Interleukin 6 receptor inhibitors in the treatment of rheumatoid arthritis during the COVID-19 pandemic, Moscow experience

Objective: to confirm the efficacy and safety of levilimab in patients with rheumatoid arthritis (RA) switched from other interleukin 6 receptor in-hibitors (iIL6R) for non-medical reasons. Patients and methods. A retrospective analysis of data from the register of patients with RA who during the COVID-19 pandemic were switched from foreign iIL6Rs to the Russian drug levilimab. Treatment regimens with levilimab in combination with synthetic disease-modifying antirheumatic drugs (sDMARDs) and/or glucocorticoids (GCs) were used, as well as a monotherapy regimen in case of DMARDs intolerance. Results and discussion. In 150 patients with RA, a successful non-medical switch to levilimab was demonstrated with the preservation and inten-sification of the clinical effect achieved on previous therapy with iIL6R. After switching to levilimab, the DAS28-CRP index decreased by an av-erage of 0.098 at 3 months and by 0.25 at 6 months (p=0.214 for both time points). There was a decrease in the proportion of patients with elevated levels of CRP, as well as with high RA activity. In a number of patients who showed high efficacy of levilimab, it became possible to reduce the dose or number of DMARDs, as well as cease GCs intake. Good tolerability and a favorable safety profile of levilimab were noted, including in relation to the new coronavirus infection that developed during therapy. Conclusion. Therapy with Russian iIL6R levilimab is effective and safe, including in patients switched from other drugs for non-medical reasons, as well as in relation to the novel coronavirus infection that developed during therapy. © 2022, Ima-Press Publishing House. All rights reserved.

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.

[Levilimab and baricitinib prescribing experience in outpatient COVID-19 patients' treatment].

AIM: To study the effect of levilimab or baricitinib in combination with standard therapy (ST) on the incidence of severe viral pneumonia associated with a new coronavirus infection COVID-19. MATERIALS AND METHODS: A multicenter, open-label observational study of the efficacy and safety of levilimab in combination with ST (group 1, n=100), baricitinib in combination with ST (group 2, n=139), or in comparison with ST (group 3, n=200) in outpatients with verified CT-1 pneumonia. RESULTS: According to the results of laboratory tests, patients treated with levilimab in combination with ST had the best dynamics of changes in CRP from reliably the highest level (mg/L) to the lowest in comparison with other groups. In the group of patients with ST, in contrast to the other groups, no dynamics of CRP was observed by day 5 of therapy. In group of hospitalized patients initially receiving levilimab in addition to ST, the rate of transfer to the intensive care unit (2 patients, 9.52%) and length of stay (4 days) was significantly lower compared to the values in patients in both the baricitinib group in combination with ST (7 patients, 15.56%; 5 days [interquartile range 36.5]) and in patients receiving ST alone (7 patients, 15.56%; 5 days [interquartile range 36.5]). Also in hospitalized patients we observed no statistically significant intergroup differences in the incidence of infectious complications and thromboembolic events, which confirms the safety of including levilimab or baricitinib in COVID-19 pathogenetic therapy regimens. Observational results support the hypothesis that the initial inclusion of levilimab or baricitinib in addition to ST is accompanied by a reduced risk of viral pneumonia progression. CONCLUSION: The addition of levilimab or baricitinib to the therapy regimen for coronavirus infection during the outpatient phase has demonstrated a preemptive anti-inflammatory effect and reduced the probability of lung tissue damage progression.

Characteristics of the Epidemic Situation Associated with Acute Respiratory Viral Infections in the Russian Federation during the Pandemic Spread of COVID-19

Annualy, SARS occupy a leading position in terms of morbidity and the magnitude of the economic damage caused both in the world and in the Russian Federation. Currently, the most widespread pandemics are caused by the influenza A (H1N1) pdm09 virus and the new SARS-CoV-2 coronavirus, which occupy a common ecological niche and require studying the manifestations of the epidemic process of ARVI for further development of measures to improve epidemiological surveillance of this group of infections. Aim of the study was to investigate the current manifestations of the epidemic process of ARVI and influenza, including in the context of a new coronavirus infection (COVID–19) pandemic, on the territory of Russia and in Moscow. Materials and methods. The assessment of the long-term dynamics of the incidence of ARVI and influenza (from 1999 to 2021), as well as its age structure in the territory of the Russian Federation and in Moscow, was carried out. The main sources of information were: WHO: «The situation with COVID-19 in the European region», the domestic information portal Stopkoronavirus.rf, as well as data from Federal State Statistical Observation forms No. 2 and No. 6. Results. During the period 2013–2019, a strong positive correlation was revealed between the incidence rates of ARVI in the Russian Federation and Moscow (p = 0.8, with p < 0.05), which became negative with the spread of SARS-CoV-2: in the country, the incidence rate of ARVI increased by 11.5% in 2020 and 15.6% in 2021., in Moscow there was a decrease of 45.1% than the average in Russia, which could be due to the quality of differential diagnosis of ARVI and COVID-19. In 2021 the incidence rate of influenza decreased by more than 2 times in all Federal Districts of the country, with the exception of the capital region, where it became the maximum-65.9 per 100 thousand population in 2021 (against 14.1 in 2019). In the age structure of influenza incidence, as well as ARVI, for the period from 2019 to 2021. the child population prevailed with the highest rates in the age groups of 1–2 years and 3–6 years. As the circulation of SARS-Cov-2 decreased to 15–19%, the activity of influenza viruses and other pathogens of the ARVI group increased (from 0.7–3.0% during the developed pandemic to 5.6–6.6% at the stage of its decline), which indicates a pronounced interference of pathogens detected at the global level in the system of Global Hospital Surveillance for flu. Conclusion. The forecast for the upcoming epidemic season 2022–2023 largely depends on the spread of the new coronavirus SARS-CoV-2, as well as its variability and the emergence of new variants. Nevertheless, there may be a significant increase in the incidence caused by the influenza A(H1N1)pdm09 virus, whose high activity was recorded in the current epidemic season in a number of countries in the Southern hemisphere. © 2022, Numikom. All rights reserved.