Operative Unit of Internal Medicine and Gastroenterology, Complesso integrato Columbus, Catholic University Sacro Cuore, Roma, Italy.
J Crohns Colitis. 2013 May;7(4):301-7. doi: 10.1016/j.crohns.2012.05.011. Epub 2012 Jun 5.
Our first objective was to evaluate the immune response to the adjuvanted 2009 A/H1N1 pandemic (pH1N1) vaccine in inflammatory bowel disease (IBD) patients treated with anti-TNF-α alone or combined with immunosuppressants (IS). Second and third aims were the safety of pH1N1 vaccine and the effects on IBD clinical activity.
36 patients with Crohn's disease (CD) and 26 with ulcerative colitis (UC) and thirty-one healthy control (HC) subjects were enrolled. 47 patients were on anti TNF-α maintenance monotherapy and 15 on anti TNF-α combined with IS. Sera were collected at baseline (T0) and 4 weeks after the vaccination (T1) for antibody determination by hemagglutination inhibition (HAI). Disease activity was monitored at T0 and T1.
Seroprotective titers (≥1:40) in patients were comparable to HC. Seroconvertion rate (≥4 fold increase in HAI titer) was lower than HC in IBD patients (p=0.009), either on anti TNF-α monotherapy (p=0.034) or combined with IS (p=0.011). Geometric mean titer (GMT) of antibodies at T1 was significantly lower in patients on combined therapy versus those on monotherapy (p=0.0017) and versus HC (p=0.011). The factor increase of GMT at T1 versus T0 was significantly lower in IBD patients versus HC (p=0.042), and in those on combined immunosuppression, both versus monotherapy (p=0.0048) and HC (p=0.0015). None of the patients experienced a disease flare.
Our study has shown a suboptimal response to pH1N1 vaccine in IBD patients on therapy with anti TNF-α and IS compared to those on anti-TNF-α monotherapy and HC.
我们的首要目标是评估单独使用抗 TNF-α 或联合免疫抑制剂（IS）治疗的炎症性肠病（IBD）患者对佐剂 2009 年 A/H1N1 大流行（pH1N1）疫苗的免疫反应。第二和第三个目标是 pH1N1 疫苗的安全性以及对 IBD 临床活动的影响。
纳入 36 例克罗恩病（CD）患者、26 例溃疡性结肠炎（UC）患者和 31 名健康对照（HC）受试者。47 例患者接受抗 TNF-α维持单药治疗，15 例患者接受抗 TNF-α联合 IS 治疗。在接种疫苗前（T0）和接种疫苗后 4 周（T1）采集血清，通过血凝抑制（HAI）法测定抗体。在 T0 和 T1 监测疾病活动。
患者的保护性抗体滴度（≥1:40）与 HC 相当。与 HC 相比，IBD 患者的血清转化率（HAI 滴度增加≥4 倍）较低，无论是在接受抗 TNF-α单药治疗（p=0.034）还是联合 IS 治疗（p=0.011）时。与单药治疗相比，联合治疗患者 T1 时抗体的几何平均滴度（GMT）明显较低（p=0.0017），与 HC 相比也较低（p=0.011）。与 HC 相比，IBD 患者 T1 时 GMT 相对于 T0 的增加倍数明显较低（p=0.042），与联合免疫抑制治疗的患者相比，T1 时 GMT 相对于 T0 的增加倍数也明显较低（p=0.0048），与 HC 相比也较低（p=0.0015）。无患者出现疾病加重。
与单独使用抗 TNF-α单药治疗和 HC 相比，联合使用抗 TNF-α和 IS 治疗的 IBD 患者对 pH1N1 疫苗的反应较差。
