Factors affecting the results of analgesic therapy. Results of the Russian multicentre study of NOTE (NSAID: Open-label Trial of Efficacy)

Non-steroidal anti-inflammatory drugs (NSAIDs) are most popular medications for the treatment of pain in common musculoskeletal diseases such as osteoarthritis (OA) and non-specific low back pain (LBP). However, the factors affecting the effectiveness of these drugs have not been determined fully. Aim: to identify factors affecting the effectiveness of NSAIDs in patients with OA and LBP. Materials and methods. An observational study was conducted to evaluate the effectiveness of a 2-week course of NSAIDs in OA and LBP in real clinical practice. The study group consisted of 3604 patients with OA and LBP (60.6% women and 39.4% men, mean age 55.0±13.4 years). According to the study design, aceclofenac (Airtal) and other NSAIDs used in the ratio 1:1. The main criterion of effectiveness was the frequency of complete pain relief after 2 weeks of therapy. In addition, the decrease of pain and general health were determined on a 10-point numerical rating scale (NRS). We compared the frequency of complete pain relief in patients who had and did not have the studied factors. The value of the studied factors was determined using OR (95% CI). Results and discussion. Most patients received aceclofenac (54.9%), as well as diclofenac (2.0%), ketoprofen (1.9%), lornoxicam (2.2%), meloxicam (13.7%), naproxen (2.1%), nimesulide (5.8%), celecoxib (5.9%), ethicoxib (7.1%) and other NSAIDs (4.4%); 56.2% of patients received muscle relaxants, mainly tolperisone (74.7%), vitamin B (10.4%), and proton pump inhibitors (42.8%). Complete pain relief was achieved in 54.8% of patients. The pain decrease and general health improvement were (for NRS) 63.9±13.4% and 61.7±14.8%, respectively. The efficacy of aceclofenac was slightly higher than in the whole group: complete pain relief was in 59.9% of patients. Adverse events in aceclofenac use were observed in 2.3% of patients, other NSAIDs-from 2.4 to 14.1%. The frequency of complete pain relief was higher in men: OR 1,239 (95% CI 1.08-1.418; p=0.002), who had the first episode of pain - OR 3.341 (95% CI 2.873-3.875; p=0.000), a good" response " to NSAIDs in history - OR 1.656 (95% CI 1.385-1.980; p=0.000) and received NSAIDs in combination with muscle relaxants - OR 1.218 (95% CI 1.067-1.390; p=0.004). The effect of therapy is lower in patients 65 years and older-OR 0,378 (95% CI 0.324-0.442; p=0,000), with body mass index >30 kg/m² - OR 0.619 (95% CI 0.529-0.723; p=0.000), with severe pain (≥7 points NRS) - OR 0.662 (95% CI 0.580-0.756; p=0.002), with pain at rest, - OR 0.515 (95% CI 0.450-0,589; p=0.000), pain at night - OR 0.581 (95% CI 0.501-0.672; p=0.000) and the presence of stiffness - OR 0.501 (95% CI 0.438-0,573; p=0.000). Treatment results are significantly worse in the cases of combination of LBP and joint pain, as well as pain in the trochanter major and pes anserinus area (

Оценка эффективности и безопасности комбинации хондроитина сульфата и глюкозамина сульфата при остеоартрите коленного и тазобедренного суставов в реальной клинической практике

