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 (

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

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<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<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