早期联合免疫抑制治疗在老年克罗恩病患者中可能是有效且安全的：REACT 的事后分析。
Early combined immunosuppression may be effective and safe in older patients with Crohn's disease: post hoc analysis of REACT.
机构信息
Division of Gastroenterology, University of California San Diego, La Jolla, California.
Division of Biomedical Informatics, University of California San Diego, La Jolla, California.
出版信息
Aliment Pharmacol Ther. 2019 May;49(9):1188-1194. doi: 10.1111/apt.15214. Epub 2019 Mar 19.
BACKGROUND
Physicians may be reluctant to prescribe combined immunosuppression in older patients with Crohn's disease due to perceived risk of treatment-related complications.
AIM
To evaluate the impact of age on risk of Crohn's disease-related complications in patients treated with early combined immunosuppression vs conventional management in a post hoc analysis of the randomised evaluation of an algorithm for Crohn's treatment (REACT), a cluster-randomised trial.
METHODS
We compared efficacy (time to major adverse outcome of Crohn's disease-related surgery, hospitalisation or serious complications; corticosteroid-free clinical remission) and safety outcomes at 24 months, between patients aged <60 vs ≥60 years randomised to early combined immunosuppression or conventional management, using Cox proportional hazard analysis or modified Poisson model. In the early combined immunosuppression arm, patients with failure to achieve clinical remission within 4-12 weeks of corticosteroids were treated with a combination of tumour necrosis factor-α antagonist plus anti-metabolite and sequentially escalated in a stepwise algorithm.
RESULTS
Of 1981 patients, 311 were ≥60 years (15.7%; 173 randomised to early combined immunosuppression and 138 to conventional management). Over 24 months, 10% of older patients developed Crohn's disease-related complications (early combined immunosuppression vs conventional management: 6.4% vs 14.5%) and 14 patients died (3.5% vs 5.8%). There was no difference between younger and older patients in risk of achieving corticosteroid-free clinical remission (<60 years, early combined immunosuppression (72.6%) vs conventional management (64.4%): relative risk [RR], 1.06 [95% CI, 0.98-1.15] vs ≥60 years, early combined immunosuppression (74.8%) vs conventional management (63.0%): RR, 1.09 [0.90-1.33], P-interaction = 0.78) or time to major adverse outcome (<60 years: hazard ratio [HR], 0.71 [0.53-0.96] vs ≥60 years: HR, 0.69 [0.31-1.51], P-interaction = 0.92) with early combined immunosuppression vs conventional management.
CONCLUSIONS
We observed no difference in efficacy and safety of early combined immunosuppression compared to conventional management in older and younger patients. Early combined immunosuppression may be considered as a treatment option in selected older patients with Crohn's disease with suboptimal disease control. Clinical Trial Identifier: NCT01030809.
背景
由于担心与治疗相关的并发症，医生可能不愿意为老年克罗恩病患者开联合免疫抑制药物。
目的
在一项对随机评估克罗恩病治疗算法（REACT）的事后分析中，评估年龄对接受早期联合免疫抑制与常规治疗的克罗恩病患者发生与疾病相关的并发症风险的影响，REACT 是一项聚类随机试验。
方法
我们使用 Cox 比例风险分析或修正泊松模型，比较了年龄<60 岁与≥60 岁的患者在接受早期联合免疫抑制或常规治疗时，在 24 个月时的疗效（与克罗恩病相关的手术、住院或严重并发症的主要不良结局的时间；无皮质类固醇的临床缓解）和安全性结局。在早期联合免疫抑制组中，4-12 周内皮质类固醇治疗未能达到临床缓解的患者接受肿瘤坏死因子-α拮抗剂加抗代谢物联合治疗，并根据逐步算法进行序贯升级。
结果
在 1981 例患者中，311 例患者≥60 岁（15.7%；173 例随机分配至早期联合免疫抑制组，138 例分配至常规治疗组）。在 24 个月期间，10%的老年患者发生与克罗恩病相关的并发症（早期联合免疫抑制组与常规治疗组：6.4%与 14.5%），14 例患者死亡（3.5%与 5.8%）。在实现无皮质类固醇的临床缓解方面，年龄较小和较大的患者之间没有差异（<60 岁，早期联合免疫抑制（72.6%）与常规治疗（64.4%）：相对风险[RR]，1.06[95%CI，0.98-1.15] vs ≥60 岁，早期联合免疫抑制（74.8%）与常规治疗（63.0%）：RR，1.09[0.90-1.33]，P 交互=0.78）或发生主要不良结局的时间（<60 岁：风险比[HR]，0.71[0.53-0.96] vs ≥60 岁：HR，0.69[0.31-1.51]，P 交互=0.92）方面，早期联合免疫抑制与常规治疗相比。
结论
我们观察到，在年龄较大和较小的患者中，与常规治疗相比，早期联合免疫抑制在疗效和安全性方面没有差异。早期联合免疫抑制可能被认为是一种治疗选择，适用于那些疾病控制不理想的老年克罗恩病患者。
临床试验注册号
NCT01030809。
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