A combination of chondroitin and glucosamine is widely used in clinical practice as both a symptomatic and structure-modifying agent for the treatment of osteoarthritis (OA). The emergence of new drugs based on this combination substantially expands treatment options for OA therapy.Objective: to evaluate the efficacy and safety of Artroflex® that is a combination of chondroitin sulfate 400 mg and glucosamine sulfate 500 mg (CS + GS) to support joint health in patients with knee and/or hip OA.Patients and methods. When implementing an open observational research program, the results of using the CS + GS complex were assessed in 644 OA patients (74.7% women) (mean age, 58.0±14.6 years) who experienced moderate/severe pain and required to continuously take non-steroidal anti-inflammatory drugs (NSAIDs). The CS + GS complex was prescribed in a dose of 2 capsules per day for 3 months. The investigators estimated changes in pain on movement by a 0 to 10 verbal pain scale, general health (GH) by a 0–10 visual analogue scale), the Lequesne index, the need for NSAIDs, and patient satisfaction with treatment and its tolerance.Results and discussion. After 3-month therapy, there were decreases in pain intensity by 49.2±16.8%, GH scores by 45.6±18.1%, the Lequesne index from 9.0 [6.0; 13.0] to 5.0 [3.0; 9.0]; less than half (45.2%) of the patients still needed for NSAIDs. 82.2% of patients were satisfied or completely satisfied with treatment results; 89.6% reported good treatment tolerance.Adverse events (apparently associated with NSAID use) were recorded in 2.2% of cases. There were no serious complications that required CS + GS treatment discontinuation or hospitalization.Conclusion. The findings have indicated that Artroflex® used to support joint health is an effective agent that controls OA symptoms and has a good safety level.Комбинация хондроитина и глюкозамина широко применяется в клинической практике как симптоматическое и структурно-модифицирующее средство для лечения остеоартрита (ОА). Появление новых препаратов на основе данной комбинации существенно расширяет возможности терапии ОА.Цель исследования – оценка эффективности и безопасности комплекса для поддержания здоровья суставов Артрофлекс®, представляющего собой комбинацию хондроитина сульфата 400 мг и глюкозамина сульфата 500 мг (ХС + ГС), у пациентов с ОА коленного и/или тазобедренного суставов.Пациенты и методы. В ходе наблюдательной открытой исследовательской программы были оценены результаты применения комплекса ХС + ГС у 644 больных ОА (средний возраст 58,0±14,6 года, 74,7% женщины), испытывающих умеренную/выраженную боль и нуждающихся в постоянном приеме нестероидных противовоспалительных препаратов (НПВП). Комплекс ХС + ГС назначали в дозе 2 капсулы в сутки сроком на 3 мес. Оценивали динамику боли при движении (по вербальной шкале боли 0–10), общего состояния здоровья (ОСЗ, по визуальной аналоговой шкале 0–10), индекса Лекена, потребность в приеме НПВП, удовлетворенность больных лечением и переносимостью терапии.Результаты и обсуждение. Через 3 мес применения выраженность боли снизилась на 49,2±16,8%, оценка ОСЗ – на 45,6±18,1%, индекс Лекена – с 9,0 [6,0; 13,0] до 5,0 [3,0; 9,0], необходимость в приеме НПВП осталась менее чем у половины больных (45,2%). Удовлетворены или полностью удовлетворены результатами лечения были 82,2% больных, хорошую переносимость терапии отметили 89,6%. Нежелательные явления (по-видимому, связанные с приемом НПВП) зафиксированы в 2,2% случаев. Серьезных осложнений, потребовавших прерывания лечения ХС + ГС или госпитализации, не выявлено.Заключение. Согласно полученным данным, комплекс для поддержания здоровья суставов Артрофлекс® – эффективное средство для контроля симптомов ОА, обладающее хорошим уровнем безопасности

RUSSIAN EXPERIENCE WITH USING MONOCLONAL ANTIBODIES TO B-LYMPHOCYTES (RITUXIMAB) IN SYSTEMIC VASCULITIDES ASSOCIATED WITH NEUTROPHIL CYTOPLASMIC ANTIBODIES (PRELIMINARY RESULTS OF THE RUSSIAN REGISTER NORMA)

In 2013, Russia registered officially the indications for the use of monoclonal antibodies to B-lymphocytes (rituximab, RTM) in systemic vasculitides associated with antineutrophil cytoplasmic antibodies (ANCA-SV). This communication presents the preliminary results of the Russian register of the RTM application in autoimmune diseases (NORMA) that has included 50 patients with ANCA-SV treated in 14 cities of the Russian Federation. Twenty-five of 50 (50%) patients received repeated courses of RTM. RTM has demonstrated a high efficacy and a good profile of treatment safety in patients with ANCA-SV in real-life national clinical practice. Among 25 patients who had been followed up for over 12 months, the remission was achieved in 92% of cases, a decrease in the ANCA-SV activity was observed in 8%. The efficacy of RTM increased when performing repeated courses, while it has been noted that the positive results can be obtained by prescribing a repeated course of RTM at a reduced dose (500–1000 mg). Prescription of the repeated courses was primarily required in patients with granulomatosis and polyangiitis affecting the lungs. Care should be taken when combining RTM treatment with cytostatics (primarily with cyclophosphamide) because of the risk of secondary immunodeficiency and infectious adverse events (AE), which have been the most frequent serious AE (12%) in patients with ANCA-SV

