Факторы, определяющие длительный успех терапии генно-инженерными биологическими препаратами при ревматоидном артрите

The necessity to achieve clinical remission or low disease activity in every patient with rheumatoid arthritis highlights the importance of combination therapy with methotrexate and biological agents for treatment of resistant to conventional disease-modifying anti-rheumatic drugs patients. Modern requirements mean not only the achievement of results but also long-term maintaining of success. The possibility to get stable results of treatment is determined by many factors such as: clinical efficacy, safety, low immunogenicity, persistence on therapy and the economic feasibility. Analysis of published data for last 5 years leads to the conclusion that etanercept has an optimal combination of these parameters among inhibitors of tumor necrosis factor alpha.Необходимость достижения клинической ремиссии или низкой активности болезни у каждого пациента с ревматоидным артритом подчеркивает важность комбинированной терапии с включением метотрексата и генно-инженерных биологических препаратов в случаях резистентности к обычным базисным противовоспалительным препаратам. Современные требования подразумевают не только достижение результата, но и его длительное (многолетнее) сохранение. Возможность достижения стабильных результатов лечения определяется сочетанием многих факторов, таких как клиническая эффективность, безопасность, низкая иммуногенность, возможность длительного применения и экономическая целесообразность. Анализ данных литературы за последние 5 лет позволяет сделать вывод, что ингибитор фактора некроза опухоли этанерцепт обладает оптимальным сочетанием этих параметров

Общероссийский регистр пациентов с ревматоидным артритом: настоящее и будущее

The article describes the All-Russian Registry of Rheumatoid Arthritis (RA) Patients launched in 2011Р2012 as an Internet-based project. The Registry aims at updating the record system of RA patients and providing reliable information on real clinical practice to improve healthcare. The aims, structure, and software of the Registry, as well as its interrelations with other registries, are described. A scheme of the interplay between healthcare facilities and the Russian Association of Rheumatologists during their work with the All-Russian Registry of Rheumatoid Arthritis Patients is proposed.Описан Общероссийский регистр больных ревматоидным артритом (РА), формирование которого началось в 2011–2012 гг. как internet-based-проекта. Цель регистра – модернизация системы учета пациентов с РА и получение достоверной информации о реальной клинической практике для улучшения качества оказания медицинской помощи. Описаны задачи, структура и программное обеспечение регистра, его взаимоотношения с другими регистрами. Представлена схема взаимодействия лечебно-профилактических учреждений и Ассоциации ревматологов России в процессе работы с Общероссийским регистром больных РА

Women, men, and rheumatoid arthritis: analyses of disease activity, disease characteristics, and treatments in the QUEST-RA Study

Introduction Gender as a predictor of outcomes of rheumatoid arthritis (RA) has evoked considerable interest over the decades. Historically, there is no consensus whether RA is worse in females or males. Recent reports suggest that females are less likely than males to achieve remission. Therefore, we aimed to study possible associations of gender and disease activity, disease characteristics, and treatments of RA in a large multinational cross-sectional cohort of patients with RA called Quantitative Standard Monitoring of Patients with RA (QUEST-RA). Methods The cohort includes clinical and questionnaire data from patients who were seen in usual care, including 6,004 patients at 70 sites in 25 countries as of April 2008. Gender differences were analyzed for American College of Rheumatology Core Data Set measures of disease activity, DAS28 (disease activity score using 28 joint counts), fatigue, the presence of rheumatoid factor, nodules and erosions, and the current use of prednisone, methotrexate, and biologic agents. Results Women had poorer scores than men in all Core Data Set measures. The mean values for females and males were swollen joint count-28 (SJC28) of 4.5 versus 3.8, tender joint count-28 of 6.9 versus 5.4, erythrocyte sedimentation rate of 30 versus 26, Health Assessment Questionnaire of 1.1 versus 0.8, visual analog scales for physician global estimate of 3.0 versus 2.5, pain of 4.3 versus 3.6, patient global status of 4.2 versus 3.7, DAS28 of 4.3 versus 3.8, and fatigue of 4.6 versus 3.7 (P LT 0.001). However, effect sizes were small-medium and smallest (0.13) for SJC28. Among patients who had no or minimal disease activity (0 to 1) on SJC28, women had statistically significantly higher mean values compared with men in all other disease activity measures (P LT 0.001) and met DAS28 remission less often than men. Rheumatoid factor was equally prevalent among genders. Men had nodules more often than women. Women had erosions more often than men, but the statistical significance was marginal. Similar proportions of females and males were taking different therapies. Conclusions In this large multinational cohort, RA disease activity measures appear to be worse in women than in men. However, most of the gender differences in RA disease activity may originate from the measures of disease activity rather than from RA disease activity itself

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update

Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib). Monotherapy, combination therapy, treatment strategies (treat-to-target) and the targets of sustained clinical remission (as defined by the American College of Rheumatology-(ACR)-EULAR Boolean or index criteria) or low disease activity are discussed. Cost aspects were taken into consideration. As first strategy, the Task Force recommends MTX (rapid escalation to 25 mg/week) plus short-term GC, aiming at >50% improvement within 3 and target attainment within 6 months. If this fails stratification is recommended. Without unfavourable prognostic markers, switching to—or adding—another csDMARDs (plus short-term GC) is suggested. In the presence of unfavourable prognostic markers (autoantibodies, high disease activity, early erosions, failure of 2 csDMARDs), any bDMARD (current practice) or Jak-inhibitor should be added to the csDMARD. If this fails, any other bDMARD or tsDMARD is recommended. If a patient is in sustained remission, bDMARDs can be tapered. For each recommendation, levels of evidence and Task Force agreement are provided, both mostly very high. These recommendations intend informing rheumatologists, patients, national rheumatology societies, hospital officials, social security agencies and regulators about EULAR's most recent consensus on the management of RA, aimed at attaining best outcomes with current therapies

