Department of Gastroenterology, Ankara City Hospital, Ankara, Turkey.
Eur Rev Med Pharmacol Sci. 2023 Jun;27(12):5757-5766. doi: 10.26355/eurrev_202306_32814.
Long-term comparison studies between infliximab (IFX) and adalimumab (ADA) with or without immunomodulator therapy are still needed in Crohn's disease (CD). In this study, we evaluated IFX and ADA for long-term clinical effectiveness and safety in CD patients who had not previously received a biologic treatment.
The data of adult CD patients were collected retrospectively between December 2007 and February 2021. We compared CD-related hospitalization, CD-related abdominal surgery, steroid use, and serious infections.
Out of 224 CD patients, 101 started IFX first (median age: 38.12 years, 61.4% male), while 123 started ADA first (median age: 30.2 years, 64.2% male). The disease durations were 7.01 years and 6.91 years for IFX and ADA, respectively. There were no significant differences between the two groups with respect to age, gender, smoking, immunomodulator usage, and disease activity score at the onset of anti-TNF therapy (p>0.05). Overall, the median follow-up time was 2.36 and 1.86 years after starting anti-tumor necrosis factor-alpha (anti-TNF) therapy in the IFX and ADA groups, respectively. Steroid use (4.0% vs. 10.6%, p=0.109), hospitalization for CD (13.9% vs. 22.8%, p=0.127), abdominal surgery for CD (9.9% vs. 13.0%, p=0.608), and major infections (1.0% vs. 0.8%, p>0.999) did not differ significantly from one another. There were also no significant differences in the rates of these outcomes between concomitant immunomodulator therapy and monotherapy (p>0.05).
In this study, we observed no significant differences in the long-term effectiveness and safety of IFX and ADA in biologic-naïve patients with CD.
在克罗恩病（CD）患者中，仍需要进行英夫利昔单抗（IFX）和阿达木单抗（ADA）与或不与免疫调节剂治疗的长期比较研究。在这项研究中，我们评估了未曾接受过生物治疗的 CD 患者中 IFX 和 ADA 的长期临床疗效和安全性。
回顾性收集 2007 年 12 月至 2021 年 2 月期间成年 CD 患者的数据。我们比较了 CD 相关住院、CD 相关腹部手术、类固醇使用和严重感染情况。
在 224 例 CD 患者中，101 例首先开始使用 IFX（中位年龄：38.12 岁，61.4%为男性），而 123 例首先开始使用 ADA（中位年龄：30.2 岁，64.2%为男性）。IFX 和 ADA 的疾病持续时间分别为 7.01 年和 6.91 年。两组在年龄、性别、吸烟、免疫调节剂使用和抗 TNF 治疗起始时疾病活动评分方面无显著差异（p>0.05）。总体而言，IFX 和 ADA 组在开始抗 TNF-α（anti-TNF）治疗后的中位随访时间分别为 2.36 年和 1.86 年。类固醇使用率（4.0%比 10.6%，p=0.109）、CD 相关住院率（13.9%比 22.8%，p=0.127）、CD 相关腹部手术率（9.9%比 13.0%，p=0.608）和重大感染率（1.0%比 0.8%，p>0.999）无显著差异。同时接受免疫调节剂治疗和单药治疗的患者在这些结局的发生率方面也无显著差异（p>0.05）。
在这项研究中，我们观察到生物初治 CD 患者中 IFX 和 ADA 的长期疗效和安全性无显著差异。
