Clinical profiles and outcomes in patients with ulcerative colitis receiving standard and higher-than-standard doses of vedolizumab: findings from a real-world study in Europe

Vedolizumab is an antibody targeting α4β7 integrin used in the treatment of ulcerative colitis (UC). Patients are commonly prescribed higher-than-standard doses if treatment response is inadequate, but little is known about the drivers and impact of increased dosing. Our objective was to use real-world data to describe vedolizumab dosages in current clinical practice, patient characteristics, physicians’ reasons for prescribing vedolizumab, and physician treatment satisfaction. Data were derived from the Adelphi Real World UC vedolizumab Chart Review, a cross-sectional survey of gastroenterologists and their UC patients, conducted in France, Germany, Italy, Spain, and the United Kingdom between December 2022 and March 2023. Gastroenterologists provided data on patient demographics, clinical characteristics, treatment and vedolizumab dosage history, reasons for dose choice, and treatment satisfaction. Data were returned on 448 patients by 112 gastroenterologists. Overall, 83.5% of patients were on a standard vedolizumab dose and 10.3% were on a higher-than-standard dose. The worsening of symptoms was the most cited reason for higher doses. Most reported symptoms at survey were fatigue, abdominal distention or pain, diarrhea, and bowel urgency, with the latter particularly in higher-than-standard dose patients. Patients on higher-than-standard dose had high rates of mild (37.0%) or moderate (26.1%) disease, and low rates of remission (33.8%). Physicians were dissatisfied with treatment control for 2.7% of standard and 26.1% of higher-than-standard dose patients. Over 10% of patients were receiving a higher-than-standard dose of vedolizumab, but despite this were found to have suboptimal clinical outcomes and low physician satisfaction.维多珠单抗（Vedolizumab）是一种靶向α4β7整合素（α4β7 integrin）的抗体，用于治疗溃疡性结肠炎（UC）。临床中，若患者治疗应答不佳，通常会被处方高于标准剂量的给药方案，但目前学界对剂量上调的驱动因素及其影响知之甚少。本研究旨在利用真实世界数据，描述当前临床实践中的维多珠单抗给药剂量、患者特征、医师开具该药物处方的原因，以及医师的治疗满意度。数据来源于《Adelphi真实世界溃疡性结肠炎维多珠单抗病历回顾研究》（Adelphi Real World UC vedolizumab Chart Review），这是一项针对胃肠病学家及其溃疡性结肠炎患者的横断面调查，于2022年12月至2023年3月间在法国、德国、意大利、西班牙及英国开展。胃肠病学家提供了患者人口统计学特征、临床特征、治疗及维多珠单抗给药史、剂量选择依据与治疗满意度相关数据。本次研究共回收112位胃肠病学家提交的448例患者数据。总体而言，83.5%的患者采用标准维多珠单抗剂量，10.3%的患者采用高于标准剂量的给药方案。症状恶化是上调剂量最常见的原因。调查中最常报告的症状为疲劳、腹胀或腹痛、腹泻及排便急迫感，其中排便急迫感在高于标准剂量的患者中尤为突出。接受高于标准剂量给药的患者中，轻度（37.0%）或中度（26.1%）疾病占比高，而临床缓解率较低（33.8%）。医师对2.7%的标准剂量患者和26.1%的高于标准剂量患者的治疗控制情况表示不满意。超过10%的患者接受了高于标准剂量的维多珠单抗治疗，但即便如此，这些患者仍存在欠佳的临床结局，且医师治疗满意度较低。