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Objective: to evaluate the symptom- and structure-modifying effect of alflutop versus placebo (PL) in patients with knee osteoarthrosis (OA).Subjects and methods. The trial enrolled 90 patients with knee OA (ACR criteria and Kellgren–Lawrence Stages II–III) and pain on walking ≥ 40 mm on a visual analogue scale (VAS) who signed their informed consent. The patients were randomly assigned to two groups: 1) 45 patients who received alflutop as 1-ml intramuscular injections for a 20-day cycle at a 6-month interval for 2 years (a total of 4 cycles during 2 years); 2) 45 patients who were given PL (isotonic sodium chloride) injections following the same pattern. As concomitant therapy ibuprofen was used in a dose of 600–1200 mg/day. The efficiency of treatment was evaluated using the OMERACT-OARSI criteria, changes in the three scales WOMAC, EQ-5D, pain and general health status (GHS) on VAS; 15-m walking time, and therapeutic efficiency assessment by the physician and patient. At the beginning and at the end of the investigation, knee joint X-ray and magnetic resonance imaging were performed and the time course of changes in the level of biochemical markers (CTX-II and COMP) was determined to evaluate the structure-modifying effect of alflutop. Adverse reactions were recorded at each visit. A Statistica 10.0 data package was used for statistical analysis.Results. At the end of the trial, the use of aflutop versus PL showed a significant pain reduction in an intent-to-treat population (p=0.003). Analysis of a per protocol population indicated that the pain reduction was more marked in the aflutop group. WOMAC showed that the differences between the groups in the absolute value of pain intensity reduction were significant. A significance stiffness reduction was seen in the alflutop group at Visit 3; no significant decrease was found in the PL group (p < 0.001). Improvements in joint function and reduction in joint WOMAC index were noted in the alflutop group after the first cycle of therapy and these remained throughout the follow-up (p = 0.001). At Visit 6, significantly better quality of life was observed only in the alflutop group (p = 0.0045). Analysis of the GHS scale revealed that the differences between the groups were significant (p = 0.03). In the alflutop and PL groups, the therapy respondents were 73 and 40%, (p = 0.001). Among the alflutop-treated patients, 79% reduced the daily dose of nonsteroidal anti-inflammatory drugs (NSAIDs) and 21% completely discontinued using them. In the PL group, only 23% needed daily lower intake of NSAIDs.Conclusion. The double-blind randomized placebo-controlled trial established the symptom-modifying effect of alflutop in patients with knee OA.

I.M. Sechenov First Moscow State Medical University The given data available in the literature offer new possibilities for the use of leflunomide in rheumatology. The conducted trials enable leflunomide to be considered as a promising agent in the treatment of inflammatory diseases of the joint and vertebral column. The encouraging results of preliminary studies of the efficacy of leflunomide in Crohn's disease, Wegener's granulomatosis, and systemic lupus erythematosus need to be confirmed in large-scale randomized controlled studies.

The paper presents the long-term outcomes of rheumatoid arthritis (RA) according to the data of a 15-year prospective follow-up and treatment in 240 patients with the disease. Disease activity resistance (stable remission of more than 2 years, a recurring course with druginduced remissions of 6-18 months, or no remissions), the degree of joint destruction progression, the functional state of patients and their survival were assessed in relation to the time of use of basic anti-inflammatory drugs (BAIDs). In groups 1, 2, and 3, BAID therapy was initiated within the first 5 months of RA, 6-11 and 12-36 months after its onset, respectively. The treatment was monitored, by estimating clinical and X-ray parameters, the functional state of the locomotor apparatus and by correcting the therapy at its stages in the absence of reliable suppression of RA activity and/or with the continuing emergence of new erosions in small joints. The early use of BAIDs under meticulous control of the degree of RA activity suppression and RA progression were shown to frequently achieve clinical and laboratory remissions and to improve functional and life prognosis in the patients.

