An Argentinean cohort of patients with rheumatic and immune-mediated diseases vaccinated for SARS-CoV-2: the SAR-CoVAC Registry—protocol and preliminary data

Abstract

Background/objective To evaluate the efficacy and safety of SARS-CoV-2 vaccine in patients with rheumatic and immune-mediated inflammatory diseases (IMIDs) in Argentina: the SAR-CoVAC registry. Methods SAR-CoVAC is a national, multicenter, and observational registry. Adult patients with rheumatic or IMIDs vaccinated for SARS-CoV-2 were consecutively included between June 1 and September 17, 2021. Sociodemographic data, comorbidities, underlying rheumatic or IMIDs, treatments received, their modification prior to vaccination, and history of SARS-CoV-2 infection were recorded. In addition, date and place of vaccination, type of vaccine applied, scheme, adverse events (AE), disease flares, and new immune-mediated manifestations related to the vaccine were analyzed. Results A total of 1234 patients were included, 79% were female, with a mean age of 57.8 (SD 14.1) years. The most frequent diseases were rheumatoid arthritis (41.2%), osteoarthritis (14.5%), psoriasis (12.7%), and spondyloarthritis (12.3%). Most of them were in remission (28.5%) or low disease activity (41.4%). At the time of vaccination, 21% were receiving glucocorticoid treatment, 35.7% methotrexate, 29.7% biological (b) disease modifying anti-rheumatic drugs (DMARD), and 5.4% JAK inhibitors. In total, 16.9% had SARS-CoV-2 infection before the first vaccine dose. Most patients (51.1%) received Gam-COVID-Vac as the first vaccine dose, followed by ChAdOx1 nCoV-19 (32.8%) and BBIBP-CorV (14.5%). Half of them (48.8%) were fully vaccinated with 2 doses; 12.5% received combined schemes, being the most frequent Gam-COVID-Vac/mRAN-1273. The median time between doses was 51 days (IQR 53). After the first dose, 25.9% of the patients reported at least one AE and 15.9% after the second, being flu-like syndrome and local hypersensitivity the most frequent manifestations. There was one case of anaphylaxis. Regarding efficacy, 63 events of SARS-CoV-2 infection were reported after vaccination, 19% occurred during the first 14 days post-vaccination, 57.1% after the first dose, and 23.8% after the second. Most cases (85.9%) were asymptomatic or mild and 2 died due to COVID-19. Conclusions In this national cohort of patients, the most common vaccines used were Gam-COVID-Vac and ChAdOx1 nCoV-19. A quarter of the patients presented an AE and 5.1% presented SARS-CoV-2 infection after vaccination, in most cases mild. Study registration This study has been registered in ClinicalTrials.gov under the number: NCT04845997. Key Points • This study shows real-world data about efficacy and safety of SARS-CoV-2 vaccination in patients with rheumatic and immune-mediated inflammatory diseases. Interestingly, different types of vaccines were used including vector-based, mRNA, and inactivated vaccines, and mixed regimens were enabled. • ...

The Third Dose of BNT162b2 COVID-19 Vaccine Does Not “Boost” Disease Flares and Adverse Events in Patients with Rheumatoid Arthritis

“…On the other hand, data on vaccine safety in ARDs are scarce and affected by several limitations. Indeed, most studies are conducted on heterogeneous populations of different ARDs, are focused on the first vaccine cycle, have a retrospective design, the occurrence of disease flares has been inferred through survey, and only one study evaluated the immunological safety (new autoantibodies appearance) [ 8 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 44 ].…”

“…The concern of disease reactivation has even increased with the innovative COVID-19 vaccines, due to a lack of ARD patients in the explored population during the pivotal trials and of long-term vaccine experience [ 18 ]. In these first two years of pandemic, different studies of vaccine safety have been developed in patients with ARDs, with RA being always well represented [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 ]. In fact, over 10.000 RA patients have been investigated for safety among the ARD population, but only four studies, including fewer than 1.000 RA patients, are exclusively focused on this disease.…”

Reply

“…They have a better safety profile but showed to be less effective. 2,7 Moreover, in the context of limited vaccine availability, mixed regimens were introduced early in Argentina. Although we were not able to demonstrate statistical differences between homologous and heterologous regimes, national cohort studies have established the superiority of the latter.…”

Efficacy and safety of the Gam-COVID-Vac in patients with immunoinflammatory rheumatic diseases: preliminary data of prospective study

“…Согласно аргентинскому национальному мультицентровому регистру, у 1234 больных с ИВРЗ, иммунизированных против COVID-19 (большинству из них вводили Гам-КОВИД-Вак или рекомбинантную аденовирусную вакцину ChAdOx1-S/nCoV-19), было зарегистрировано 63 (5,1%) случая инфицирования SARS-CoV-2. В большинстве наблюдений (85,9%) имело место бессимптомное или легкое течение COVID-19 [14]. По данным Санкт-Петербургского регистра, включавшего 2134 больных с ИВРЗ, после вакцинации Гам-КОВИД-Вак продемонстрировано снижение заболеваемости новой коронавирусной инфекцией с 26,2 до 0,25% в отсутствие летальных исходов среди иммунизированных лиц (смертность среди неиммунизированных составила 2,8%; p<0,0001) [15].…”

“…Isnardi и соавт. [14] после введения первой дозы Гам-КОВИД-Вак (n=631) зарегистрировали гриппоподобный синдром у 11% пациентов, местные НЯ у 8%, после второй (n=193) -у 5% и 3% соответственно. В дальнейшем с увеличением выборки было продемонстрировано, что частота упомянутых НЯ после вакцинации первым компонентом была значимо выше, чем после введения второго компонента (13% и 7%; 9% и 5% соответственно; p<0,001 для всех вакцин, включая Гам-КОВИД-Вак) [22].…”