Safety of Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis: Results from a Real-World Canadian Setting.

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2025-09-19 DOI:10.1007/s40744-025-00788-0

Regan Arendse, Proton Rahman, Philip Baer, Derek Haaland, Louis Bessette, Dalton Sholter, Meagan Rachich, Emmanouil Rampakakis, Anne Marilise Marrache, Allen J Lehman, Odalis Asin-Milan

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引用次数: 0

Abstract

Introduction: This work aims to describe the risk of major adverse cardiovascular events (MACE), malignancy, and mortality in real-world patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial spondyloarthritis (axSpA) treated with subcutaneous (SC) golimumab.

Methods: This post hoc analysis included patients treated with SC golimumab from the BioTRAC registry. Incidence rates (IR) per 100 patient-years (PYs) and time to onset of adverse events of special interest (AEoSI), including MACE, malignancies, mortality, serious AEs (SAEs), and serious infections (SIs), were assessed in subgroups based on age, sex, prior tumor necrosis factor inhibitor experience, smoking status, and baseline methotrexate and oral steroid use. All analyses were stratified by indication.

Results: Of 1231 patients included, 529 had RA, 281 had PsA, and 421 had axSpA. At baseline, mean patient age was 57.7, 52.8, and 45.7 years in the RA, PsA, and axSpA groups, respectively. Most patients with RA (76.2%) and PsA (53.7%); 40.9% of patients with axSpA were female. The IR (95% confidence interval) for MACE was 1.1 (0.6, 2.0) events/100 PYs in the RA group with no events in the PsA and axSpA groups. Malignancy IRs were 1.4 (0.8, 2.3), 0.4 (0.0, 1.3), and 1.0 (0.4, 2.1)/100 PYs. SAE incidence ranged from 7.6 (5.5, 10.3)/100 PYs in the PsA group to 11.4 (9.4, 13.6) in the RA group, and that of SIs from 1.3 (0.5, 2.7)/100 PYs in patients with PsA to 2.3 (1.4, 3.4) in patients with RA. IRs for mortality were 0.7 (0.3, 1.4; n = 7), 0.2 (0.0, 1.0; n = 1), and 0.3 (0.0, 1.1; n = 2)/100 PYs in RA, PsA, and axSpA, respectively. Older patients with RA had a significantly shorter time to MACE (p = 0.007).

Conclusions: Patients with RA, PsA, and axSpA treated with SC golimumab in the real world had a low incidence of MACE, malignancy, and all-cause mortality, further confirming the safety of golimumab for the treatment of rheumatic diseases.

Trial registration number and date: ClinicalTrials.gov identifier, NCT00741793, August 22, 2008.

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Golimumab在类风湿关节炎、银屑病关节炎和轴性脊柱炎患者中的安全性：来自加拿大真实环境的结果

本研究旨在描述现实世界中接受皮下（SC） golimumab治疗的类风湿性关节炎（RA）、银屑病关节炎（PsA）或轴性脊柱炎（axSpA）患者的主要不良心血管事件（MACE）、恶性肿瘤和死亡率的风险。方法：这项事后分析纳入了来自BioTRAC注册的接受SC golimumab治疗的患者。每100患者年（PYs）的发病率（IR）和特殊关注不良事件（AEoSI）发生的时间，包括MACE、恶性肿瘤、死亡率、严重不良事件（SAEs）和严重感染（SIs），根据年龄、性别、既往肿瘤坏死因子抑制剂经验、吸烟状况和基线甲氨蝶呤和口服类固醇使用情况进行亚组评估。所有分析均按适应症分层。结果：纳入的1231例患者中，529例为RA， 281例为PsA， 421例为axSpA。基线时，RA、PsA和axSpA组患者的平均年龄分别为57.7岁、52.8岁和45.7岁。RA（76.2%）和PsA（53.7%）患者最多；40.9%的axSpA患者为女性。RA组MACE的IR（95%置信区间）为1.1（0.6,2.0）事件/100 PYs， PsA和axSpA组无事件。恶性肿瘤的ir分别为1.4（0.8,2.3）、0.4（0.0,1.3）和1.0 (0.4,2.1)/100 PYs。SAE的发生率从PsA组的7.6 (5.5,10.3)/100 PYs到RA组的11.4 (9.4,13.6)，si的发生率从PsA组的1.3 (0.5,2.7)/100 PYs到RA组的2.3（1.4,3.4）。RA、PsA和axSpA的死亡率IRs分别为0.7 （0.3,1.4,n = 7）、0.2 （0.0,1.0,n = 1）和0.3 (0.0,1.1,n = 2)/100 PYs。老年RA患者到MACE的时间明显缩短（p = 0.007）。结论：在现实世界中，SC golimumab治疗的RA、PsA和axSpA患者MACE、恶性肿瘤和全因死亡率发生率较低，进一步证实了golimumab治疗风湿性疾病的安全性。试验注册号和日期：ClinicalTrials.gov识别码，NCT00741793, 2008年8月22日。

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Rheumatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Ethics and Disclosures The journal is a member of the Committee on Publication Ethics (COPE) and subscribes to its principles on how to deal with acts of misconduct thereby committing to investigate allegations of misconduct in order to ensure the integrity of research. Content in this journal is peer-reviewed (Single-blind). For more information on our publishing ethics policies, please see here: https://www.springer.com/gp/editorial-policies Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of rheumatologic therapies. 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