Safety and Immunogenicity of Coronavac and Chadox1 Vaccines against Sars-Cov-2 in Patients with Rheumatoid Arthritis: Brazilian Multicentric Study

Objectives: To evaluate the safety and immunogenicity of CoronaVac and ChAdOx1 vaccines against SARS-CoV-2 in patients with Rheumatoid Arthritis (RA). Method(s): These data are from the 'SAFER (Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases)' study, a Brazilian multicentric longitudinal phase IV study to evaluate COVID-19 vaccine in immunomediated rheumatic diseases (IMRDs). Adverse events (AEs) in patients with RA were assessed after two doses of ChAdOx1 or CoronaVac. Stratification of postvaccination AEs was performed using a diary, filled out daily. The titers of neutralizing antibodies against the receptor-biding domain of SARS-CoV-2 (anti-RBD) were measured by chemilumine scence test after each dose of immunizers. Proportions between groups were compared using the Chi-square and Fisher's exact tests for categorical variables. Clinical Disease Activity Index (CDAI) before and after vaccination was assessed using the McNemar test. Result(s): A total of 188 patients with RA were included in the study, most of them were female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed. The more common AEs after the first dose were pain at injection site (46,7%), headache (39,4%), arthralgia (39,4%) and myalgia (30,5%), and ChAdOx1 had a higher frequency of pain at the injection site (66% vs 32 %, p alpha 0.001) arthralgia (62% vs 22%, p alpha 0.001) and myalgia (45% vs 20%, p alpha 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection site (37%), arthralgia (31%), myalgia (23%) and headache (21%). Arthralgia (41,42 % vs 25 %, p = 0.02) and pain at injection site (51,43% vs 27%, p = 0.001) were more common with ChAdOx1. No patients had a flare after vaccination. The titers of anti-RBDafter two doses of ChAdOx1 were higher compared to two doses of CoronaVac (6,03 BAU/mL vs 4,67 BAU/mL, p alpha 0,001). Conclusion(s): The frequency of local adverse effects, particularly pain at injection site, was high. AEs were more frequent with ChAdOx1, especially after the first dose. The use of the immunizers dis not change the degree of inflammatory activity of the disease. In patients with RA, ChAdOx1 was more immunogenic than CoronaVac. .

COVID-19 in rheumatoid arthritis patients receiving baricitinib: Observations from patient registry

Background/Purpose: Rheumatoid arthritis (RA) patients have higher COVID-19 risks [1,2]. Data suggest that some RA biologics, including baricitinib, may be beneficial for COVID-19 outcomes [3,4]. We used data from RA registry to evaluate impact of COVID-19 on RA activity in patients receiving baricitinib. Method(s): Current study is a single center registry of RA patients receiving baricitinib as a part of routine treatment. Study center accumulates most of RA patients who started baricitinib in Moscow (Russia) from July 2020 to data cutoff (January 2022). We analyzed medical records data for demographics, disease history, and change of disease activity indexes. Medical record data were allocated to visit 1 (baseline), closest to 4 and 8 months after baricitinib initiation (visits 2 and 3). Patients, who had no baricitinib interruptions, were divided in strata according to COVID status between visits 1 and 2. Result(s): At the time of data cutoff registry included data from 142 RA patients receiving baricitinib. Median duration of treatment was 14.5 (interquartile range [IQR] 10-29) weeks. Clinical RA indexes measures are compiled in Table 1. Of 142 patients, 52 had COVID-19 between visits 1 and 2 without baricitinib interruption. Swollen joint counts (SJCs) and tender joint counts (TJCs) were comparable across 3 visits except TJC at visit 3 (P < 0.05). Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP), Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) had comparable change regardless of COVID-19 status (P > 0.05). Simplified Disease Activity Index for Rheumatoid Arthritis (SDAI) and Clinical Disease Activity Index (CDAI) were higher in COVID-19 survivors at visit 3 (P < 0.05). (Table Presented) Conclusion(s): We conclude that, overall, COVID-19 had no significant impact on RA activity during baricitinib treatment. Further follow-up needed to find out reasons for TJC/SDAI/CDAI increase in COVID-19 survivors >=4 months after infection.

Locomotive syndrome in rheumatoid arthritis patients during the COVID-19 pandemic.

