• J Chin Med Assoc · Feb 2022

    Real-world effectiveness and safety of golimumab in rheumatoid arthritis treatment: A two-center study in Taiwan.

    • Chun-Chun Wang, Kuo-Sen Tseng, Yen-Po Tsao, Wei-Sheng Chen, Chien-Chih Lai, Yi-Syuan Sun, Hsien-Tzung Liao, Ming-Han Chen, and Chang-Youh Tsai.
    • Division of Allergy, Immunology and Rheumatology, Department of Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan, ROC.
    • J Chin Med Assoc. 2022 Feb 1; 85 (2): 175182175-182.

    BackgroundThe real-world outcomes of golimumab (GLM) use have been rarely studied in Asian patients with rheumatoid arthritis (RA). This study assessed the real-world effectiveness and safety of GLM in a Taiwanese cohort.MethodsOne hundred and eight GLM-treated RA patients were enrolled. Predictors of a good European League Against Rheumatism (EULAR) response at 24 months and drug retention were identified through multivariate analyses.ResultsAfter 24 months of GLM treatment, the mean Disease Activity Score using 28 joint counts with the erythrocyte sedimentation rate (DAS28-ESR) decreased from 6.7 to 3.1 (p < 0.001). Up to 58.9% of patients achieved a good EULAR response at 24 months. Multivariate logistic regression analysis revealed that after adjustment for other variables, a higher baseline C-reactive protein was an independent negative predictor of good EULAR responses (odds ratio, 0.82; 95% confidence interval [CI], 0.67-0.99; p = 0.043). During the mean follow-up period of 38.3 months, 15 (13.9%) patients discontinued GLM due to treatment failure. In multivariate analysis, high baseline ESR level, high DAS28-ESR, and the experience of biologic therapy were independent risk factors for GLM discontinuation (adjusted hazard ratio [HR], 1.03; 95% CI, 1.01-1.05; p = 0.003; adjusted HR, 2.93; 95% CI, 1.42-6.08; p = 0.004; and adjusted HR, 5.00; 95% CI, 1.75-14.26; p = 0.003, respectively). In receiver operator characteristic curve analysis, the optimal cutoff values of baseline ESR and DAS28-ESR for predicting drug survival were 52 mm/h (sensitivity: 60.0% and specificity: 77.4%) and 7.7 (sensitivity: 46.7% and specificity: 94.3%), respectively. During the follow-up period, 22 patients (20.4%) developed adverse events. The safety profile of GLM in this study was comparable with that in previous clinical trials.ConclusionGLM was effective and safe for the real-life management of Taiwanese RA patients and showed a high retention rate in biologic-naive patients compared with biologic-experienced patients.Copyright © 2021, the Chinese Medical Association.

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