COVID-19 Pandemic and IBS. Results of the All-Russian Observational Non-interventional Program to Study the Effectiveness of the Drug Kolofort® in Real Clinical Practice in Patients with Irritable Bowel Syndrome After a New Coronavirus Infection (VESNA)

Aim: to study the effectiveness and safety of using the drug Kolofort® in outpatients with irritable bowel syndrome (IBS) after a new coronavirus infection.Materials and methods. An observational non-interventional program was conducted in patients with exacerbation of IBS symptoms after a new coronavirus infection. One hundred forty-one patients took part in the study. The final efficacy analysis included data from 127 study participants. All patients complained of increased/appearing gastrointestinal symptoms that appeared within 1–6 months after the infection (all patients had a history of COVID-19 infection). To assess the presence and severity of symptoms of the disease, the “7 × 7” questionnaire was used before the start of treatment and three months after the start of treatment.Results. At the stage of inclusion in the program, the average total score on the “7 × 7” questionnaire was 17.36, which corresponded to a moderately severe disorder. During the treatment period, the average total score decreased to 6.14, which corresponded to borderline disorder. In addition, significant improvement was observed for each symptom separately. After three months of therapy, doctors rated the overall impression of the treatment on a 5-point Likert scale from “very effective” to “ineffective”. The average score was 4.24. In addition, no serious adverse events were identified while taking the drug.Conclusion. In real clinical practice, the drug Kolofort® demonstrated high clinical efficacy in the treatment of patients with IBS after COVID-19 infection

The rs7574865 polymorphism of the <i>STAT4</i> gene and risk of early rheumatoid arthritis development (the REMARKA study)

The aim of the study was investigation of association of the rs7574865 polymorphism of STAT4 gene (Signal Transducer and Activator of Transcription 4, a family of signal transduction and transcription activation molecules 4) with very early rheumatoid arthritis (RA) in Russian patients, and the study of the relationship of "phenotype – genotype", particularly of positivity for antibodies to cyclic citrullinated peptides (ACCP), their concentration, the presence of erosive joint damage at inclusion in patients the study with the STAT4 gene polymorphism. Material and methods. The study was conducted in the framework of the program REMARKA (Russian study of Methotrexate and biological drugs in Early active Arthritis). 85 patients with very early RA with a duration of symptoms no more than 6 months, not receiving disease modifying anti-rheumatic drugs (DMARD) and biologicals were included. Results and discussion. The analysis of the distribution of genotypes and alleles of STAT4 rs7574865 polymorphism showed that the frequencies of g/G, G/T and T/T genotypes differ at the level of the prominent tendency to statistical significance between patients with RA and the control group (p=0.05). The frequency of minor allele T in RA is significantly higher than that in the control group, and this allele is associated with a predisposition to RA [odds ratio (OR) 1.7; 95% confidence interval (CI) 1.1–2.8; p=0.03]. In the study of the "genotype – phenotype" relationship, STAT4 gene polymorphism correlated with erosive joint damage (r2=0.289; p=0.008). In carriers of the homozygous genotype TT, the number of erosions at inclusion in the study was significantly higher compared with carriers of genotypes GG/GT (median 5.50 [0.754; 7.5] and 0.00 [0.00; 2.00], respectively; p=0.003). The risk of erosion is also associated with the polymorphism of the STAT4 gene (OR 8.6; 95% CI 1.0–204.9; p=0.03). A difference of the ACCP level depending on STAT4 gene polymorphism was revealed: carriers of at least one minor allele T (G/T+T/T) had significantly higher concentration of ACCP than that in carriers of homozygous GG genotype: 248.97±151.00 and 179.51±147.01 U/ml, respectively; p=0.048).Conclusion. The study showed that in Russian patients with very early RA, the STAT4 gene rs7574865 polymorphism is associated with both predisposition to the disease and prognostically unfavorable manifestations (phenotypes) of the disease, namely, with the development of erosion in the early stages of the disease and an increase of the ACCP level