The effects of sarilumab as monotherapy and in combination with non-methotrexate disease-modifying anti-rheumatic drugs on unacceptable pain in patients with rheumatoid arthritis: A post-hoc analysis of the HARUKA phase 3 study.

IF 1.8 4区医学 Q3 RHEUMATOLOGY

Modern Rheumatology Pub Date : 2024-12-25 DOI:10.1093/mr/roae055

Yoshiya Tanaka, Toshiya Takahashi, Hubert van Hoogstraten, Naoto Kato, Hideto Kameda

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引用次数: 0

Abstract

Objectives: To investigate unacceptable pain [UP; visual analogue scale (VAS) >40 mm] and uncontrolled inflammation [C-reactive protein (CRP) ≥1.0 mg/dL] in patients with active rheumatoid arthritis (RA) receiving sarilumab (SAR) as monotherapy or in combination with non-methotrexate conventional synthetic disease-modifying antirheumatic drugs (SAR + csDMARDs).

Methods: In the HARUKA Phase 3 study (NCT02373202), Japanese patients received either SAR monotherapy (n = 61) or SAR + csDMARDs (n = 30). In this post-hoc analysis, changes in the proportions of patients with/without UP and controlled/uncontrolled inflammation were assessed over 52 weeks.

Results: At baseline, 80.3% (49/61) of patients receiving SAR monotherapy had UP and this proportion decreased with treatment to 55.9% (33/59) at Week 4 and 15.5% (9/58) at Week 52. The SAR + csDMARDs group achieved a reduction in UP from 73.3% (22/30) at baseline to 34.5% (10/29) at Week 4 and 0% (0/24) by Week 52. At baseline, 34.4% (21/61) and 50% (15/30) of patients had both UP and uncontrolled inflammation in the SAR monotherapy and SAR + csDMARDs groups; by Week 2, the proportions decreased to 6.6% (4/61) and 3.3% (1/30), respectively; and 0% in both groups by Week 52.

Conclusion: UP and inflammation were reduced in patients with active RA in Japan in both SAR monotherapy and SAR + csDMARDs treatment groups.

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萨利单抗单药治疗和与非甲氨蝶呤类疾病修饰抗风湿药联合治疗对类风湿性关节炎患者难以接受的疼痛的影响：HARUKA 3 期研究的事后分析。

目的研究活动性类风湿性关节炎（RA）患者在接受沙利单抗（SAR）单药治疗或与非甲氨蝶呤类常规合成改善病情抗风湿药（SAR+csDMARDs）联合治疗后出现的不可接受的疼痛（UP；视觉模拟评分量表[VAS]>40 mm）和无法控制的炎症（C反应蛋白[CRP]≥1.0 mg/dL）：在HARUKA 3期研究（NCT02373202）中，日本患者接受了SAR单药治疗（61例）或SAR+csDMARDs（30例）。在这项事后分析中，对52周内有/无UP和炎症控制/未控制患者比例的变化进行了评估：基线时，接受SAR单药治疗的患者中有80.3%（49/61）患有UP，随着治疗的进行，这一比例在第4周降至55.9%（33/59），在第52周降至15.5%（9/58）。SAR+csDMARDs组的UP率从基线时的73.3%（22/30）降至第4周时的34.5%（10/29）和第52周时的0%（0/24）。基线时，SAR单药组和SAR+csDMARDs组分别有34.4%（21/61）和50%（15/30）的患者有UP和未控制的炎症；到第2周，比例分别降至6.6%（4/61）和3.3%（1/30）；到第52周，两组均为0%：在日本，SAR 单药治疗组和 SAR+csDMARDs 治疗组活动性 RA 患者的 UP 和炎症均有所减轻。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Modern Rheumatology RHEUMATOLOGY-

CiteScore

4.90

自引率

9.10%

发文量

146

审稿时长

1.5 months

期刊介绍： Modern Rheumatology publishes original papers in English on research pertinent to rheumatology and associated areas such as pathology, physiology, clinical immunology, microbiology, biochemistry, experimental animal models, pharmacology, and orthopedic surgery. Occasional reviews of topics which may be of wide interest to the readership will be accepted. In addition, concise papers of special scientific importance that represent definitive and original studies will be considered. Modern Rheumatology is currently indexed in Science Citation Index Expanded (SciSearch), Journal Citation Reports/Science Edition, PubMed/Medline, SCOPUS, EMBASE, Chemical Abstracts Service (CAS), Google Scholar, EBSCO, CSA, Academic OneFile, Current Abstracts, Elsevier Biobase, Gale, Health Reference Center Academic, OCLC, SCImago, Summon by Serial Solutions