Midha Vandana, Mahajan Ramit, Mehta Varun, Narang Vikram, Singh Arshdeep, Kaur Kirandeep, Sood Ajit
Department of Internal Medicine, Dayanand Medical College & Hospital, Ludhiana, India.
Department of Gastroenterology, Dayanand Medical College & Hospital, Ludhiana, India.
Intest Res. 2018 Jan;16(1):83-89. doi: 10.5217/ir.2018.16.1.83. Epub 2018 Jan 18.
BACKGROUND/AIMS: Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited.
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.
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.
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.
背景/目的：阿达木单抗生物类似药Exemptia的疗效和安全性数据有限。
在印度Dayanand医学院和医院接受治疗的中度至重度活动性激素难治性溃疡性结肠炎（UC）患者可选择环孢素A、生物制剂或生物类似药，或手术治疗。对接受阿达木单抗生物类似药Exemptia治疗的患者进行回顾性分析。这些患者在第0周接受160mg Exemptia的诱导给药方案，第2周接受80mg，然后从第4周开始至第8周每隔一周接受40mg。在第8周使用梅奥评分评估临床反应和缓解情况。
共有29例中度至重度激素难治性活动性UC患者（男性占62.1%；平均年龄34.9±9.7岁）接受了Exemptia诱导给药方案治疗（平均病程6.3±5.1年；9例患者[31.1%]为全结肠炎；20例患者[68.9%]为左侧结肠炎）。就诊时的平均梅奥评分为8.2±1.4。在第8周时，7例患者（24.1%）出现临床反应，而仅1例患者（3.5%）实现临床缓解。在无反应者（n = 21）中，4例患者需要进行结肠切除术，1例死亡，1例失访，10例接受了粪便微生物群移植，3例接受了英夫利昔单抗治疗，2例患者分别接受了环孢素和他克莫司治疗。4例患者（13.8%）发生了肺外结核。
阿达木单抗生物类似药Exemptia在中度至重度激素难治性UC中实现临床反应和缓解的疗效有限，在印度等发展中国家有获得或重新激活结核病的重大风险。
