А. Е. Karateev, Е. Y. Polishchuk, Е. S. Filatova, V. N. Amirdzhanova, V. N. Khlaboshina, А. М. Lila, A. A. Baranov, N. A. Lapkina, G. A. Togizbayev
{"title":"Olokizumab 对类风湿性关节炎慢性疼痛的影响：PROLOGUE 观察性研究的结果。","authors":"А. Е. Karateev, Е. Y. Polishchuk, Е. S. Filatova, V. N. Amirdzhanova, V. N. Khlaboshina, А. М. Lila, A. A. Baranov, N. A. Lapkina, G. A. Togizbayev","doi":"10.1111/1756-185X.15320","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aim</h3>\n \n <p>Evaluate the efficacy and safety ® (olokizumab) in patients with rheumatoid arthritis (RA) in real-world clinical practice, with a targeted assessment of patient report outcomes (PRO) and central sensitization.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>An open-label observational non-interventional study was conducted, enrolling 183 patients with moderate and severe RA activity. All patients received OKZ 64 mg SC as injections every 4 weeks (Q4W) with methotrexate. The patients' follow-up period was 24 weeks or less. RA activity (DAS28-CRP), pain severity (NRS), patient global assessment (PGA, NRS), functional impairment (NRS), fatigue (FACIT-F), central sensitization (central sensitization inventory, CSI), and symptoms of neuropathic pain (PainDETECT) were evaluated.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>The study cohort was comprised of 144 patients. And 39 patients were lost to follow-up, refused OKZ treatment, or were not dosed with OKZ for administrative reasons. In 6 months, DAS28-CRP decreased to 3.3 ± 0.9 (<i>p</i> < .001) and statistically significant reductions in pain intensity, PGA, functional impairment, and fatigue were achieved. Pain intensity decreased as early as 2 days after the first OKZ administration (<i>p</i> < .05). The number of patients with CSI >40 in 24 weeks decreased from 71.0% to 21.0% (<i>p</i> < .001), with PainDETECT >18 – from 21.5% to 13.2%. NSAIDs use decreased from 70.8% to 33.8% (<i>р</i> < .001), steroids – from 54.2% to 32.6%. AEs were reported in 14.2% patients, serious events were observed in three patients.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>OKZ is effective in reducing RA activity and controlling chronic pain related to dysfunction of the nociceptive system.</p>\n </section>\n </div>","PeriodicalId":14330,"journal":{"name":"International Journal of Rheumatic Diseases","volume":"27 10","pages":""},"PeriodicalIF":2.4000,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1756-185X.15320","citationCount":"0","resultStr":"{\"title\":\"Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study\",\"authors\":\"А. Е. Karateev, Е. Y. Polishchuk, Е. S. Filatova, V. N. Amirdzhanova, V. N. Khlaboshina, А. М. Lila, A. A. Baranov, N. A. Lapkina, G. A. Togizbayev\",\"doi\":\"10.1111/1756-185X.15320\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aim</h3>\\n \\n <p>Evaluate the efficacy and safety ® (olokizumab) in patients with rheumatoid arthritis (RA) in real-world clinical practice, with a targeted assessment of patient report outcomes (PRO) and central sensitization.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>An open-label observational non-interventional study was conducted, enrolling 183 patients with moderate and severe RA activity. All patients received OKZ 64 mg SC as injections every 4 weeks (Q4W) with methotrexate. The patients' follow-up period was 24 weeks or less. RA activity (DAS28-CRP), pain severity (NRS), patient global assessment (PGA, NRS), functional impairment (NRS), fatigue (FACIT-F), central sensitization (central sensitization inventory, CSI), and symptoms of neuropathic pain (PainDETECT) were evaluated.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>The study cohort was comprised of 144 patients. And 39 patients were lost to follow-up, refused OKZ treatment, or were not dosed with OKZ for administrative reasons. In 6 months, DAS28-CRP decreased to 3.3 ± 0.9 (<i>p</i> < .001) and statistically significant reductions in pain intensity, PGA, functional impairment, and fatigue were achieved. Pain intensity decreased as early as 2 days after the first OKZ administration (<i>p</i> < .05). The number of patients with CSI >40 in 24 weeks decreased from 71.0% to 21.0% (<i>p</i> < .001), with PainDETECT >18 – from 21.5% to 13.2%. NSAIDs use decreased from 70.8% to 33.8% (<i>р</i> < .001), steroids – from 54.2% to 32.6%. 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Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study
Aim
Evaluate the efficacy and safety ® (olokizumab) in patients with rheumatoid arthritis (RA) in real-world clinical practice, with a targeted assessment of patient report outcomes (PRO) and central sensitization.
Methods
An open-label observational non-interventional study was conducted, enrolling 183 patients with moderate and severe RA activity. All patients received OKZ 64 mg SC as injections every 4 weeks (Q4W) with methotrexate. The patients' follow-up period was 24 weeks or less. RA activity (DAS28-CRP), pain severity (NRS), patient global assessment (PGA, NRS), functional impairment (NRS), fatigue (FACIT-F), central sensitization (central sensitization inventory, CSI), and symptoms of neuropathic pain (PainDETECT) were evaluated.
Results
The study cohort was comprised of 144 patients. And 39 patients were lost to follow-up, refused OKZ treatment, or were not dosed with OKZ for administrative reasons. In 6 months, DAS28-CRP decreased to 3.3 ± 0.9 (p < .001) and statistically significant reductions in pain intensity, PGA, functional impairment, and fatigue were achieved. Pain intensity decreased as early as 2 days after the first OKZ administration (p < .05). The number of patients with CSI >40 in 24 weeks decreased from 71.0% to 21.0% (p < .001), with PainDETECT >18 – from 21.5% to 13.2%. NSAIDs use decreased from 70.8% to 33.8% (р < .001), steroids – from 54.2% to 32.6%. AEs were reported in 14.2% patients, serious events were observed in three patients.
Conclusion
OKZ is effective in reducing RA activity and controlling chronic pain related to dysfunction of the nociceptive system.
期刊介绍：
The International Journal of Rheumatic Diseases (formerly APLAR Journal of Rheumatology) is the official journal of the Asia Pacific League of Associations for Rheumatology. The Journal accepts original articles on clinical or experimental research pertinent to the rheumatic diseases, work on connective tissue diseases and other immune and allergic disorders. The acceptance criteria for all papers are the quality and originality of the research and its significance to our readership. Except where otherwise stated, manuscripts are peer reviewed by two anonymous reviewers and the Editor.
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