Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study

IF 2.4 4区 医学 Q2 RHEUMATOLOGY International Journal of Rheumatic Diseases Pub Date : 2024-10-23 DOI:10.1111/1756-185X.15320
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
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Abstract

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.

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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。
目的:评估®(olokizumab)在实际临床实践中对类风湿关节炎(RA)患者的疗效和安全性,有针对性地评估患者报告结果(PRO)和中枢敏感性:我们开展了一项开放标签观察性非干预研究,共招募了 183 名中度和重度类风湿关节炎活动期患者。所有患者每4周(Q4W)接受一次OKZ 64毫克皮下注射,同时服用甲氨蝶呤。患者的随访期为 24 周或更短。研究人员对患者的RA活动度(DAS28-CRP)、疼痛严重程度(NRS)、患者整体评估(PGA、NRS)、功能障碍(NRS)、疲劳(FACIT-F)、中枢敏化(中枢敏化清单,CSI)和神经性疼痛症状(PainDETECT)进行了评估:研究队列由 144 名患者组成。结果:研究队列由 144 名患者组成,其中 39 名患者失去了随访机会、拒绝接受 OKZ 治疗或因管理原因未使用 OKZ。6个月后,DAS28-CRP降至3.3 ± 0.9(P 40);24周后,DAS28-CRP从71.0%降至21.0%(P 18 - 从21.5%降至13.2%)。非甾体抗炎药的使用率从 70.8% 降至 33.8% (р 结论:OKZ能够有效减少RA活动,控制与痛觉系统功能障碍有关的慢性疼痛。
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来源期刊
CiteScore
3.70
自引率
4.00%
发文量
362
审稿时长
1 months
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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