Evaluation of the efficacy and safety of a combination of chondroitin sulfate and glucosamine sulfate for knee and hip osteoarthritis in real clinical practice

A combination of chondroitin and glucosamine is widely used in clinical practice as both a symptomatic and structure-modifying agent for the treatment of osteoarthritis (OA). The emergence of new drugs based on this combination substantially expands treatment options for OA therapy.Objective: to evaluate the efficacy and safety of Artroflex® that is a combination of chondroitin sulfate 400 mg and glucosamine sulfate 500 mg (CS + GS) to support joint health in patients with knee and/or hip OA.Patients and methods. When implementing an open observational research program, the results of using the CS + GS complex were assessed in 644 OA patients (74.7% women) (mean age, 58.0±14.6 years) who experienced moderate/severe pain and required to continuously take non-steroidal anti-inflammatory drugs (NSAIDs). The CS + GS complex was prescribed in a dose of 2 capsules per day for 3 months. The investigators estimated changes in pain on movement by a 0 to 10 verbal pain scale, general health (GH) by a 0–10 visual analogue scale), the Lequesne index, the need for NSAIDs, and patient satisfaction with treatment and its tolerance.Results and discussion. After 3-month therapy, there were decreases in pain intensity by 49.2±16.8%, GH scores by 45.6±18.1%, the Lequesne index from 9.0 [6.0; 13.0] to 5.0 [3.0; 9.0]; less than half (45.2%) of the patients still needed for NSAIDs. 82.2% of patients were satisfied or completely satisfied with treatment results; 89.6% reported good treatment tolerance.Adverse events (apparently associated with NSAID use) were recorded in 2.2% of cases. There were no serious complications that required CS + GS treatment discontinuation or hospitalization.Conclusion. The findings have indicated that Artroflex® used to support joint health is an effective agent that controls OA symptoms and has a good safety level

Rheumatoid arthritis in real clinical practice: initiation of therapy with biological agents. Results of the «Computer Terminals of Self-Assessment for Patients with Rheumatic Diseases» («TERMINAL-II») project

