Massimi Davide, Barberio Brigida, Bertani Lorenzo, Costa Francesco, Ferronato Antonio, Facchin Sonia, Cardin Romilda, Cingolani Linda, Casadei Cesare, D'Incà Renata, Zingone Fabiana, Savarino Edoardo Vincenzo
Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Therap Adv Gastroenterol. 2021 Jun 27;14:17562848211023384. doi: 10.1177/17562848211023384. eCollection 2021.
Current literature still lacks studies evaluating the effectiveness and safety of switching from Infliximab originator to SB2 biosimilar in Inflammatory Bowel Diseases (IBDs). We aimed to verify the ability of SB2 to maintain the clinical and biochemical response induced by originator after switching. As secondary outcome, we aimed to verify safety, tolerability and immunogenicity of SB2 biosimilar compared with its IFX originator.
We prospectively enrolled all patients who switched from originator to SB2 at three Italian IBD Units from August 2018 to April 2020. We collected clinical and biochemical data at the time of switch (T0), and at the first (T1) and the second (T2) visits after switching (mean time from switching: 135 and 329 days, respectively). In addition, data regarding therapeutic drug monitoring at T0 and T1 were recorded.
Eighty-five IBD patients (28 with Ulcerative Colitis and 57 with Crohn's Disease) were included in the study. At T1, we observed statistically significant modifications in clinical activity of disease (70 patients were in clinical remission at baseline and 60 at T1 p = 0.02), but not at T2 (p = 0.3). Fecal calprotectin values were not different both at T1 and T2 (both p = 0.9) as well as the rate of concomitant treatment with steroids (p = 0.2 and p = 0.1) or immunosuppressants (p = 0.1 and p = 1.0). Moreover, the need for therapeutic optimization from T0 to T1 and from T1 to T2 was found significant (both p = 0.01). No anti-drug antibodies were identified at T1, and no serious adverse events were recorded.
Overall, our data show that most of the patients switching from Infliximab originator to SB2 maintain the clinical and biochemical remission for at least 1 year. Further data are necessary to understand the clinical implications of these findings in the long term.
目前的文献中仍缺乏关于在炎症性肠病（IBD）中从英夫利昔单抗原研药转换为SB2生物类似药的有效性和安全性评估研究。我们旨在验证SB2在转换后维持原研药诱导的临床和生化反应的能力。作为次要结果，我们旨在验证SB2生物类似药与英夫利昔单抗原研药相比的安全性、耐受性和免疫原性。
我们前瞻性纳入了2018年8月至2020年4月在意大利三个IBD治疗中心从原研药转换为SB2的所有患者。我们在转换时（T0）、转换后的第一次（T1）和第二次（T2）就诊时（转换后的平均时间分别为135天和329天）收集临床和生化数据。此外，记录了T0和T1时的治疗药物监测数据。
85例IBD患者（28例溃疡性结肠炎和57例克罗恩病）纳入研究。在T1时，我们观察到疾病临床活动有统计学意义的改变（70例患者基线时临床缓解，T1时60例，p = 0.02），但T2时无差异（p = 0.3）。粪便钙卫蛋白值在T1和T2时均无差异（均p = 0.9），同时使用类固醇（p = 0.2和p = 0.1）或免疫抑制剂（p = 0.1和p = 1.0）的比例也无差异。此外，发现从T0到T1以及从T1到T2进行治疗优化的必要性具有统计学意义（均p = 0.01）。T1时未鉴定出抗药抗体，也未记录到严重不良事件。
总体而言，我们的数据表明，大多数从英夫利昔单抗原研药转换为SB2的患者至少1年内维持临床和生化缓解。需要更多数据来长期了解这些发现的临床意义。
