A comparison of incidence and risk factors for serious adverse events in rheumatoid arthritis patients with etanercept or adalimumab in Korea and Japan

Cho, Soo-Kyung; Sakai, Ryoko; Nanki, Toshihiro; Koike, Ryuji; Watanabe, Kaori; Yamazaki, Haruka; Nagasawa, Hayato; Tanaka, Yoshiya; Nakajima, Ayako; Yasuda, Shinsuke; Ihata, Atsushi; Ezawa, Kazuhiko; Won, Soyoung; Choi, Chan-Bum; Sung, Yoon‐Kyoung; Kim, Tae‐Hwan; Jun, Jae‐Bum; Yoo, Dae-Hyun; Miyasaka, Nobuyuki; Bae, Sang Cheol; Harigai, Masayoshi

doi:10.3109/14397595.2013.860695

Cited by 6 publications

(3 citation statements)

References 22 publications

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“…In contrast, in the spine, we found no evidence that MRI is better than radiographs in detecting change of structural damage. Despite the disappointing results with MRI, our results are in line with previous studies, showing that spinal radiographic progression can be detected even in early phases of the disease (4,27). A recent study has shown that low‐dose computerized tomography of the spine is more sensitive at detecting new syndesmophytes than conventional radiographs, which promises to further expand our ability to detect change in axial damage (28).…”

Section: Discussionsupporting

confidence: 92%

Imaging Outcomes for Axial Spondyloarthritis and Sensitivity to Change: A Five‐Year Analysis of the DESIR Cohort

Sepriano

Smolen

Heijde

et al. 2022

Arthritis Care & Research

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Objective To compare the sensitivity to change of different imaging scoring methods in patients with early axial spondyloarthritis (SpA). Methods Patients from the Devenir des Spondylarthropathies Indifferérenciées Récentes (DESIR) cohort fulfilling the Assessment of SpondyloArthritis international Society criteria for axial SpA were included. Radiographs and magnetic resonance imaging (MRI) of the sacroiliac (SI) joints and spine were obtained at baseline, 1, 2, and 5 years. Each image was scored by 2 or 3 readers in 3 separate reading waves. The rate of change of outcomes measuring inflammation of the spine and SI joints (e.g., Spondyloarthritis Research Consortium of Canada [SPARCC] score) and structural damage on MRI (e.g., ≥3 fatty lesions) and radiographs (e.g., modified New York grading) was assessed using multilevel generalized estimating equation models (taking all readers and waves into account). To allow comparisons across outcomes, rates were standardized (difference between the individual's value and the population mean divided by the SD). Results In total, 345 patients were included. Inflammation detected on MRI of the SI joints (MRI‐SI joints) (standardized rate range –0.278, –0.441) was more sensitive to change compared to spinal inflammation (range –0.030, –0.055). Structural damage in the SI joints showed a higher standardized rate of change on MRI‐SI joints (range 0.015, 0.274) compared to radiography of the SI joints (range 0.043, 0.126). MRI‐SI joints damage defined by ≥3 fatty lesions showed the highest sensitivity to change (0.274). Spinal structural damage slowly progressed over time with no meaningful difference between radiographic (range 0.037, 0.043) and MRI structural outcomes (range 0.008, 0.027). Conclusion Structural damage assessed in pelvic radiographs has low sensitivity to change, while fatty lesions detected on MRI‐SI joints are a promising alternative. In contrast, MRI of the spine is not better than radiography of the spine in detecting structural changes in patients with early axial SpA.

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Section: Discussionsupporting

confidence: 92%

Imaging Outcomes for Axial Spondyloarthritis and Sensitivity to Change: A Five‐Year Analysis of the DESIR Cohort

Sepriano

Smolen

Heijde

et al. 2022

Arthritis Care & Research

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“…From 813 abstracts, we selected 309 publications from 36 registers. Sixteen published reviews allowed us to identify 7 other registries with no publication identified in databases (hand search) [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17].…”

Section: Resultsmentioning

confidence: 99%

Safety of biologic DMARDs in RA patients in real life: A systematic literature review and meta-analyses of biologic registers

2017

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“…A retrospective registry of Korean patients with RA (REtrospective study for Safety and Effectiveness of Anti-RA treatment with biologiCs, RESEARCh) was established to evaluate the safety and effectiveness of biologic DMARDs [ 13 ]. Patients who meet the 1987 American College of Rheumatology criteria for RA who had ever been given biologic DMARDs from December 2000 to June 2011 were identified from the medical records of Hanyang University Hospital for Rheumatic Diseases and enrolled in the RESEARCh database.…”

Section: Methodsmentioning

confidence: 99%

Drug retention and safety of TNF inhibitors in elderly patients with rheumatoid arthritis

Cho

Sung

Kim

et al. 2016

BMC Musculoskelet Disord

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BackgroundThe concerns about the development of adverse events (AEs) in elderly RA patients as a result of age-related changes in drug metabolism and the presence of comorbid illnesses are emphasizing due to increasing prevalence of rheumatoid arthritis (RA) in old age. However, they tend to be inadequately represented in RA clinical trials because of the exclusion criteria that are commonly applied. The tolerability and safety of TNF inhibitors in elderly patients have not been also evaluated in clinical practice. This study aimed to evaluate the retention rate and safety of TNF inhibitors (TNFI) in elderly RA patients.MethodsTotal 429 RA patients (838 person-years [PYs]) treated with TNFI from a retrospective biologic DMARDs registry. Patients were divided into an elderly (age ≥60 years) and a younger group (<60 years). The drug retention rates of both groups were compared using Kaplan-Meier curves. Potential predictors of TNFI discontinuation in the elderly were examined using Cox regression analysis. The incidence rate (IR) of serious adverse events (SAEs) in the elderly group was compared to that of the young group.ResultsOf the patients, 24.9 % (n = 107, 212 PYs) were in the elderly group. Regarding the retention rates of TNFI in 3 years, there was no significant difference between the elderly and younger group (p = 0.33). The major cause of discontinuation in elderly patients was AE (34.3 %), whereas that was drug ineffectiveness (41.7 %) in younger patients. Age (HR 1.09, CI 1.02-1.16) was a predictor of discontinuation, while the presence of comorbidity (HR 0.37, CI 0.15-0.91) had a protective effect against drug discontinuation in the elderly. The IR of SAEs in the elderly (6.13/100 PYs) was higher than in the younger group (5.11/100 PYs).ConclusionsThe retention rate of TNFI in the elderly was comparable with that in younger patients. The major cause of discontinuation in the elderly patients was AEs, while it was drug ineffectiveness in younger patients. The IR of SAEs in the elderly was higher than in the younger patients.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-1185-6) contains supplementary material, which is available to authorized users.

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A comparison of incidence and risk factors for serious adverse events in rheumatoid arthritis patients with etanercept or adalimumab in Korea and Japan

Abstract: The IR of SAE in Japan, especially infection, was higher than that of Korea, which was attributed to the difference of demographic and clinical characteristics of RA patients and treatment profiles.

Cited by 6 publications

References 22 publications

Imaging Outcomes for Axial Spondyloarthritis and Sensitivity to Change: A Five‐Year Analysis of the DESIR Cohort

Imaging Outcomes for Axial Spondyloarthritis and Sensitivity to Change: A Five‐Year Analysis of the DESIR Cohort

Safety of biologic DMARDs in RA patients in real life: A systematic literature review and meta-analyses of biologic registers

Drug retention and safety of TNF inhibitors in elderly patients with rheumatoid arthritis

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