Second Department of Internal Medicine, Osaka Medical College, Takatsuki City, Osaka 569-8686, Japan.
World J Gastroenterol. 2013 May 7;19(17):2676-82. doi: 10.3748/wjg.v19.i17.2676.
To assess adalimumab's efficacy with concomitant azathioprine (AZA) for induction and maintenance of clinical remission in Japanese Crohn's disease (CD) patients.
This retrospective, observational, single-center study enrolled 28 consecutive CD patients treated with adalimumab (ADA). Mean age and mean disease duration were 38.1 ± 11.8 years and 11.8 ± 10.1 years, respectively. The baseline mean Crohn's disease activity index (CDAI) and C-reactive protein were 177.8 ± 82.0 and 0.70 ± 0.83 mg/dL, respectively. Twelve of these patients also received a concomitant stable dose of AZA. ADA was subcutaneously administered: 160 mg at week 0, 80 mg at week 2, followed by 40 mg every other week. Clinical response and remission rates were assessed via CDAI and C-reactive protein for 24 wk.
The mean CDAI at weeks 2, 4, 8, and 24 was 124.4, 120.2, 123.6, and 135.1, respectively. The CDAI was significantly decreased at weeks 2 and 4 with ADA and was significantly suppressed at 24 wk with ADA/AZA. Overall clinical remission rates at weeks 4 and 24 were 66.7% and 63.2%, respectively. Although no statistically significant difference in C-reactive protein was demonstrated, ADA with AZA resulted in a greater statistically significant improvement in CDAI at 24 wk, compared to ADA alone.
Scheduled ADA with concomitant AZA may be more effective for clinical remission achievement at 24 wk in Japanese Crohn's disease patients.
评估阿达木单抗联合硫唑嘌呤(AZA)用于诱导和维持日本克罗恩病(CD)患者临床缓解的疗效。
本回顾性、观察性、单中心研究纳入了 28 例接受阿达木单抗(ADA)治疗的 CD 患者。平均年龄和平均病程分别为 38.1±11.8 岁和 11.8±10.1 年。基线时克罗恩病活动指数(CDAI)和 C 反应蛋白的平均值分别为 177.8±82.0 和 0.70±0.83mg/dL。其中 12 例患者还接受了稳定剂量的 AZA 联合治疗。ADA 皮下注射:第 0 周 160mg,第 2 周 80mg,随后每 2 周 40mg。通过 CDAI 和 C 反应蛋白评估 24 周的临床应答和缓解率。
第 2、4、8 和 24 周时 CDAI 的平均值分别为 124.4、120.2、123.6 和 135.1。ADA 治疗后第 2 和第 4 周 CDAI 显著下降,ADA/AZA 治疗 24 周时 CDAI 显著抑制。第 4 和第 24 周时总体临床缓解率分别为 66.7%和 63.2%。尽管 C 反应蛋白无统计学显著差异,但与 ADA 单药治疗相比,ADA 联合 AZA 治疗 24 周时 CDAI 的改善具有统计学显著意义。
在日本 CD 患者中,计划使用 ADA 联合 AZA 可能更有助于在 24 周时实现临床缓解。