Abstract
Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥75years) with rheumatoid arthritis. This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24weeks. The study population was divided into two age groups (younger: <75years and elderly: ≥75years), and the safety, effectiveness, and treatment persistence of golimumab were assessed. Also, the reasons for discontinuing golimumab treatment were analyzed by multi-logistic regression. During golimumab treatment over 24weeks, younger and elderly groups exhibited comparable improvement of disease activity as measured by EULAR response criteria with similar overall rates of adverse events. However, the survival curve of golimumab for elderly patients was significantly different from that for younger patients due largely to the discontinuation at 4weeks. The most common reason for discontinuation in elderly patients was patient choice, while it was disease progression in younger patients. Analysis of elderly patients who discontinued treatment by their own decision identified EULAR good response as a factor associated with continuation of golimumab treatment whereas no predictive factor associated with discontinuation was identified. The safety and effectiveness of golimumab treatment in elderly Japanese patients aged 75years or older were comparable to those in younger patients in real-world clinical practice. Analysis of the survival curves suggested that continuous use of golimumab might further improve clinical benefit of golimumab in elderly patients, underpinning the importance of effective communication between physicians and elderly patients based on the treat-to-target strategy. Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation.
Highlights
Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials
With the advent of the era of a ‘‘super-aged society’’ [28], the population of elderly people diagnosed with Rheumatoid arthritis (RA) is on the rise [8]
A database study has demonstrated that the peak age at onset of RA has shifted from 50–59 to 60–69 years of age over the past decade [9], suggesting that more elderly people tend to start suffering from RA in Japan
Summary
Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (C 75 years) with rheumatoid arthritis. It has been suggested that the peak age at onset of RA has increased from 50–59 years in 2002–2003 to 60–69 years in 2012–2013 in Japan [9], necessitating better understanding of elderly RA in a real-world clinical setting and development of its treatment strategies. GLM is a human monoclonal antibody developed to inhibit signaling activities of TNFa [13, 14] and indicated for the treatment of several rheumatic diseases such as active RA [15], ankylosing spondylitis [16], and psoriatic arthritis [17]. In Japan, GLM is approved to be administered subcutaneously for the treatment of moderate to severe RA inadequately responded to conventional therapies
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