Division of Digestive Care and Endoscopy, Department of Medicine, Dalhousie University, Halifax, NS, Canada.
Division of Gastroenterology, Montreal General Hospital, McGill University Health Centre, Montreal, QC, Canada.
Adv Ther. 2021 Jul;38(7):4115-4129. doi: 10.1007/s12325-021-01818-3. Epub 2021 Jun 22.
Adalimumab and golimumab are subcutaneously administered anti-tumor necrosis factor α (TNFα) biologics used in the treatment of ulcerative colitis (UC). To date, no studies have directly compared treatment patterns and healthcare resource utilization (HRU) among patients with UC receiving these therapies in a real-world setting. The objective of this study was to compare these outcomes among patients with UC treated with either adalimumab or golimumab using a US claims database.
Patients with UC treated with golimumab or adalimumab were identified using the US Optum Clinformatics Data Mart database. Outcomes of interest included treatment patterns (discontinuations, dose optimizations, persistence, and concomitant medication use) and HRU (outpatient office visits, emergency room [ER] visits, and inpatient stays). Propensity score matching (PSM) was used to account for differences in confounding variables between groups.
Overall, 990 patients were identified (golimumab: n = 277; adalimumab: n = 713). After PSM, 246 patients were included in each group. There were no significant differences between the adalimumab and golimumab groups over the full follow-up period in terms of treatment discontinuations (53.7% vs. 51.2%; P = 0.5881), dose optimizations (35.4% vs. 39.4%; P = 0.3515), or persistence (338.2 vs. 361.2 days; P = 0.4194). During the year after initiating therapy, there were no significant differences in concomitant immunosuppressant (21.9% vs. 21.7%; P = 0.9686) or corticosteroid use (74.7% vs. 78.8%; P = 0.3573) or in HRU outcomes including outpatient office visits (93.3% vs. 94.0%; P = 0.7660), ER visits (15.2% vs. 10.9%; P = 0.2238), and inpatient stays (15.2% vs. 13.6%; P = 0.6680).
In this nationwide PSM cohort study of patients with UC receiving golimumab or adalimumab, no significant differences were observed between groups for treatment patterns or HRU outcomes. High rates of concomitant corticosteroid use, treatment discontinuations, and HRU while on therapy highlight key unmet needs in the treatment of UC.
阿达木单抗和戈利木单抗是皮下注射的抗肿瘤坏死因子 α（TNFα）生物制剂，用于治疗溃疡性结肠炎（UC）。迄今为止，尚无研究直接比较在真实世界环境中接受这些治疗的 UC 患者的治疗模式和医疗资源利用（HRU）。本研究的目的是使用美国索赔数据库比较 UC 患者接受阿达木单抗或戈利木单抗治疗的这些结果。
使用美国 Optum Clinformatics Data Mart 数据库确定接受戈利木单抗或阿达木单抗治疗的 UC 患者。感兴趣的结局包括治疗模式（停药、剂量优化、持续治疗和伴随药物使用）和 HRU（门诊就诊、急诊就诊和住院治疗）。使用倾向评分匹配（PSM）来解释组间混杂变量的差异。
总体而言，确定了 990 名患者（戈利木单抗组：n=277；阿达木单抗组：n=713）。PSM 后，每组纳入 246 名患者。在整个随访期间，阿达木单抗组和戈利木单抗组在停药（53.7% vs. 51.2%；P=0.5881）、剂量优化（35.4% vs. 39.4%；P=0.3515）或持续治疗（338.2 vs. 361.2 天；P=0.4194）方面无显著差异。在开始治疗后的一年中，伴随免疫抑制剂（21.9% vs. 21.7%；P=0.9686）或皮质类固醇的使用（74.7% vs. 78.8%；P=0.3573）或 HRU 结局，包括门诊就诊（93.3% vs. 94.0%；P=0.7660）、急诊就诊（15.2% vs. 10.9%；P=0.2238）和住院治疗（15.2% vs. 13.6%；P=0.6680）方面均无显著差异。
在这项针对接受戈利木单抗或阿达木单抗治疗的 UC 患者的全国性 PSM 队列研究中，两组之间的治疗模式或 HRU 结局无显著差异。治疗过程中皮质类固醇的高使用率、停药和 HRU 突显了 UC 治疗中的关键未满足需求。
