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The paper gives the recommendations for the assessment of disease activity and functional status in patients with ankylosing spondylitis in clinical practice, which have been developed by experts, by taking into account international and Russian experience in managing these patients.
В статье представлены рекомендации по лекарственной терапии аксиальных спондилоартритов, разработан-ные Экспертной группой по изучению спондилоартритов (ЭкСпА). Рекомендации описывают тактику веде-ния пациентов в наиболее частых клинических ситуациях, направленную на обеспечение максимальной эф-фективности и безопасности лечения. Ключевые слова: спондилоартриты; аксиальные спондилоартриты; анкилозирующий спондилит; болезнь Бехтерева; нестероидные противовоспалительные препараты; ингибиторы фактора некроза опухоли α; ин-гибиторы интерлейкина 17; безопасность терапии. Для ссылки: Гайдукова ИЗ, Ребров АП, Лапшина СА и др. Применение нестероидных противовоспали-тельных препаратов и генно-инженерных биологических препаратов для лечения аксиальных спондилоар-тритов. Рекомендации Экспертной группы по изучению спондилоартритов при Общероссийской общест-венной организации «Ассоциация ревматологов России». Научно-практическая ревматология. 2017;55(5):474-484. The paper gives recommendations for the drug therapy of axial spondyloarthritides, which have been developed by the Spondyloarthritis Study Group of Experts. The recommendations describe the patient management tactic in the most common clinical situations, which is aimed at maximizing the efficacy and safety of treatment. Key words: spondyloarthritides; axial spondyloarthritides; ankylosing spondylitis; Bechterew's disease; nonsteroidal anti-inflammatory drugs; tumor necrosis factor-α inhibitors; interleukin-17 inhibitors; safety of therapy. For reference: Gaidukova IZ, Rebrov AP, Lapshina SA, et al. Use of nonsteroidal anti-inflammatory drugs and biological agents for the treatment of axial spondyloarthritides. USE OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS AND BIOLOGICAL AGENTS FOR THE TREATMENT OF AXIAL SPONDYLOARTHRITIDES. RECOMMENDATIONS OF THE SPONDYLOARTHRITIS STUDY GROUP OF EXPERTS, ALL-RUSSIAN PUBLIC ORGANIZATION «THE ASSOCIATION OF RHEUMATOLOGY
The paper discusses the process for validation of the Russian-language EQ-5D-5L version to assess quality of life. According to international and national guidelines, the primary goal of treating spondyloarthritis (SpA) is to preserve the quality of life (QOL) of a patient as long as possible, by achieving control of the main symptoms of the disease and inflammation, by preventing the development and progression of structural changes in the locomotor system, and by preserving/normalizing the patient's functional activity and social adaptation. QOL is the integral characteristic of the physical, psychological, social and emotional status of the patient, which is assessed on the basis of his subjective perception. At the moment, there are no generally accepted national tools for assessing QOL in Russia, so the problem of adaptation and validation of international questionnaires is very actual.Objective: to evaluate the psychometric properties of the Russian-language EQ-5D-5L version in patients with SpA.Subjects and methods. Examinations were made in 163 patients older than 18 years with axial or peripheral SpA, who met the Assessment of Spondyloarthritis International Society (ASAS) criteria. The disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); their functional status was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI). The ASAS Health Index (HI) was used to comprehensively analyze the impact of SpA on the patient's health. The EQ-5D-5L version was employed for the first time in Russia to assess the quality of life of patients. Its main psychometric properties, such as reproducibility, validity, sensitivity, were evaluated.Results and discussion. The median age of the patients was 39.50 [28.00; 48.00] years. Among them, there were 64.8% of men. The median value of EQ-5D (a 5L version) was 0.53 [0.29; 0.65]. There were statistically significant relationships between the EQ-5D-5L values and BASDAI, BASFI, ASDAS, BASMI, ASAS HI, and the SF-36 questionnaire for QOL assessment. The test-retest reliability study showed that the internal consistency (Cronbach's alpha) was 0.96. The median value of the EQ-5D-5L was 0.55 [0.37; 0.63] at the first visit and 0.60 [0.40; 0.69] at the second visit after prescribing therapy (p = 0.01).Conclusion. The validation has indicated that the EQ-5D-5L version is a reliable, change-sensitive, easy-to-use, and physician-patient-friendly tool to assess QOL.
