FREQUENCY OF VACCINE-RELATED ADVERSE EVENTS IN PATIENTS WITH RHEUMATIC DISEASE

BackgroundPatients with rheumatic diseases are at greater risk of developing serious infections due to dysregulation of the immune system and the use of immunosuppressants1. Therefore, preventing infection is crucial, with vaccination being the most important primary prevention intervention, leading to a lower rate of hospital admissions due to infections. However, vaccine hesitancy among persons with rheumatic diseases is widespread due to concerns regarding the safety of vaccines2.ObjectivesDescribe the frequency of adverse events associated with vaccination in patients with rheumatic diseases.MethodsObservational, descriptive, cross-sectional and retrospective study was carried out in patients with rheumatic diseases from the Rheumatology Department of the Hospital Regional 1° de Octubre ISSSTE, from February to May 2022;it included patients over 18 years of age with an established diagnosis of rheumatic disease who had received a vaccine;the researcher applied the vaccine-associated adverse events survey to those patients who agreed to participate by signing the informed consent. The sample size was of 95 patients. Descriptive statistics and summary measures were employed for analysis. We used the chi-square test or Fisher's exact test (when <5) for the comparative analysis of the frequencies of nominal qualitative variables. P<0.05 was considered significant.ResultsThe survey was applied to 115 patients. 85.2% were women;mean age 57.9 years;61.7% had rheumatoid arthritis (RA), followed by systemic lupus erythematosus (SLE) in 13.9%. 55.6% of the patients were treated with steroids, 52.2% received bDMARDs and 48.7% csDMARDs. Patients received various vaccines, of which the most frequent was the one for COVID-19, with 99.1% of included patients having received at least one dose, followed by influenza in 30.4%. 78% of the patients who received at least one dose of a vaccine against COVID-19 presented ≥1 adverse events. The disease in which the highest frequency of adverse events occurred was RA, without this difference being statistically significant (Table 1). The adverse events according to the type of COVID-19 vaccine were the following: Sputnik-V 80%, Pfizer 76.6% and AstraZeneca 76.1%, without statistically significant difference between vaccine types. The most frequently occurring adverse events were injection site pain (80.1%), headache (30.7%), and fatigue (30.7%);In addition, the main vaccine-associated musculoskeletal symptoms were joint pain, myalgia, and morning joint stiffness (Figure 1), which on most cases improved after a NSAID use. Joint pain was more frequent after the second dose of certain vaccine types.Table 1.Frequency of AE after COVID-19 vaccination in patients according to disease.AE (%)pRA560.790SLE140.326Spondyloarthritis40.068Osteoarthritis60.614ConclusionVaccination-associated AE occurred more frequently than reported in international studies;however, they were not more serious. Providing this information to patients is important to improve vaccine acceptance. In addition, the administration of NSAID after the application of the vaccine could be proposed to reduce the presence of side effects.References[1]Rotondo, Cinzia, et. al. Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study. Vaccines, 2021;9(7):730-440.[2]Furer, Victoria, et. al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2020;79:39–52.AcknowledgementsTo the residents and staff at HR 1 Octubre for their help in compilating data.Disclosure of InterestsDaniel Xavier Xibille Friedmann Speakers bureau: GSK, Lilly, UCB, Paid instructor for: GSK, Lilly, UCB, Consultant of: GSK, Lilly, UCB, Vanessa Balderas Reyes: None declared, María Olvera: None declared, María Alcocer León: None declared, ALFREDO ALEXANDRI REYES SALINAS Paid instructor for: Abbvie, Janssen, ovartis, Minerva Rodríguez Falcón: None declared, Sandra Miriam Carrillo Vazquez Speakers bureau: Abbvie, Janssen, UCB, Paid instructor for: Abbvie, Janssen, UCB, Consultant of: Abbvie, Janssen, UCB.

Use of baricitinib and tocilizumab for the treatment of moderate to severe COVID-19 in hospitalized patients

Background: SARS-CoV2 infection and COVID-19 associated pneumonia are associated to a dysregulated inflammatory response known as cytokine storm and the use of cytokine inhibitors, especially those targeting IL-6, has been proposed as a therapeutic alternative in these patients. Janus Kinase (JAK) inhibitors in combination to the antiviral Remdesivir have shown evidence of reducing recovery time and accelerating improvement in clinical status among patients with COVID-19, notably among those receiving high-flow oxygen or noninvasive ventilation1. Objectives: To describe the outcomes associated with the use of Tocilizumab (TCZ) and Baricitinib (Bari) in patients hospitalized for COVID-19. Methods: Descriptive study nested in a cohort. Patients from the General Hospital of Cuernavaca who were hospitalized due to COVID-19 associated pneumonia and/or respiratory failure requiring supplemental oxygen or invasive/ non-invasive assisted mechanical ventilation (AMV) were analyzed. All patients had a positive RT-PCR upon hospital admission, sampled under standardized conditions. The clinical and demographic data of the patients upon hospitalization were obtained from the instrument on a specific platform (SISVER) used on a national basis. Severe disease was considered as the need for any type of AMV. TCZ was used at 400-600 mg in two infusions (baseline and at 72 hours), Bari at 4 mg daily for 14 days. The outcomes were the need for AMV, death, or discharge. A p≤ 0.05 was considered statistically significant. Results: Data from 404 SARS-CoV2 positive patients were analyzed. 269 (65.9%) were men. The mean age of the patients was 57.5 years (18-94;SD 15.3). 59.6% of the patients had one or more comorbidities (Diabetes and Hypertension in most cases [31.8%]). 22.8% of the patients had a history of current or previous smoking. Mean hospital stay was 7.4 days (1-36;SD 5.9). 15.9% of the patients required invasive or non-invasive AMV. 11 patients were treated with TCZ and 30 patients received treatment with Baricitinib. 5 of the 11 patients with TCZ required AMV (all but one were intubated), but only 6 of the 30 (20%) with Bari required AMV (all except one received CPAP). The use of Baricitinib was correlated with a reduction in the use of AMV (p 0.01). 6 patients with TCZ were discharged due to improvement and 5 died. In the case of Bari, 19 improved and were discharged and 11 died, significantly correlating with lower mortality (p 0.05). The use TCZ was not associated with a reduced hospitalization (50% remained hospitalized for more than 10 days) but patients receiving Baricitinib had significantly shorter hospital stays (86.6% had a hospital stay of less than 10 days) than those receiving TCZ (p<0.0001). Conclusion: The patients that were treated with Baricitinib and required AMV most often improved with non-invasive CPAP while the majority of the patients under AMV receiving TCZ were treated with an invasive mode, although this was due in part to the fact that TCZ can be employed intravenously and is more practical for intubated patients in whom oral drug administration is limited. Baricitinib was significantly associated with a better outcome (hospital discharge due to improvement) and a significantly shorter hospital stay.