Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study.
Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study.
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DOI：
10.5217/ir.2020.00013
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发表时间：
2021-07
影响因子：
4.9
通讯作者：
Hibi T
中科院分区：
文献类型：
--
作者：
Suzuki Y;Hagiwara T;Kobayashi M;Morita K;Shimamoto T;Hibi T
阿达木单抗的安全性和有效性在日本肠白塞病患者中进行的III期试验中得到证实。本研究的目的是评价阿达木单抗在日本肠白塞病患者中的长期安全性和有效性。这项前瞻性、全病例、上市后研究在254家研究中心的接受阿达木单抗治疗的日本肠白塞病患者中进行。主要终点是药物不良反应的发生率。有效性终点包括总体改善评级和C反应蛋白水平的变化。在473例登记患者中，安全性和有效性人群中分别有462例和383例患者接受阿达木单抗治疗，平均时间分别为515.3天和579.5天。总体而言，395例患者（85.5%）接受阿达木单抗推荐剂量治疗。120例（25.97%）患者报告了药物不良反应，51例（11.04%）患者报告了严重药物不良反应。合并症患者（P<0.0001）、合并口服糖皮质激素患者（P <0.0001）和未自行给予阿达木单抗的患者（P=0.0257）的药物不良反应发生率显著较高。研究结束时，324例患者的总体改善评级为“有效”（n = 156，40. 7%）或“显著有效”（n = 168，43. 9%）（总体有效，84. 6%）。平均C反应蛋白水平（mg/dL）从基线时的1.96（n = 324）降至第24周时的0.58（n = 208）和第156周时的0.25（n = 37）。这项大型真实世界研究证实了阿达木单抗在肠道白塞病患者中的长期安全性和有效性。未发现新的安全性问题。（临床试验注册号：NCT 01960790）
The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P<0.0001), patients taking concomitant oral corticosteroids (P<0.0001), and those not self-administering adalimumab (P=0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)