Real-World Evidence of Effectiveness and Safety of Vedolizumab for Inflammatory Bowel Disease in Taiwan: A Prospective Nationwide Registry (VIOLET) Study

被引:17
作者
Lin, Wei-Chen [1 ]
Tai, Wei-Chen [2 ]
Chang, Chung-Hsin [3 ]
Tu, Chia-Hung [4 ]
Feng, I-Che [5 ]
Shieh, Ming-Jium [6 ]
Chung, Chen-Shuan [7 ]
Yen, Hsu-Heng [8 ]
Chou, Jen-Wei [9 ]
Wong, Jau-Min [4 ]
Liu, Yu-Hwa [10 ]
Huang, Tien-Yu [11 ]
Chuang, Chiao-Hsiung [12 ]
Tsai, Tzung-Jiun [13 ]
Chiang, Feng-Fan [14 ]
Lu, Chien-Yu [15 ]
Hsu, Wen-Hung [15 ]
Yu, Fang-Jung [15 ]
Chao, Te-Hsin [16 ]
Wu, Deng-Chyang [15 ]
Ho, Ai-Sheng [17 ]
Lin, Hung-Hsin [18 ]
Feng, Chun-Lung [19 ]
Wu, Keng-Liang [20 ]
Wong, Ming-Wun [21 ]
Tung, Chien-Chih [22 ]
Lin, Chun-Chi [18 ]
Chen, Chia-Chang [3 ]
Hu, Huang-Ming [15 ,23 ]
Lu, Lung-Sheng [24 ]
Wang, Huann-Sheng [25 ]
Wu, I-Chen [15 ]
Kuo, Hsin-Yu [26 ,27 ]
Wu, Jia-Feng [28 ]
Yao Shih, Hsiang [15 ]
Ni, Yen-Hsuan [29 ]
Tang, Shu-Lun [30 ]
Chen, Peng-Hsu [30 ]
Wei, Shu-Chen [3 ]
机构
[1] Mackay Mem Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Taipei, Taiwan
[2] Kaohsiung Chang Gung Mem Hosp, Dept Internal Med, Div Hepatogastroenterol, Kaohsiung, Taiwan
[3] Taichung Vet Gen Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Taichung, Taiwan
[4] Natl Taiwan Univ, Natl Taiwan Univ Hosp, Dept Internal Med, Coll Med, Taipei, Taiwan
[5] Chi Mei Med Ctr, Div Gastroenterol & Hepatol, Tainan, Taiwan
[6] Natl Taiwan Univ Hosp, Dept Oncol, Taipei, Taiwan
[7] Far Eastern Mem Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, New Taipei City, Taiwan
[8] Changhua Christian Hosp, Dept Internal Med, Div Gastroenterol, Changhua, Taiwan
[9] China Med Univ Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Taichung, Taiwan
[10] Shin Kong Wu Ho Su Mem Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, 7 Zhongshan S Rd, Taipei 100, Taiwan
[11] Triserv Gen Hosp, Natl Def Med Ctr, Dept Internal Med, Div Gastroenterol, Taipei, Taiwan
[12] Natl Cheng Kung Univ, Med Coll & Hosp, Dept Internal Med, Tainan, Taiwan
[13] Kaohsiung Vet Gen Hosp, Dept Med, Div Gastroenterol & Hepatol, Kaohsiung, Taiwan
[14] Taichung Vet Gen Hosp, Dept Surg, Div Colon & Rectal Surg, Taichung, Taiwan
[15] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Dept Internal Med, Div Gastroenterol, Kaohsiung, Taiwan
[16] Taichung Vet Gen Hosp, Dept Surg, Div Colon & Rectal Surg, Chiayi & Wangiao Branch, Taichung, Taiwan
[17] Cheng Hsin Gen Hosp, Dept Internal Med, Div Gastroenterol, Taipei, Taiwan
[18] Taipei Vet Gen Hosp, Dept Surg, Div Colon & Rectal Surg, Taipei, Taiwan
[19] China Med Univ, Div Gastroenterol & Hepatol, Hsinchu Hosp, Hsinchu, Taiwan
[20] Kaohsiung Chang Gung Mem Hosp, Dept Internal Med, Div Hepatogastroenterol, Kaohsiung, Taiwan
[21] Tzu Chi Univ, Hualien Tzu Chi Hosp, Buddhist Tzu Chi Med Fdn, Dept Med, Hualien, Taiwan
[22] Natl Taiwan Univ Hosp, Dept Integrated Diagnost & Therapeut, Taipei, Taiwan
[23] Kaohsiung Municipal Tatung Hosp, Dept Internal Med, Kaohsiung, Taiwan
[24] Chang Gung Univ, Kaohsiung Chang Gung Mem Hosp, Dept Internal Med, Div Hepatogastroenterol,Coll Med, Kaohsiung, Taiwan
[25] Natl Yang Ming Chiao Tung Univ, Taipei Vet Gen Hosp, Dept Surg, Div Colorectal Surg, Taipei, Taiwan
[26] Natl Cheng Kung Univ, Natl Cheng Kung Univ Hosp, Coll Med, Dept Internal Med, Tainan, Taiwan
[27] Natl Cheng Kung Univ, Inst Clin Med, Coll Med, Tainan, Taiwan
[28] Natl Taiwan Univ Hosp, Dept Pediat, Taipei, Taiwan
[29] Natl Taiwan Univ, Coll Med, Dept Pediat, Taipei, Taiwan
[30] Takeda Pharmaceut Taiwan Ltd, Taipei, Taiwan
关键词
vedolizumab; Crohn's disease; ulcerative colitis; reimbursement; ULCERATIVE-COLITIS; MAINTENANCE THERAPY; INDUCTION; ASSOCIATION; MANAGEMENT; REMISSION; RISK;
D O I
10.1093/ibd/izac269
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background This nationwide prospective registry study investigated the real-world effectiveness, safety, and persistence of vedolizumab (VDZ) in inflammatory bowel disease (IBD) patients in Taiwan. Disease relapse rates after VDZ discontinuation due to reimbursement restriction were assessed. Methods Data were collected prospectively (January 2018 to May 2020) from the Taiwan Society of IBD registry. Results Overall, 274 patients (147 ulcerative colitis [UC] patients, 127 Crohn's disease [CD] patients) were included. Among them, 70.7% with UC and 50.4% with CD were biologic-naive. At 1 year, 76.0%, 58.0%, 35.0%, and 62.2% of UC patients and 57.1%, 71.4%, 33.3%, and 30.0% of CD patients achieved clinical response, clinical remission, steroid-free remission, and mucosal healing, respectively. All patients underwent hepatitis B and tuberculosis screening before initiating biologics, and prophylaxis was recommended when necessary. One hepatitis B carrier, without antiviral prophylaxis due to economic barriers, had hepatitis B reactivation during steroid tapering and increasing azathioprine dosage, which was controlled with an antiviral agent. No tuberculosis reactivation was noted. At 12 months, non-reimbursement-related treatment persistence rates were 94.0% and 82.5% in UC and CD patients, respectively. Moreover, 75.3% of IBD patients discontinued VDZ due to mandatory drug holiday. Relapse rates after VDZ discontinuation at 6 and 12 months were 36.7% and 64.3% in CD patients and 42.9% and 52.4% in UC patients, respectively. Conclusions The findings demonstrated VDZ effectiveness in IBD patients in Taiwan, with high treatment persistence rates and favorable safety profiles. A substantial IBD relapse rate was observed in patients who had mandatory drug holiday.
引用
收藏
页码:1730 / 1740
页数:11
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