Научно-практическая ревматология (Aug 2010)

RESULTS OF A CROSS-SECTIONAL EPIDEMIOLOGICAL STUDY DETERMINING THE NEEDS FOR GENETIC ENGINEERINGBIOLOGICALS FOR THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL CLINICAL PRACTICE IN RUSSIA(IRACL)COMMUNICATION 2. DETERMINATION OF NEEDS FOR GENETIC ENGINEERING BIOLOGICALS

  • Shandor Fedorovich Erdes,
  • O M Folomeyeva,
  • E A Telnykh,
  • E A Galushko

DOI
https://doi.org/10.14412/1995-4484-2010-1164
Journal volume & issue
Vol. 48, no. 4
pp. 40 – 48

Abstract

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Genetic engineering biologicals (GEBs) show promises in treating rheumatoid arthritis (RA), their efficacy and tolerability have been studied and indications and contraindications defined. However, the extensive application of GEBs is limited due to their high cost. In Russia, GEB therapy is paid by the government. To plan and optimize expenditures, it is necessary to have standardized indications and to know the number of patients who need biological therapy. Objective: To define a need for GEBs (tumor necrosis factor-ƒ (TNF-ƒ) inhibitors) in patients with RA in real clinical practice in Russia. Subjects and methods. The study comprised 2 stages. At Stage 1, the expert method was used to develop a standardized scale to define indications for GEB therapy in patients with RA (StansRA). Disease activity (DAS 28) and duration, progression rate, and tolerability of earlier used basic anti-inflammatory drugs, including methotrexate (MT) in a dose of ≥15 mg/week were considered. Each index was estimated as scores. According to the total scores (min 0, max 0), the patients were divided into 4 groups: 1) GEBs are absolutely indicated (≥7 scores); 2) more likely indicated (5-6 scores); 3) more unlikely indicated (3-4 scores); 4) absolutely contraindicated (5.1) RA activity (27 and 65%, respectively). 69% took MT (mean dose 12.52.5 mg). Results. 4.4% of the 1810 patients had contraindications for GEB therapy. According to the StansRA, GEB therapy is absolutely contraindicated in 6% of cases and 52.7% had indications for GEB use (absolutely and more likely indicated in 9.5 and 43%, respectively). Of them, only 7 (0.5%) patients collected the maximum (9) scores; 33 (2.2%) patients had 8 scores; 101 (6.8%) had 7 scores. Conclusion. The StansRA developed and tested at the population level aids in reducing subjectivism to use these medicines and in optimizing financial expenses on the treatment of patients with RA in real clinical practice in Russia.

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