Objective: to assess quality-of-life (QoL) dynamics in patients with rheumatoid arthritis (RA) when initiating therapy with biological agents (BAs) in real clinical practice.Patients and methods. The investigation enrolled patients with RA from the patient cohort participating in the TERMINAL-II multicenter Russian study, who newly initiated BA therapy. In the self-assessment terminal, the patient completed HAQ, EQ-5D, and RAPID-3 questionnaires. DAS28, SDAI, CDAI, and RAPID-3 were used to determine disease activity. The patient's functional status and QoL were assessed using the HAQ index and the EQ-5D questionnaire, respectively. The efficiency of the therapy was analyzed 6 months after the start of the study according to the standard procedures.Results and discussion. The investigation enrolled 156 RA patients: 79.6% females; mean age, 45.8±13.2 years; disease duration, 7.6±5.6 years. The patients had high RA activity (a mean DAS28 of 5.2±1.2, a mean SDAI of 39.5±16.4, a mean CDAI of 27.5±10.4, and a mean RAPID-3 of 15.1±3.6) and previous inefficacy of synthetic disease-modifying antirheumatic drugs (DMARDs) after at least 6 months of therapy. Only 1.2% of patients had a good functional status comparable to the population-based control (HAQ 40.5). 70% of patients needed to take non-steroidal anti-inflammatory drugs (NSAIDs). The first BA was chosen in accordance with the recommendations for administration of BAs and in terms of their availability in a specific region of the Russian Federation. The first prescribed BA was tumor necrosis factor-a (TNF-a) inhibitors in 112 (71.8%)patients, anti-B-cell therapy in 14 (9.0%), an interleukin-6 receptor inhibitor in 16 (10.3%), and a leukocyte costimulatory inhibitor in 14 (9.0%). Comparison of the patients receiving newly initiated therapy with TNF-a inhibitors and drugs with other mechanisms of action showed that the patients who had abatacept received higher doses of methotrexate (MTX), but lower doses of glucocorticoids (GCs) than those who were prescribed rituximab and tocilizumab. A statistically significant decrease in DAS28, SDAI, CDAI, and RAPID-3 scores was achieved after 6 months of therapy. Improvements of functional status and QoL in patients were also noted (p<0.0001). The patients continued to receive MTX. During the follow-up period, its dose remained almost unchanged: it averaged 15.7±3.8 and 15.7±3.7 mg/week at the beginning and the end of the study, respectively. Due to decreased inflammation, the dose of CS was reduced (on average, from 5.8±2.5 to 5.1±2.6 mg/day; p=0.02), the number of patients requiring NSAIDs declined (from 72.4 to 63.8%). DAS28, SDAI, and CDAI remission and low disease activity were achieved in 38.1, 16.5, and 20% of patients, respectively. The functional status improved in most patients with RA: 20, 50, and 70% improvements in HAQ were observed in 59.4, 46.9, and 28.7% of cases, respectively. QoL improvements were seen in two thirds of the patients: 30, 50, and 70% improvements in 58.3, 29.5, and in 23.7%. After 6-month follow-up, GC therapy was completely discontinued in 4.6% of patients; their dose was reduced in 5.3%, and 8.6% completely refused to take NSAIDs.Conclusion. Biologic therapy was shown to be effective in RA patients with an inadequate response to synthetic NSAIDs in real clinical practice. The patients preferred the subcutaneous injection of BAs. Biologic treatment in most patients was initiated with TNF-a inhibitors, mainly with adalimumab. Six-month therapy could reduce disease activity and improve functional status and health-related QoL in two thirds of severe patients

PREVALENCE AND RISK FACTORS OF LOW-ENERGY SKELETAL FRACTURES IN PATIENTS WITH CHRONIC INFLAMMATORY DISEASES. THE RESULTS OF A MULTICENTER STUDY OF THE RUSSIAN ASSOCIATION ON OSTEOPOROSIS GLUKOST

Objectives. This study is a part of GLUKOST study hosted and organized by the Russian Association of Osteoporosis. The aim was to estimate the incidence and risk factors of fractures in patients with chronic inflammatory diseases. Materials and Methods. A specially designed questionnaire was introduced to patients with chronic inflammatory diseases in different regions of Russia. The study included 2342 patients aged 18 to 89 years (mean age 53.02 ± 14.03 years, 591 men and 1181 women). The patients were allocated into two groups: group 1 (n = 1402) - patients never prescribed oral long acting glucocorticoids (OGC); group 2 (n = 929) - patients who received oral long acting glucocorticoids for more than 2 months or continue to take at the time of the survey. The median duration of OGC therapy was 3 years, the median daily dose - 10 mg of prednisone or equivalent. Results. Low-energy fractures of the skeleton were identified in 9.0% of patients not receiving therapy OGC, and 15.5% of patients receiving or previously treated with this therapy. Significant risk factor for fractures was the length of a chronic inflammatory disease. OGC therapy increased the risk (adjusted odds ratio (95% confidence interval (95% CI)) of osteoporotic fractures, regardless of their location by 2.2-fold (95% CI 1.63-3.02, p <0,001), vertebral fractures - by 5.0 - fold (95% CI 2.05-12.37, p <0.001), distal forearm 1.8-fold (95% CI 1.10-2.84, p = 0.02). The frequency of fractures in group 2 was increased in men and women of different age groups, but a significant increase in risk was demonstrated only in postmenopausal women and men 50 years and older. We were unable to identify a relationship of fractures with a daily dose of OGC. Conclusion. The main risk factors for osteoporotic fractures in patients with chronic inflammatory diseases are age, duration of the underlying disease, and long-term use of oral glucocorticoids

