PURPOSE To study the drug retention rate (DRR), causes, and predictors of discontinuation of adalimumab (ADA) in a real-world uveitis setting. DESIGN Multicentric, nationwide, registry-based, ambispective, observational study. PARTICIPANTS Patients treated with ADA for noninfectious uveitis (NIU) in the Biotherapies for Uveitis (BioÚvea) Spanish registry from November 2016 to November 2017. METHODS Demographics, clinical data, timing, and reasons for discontinuation, if occurred, were recorded. The DRR and drug retention time (DRT) were estimated using the Kaplan-Meier method. Median follow-up was analyzed by reverse Kaplan-Meier. Log-rank test was used for comparisons. Cox proportional-hazards model (PHM) and propensity score matching were used to identify predictors for discontinuation due to inefficacy and adverse events. MAIN OUTCOME MEASURES Drug retention rate and DRT. RESULTS A total of 392 patients were analyzed, including 218 women. Median age was 39 (interquartile range, 25) years. Nonanterior uveitis was recorded in 242 patients. Median follow-up was 49.07 (0.97-131.67) months, median DRT (survival) was 69.3 months, and 14 patients were lost to follow-up. The DRR at 6, 12, 24, and 60 months was 92.97%, 87.68%, 76.31%, and 54.28%, respectively. Adalimumab was discontinued in 151 patients. Discontinuation was due to lack or loss of efficacy in 74 patients, adverse event in 34 patients, and sustained quiescence in 25 patients. Recorded adverse events included infections in 10 patients and malignant neoplasms in 3 patients. Concurrent classic immunomodulatory therapy (IMT) was given to 251 patients. We did not find DRT differences regarding the use of concurrent IMT. Adalimumab was prescribed as a second or greater biotherapy line in 76 patients who showed shorter DRT (P = 0.038). Starting ADA in nonbiotherapy-naive patients was a predictor for "discontinuation due to inefficacy," whereas undifferentiated uveitis was a predictor for "discontinuation due to adverse event." Drug retention time was significantly shorter when spared or intensified, mainly due to discontinuation after sustained quiescence. CONCLUSIONS Drug retention rate of ADA in uveitis at 60 months was 54.28%, with a good safety profile. The use of concurrent IMT did not show a significant influence on DRT. The use of ADA as a second or further biotherapy could be predictive for discontinuation due to inefficacy. Undifferentiated uveitis may be prone to premature discontinuation of ADA due to adverse events.

中文翻译：

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葡萄膜炎中阿达木单抗的药物保留率和停药原因：来自葡萄膜炎生物疗法（Bio Realvea）研究组的真实数据。

目的研究在现实的葡萄膜炎环境中阿达木单抗（ADA）停药的药物保留率（DRR），原因和预测因素。设计多中心，全国性，基于注册表的前瞻性观察研究。研究对象2016年11月至2017年11月在西班牙葡萄膜生物治疗法（BioÚvea）中接受ADA治疗的非感染性葡萄膜炎（NIU）患者。使用Kaplan-Meier方法估算DRR和药物保留时间（DRT）。中位随访通过反向Kaplan-Meier分析。使用对数秩检验进行比较。使用Cox比例风险模型（PHM）和倾向得分匹配来确定因无效和不良事件而终止治疗的预测因素。主要观察指标药物保留率和DRT。结果总共分析了392例患者，其中包括218例女性。中位年龄为39岁（四分位间距为25岁）。记录了242例非前葡萄膜炎。中位随访时间为49.07（0.97-131.67）个月，中位DRT（生存期）为69.3个月，有14例患者失访。在6、12、24和60个月时的DRR分别为92.97％，87.68％，76.31％和54.28％。151例患者停用了阿达木单抗。停药归因于74例患者缺乏疗效或丧失疗效，34例患者出现不良事件以及25例患者持续静止。记录的不良事件包括10例患者的感染和3例患者的恶性肿瘤。并发经典免疫调节治疗（IMT）给予251例患者。在并发IMT的使用方面，我们没有发现DRT的差异。在显示较短DRT的76例患者中，将Adalimumab列为第二或更大的生物治疗方案（P = 0.038）。在未进行过生物疗法的患者中开始ADA是“由于无效而停药”的预测因素，而未分化的葡萄膜炎则是“由于不良事件而停药”的预测因素。保留或加强治疗后，药物保留时间显着缩短，这主要是由于持续静止后停药。结论ADA在葡萄膜炎中的药物保留率在60个月时为54.28％，具有良好的安全性。并发IMT的使用对DRT没有显着影响。ADA作为第二种或进一步的生物治疗方法的使用可以预测由于无效而终止治疗的可能性。