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

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 (<3 scores). At Stage 2, a
total of 1810 patients with RA (mean age 54.111.4 years; male/female ratio 1:5.2) who met the 1987 ACR criteria were simultaneously
examined in the clinics of 23 Russias regions. The mean disease duration was 8.8 years (min 3 months; max 30 years); DAS 28 5.51.4.
There were predominant patients with moderate (DAS 28 3.2-5.1) and high (DAS 28 >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.

rheumatoid arthritis, treatment, need for tumor necrosis factor-ƒ inhibitors

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