Ревматоидный артрит в реальной клинической практике: инициация терапии генно-инженерными биологическими препаратами. Результаты проекта «Компьютерные терминалы самооценки для пациентов с ревматическими заболеваниями» («ТЕРМИНАЛ-И»)

Objective: to assess quality-of-life (QoL) dynamics in patients with rheumatoid arthritis (RA) when initiating therapy with biological agents (BAs) in real clinical practice.Patients and methods. The investigation enrolled patients with RA from the patient cohort participating in the TERMINAL-II multicenter Russian study, who newly initiated BA therapy. In the self-assessment terminal, the patient completed HAQ, EQ-5D, and RAPID-3 questionnaires. DAS28, SDAI, CDAI, and RAPID-3 were used to determine disease activity. The patient's functional status and QoL were assessed using the HAQ index and the EQ-5D questionnaire, respectively. The efficiency of the therapy was analyzed 6 months after the start of the study according to the standard procedures.Results and discussion. The investigation enrolled 156 RA patients: 79.6% females; mean age, 45.8±13.2 years; disease duration, 7.6±5.6 years. The patients had high RA activity (a mean DAS28 of 5.2±1.2, a mean SDAI of 39.5±16.4, a mean CDAI of 27.5±10.4, and a mean RAPID-3 of 15.1±3.6) and previous inefficacy of synthetic disease-modifying antirheumatic drugs (DMARDs) after at least 6 months of therapy. Only 1.2% of patients had a good functional status comparable to the population-based control (HAQ 40.5). 70% of patients needed to take non-steroidal anti-inflammatory drugs (NSAIDs). The first BA was chosen in accordance with the recommendations for administration of BAs and in terms of their availability in a specific region of the Russian Federation. The first prescribed BA was tumor necrosis factor-a (TNF-a) inhibitors in 112 (71.8%)patients, anti-B-cell therapy in 14 (9.0%), an interleukin-6 receptor inhibitor in 16 (10.3%), and a leukocyte costimulatory inhibitor in 14 (9.0%). Comparison of the patients receiving newly initiated therapy with TNF-a inhibitors and drugs with other mechanisms of action showed that the patients who had abatacept received higher doses of methotrexate (MTX), but lower doses of glucocorticoids (GCs) than those who were prescribed rituximab and tocilizumab. A statistically significant decrease in DAS28, SDAI, CDAI, and RAPID-3 scores was achieved after 6 months of therapy. Improvements of functional status and QoL in patients were also noted (p&lt;0.0001). The patients continued to receive MTX. During the follow-up period, its dose remained almost unchanged: it averaged 15.7±3.8 and 15.7±3.7 mg/week at the beginning and the end of the study, respectively. Due to decreased inflammation, the dose of CS was reduced (on average, from 5.8±2.5 to 5.1±2.6 mg/day; p=0.02), the number of patients requiring NSAIDs declined (from 72.4 to 63.8%). DAS28, SDAI, and CDAI remission and low disease activity were achieved in 38.1, 16.5, and 20% of patients, respectively. The functional status improved in most patients with RA: 20, 50, and 70% improvements in HAQ were observed in 59.4, 46.9, and 28.7% of cases, respectively. QoL improvements were seen in two thirds of the patients: 30, 50, and 70% improvements in 58.3, 29.5, and in 23.7%. After 6-month follow-up, GC therapy was completely discontinued in 4.6% of patients; their dose was reduced in 5.3%, and 8.6% completely refused to take NSAIDs.Conclusion. Biologic therapy was shown to be effective in RA patients with an inadequate response to synthetic NSAIDs in real clinical practice. The patients preferred the subcutaneous injection of BAs. Biologic treatment in most patients was initiated with TNF-a inhibitors, mainly with adalimumab. Six-month therapy could reduce disease activity and improve functional status and health-related QoL in two thirds of severe patients.