目的:阿达木单抗生物仿制药Exemptia的疗效和安全性数据有限。
方法:在Dayanand医学院和医院治疗的中度至重度活动性类固醇难治性溃疡性结肠炎(UC)患者,向印度提供了环孢菌素A,生物制品或生物仿制药,或手术。对接受阿达木单抗生物仿制药治疗的患者进行了回顾性分析,例外。这些患者在第0周给予160mgExemptia,在第2周给予80mg,然后在第4周至第8周每隔一周给予40mg的诱导给药方案。在第8周使用Mayo评分评估临床反应和缓解。
结果:共有29例患者(62.1%为男性;平均年龄,34.9±9.7年),中度至重度类固醇难治性活动性UC(平均病程,6.3±5.1年;9例患者的泛结肠炎[31.1%];20例患者的左侧结肠炎[68.9%])采用Exemptia诱导给药方案进行治疗。演示时的平均Mayo评分为8.2±1.4。在第8周,7例患者(24.1%)出现临床反应,而仅在1例患者中观察到临床缓解(3.5%)。在无应答者中(n=21),4例患者需要结肠切除术,1人死亡,1失去了随访,10人接受了粪便微生物移植,3例服用英夫利昔单抗,2例患者给予环孢素和他克莫司,分别。4例(13.8%)发生肺外结核。
结论:阿达木单抗生物仿制药Exemptia在中至重度类固醇难治性UC的临床反应和缓解方面疗效有限,在印度等发展中国家,结核病的发生或重新激活的风险很大。
OBJECTIVE: Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited.
METHODS: Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8. The clinical response and remission were assessed at week 8 using Mayo score.
RESULTS: A total of 29 patients (62.1% male; mean age, 34.9 ± 9.7 years) with moderate-to-severe steroid-refractory active UC (mean disease duration, 6.3±5.1 years; pancolitis in 9 patients [31.1%]; left-sided colitis in 20 patients [68.9%]) were treated with the Exemptia induction dosing schedule. The mean Mayo score at presentation was 8.2±1.4. At week 8, clinical response was observed in 7 patients (24.1%), whereas clinical remission was observed only in 1 patient (3.5%). Among the non-responders (n=21), 4 patients required colectomy, 1 died, 1 was lost to follow-up, 10 were offered fecal microbiota transplant, 3 were administered infliximab, and 2 patients were administered cyclosporine and tacrolimus, respectively. Four patients (13.8%) developed extrapulmonary tuberculosis.
CONCLUSIONS: The adalimumab biosimilar Exemptia has limited efficacy for the attainment of clinical response and remission in moderate-to-severe steroid-refractory UC, with a significant risk of acquisition or reactivation of tuberculosis in developing countries such as India.