Netakimab (NTK) is a humanized anti-interleukin-17А (IL-17A) monoclonal antibody approved for the treatment of psoriatic arthritis, ankylosing spondylitis, moderate to severe psoriasis. Here, we present the results of the 24-weeks double blind period of the PATERA study.Objective. The objective of the study was to evaluate the efficacy and safety of NTK compared to placebo in patients with psoriatic arthritis (PsA).Patients and methods. 194 patients with active PsA with an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs, conventional or biologic disease-modifying antirheumatic drugs, were randomized in a 1:1 ratio to receive subcutaneous 120 mg NTK or placebo at weeks 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. At week 16 ACR20 (20% improvement in the American College of Rheumatology response criteria) non-responders in placebo group were reassigned to NTK in a blinded manner. The primary endpoint was the proportion of patients achieved ACR20 response at week 24.Results. 82,5% of patients in the NTK group and 9.3% of patients in the placebo group achieved ACR20 at week 24 with the 95% CI [0,63; 0,84] (p < 0,0001). Skin manifestations and axial disease significantly improved with NTK. The safety profile of NTK was comparable to placebo. The most frequent treatment-related AEs were expected and common for all other IL-17 inhibitors: increased alanine aminotransferase (ALT), infections, lymphopenia.Conclusion. NTK in the dose of 120 mg has superior efficacy over placebo in patients with active psoriatic arthritis. The safety profile is consistent with other IL-17 inhibitors.
Спондилоартриты -группа воспалительных заболеваний суставов, имеющих общие клинические, генетические и рент-генологические особенности [1,2]. Спондилоартриты могут протекать с преимущественно периферическим или аксиаль-ным поражением [3,4]. Аксиальные спондилоартриты (аксС-пА) подразделяют на нерентгенологические (нр-аксСпА) и рентгенологические (анкилозирующий спондилит -АС) [3,4]. В последней декаде XX в. и начале XXI в. про-изошло изменение не только концепции спондилоартритов, но и пересмотр подходов к лечению этих заболеваний [2,[5][6][7]. Нестероидные противовоспалительные препараты (НПВП) при любом аксСпА рассматриваются как болезнь-модифицирующие средства, способные тормозить прогрес-сирование структурных изменений, в связи с чем их назна-
Netakimab (NTK) is a humanized anti-interleukin-17A monoclonal antibody. To date, the drug has been approved to treat ankylosing spondylitis (AS), psoriatic arthritis, and plaque psoriasis. The paper gives the data obtained during 52-week follow-up of AS patients in the phase III ASTERA study.Objective: to study the efficacy and safety of NTK when used long in patients with active AS.Patients and methods. The investigation enrolled 228 patients with active AS, in whom nonsteroidal anti-inflammatory drugs or biological agents were ineffective. The patients were randomized in a 1:1 ratio to receive NTK 120 mg or placebo. The drug was administered subcutaneously at weeks 0, 1, 2, and then once every 2 weeks. Patients who received placebo and achieved a 20% improvement according to the ASAS criteria (ASAS20) were excluded from the study at week 16. At this week, patients who took placebo and did not achieve an ASAS20 response were switched to subcutaneous NTK at 120 mg dose once every two weeks. The follow-up period was 52 weeks.Results and discussion. Patients with active AS who received NTK were more likely to respond to treatment than those who took placebo. The proportion of people who achieved 40% improvement (ASAS40) during treatment with NTK increased throughout the follow-up period and amounted to 80.7% at week 52. Positive changes were achieved in all used clinical and laboratory parameters of AS activity. There was also a decrease in inflammatory changes, as shown by magnetic resonance imaging (MRI). The adverse events (AEs) were mainly laboratory abnormalities and upper respiratory tract infections. Treatment-related AEs were recorded in no more than one third of patients and they were mild to moderate. Severe AEs were singular.Conclusion. Response to NTK therapy generates in the first weeks of drug use and increases throughout a year. The safety profile of NTK when used long is generally favorable.
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