Эффективность и безопасность лефлуномида* при ревматоидном артрите в реальной клинической практике (результаты Российского наблюдательного многоцентрового исследования)

Methotrexate or leflunomide is recommended to be used as the first synthetic disease-modifying anti-rheumatic drug to treat rheumatoid arthri- tis (RA). In 2011, ELAFRA (leflunomide, Haupt Pharma Munster GmbH, Germany; license LP-000804 registered October 3, 2011) was cer- tified and approved in Russia. This surveillance study was aimed at assessing the effectiveness and tolerability of ELAFRA in RA patients in real-life clinical practice. Material and Methods. The study involved patients corresponding to the 1987 RA classification criteria, with varying disease duration. The patients were monitored at 33 Russian medical institutions in March–December 2013. According to the drug label, ELAFRA was prescribed at a dose of 10  mg/day during the first 3 days and subsequently at a dose of 20 mg/day. In case of adverse effects (AEs), the daily dose was recommended to be reduced to 10 mg. The patients were examined before the drug was prescribed; as well as 1, 3, 6 months after therapy was started. The number of painful swollen joints and pain intensity according to the Visual Analog Scale (VAS) were assessed. The patients were subjected to laboratory exam- ination (blood test; ESR test; C-reactive protein (CRP) test). RA activity was determined using the DAS28 index. AEs were identified. The data on 99 patients (87 females and 12 males; mean age: 51.1±11.1 years; mean disease duration 74.9±65.7 months) were used for sta- tistical analysis. Disease activity was moderate in 9 patients and high in 90 patients. Results . Six-month therapy with ELAFRA reduced the mean number of swollen joints from 13.7 to 5.1 and the number of painful joints, from 14.9 to 9.5. VAS pain intensity decreased from 62.7 to 29.6 mm; ESR decreased from 38.8 to 22.18 mm/h; SRP, from 24.9 to 13.0. Low and moderate RA activity according to DAS28 and CDAI indices after treatment was observed in 63 and 46 patients, respectively. No serious AEs have been revealed; non-serious AEs were reported for 8 patients. The drug therapy was cancelled in only 3 patients: because of an AE; because of insufficient effectiveness; and because of personal reasons in one patient. Conclusion . The results indicate that ELAFRA drug is characterized by good clinical effectiveness and tolerability.