Objective. To study the functional outcomes of rheumatoid arthritis (RA) 1, 3, 5, and 8 years after use of various procedures of anti-inflammatory therapy. Subjects and methods. One hundred patients with valid RA were examined. The patients were divided into 3 groups: 1) 38 patients received basic anti-inflammatory drugs (BAIDs) only; 2) 37 patients took BAIDs in combination with glucocorticoids (GCs); 3) 25 patients had synchronous programmed intensive therapy. Results. The early use of therapy with BAIDs without GCs in controlled therapy allows functional outcome improvement in patients in RA to greater extent. No therapy control leads to functional outcome worsening in RA. During a long follow-up, there is a reduction in the correlation of the Health Assessment Questionnaire (HAQ) scores with the parameters reflecting disease activity and an increase in the correlation of the HAQ with those reflecting the progression of RA. The development of the structural and anatomic changes in hand periarticular tissues with the formation of irreversible deformities does not correlate with the HAQ score in patients with RA.

The paper considers the tolerability of Voltaren versus other nonsteroidal anti-inflammatory drugs, including generics. A wealth of clinical experience in using Voltaren leads to the conclusion on its good tolerability and significant anti-inflammatory and analgesic activities.

Ревматоидный артрит (РА) – системное воспалительное заболевание с преимущественным поражением суставов, обычно полиартикулярное. Заболевание может дебютировать с постепенно- го нарастания активности воспаления или остро, может иметь неуклонно прогрессирующее течение или протекать с периодическими обострениями, следующими за улучшением. Хронический характер течения РА обусловливает нарушение функциональных способностей больного, что в тяжелых случаях может привести пациента к необходимости передвижения на коляске или даже к невозможности покинуть постель. Несмотря на успехи терапии, в целом прогноз РА остается серьезным. В первую очередь это касается функциональной недостаточности (ФН) больных и снижению (утрате) их трудоспособности. По заключению T. Pincus и L.F Callahan [1] через 10 лет от начала болезни инвалидизируется 60% пациентов. В Швеции, по данным E.Fex и соавт.[2], через 8 лет от начала болезни не могли работать 37% больных. В Москве, по материалам О.М. Фоломеевой и соавт. [3], в 1999 г. стойкая нетрудоспособность при РА наступала в среднем через 8 лет от начала болезни, средний возраст выхода на инвалидность составил 48,5 года. РА ассоциируется также с повышением летальности, чаще всего по причине кардиоваскулярных заболеваний как следствия хронического воспаления, повышения риска развития лимфом, коррелирующим с тяжестью заболевания, а не с видом проводимой терапии, кроме того, осложнения терапии также могут влиять на продолжительность жизни больных. В настоящее время стало очевидным, что рано начатое лечение базисными противовоспалительными препаратами (БПВП) способно существенно улучшить функциональный и жизненный прогноз при РА. Однако проблема ранней диагностики РА до сих пор не решена, поскольку диагностические критерии РА не соответствуют цели как можно более ранней дифференциации раннего РА от других форм артритов [4] (рис.1). Это приводит к задержке с назначением БПВП и ухудшает функциональный прогноз при РА.

Literature digest is presented concerning to gastrointestinal and cardiovascular safety of selective COX- 2 inhibitors including results of Russian clinico-endoscopic study of celebrex efficacy and tolerability in osteoarthritis (OA). Celebrex was administered to the pts with risk factors of gastrointestinal and cardiovascular adverse events development. Results of longstanding treatment of pts with OA and rheumatoid arthritis (RA) which were prospectively followed up are presented. Celebrex was shown to have high efficacy (about 90% responders) and good tolerability independently on age, duration of treatment and daily dose. Esophagogastroduodenoscopy revealed ulcer development in 4% pts with OA with history of ulcer and in 2,4% pts with RA.

Aim. To study effectiveness and tolerance of monoclonal antibodies to tumor necrosis factor (the drug remicade) in patients with rheumatoid arthritis (RA). Material and methods. Remicade treatment results are considered for 25 RA patients receiving methotrexate the activity of which was inadequate for these patients. Remicade was infused intravenously in a dose 200 mg 4 times for 22 weeks. Results. Remicade produced positive clinical and laboratory effects as early as the first infusion. The response was observed during 22 weeks of the treatment in 17 of 25 patients. Remicade tolerance was good. One patient failed the treatment because of development of collapse. Conclusion. Pilot results of remicade trial point to its high therapeutic potential and perspectives in rheumatology.

