Department of Internal Medicine and Gastroenterology with Inflammatory Bowel Diseases Unit, Central Clinical Hospital of the Ministry of the Interior and Administration, Warsaw, Poland
Department of Gastroenterology and Internal Medicine, Medical University of Bialystok, Białystok, Poland
Pol Arch Intern Med. 2019 Aug 29;129(7-8):484-489. doi: 10.20452/pamw.14901. Epub 2019 Jul 17.
An infliximab biosimilar has been shown to be equivalent to originator infliximab. However, data concerning the drug's efficacy and safety in patients with Crohn disease (CD) are still limited.
The aim of the study was to assess the efficacy, tolerability, and safety of an infliximab biosimilar in the Polish population with CD in comparison to its originator biologic and adalimumab.
This was a retrospective, single‑center study of 286 consecutive patients with CD. They received originator infliximab, an infliximab biosimilar, or adalimumab on the basis of the same inclusion criteria. Disease activity was estimated at baseline, after induction therapy, after 1 year of treatment, and during 12 months of follow‑up.
There were no differences in the Crohn's Disease Activity Index in patients treated with infliximab, infliximab biosimilar, or adalimumab. Clinical response, clinical remission, and glucocorticoid‑free remission rates were also comparable between groups. The relapse rate was similar in groups receiving infliximab biosimilar and adalimumab (54% and 61%, respectively), with relapses occurring more often in patients receiving infliximab (83% of patients during 12‑month follow‑up; P <0.001).
We showed the same efficacy and safety of the infliximab biosimilar in comparison to the originator drug and adalimumab in the Polish population, not only during induction and 1‑year therapy, but also during 12‑month follow‑up.
一种英夫利昔单抗生物类似药已被证明与原研英夫利昔单抗等效。然而，关于该药在克罗恩病（CD）患者中的疗效和安全性的数据仍然有限。
本研究旨在评估一种英夫利昔单抗生物类似药在波兰 CD 患者中的疗效、耐受性和安全性，并将其与原研生物制剂和阿达木单抗进行比较。
这是一项回顾性、单中心研究，共纳入 286 例连续 CD 患者。他们根据相同的纳入标准接受原研英夫利昔单抗、英夫利昔单抗生物类似药或阿达木单抗治疗。在基线、诱导治疗后、治疗 1 年后和 12 个月随访期间评估疾病活动度。
接受英夫利昔单抗、英夫利昔单抗生物类似药或阿达木单抗治疗的患者的克罗恩病活动指数无差异。各组间临床应答、临床缓解和无糖皮质激素缓解率也相似。接受英夫利昔单抗生物类似药和阿达木单抗治疗的患者复发率相似（分别为 54%和 61%），在接受英夫利昔单抗治疗的患者中复发更为常见（在 12 个月随访期间，83%的患者复发；P<0.001）。
我们在波兰人群中证明了英夫利昔单抗生物类似药与原研药物和阿达木单抗具有相同的疗效和安全性，不仅在诱导和 1 年治疗期间，而且在 12 个月随访期间也是如此。
