Background

Rituximab (chimeric anti-CD20 monoclonal antibody) treatment is approved for chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Rituximab-abbs (first biosimilar approved in 2017) is expected to significantly reduce healthcare economic burden due to lower acquisition costs. This non-interventional, non-comparative study assessed real-world effectiveness and tolerability of rituximab-abbs and rituximab in treatment-naive patients with CLL or NHL.

Materials and methods

Via an online physician survey, 46 UK-registered hematologists and oncologists retrospectively reported on randomly selected patients aged ≥18 years with CLL or NHL with rituximab-abbs or rituximab as first-line immunotherapy. Overall, 201 patient charts were examined across 4 cohorts: rituximab-abbs in CLL, rituximab-abbs in NHL, rituximab in CLL, rituximab in NHL.

Results

Demographic profiles across cohorts were similar. Most patients (94 %–100 %) received combination therapy (rituximab-abbs or rituximab mainly with chemotherapy). For both treatments, overall response rate (94 %–98 %) and 1-year overall survival (98 %–100 %) were very high for patients with CLL or NHL. Most common serious adverse events were neutropenia, fatigue, anemia and infusion reactions. The majority of patients (54 %–66 %) did not experience a grade ≥3 adverse event. Healthcare resource utilization was similarly high across cohorts, driven by diagnostic testing, oncologist office visits, and day-case hospital admissions; many patients required supportive medical therapies. Mean annual savings of ∼£1000/patient driven by acquisition costs occurred with rituximab-abbs versus rituximab, administration costs were similar.

Conclusion

Rituximab-abbs and rituximab demonstrated similar effectiveness and tolerability in treating CLL and NHL in routine UK clinical practice and demonstrate the utility of the biosimilar as a cost-saving alternative treatment.

中文翻译：

---

评估利妥昔单抗、生物仿制药和利妥昔单抗在 CLL 或 NHL 患者中的疗效：一项真实的英国研究

背景

利妥昔单抗（嵌合抗 CD20 单克隆抗体）治疗被批准用于慢性淋巴细胞白血病（CLL）和非霍奇金淋巴瘤（NHL）。利妥昔单抗（Rituximab-abbs）（2017 年批准的首个生物仿制药）由于购置成本较低，有望显着降低医疗保健经济负担。这项非干预性、非比较性研究评估了利妥昔单抗和利妥昔单抗在未接受治疗的 CLL 或 NHL 患者中的真实疗效和耐受性。

材料和方法

通过在线医师调查，46 名英国注册的血液学家和肿瘤学家回顾性报告了随机选择的年龄≥18 岁的 CLL 或 NHL 患者，他们使用利妥昔单抗或利妥昔单抗作为一线免疫治疗。总体而言，在 4 个队列中检查了 201 个患者图表：CLL 中的利妥昔单抗-Abs、NHL 中的利妥昔单抗-Abs、CLL 中的利妥昔单抗、NHL 中的利妥昔单抗。

结果

各群组的人口统计资料相似。大多数患者 (94 %–100 %) 接受联合治疗（利妥昔单抗-abbs 或利妥昔单抗主要与化疗联合）。对于这两种治疗，CLL 或 NHL 患者的总反应率 (94 %–98 %) 和 1 年总生存率 (98 %–100 %) 都非常高。最常见的严重不良事件是中性粒细胞减少、疲劳、贫血和输液反应。大多数患者 (54 %–66 %) 未发生 ≥ 3 级不良事件。受诊断测试、肿瘤科医生就诊和日间住院病例的推动，各队列的医疗资源利用率同样高；许多患者需要支持性药物治疗。利妥昔单抗与利妥昔单抗相比，平均每年节省约 1000 英镑/患者的购置成本，管理成本相似。

结论

在英国常规临床实践中，Rituximab-abbs 和 rituximab 在治疗 CLL 和 NHL 方面表现出相似的有效性和耐受性，并证明了生物仿制药作为一种节省成本的替代治疗的效用。