The article discusses the social significance of osteoarthritis as a widespread disease that develops mainly in older people, which makes it difficult to carry out anti-inflammatory and analgesic therapy due to the frequent combination of osteoarthritis with other diseases at this age, the need to treat comorbid conditions, which is often poorly combined with systemic therapy with non-steroidal anti-inflammatory drugs. It is noted that osteoarthritis not only worsens the quality of life of patients, but also leads to a decrease in the length of their life, which emphasizes the medical and social importance of conducting the safest possible therapy for this disease. Data on the negative impact of the presence of chronic pain on the progression of osteoarthritis are presented. The negative aspects of the use of oral forms of non-steroidal anti-inflammatory drugs are discussed: the development of adverse events primarily from the gastrointestinal tract and cardiovascular system, the negative effect on the synthesis of glycoaminoglycans («chondronegative effect»). Discusses the place of topical forms of NSAIDs in the treatment of patients with osteoarthritis in accordance with the recommendations of the International society for the use of topical forms of NSAIDs in the management of patients with osteoarthritis of large and small joints. Data on transdermal transport of the topical form of diclofenac, a small molecule with lipophilic properties, are presented. Data on the effectiveness of topical forms of diclofenac in comparison with oral forms are presented according to numerous randomized controlled trials, and the comparable effectiveness of both forms of diclofenac is demonstrated, with maximum safety of the topical form. A special structure of Voltaren® Emulgel (Voltaren® Emulgel), combining the properties of a gel and cream, which provides rapid transdermal penetration and longer retention of the active substance in the area of inflammation, is described, as well as a special prolonged form of Voltaren® Emulgel), which creates additional convenience for use.

According to modern ideas, pain is a multidisciplinary problem with serious medical and socio-economic importance. The most common pain occurs in various structures of the musculoskeletal system. It is noted that the universal mechanism of acute and chronic pain is inflammation, which requires therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). Data on the effectiveness and good tolerability of local NSAIDs are presented. The latest recommendations of the international Committee ESCEO 2019 on the management of patients with osteoarthritis (OA), which confirms the effectiveness and safety of local forms of NSAIDs, in connection with which, ESCEO recommends their use in elderly patients, in patients with comorbid conditions and at high risk of adverse reactions. It is also envisaged to use these drugs for the treatment of OA before the appointment of systemic NSAIDs. The results of randomized clinical trials (RCTS) and meta-analyses confirming clinical efficacy and safety in the treatment of acute and chronic pain by one of the representatives of local NSAIDs-diclofenac sodium gel are presented. Diclofenac sodium gel has been shown to be more effective than placebo in the treatment of acute and chronic pain. Good tolerability of the drug was observed in patients in different age groups, including patients older than 65 years, and in patients with comorbid conditions. The results obtained indicate the effectiveness and good tolerability of diclofenac sodium gel, including long-term, and allow the drug to be widely used as symptomatic therapy for the treatment of acute and chronic pain, including in elderly patients and patients with comorbid conditions.

Treatment of diseases of the musculoskeletal system to date remains not only a serious medical, but also socio-economic problem. Chronic diseases of the joints and spine are one of the most common causes of disability in patients. The main clinical manifestations of most diseases of the musculoskeletal system are pain and inflammation, which requires adequate antiinflammatory therapy. The data on various mechanisms of action of non-steroidal anti-inflammatory drug (NSAID) diclofenac (Voltaren), as well as the results of clinical studies and meta-analyses confirming its effectiveness and good tolerability are presented. The data of experimental and clinical studies of the efficacy and safety of local forms of diclofenac-Voltaren Emulgel (diclofenac-diethylamine) –are presented. Provides information about the form of the Voltaren Emulgel 2% for 12 hours. It is shown that a wide range of analgesic and anti-inflammatory effects of diclofenac (Voltaren), and good tolerance can be used as symptomatic therapy in the treatment of diseases of the musculoskeletal system.