A new trend in pathogenetic treatment of rheumatoid arthritis: tofacitinib, the first inhibitor of Janus kinase

The Problem of effective treatment of rheumatoid arthritis (RA) has not been solved yet. In patients with an inadequate response to the synthetic disease-modifying antirheumatic drugs (DMARDs), TNF inhibitors and other genetically engineered (GE) drugs may give an incomplete effect or be totally ineffective in 20–40% of cases. The search for new therapeutic options is very active in many directions, including modulation of intracellular signaling pathways. The most impressive clinical results in RA patients have been achieved for Janus kinase (JAK) inhibitor, tofacitinib, – Tofa (CP-690,550), a low molecular weight drug for oral administration. Unlike the conventional synthetic DMARD, Tofa belongs to targeted therapy drugs; its pharmacological effects largely resemble those of GE drugs (blockade of the biological effects of cytokines). In particular, some features of its mechanism of action (e.g., interleukin 6 inhibition) make it similar to tocilizumab. In all trials, Tofa proved to exhibit high clinical efficacy and satisfactory safety. Tofa was shown to be significantly more effective than methotrexate and placebo (in monotherapy, as well as in combination with DMARDs) in RA patients with an inadequate response to standard DMARDs and TNFa inhibitors (regarding response to treatment, individual parameters of disease activity, achievement of low disease activity and remission, functional impairment). Furthermore, Tofa can inhibit joint damage progression

Factors determining long-term success of biologic therapy in rheumatoid arthritis

The necessity to achieve clinical remission or low disease activity in every patient with rheumatoid arthritis highlights the importance of combination therapy with methotrexate and biological agents for treatment of resistant to conventional disease-modifying anti-rheumatic drugs patients. Modern requirements mean not only the achievement of results but also long-term maintaining of success. The possibility to get stable results of treatment is determined by many factors such as: clinical efficacy, safety, low immunogenicity, persistence on therapy and the economic feasibility. Analysis of published data for last 5 years leads to the conclusion that etanercept has an optimal combination of these parameters among inhibitors of tumor necrosis factor alpha

Evaluation of Physicians’ Knowledge and Attitudes Towards Biosimilars in Russia and Issues Associated with Their Prescribing

Physician awareness and perceptions towards biosimilars are important factors in their adoption to clinical practice. Our objectives were to assess levels of knowledge and attitudes towards biosimilars and key policies on their use among Russian physicians, define the level of interest in new information on biosimilars, and determine what evidence drives treatment decisions in Russia. Physicians with awareness of biologics across different specialties and regions of Russia completed an online survey. A Likert and other rating scales were used to collect opinions, which were summarized descriptively. Responses of subgroups of respondents were compared using t-tests. Among 206 respondents (n = 51 rheumatologists; n = 53 gastroenterologists; n = 50 hematologists; n = 52 oncologists), 66% had positive impressions regarding the introduction of biosimilars in Russia. Overall, 80% lacked understanding of the differences between biosimilars and generics. In all, 67% supported prescribing biologics by distinguishable names and were negative about tender policies limiting choice of therapies for patients. The majority believed in mandatory publication of clinical trial results on biosimilars (94%), agreed biosimilars should be subject to rigorous post-marketing surveillance (98%), and expressed willingness to learn more about biosimilars (94%). Biosimilar education among Russian physicians is required, which may help shape balanced and evidence-based policies for biosimilars in Russia

All-russian registry of rheumatoid arthritis patients: present and future

The article describes the All-Russian Registry of Rheumatoid Arthritis (RA) Patients launched in 2011Р2012 as an Internet-based project. The Registry aims at updating the record system of RA patients and providing reliable information on real clinical practice to improve healthcare. The aims, structure, and software of the Registry, as well as its interrelations with other registries, are described. A scheme of the interplay between healthcare facilities and the Russian Association of Rheumatologists during their work with the All-Russian Registry of Rheumatoid Arthritis Patients is proposed

Current Management Strategy for Osteoarthritis Patients: a Review

A strategic approach is crucial to the management of patients with osteoarthritis (OA). It should be based on the current understanding of the pathogenesis of OA as an inflammatory disease. A review of current clinical guidelines for the management of patients with OA shows significant differences in the evaluation of pharmacological approach, especially the place of symptomatic slow-acting drugs for osteoarthritis, (SYSADOA) and a certain consensus in relation to non-pharmacological methods (primarily exercise, patient education, body weight control, various physiotherapy methods, orthotics and massage/manual therapy). It should also be taken into account the international “treat to target” recommendations, the main idea of which is careful regular monitoring of the patient’s condition and adaptation of treatment tactics depending on the response to treatment. Based on the analysis of literature data and their own clinical experience, the authors developed an algorithm for the strategy of complex therapy of OA, including the following steps: 1) pain control (2-4 weeks), 2) inflammation control (4-6 weeks); 3) control over cartilage degradation (6 weeks – 12 months). For each stage, a specific combination of systemic pharmacotherapy (non-steroidal anti-inflammatory drugs, SYSADOA), intra-articular administration of glucocorticoids and hyaluronic acid, exercises and magnetotherapy (pulsed electromagnetic field) was proposed. A staged comprehensive strategy for the treatment of patients with OA should help to achieve control over the symptoms, while minimizing the duration of NSAIDs and avoiding polypharmacy, and further achievement of inhibition of structural progression