Цель исследования — оценить динамику качества жизни (КЖ) больных РА при инициации терапии генно-инженерными биологическими препаратами (ГИБП) в реальной клинической практике.Пациенты и методы. В исследование включены пациенты с РА из когорты больных, входящих в многоцентровое российское исследование «ТЕРМИНАЛ-II», которым впервые была инициирована терапия ГИБП. В терминале самооценки пациент заполнял опросники HAQ, EQ-5D и RAPID-3. Для определения активности заболевания использовали индексы DAS28, SDAI, CDAI и RAPID-3. Оценка функционального состояния больного проводилась по индексу HAQ, а КЖ — по опроснику EQ-5D. Эффективность терапии анализировали через 6 мес после начала исследования по стандартным методикам.Результаты и обсуждение. В исследование включено 156 больных РА: 79,6% женщин, средний возраст — 45,8+13,2 года, длительность заболевания — 7,6+5,6 года. Больные характеризовались высокой активностью РА (среднее значение DAS28 5,2±1,2; SDAI 39,5+16,4; CDAI27,5+10,4; RAPID-315,1+3,6) и предшествующей неэффективностью синтетических базисных противовоспалительных препаратов (БПВП) после как минимум 6 мес терапии. Только 1,2% пациентов имели хорошее функциональное состояние, сравнимое с популяционным контролем (HAQ40,5). Потребность в приеме нестероидных противовоспалительных препаратов (НПВП) испытывали 70% больных. Выбор первого ГИБПпроводился в соответствии с рекомендациями по их применению и с учетом наличия в конкретном регионе Российской Федерации. Ингибиторы фактора некроза опухоли а (ФНОа) были назначены в качестве первого ГИБП 112 (71,8%) пациентам, анти-В-клеточная терапия — 14 (9,0%), ингибитор рецепторов к интерлейкину 6 — 16 (10,3%), ингибитор костимуляции лейкоцитов — 14 (9,0%). Сравнение больных с впервые инициированной терапией ингибиторами ФНОа и препаратами с другими механизмами действия показало, что больные, которым вводили абатацепт (АБЦ), получали более высокие дозы метотрексата (МТ), но более низкие дозы глюкокортикоидов (ГК), чем пациенты, которым назначали ритуксимаб (РТМ) и тоцилизумаб (ТЦЗ). По всем индексам (DAS28, SDAI, CDAI, RAPID-3) после 6 мес терапии было достигнуто статистически значимое уменьшение активности заболевания. Отмечалось также улучшение функционального статуса и КЖ больных (р&lt;0,0001). Пациенты продолжали получать МТ. Его доза за время наблюдения практически не изменилась: в начале исследования она составляла в среднем 15,7+3,8 мг/нед, в конце — 15,7+3,7 мг/нед. В связи с уменьшением активности воспаления доза ГК была снижена (в среднем с 5,8+2,5 до 5,1+2,6 мг/сут; р=0,02), сократилось число больных, нуждающихся в применении НПВП (с 72,4 до 63,8%). Ремиссии и низкой активности заболевания по DAS28 удалось достичь у 38,1% больных, по SDAI—у 16,5% и по CDAI — у 20%. Функциональное состояние улучшилось у большинства больных РА: 20% улучшение по индексу HAQ отмечено в 59,4% случаев; 50% — в 46,9%; 70% — в 28,7%. Улучшение КЖнаблюдалось у 2/3 больных: 30% улучшение — у 58,3%; 50% — у 29,5%; 70% — у 23,7%. После 6мес наблюдения у 4,6% пациентов была полностью отменена терапия ГК, у 5,3% снижена их доза, 8,6% полностью отказались от приема НПВП.Выводы. Показана эффективность терапии ГИБП у больных РА с неадекватным ответом на синтетические БПВП в реальной клинической практике. Предпочтения больных по способу введения ГИБП были отданы подкожным формам. У большинства пациентов лечение ГИБП начиналось с ингибиторов ФНОа, преимущественно с адалимумаба. Через 6 мес терапии у 2/3 тяжелых пациентов удалось снизить активность заболевания, улучшить функциональное состояние и КЖ, связанное со здоровьем