Predictors of Hospitalization in Breakthrough COVID-19 among Fully Vaccinated Individuals with Immune-Mediated Rheumatic Diseases: Data from SAFER-Study.

Breakthrough COVID-19 (occurring in fully vaccinated people) has been described. Data on its characteristics among immune-mediated rheumatic disease (IMRD) patients are scarce. This study describes breakthrough COVID-19 occurring in IMRD patients participating in the SAFER-study, a Brazilian multicentric cohort evaluating the safety, effectiveness, and immunogenicity of SARS-CoV-2 vaccines in patients with autoimmune diseases. A descriptive analysis of the population and a binary logistic regression model were performed to evaluate the predictors of COVID-19-related hospitalization. A p-value < 0.05 was significant. The included 160 patients were predominantly females (83.1%), with a mean (SD) age of 40.23 (13.19) years. The patients received two (19%), three (70%), or four (11%) vaccine doses. The initial two-dose series was mainly with ChAdOx1 (Oxford/AstraZeneca) (58%) or BBIBP-CorV (Sinopharm-Beijing) (34%). The first booster (n = 150) was with BNT162b2 (BioNtech/Fosun Pharma/Pfizer) (63%) or ChAdOx1 (29%). The second booster (n = 112) was with BNT162b2 (40%) or ChAdOx1 (26%). The COVID-19 hospitalization rate was 17.5%. IMRD moderate/high activity (OR: 5.84; CI: 1.9-18.5; p = 0.002) and treatment with corticosteroids (OR: 2.94; CI: 1.02-8.49; p = 0.0043) were associated with higher odds of hospitalization, while increasing the number of vaccine doses was protective (OR: 0.37; CI: 0.15-0.9; p = 0.032). These findings, along with previous reassuring results about the safety of the COVID-19 vaccines, argue in favor of booster vaccination in IMRD patients.

Safety of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with rheumatoid arthritis: data from the Brazilian multicentric study safer.

BACKGROUND: Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA. OBJECTIVE: To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. METHODS: This data are from the study "Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases," a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. RESULTS: A total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines. CONCLUSION: In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.

Effectiveness of non-pharmacological interventions in reducing pain in preterm infants: A systematic review and network meta-analysis.

OBJECTIVE: To identify the most effective non-pharmacological measures for pain control in preterm infants in the Neonatal Intensive Care Unit (NICU). METHODS: A Systematic review and network meta-analysis of randomized clinical trials published in English, Portuguese, and Spanish from April 2020 to December 2023. The data sources used were MedLine via PubMed, LILACS, EMBASE, The Cochrane Central Register of Controlled Trials, and Pedro. We performed the risk of bias analysis with Rob 2 and the certainty of the evidence and strength of the recommendation using the Grading of Recommendations Assessment, Development, and Evaluation system. We assessed heterogeneity using the Higgins and Thompson I2 test, the classification of interventions using the P-score, and inconsistencies using the Direct Evidence Plot. RESULTS: From 210 publications identified, we utilized 12 studies in analysis with 961 preterm infants, and we combined ten studies in network meta-analysis with 716 preterm infants, and 12 combinations of non-pharmacological measures. With moderate confidence, sensory saturation, sugars, non-nutritive sucking, maternal heart sound, lullaby, breast milk odor/taste, magnetic acupuncture, skin-to-skin contact, and facilitated tucking have been shown to reduce pain in preterm infants when compared to no intervention, placebo, proparacaine or standard NICU routine: sensory saturation [SMD 5,25 IC 95%: -8,98; -1,53], sugars [SMD 2,32 IC 95%: -3,86; -0,79], pacifier [SMD 3,74 IC 95%: -7,30; 0,19], and sugars and pacifier SMD [3,88 IC 95% -7,72; -0,04]. CONCLUSION: Non-pharmacological measures are strongly recommended for pain management in preterm infants in the NICU. IMPLICATIONS FOR CLINICAL PRACTICE: The findings of this study have important implications for policy and practice. This is the only systematic review that compared the effectiveness of non-pharmacological measures, thus making it possible to identify which measure presents the best results and could be the first choice in clinical decision making.