The most common reason for a patient to contact a doctor is the pain accompanying about 70% of all known diseases. The article introduces the basic principles for treating acute and chronic pain. The role of inflammation in pathogenesis of acute and chronic pain is shown. It provides information on the effectiveness and safety of a non-steroid anti-inflammatory drug (NSAIDs) Nimesulide in the treatment of acute and chronic pain. Information is provided on the variety of Nimesulide mechanisms that allow it to be used in various rheumatic diseases as well as in other areas of medicine. The results of clinical research and analyses are presented that confirm the high efficiency and good tolerability of Nimesulide. The years of experience in the application of the granular form of Nimesulide (Nimesil®) by domestic clinicians indicate a high rate of development and a expressed anagesic, anti-inflammatory effects combined with good tolerability, which makes it possible to use the drug successfully in treating acute and chronic pain.

The present study considers a care of a 42-year old female patient with a severe variant of rheumatoid arthritis and extra-articular manifestations. The debut clinical symptoms included polyarthritis, fever, and anemia. On selection of a basic therapy, intolerance (leucopenia, flu-like syndrome) and inefficiency of treatment regimen have been revealed. Administration of a genetically engineered biological drug resulted in the development of tuberculosis and the patient required a long break in the biotherapy for a specific treatment course. The use of anti-TNF agents is associated with an increased risk to tuberculosis and anti-TNF agents are stopped when active tuberculosis develops. However, discontinuation of treatment results in a flare of the underlying disease. The rituximab therapy was initiated because the clinicolaboratory activity was high. Due to the strategy “Treat to Target”, the patient reached improvement by classification criteria and clinical and laboratory remission. The use of high doses of glucocorticoids during the patient’s planning pregnancy led to the development of secondary osteoporosis with spontaneous fractures of pelvic bones and ribs, expressed progression of erosive process, deformations of small and large joints. Specific features of the course of disease with formation of a severe progressing form of rheumatoid arthritis and the conducted treatment were considered from the point of view of difficulty in the selection of therapy when rheumatologists had a limited arsenal of drugs. The risk of re-onset of tuberculosis infection mandates careful follow-up.

Polymyalgia rheumatica is a systemic inflammatory disease that is rarely diagnosed in clinical practice due to the low awareness of physicians and the absence of specific diagnostic markers. The case report is of particular interest due to the absence of typical laboratory signs and the presence of concomitant diseases in the patient with similar clinical manifestations. Timely diagnosis and the appointment of adequate therapy made it possible to achieve clinical and laboratory remission without irreversible consequences for the patient’s health.

Objective. To study efficacy and safety of different schemes of alflutop (AT) administration in pts with osteoarthritis (OA). Material and methods 45 pts (40 womene and 5 men) with knee or hip OA or nodular form of the disease were included. Mean age was 60,3± 10,0 years, mean disease duration - 8,0±6,0 years, mean duration of the last exacerbation - 5,6±5,4 months. Pts with 2 (27 pts) and 3(15 pts) X-ray OA stage and 2 functional class (30 pts) prevailed. Pts were devided into 3 comparable groups, 15 pts in each. Pts of the group 1 received AT I ml/day intramuscularly (im) during 3 weeks, group 2 pts received intra-articular (ia) injections of AT 2 ml twice a week for 3 weeks and then im for 20 days. In group 3 ia (6) and im (20) injections were performed^simultaneously. During 12 months of follow up every pt received 2 appropriate courses. Results. 41 pts completed the study. AT significantly decreased joint pain at rest and at movement measured visual analog scale and WOMAC index in all groups. It also improved functional activity of pts (according to WOMAC index). Improvement according to doctor assessment was achieved after the second course in 78% of pts in group I, in 92% in group 2 and in 86% in group 3. Sonography of knee joints showed significant decrease of synovial membrane thickness (as a sign of synovitis) as well as increase parts of intra-articular hyaline cartilage thickness in group 2 and 3 pts. There was no radiological progression year of follow up. Tolerability was good. The drug was stopped due to adverse events in only 3 pts (dermatitis at the site of injection-1, increase of joint pain after intra-articular injections- 2) . In 3 other pts side effects were mild, and treatmend was continued. Conclusion. Combined Im and AT administration provides anti-inflammatory, analgesic and possible chondroprotective effect in OA pts.