Molnár Tamás, Farkas Klaudia, Nyári Tibor, Szepes Zoltán, Nagy Ferenc, Kiss Tamás, Wittmann Tibor
Szegedi Tudományegyetem, Általános Orvostudományi Kar I. Belgyógyászati Klinika Szeged Korányi fasor 8-10. 6720.
Orv Hetil. 2011 Jun 12;152(24):951-7. doi: 10.1556/OH.2011.29128.
Secondary loss of response (initial good response followed by loss of response and flare up) is a frequent event occurring during biological therapy. The aim of this study was to assess loss of efficacy in patients with Crohn's disease treated with infliximab or adalimumab for a year. Secondary goals were to identify clinical or laboratory predictors of loss of response and to evaluate whether the frequency of dose escalation differs in patients receiving infliximab or adalimumab. Data were provided by a computerized database.
Sixty-one patients with Crohn's disease achieved remission after induction therapy and received regular maintenance treatment. 35 of them were on infliximab, and 26 on adalimumab therapy. None of the patients treated with infliximab received previous biological therapy, while 10 of the adalimumab-treated patients were naïve to biological therapy. Authors compared the data of patients who relapsed with those who remained in remission and also the characteristics of infliximab-treated patients with adalimumab-naïve patients. Data were analyzed using Chi-square test. Kaplan Meier curve was used to show the time of loss of efficacy.
Remission was achieved in 70.5%, and response was achieved in 29.5% of the patients after induction. Loss of response occurred in 22 of the 61 patients after a year of therapy. The proportion of remission after induction was significantly lower in patients who lost response vs. those who remained in remission. More patients with sustained remission received immunosuppressive therapy before and during the biological therapy vs. those with loss of response. Loss of response was significantly more frequent and occurred earlier in adalimumab-naive patients vs. infliximab-treated patients.
The need for dose escalation should be calculated in the budget in the majority of patients, especially in adalimumab-treated patients.
继发性反应丧失（最初反应良好，随后反应丧失并病情复发）是生物治疗期间常见的事件。本研究的目的是评估接受英夫利昔单抗或阿达木单抗治疗一年的克罗恩病患者的疗效丧失情况。次要目标是确定反应丧失的临床或实验室预测指标，并评估接受英夫利昔单抗或阿达木单抗治疗的患者中剂量递增频率是否存在差异。数据由计算机化数据库提供。
61例克罗恩病患者在诱导治疗后实现缓解并接受定期维持治疗。其中35例接受英夫利昔单抗治疗，26例接受阿达木单抗治疗。接受英夫利昔单抗治疗的患者均未接受过先前的生物治疗，而接受阿达木单抗治疗的患者中有10例未接受过生物治疗。作者比较了复发患者与仍处于缓解状态患者的数据，以及接受英夫利昔单抗治疗患者与未接受过阿达木单抗治疗患者的特征。数据采用卡方检验进行分析。使用Kaplan Meier曲线显示疗效丧失时间。
诱导治疗后70.5%的患者实现缓解，29.5%的患者有反应。61例患者中有22例在治疗一年后出现反应丧失。反应丧失的患者诱导后缓解的比例显著低于仍处于缓解状态的患者。与反应丧失的患者相比，更多持续缓解的患者在生物治疗前和治疗期间接受了免疫抑制治疗。未接受过阿达木单抗治疗的患者比接受英夫利昔单抗治疗的患者反应丧失更频繁且发生更早。
大多数患者，尤其是接受阿达木单抗治疗的患者，应在预算中计算剂量递增的需求。
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