V.A. Nasonova Research Institute of Rheumatology, Moscow, Russian Federation.
Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian Federation, Moscow, Russian Federation.
Int J Rheum Dis. 2024 Oct;27(10):e15320. doi: 10.1111/1756-185X.15320.
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.
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.
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.
OKZ is effective in reducing RA activity and controlling chronic pain related to dysfunction of the nociceptive system.
评估 ®（奥洛昔单抗）在真实临床环境中治疗类风湿关节炎（RA）患者的疗效和安全性，重点评估患者报告结局（PRO）和中枢敏化。
开展一项开放性、观察性、非干预性研究，纳入 183 例中度和重度 RA 活动度的患者。所有患者均接受 OKZ 64mg SC 每 4 周（Q4W）注射治疗，同时接受甲氨蝶呤治疗。患者的随访期为 24 周或更短。评估 RA 活动度（DAS28-CRP）、疼痛严重程度（NRS）、患者总体评估（PGA，NRS）、功能障碍（NRS）、疲劳（FACIT-F）、中枢敏化（中枢敏化量表，CSI）和神经病理性疼痛症状（PainDETECT）。
研究队列包括 144 例患者。39 例患者失访、拒绝 OKZ 治疗或因管理原因未接受 OKZ 治疗。6 个月时，DAS28-CRP 降至 3.3±0.9（p<0.001），疼痛强度、PGA、功能障碍和疲劳均有显著改善。首次 OKZ 给药后 2 天疼痛强度即开始下降（p<0.05）。24 周时，CSI>40 的患者比例从 71.0%降至 21.0%（p<0.001），PainDETECT>18 的患者比例从 21.5%降至 13.2%。NSAIDs 的使用率从 70.8%降至 33.8%（p<0.001），皮质类固醇的使用率从 54.2%降至 32.6%。14.2%的患者报告出现不良反应，3 例患者出现严重事件。
OKZ 可有效降低 RA 活动度，并控制与伤害性感受系统功能障碍相关的慢性疼痛。