This study aimed to longitudinally evaluate the development of locomotive syndrome (LS) in rheumatoid arthritis (RA) patients during the COVID-19 pandemic using the 25-question Geriatric Locomotive Function Scale (GLFS-25). Subjects were 286 RA patients (female, 70.6%; mean age, 64.2 years) who had GLFS-25 and Clinical Disease Activity Index (CDAI) data available for a 1-year period during the COVID-19 pandemic and who did not have LS at baseline. Associations between subject characteristics and development of LS were determined using logistic regression analysis. Among the 286 patients, 38 (13.3%, LS group) developed LS at 1 year after baseline. In the LS group, scores of the GLFS-25 categories "GLFS-5" and "Social activities" were significantly increased at 1 year relative to baseline. GLFS-5 is a quick 5-item version of the GLFS-25, including questions regarding the difficulty of going up and down stairs, walking briskly, distance able to walk without rest, difficulty carrying objects weighing 2 kg, and ability to carry out load-bearing tasks and housework. A significant correlation was also observed between changes in "Social activities" and that of "GLFS-5." Multivariable logistic regression analysis revealed that the development of LS was significantly associated with BMI (OR: 1.11 [95% confidence interval (CI): 1.00-1.22]) and CDAI (OR: 1.08 [95%CI: 1.00-1.16]) at baseline. Adequate exercise and tight control of RA disease activity are important for preventing the development of LS in view of restrictions on going out imposed during the COVID-19 pandemic. GLFS-5 is useful for evaluating the physical function of RA patients.

TIGHT CONTROL in PATIENTS with RHEUMATOID ARTHRITIS TREATED with TARGETED THERAPIES ACROSS the COVID-19 PANDEMIC ERA

Background: The ongoing coronavirus disease 2019 (COVID-19) pandemic and subsequent waves still represent a healthcare issue. Their impact on the treat-to-target (T2T) strategy in rheumatoid arthritis (RA) patients has been seldom investigated. Difficult access to rheumatology outpatient clinic, laboratory and imaging investigations as well as nationwide containment measures could potentially affect disease activity and tight-control strategy. Recently, we reported how a telephone-based tight control strategy ensured satisfactory management of RA treated with targeted therapies during the frst wave of the pandemic [1]. However, the performance of our different patterns of healthcare delivery across different pandemic waves has not been studied yet. Objectives: To analyze the impact of different patterns of healthcare delivery on remission of RA patients treated with targeted therapies during the frst wave (2020) and second/third waves (2021) of pandemic compared to the pre-pan-demic period (2019). Methods: In this observational real-life study, data of our cohort of RA patients treated with biologic or targeted synthetic drugs were extracted from a longitudinal registry. Clinical Disease Activity Index (CDAI) was analyzed in the same period from 22nd of February to 18th of May for three consecutive years: before the pandemic (2019), during the frst wave (2020), and during the second/third waves (2021). During the frst wave, patients could choose whether to receive home drug delivery or to maintain their face-to-face visits, in the other periods only in-person visits were delivered. A generalized linear model with the binomial error was ftted to evaluate the difference in the proportion of patients in CDAI remission. Quantile regression was used to compare the median of CDAI in difficult-to-treat (D2T) patients [2]. In both models, the correlation of different measurements on the same patient was considered. Results: In the pre-pandemic period (2019), 407 RA patients were included in this study. During the frst wave (2020) we analyzed 450 patients, of whom 359 patients chose in-person visits, while 91 patients home drug delivery and virtual visit. Finally, 540 patients were included in 2021 (second/third wave). The percentages of patients in CDAI remission were similar in the three periods (prevalence ratio 1.07, p-value 0.423 between 2020 and 2019, and 1.01, p-value 0.934 between 2021 and 2019). The CDAI remission rate was 40.55% (N=163), 43.18% (N=155) and 40.82% (N=220) in 2019, 2020 and 2021, respectively. The disease activity profile during the three periods is reported in detail in the Table 1 below. Among our cohort of D2T patients, the median value of CDAI before (2019), during the frst wave (2020), and during the second/third wave (2021) changed signifcantly (p= 0.053 between 2020 and 2019 and p=0.006 between 2021 and 2019). Conclusion: Although the pandemic has imposed changes in our healthcare delivery, these different strategies seem to be effective in ensuring satisfactory management of RA treated with targeted therapies. The approaches modulated in the context of the different periods have been a feasible compensation for ensuring disease control even in D2T patients.