Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial

doi:10.3389/fmed.2020.566160

中山醫學大學機構典藏 CSMUIR > 中山醫學大學研究成果 > 期刊論文 > Item 310902500/24672

Please use this identifier to cite or link to this item: https://ir.csmu.edu.tw:8080/ir/handle/310902500/24672

Title:	Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial
Authors:	Wei, JCC;Tsou, HK;Leong, PY;Chen, CY;Huang, JX
Keywords:	ankylosing spondylitis;etanercept;adalimumab;efficacy;safety
Date:	2020
Issue Date:	2022-08-09T08:06:08Z (UTC)
Publisher:	FRONTIERS MEDIA SA
Abstract:	Background: Anti-tumor necrosis factor biological agents had been proved to have a dramatic effect in ankylosing spondylitis (AS). We aimed to determine the efficacy and safety of crossover effects of adalimumab vs. etanercept in AS patients. Methods: A randomized, open-label crossover study was done in patients with active AS. Patients were randomized into two sequence groups, etanercept first (treatment arm) vs. adalimumab first (control arm) 8 weeks and then switched over for another 8 weeks. The primary endpoints were the difference of the Bath AS activity index and AS disease activity score (ASDAS)crp at week 16. Secondary endpoints were ASDASesr, ASAS20, and ASAS40 response rates and the proportion of patients achieving ASDAS inactive disease and low disease activity at weeks 8 and 16. Patient global assessment and preference was grading on a numerical scale. Results: A total of 21 patients were screened, and 19 of them were randomly allocated into the treatment arm (n = 9) and control arm (n = 9). At baseline, age, sex, Bath AS activity index, and ASDAS of both arms were comparable (p > 0.05). Both arms showed dramatic improvement, whereas no significance was observed between the changes of ASDAScrp (0.90 +/- 1.39 vs. 1.24 +/- 1.40 at week 8, p = 0.612; 1.02 +/- 1.22 vs. 1.26 +/- 1.44 at week 16, p = 0.707, respectively). ASAS20 and ASAS40 response rates were also comparable at week 8 (33 vs. 44%, p = 1.000; 22 vs. 22%, p = 1.000) and week 16 (22 vs. 22%, p = 1.000; 22 vs. 22%, p = 1.000), respectively. Both arms were well-tolerated without a serious adverse event. Adalimumab was relatively more favorable by patients in both arms, with a total mean grading score of 0.4 (-5-5, p = 0.218). Conclusion: Etanercept and adalimumab can both dramatically improve disease activity in 16 weeks. Crossover administration of etanercept and adalimumab revealed comparable efficacy and safety.
URI:	http://dx.doi.org/10.3389/fmed.2020.566160 https://www.webofscience.com/wos/woscc/full-record/WOS:000588788100001 https://ir.csmu.edu.tw:8080/handle/310902500/24672
Relation:	FRONTIERS IN MEDICINE ,2020 ,v7
Appears in Collections:	[中山醫學大學研究成果] 期刊論文

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