Domenico; Fusaro, Enrico; Sebastiani, Marco; Quartuccio, Luca; Franceschini, Franco; Sainaghi, Pier Paolo; Orsolini, Giovanni; Angelis, Rossella De; Danielli, Maria Giovanna; Traboco, Lisa S; Wibowo, Suryo Anggoro Kusumo; Serrano, Jorge Rojas; Torre, Ignacio García‐De La; Tehozol, Erick Adrian Zamora; Loarce-Martos, Jesús; Prieto‐González, Sergio; Gil‐Vila, Albert; Aránega, Raquel; Nakashima, Ran; Sato, Shinji; Kimura, Naoki; Kaneko, Yuko; Tomaras, Stylianos; Gromova, Margarita Aleksandrovna; Aharonov, Or

doi:10.1007/s00296-021-05046-4

Cited by 41 publications

(26 citation statements)

References 13 publications

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“…Analogously, no relevant adverse events have been generally reported. Although registrative studies related to COVID-19 vaccination did not include patients affected by severe autoimmune diseases, after roughly one year after the start of the global vaccination campaign, a growing number of real-life data is available about efficacy and safety of anti-SARS-CoV-2 vaccines in patients affected by severe rheumatic disorders [13][14][15].…”

Section: Discussionmentioning

confidence: 99%

Relapses of idiopathic inflammatory myopathies after vaccination against COVID-19: a real-life multicenter Italian study

et al. 2022

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Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccination plays a crucial role as pivotal strategy to curb the coronavirus disease-19 (COVID-19) pandemic. The present study described the clinical status of patients affected by idiopathic inflammatory myopathies (IIM) after COVID-19 vaccination to assess the number of relapses. We included all patients affected by IIM and followed by Myositis Clinic, Rheumatology and Respiratory Diseases Units, Siena University Hospital, Bari University Hospital, Policlinico Umberto I, Sapienza University, Rome, and Policlinico Paolo Giaccone, Palermo. They underwent a telephone survey. A total of 119 IIM patients (median, IQR 58 (47–66) years; 32males; 50 dermatomyositis, 39 polymyositis and 30 anti-synthetase syndrome) were consecutively enrolled. Except four patients who refused the vaccination, 94 (81.7%) received Comirnaty, 16 (13.9%) Spikevax, 5 (4.4%) Vaxzevria. Seven (6.1%) patients had flare after vaccination. One of them had life-threatening systemic involvement and died two months after second dose of COVID-19 vaccination. From logistic regression analysis, Chi2-log ratio = 0.045,the variable that most influences the development of flare was the number of organs involved (p = 0.047). Sixty-eight patients received the third dose of COVID-19 vaccination: 51(75%) Comirnaty and 17 (25%) Moderna. No patients had flares after third dose. Our study represents the largest cohort of IIM patients in which the incidence of recurrence after anti-SARS-CoV-2 vaccine was assessed. In line with real-life data from other diseases, we found a clinical non-statistically significant risk of relapse in our patients, which occurred seldom, usually mild and in patients with a more severe and aggressive course of disease.

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Section: Discussionmentioning

confidence: 99%

Relapses of idiopathic inflammatory myopathies after vaccination against COVID-19: a real-life multicenter Italian study

et al. 2022

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“…For this reason, MCV patients are supposed to have an increased risk of a more severe course of SARS-Coronavirus 2 (SARS-CoV-2) disease (COVID-19) (2), including hospitalisation and death; therefore, these subjects have been included in priority programs for vaccination against SARS-CoV-2 in Italy (3,4). Reassuring safety data emerged from the EULAR Coronavirus Vaccine physician-reported registry (COVAX) (5); however, a significant proportion of patients with autoimmune diseases included in another study reported unwillingness to get vaccinated against SARS-CoV-2, due to concerns about the lack of safety data in these patients, fear of side effects and disease flare (6). These troubles partially arise from the exclusion of patients with immunemediated inflammatory diseases from SARS-CoV-2 vaccine clinical development programmes (5,6).…”

Section: Introductionmentioning

confidence: 99%

COVID-19 vaccination rate and safety profile in a multicentre Italian population affected by mixed cryoglobulinaemic vasculitis

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Testoni

Visentini

et al. 2022

Clinical and Experimental Rheumatology

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ObjectivesMixed cryoglobulinaemic vasculitis (MCV) is an immune-complex-mediated systemic vasculitis characterised by heterogeneous clinical manifestations mainly involving lymphatic system, skin, kidney and peripheral nervous system. Although MCV patients have been included in priority programs for vaccination against SARS-CoV-2 in Italy, limited information is available for these patients. Aims of this multicentre Italian study were to investigate SARS-CoV-2 vaccination rate in MCV patients and its safety profile. Methods All MCV patients referring to participating centres were assessed with an interview-based survey about vaccination,reasons for not getting vaccinated, adverse events (AE), and disease flares within a month after vaccination. Results.A total of 416 patients were included in the study. Among participants, 7.7% did not get vaccinated, mainly for fear related to vaccine side-effects (50%) or medical decision (18.8%). They were more frequently treated with chronic glucocorticoids or rituximab (p=0.049 and p=0.043, respectively). Mild and self-limiting AE were recorded in 31.7% of cases, while post-vaccination vasculitis flares were observed in 5.3% of subjects. Disease relapses were mainly observed in patients with peripheral neuropathy or skin vasculitis (40% and 25%, respectively). Conclusions.Vaccination against SARS-CoV-2 has been performed in a high percentage of MCV patients with encouraging safety profile. Vasculitis flares rate was in line with that observed for other autoimmune diseases, despite patients with purpura or peripheral neuropathy seem to be at risk for symptoms' exacerbation. Patients' hesitancy, rituximab and glucocorticoids treatment were the main reasons for delaying vaccination.

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“…Limitations of this study include potential errors in coding entry and an inability to determine DM severity at time of vaccination. We hope that future studies like the ongoing COVAD study address this gap [ 10 ].…”

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COVID-19 vaccination outcomes among patients with dermatomyositis: a multicentered analysis

et al. 2022

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COVID-19 vaccination in autoimmune disease (COVAD) survey protocol

Cited by 41 publications

References 13 publications

Relapses of idiopathic inflammatory myopathies after vaccination against COVID-19: a real-life multicenter Italian study

Relapses of idiopathic inflammatory myopathies after vaccination against COVID-19: a real-life multicenter Italian study

COVID-19 vaccination rate and safety profile in a multicentre Italian population affected by mixed cryoglobulinaemic vasculitis

COVID-19 vaccination outcomes among patients with dermatomyositis: a multicentered analysis

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