Bordeaux, France.
Lyon, France.
Aliment Pharmacol Ther. 2020 May;51(9):852-860. doi: 10.1111/apt.15680. Epub 2020 Mar 22.
Few data exist to help select a second biologic agent in patients with refractory ulcerative colitis (UC).
To compare the efficacy of infliximab (IFX) and vedolizumab (VDZ) in UC patients who failed a first subcutaneous anti-tumor necrosing factor (TNF) agent.
Consecutive UC patients from 12 French centres starting IFX or VDZ after at least one injection of adalimumab or golimumab have been included in a retrospective study. Outcomes were clinical remission at week 14, survival without treatment discontinuation and survival without UC-related event.
Among the 225 patients included, clinical remission at week 14 was achieved in 40/154 (26%) patients treated with IFX and in 35/71 (49%) treated with VDZ (P = 0.001). After a propensity score matching analysis, this difference remained significant (odds ratio: 1.67; 95% confidence interval: 1.08-2.56; P = 0.02). With a median follow-up of 117 weeks, survival rates without treatment discontinuation at years 1 and 3 were 50% and 29% with IFX, and 80% and 55% with VDZ, respectively (P < 0.001). Regarding survival without UC-related event, they were 49% and 27% with IFX, and 74% and 52% with VDZ (P < 0.01).
After failure of a first subcutaneous anti-TNF agent, UC patients were more likely to achieve clinical remission with VDZ than those treated with IFX. Although due to prescription habits patients in the IFX group had a significantly more severe disease, these differences remained after adjustments and subgroup analyses. Such results have to be confirmed prospectively and warrant dedicated head-to-head trials.
在难治性溃疡性结肠炎(UC)患者中,很少有数据可以帮助选择第二种生物制剂。
比较英夫利昔单抗(IFX)和维得利珠单抗(VDZ)在首次皮下抗肿瘤坏死因子(TNF)治疗失败的 UC 患者中的疗效。
本回顾性研究纳入了来自法国 12 个中心的连续 UC 患者,他们在至少接受一次阿达木单抗或戈利木单抗皮下注射后开始使用 IFX 或 VDZ。主要终点为治疗第 14 周时的临床缓解,无治疗停药生存率和无 UC 相关事件生存率。
在纳入的 225 例患者中,IFX 组 154 例患者中有 40 例(26%)在第 14 周时达到临床缓解,VDZ 组 71 例患者中有 35 例(49%)达到临床缓解(P=0.001)。在倾向评分匹配分析后,这一差异仍然显著(优势比:1.67;95%置信区间:1.08-2.56;P=0.02)。中位随访 117 周后,IFX 组和 VDZ 组的无治疗停药生存率在第 1 年和第 3 年分别为 50%和 29%,80%和 55%(P<0.001)。对于无 UC 相关事件生存率,IFX 组和 VDZ 组分别为 49%和 27%,74%和 52%(P<0.01)。
在首次皮下抗 TNF 治疗失败后,UC 患者使用 VDZ 更有可能达到临床缓解,而 IFX 则不然。尽管由于处方习惯,IFX 组患者的疾病严重程度显著更高,但在调整和亚组分析后,这些差异仍然存在。这些结果需要前瞻性证实,并需要专门的头对头试验。