EHA 2024: Rituximab Biosimilars Improve Quality of Life, Infusion-Related Reactions

Two posters presented at the European Hematology Association’s annual meeting (EHA 2024) evaluated how rituximab biosimilars impact quality of life¹ and infusion-related reactions (IRR) in patients with lymphatic cancers.²

In the first study, the researchers looked at how quality of life was informed by biosimilar rituximab therapy.¹

The treatment of hematologic malignancies has led to significant advancements in survival rates and patient outcomes. However, the impact of these treatments on the quality of life (QOL) of patients remains a critical concern. QOL encompasses a wide range of patient experiences, including physical, functional, emotional, and social well-being. In hematologic malignancies, the disease and its treatment can profoundly affect various aspects of a patient's life.

According to the authors, the QOL measure is crucial for understanding the challenges faced by individuals with hematologic diseases, emphasizing the need for patient-centered care strategies to improve overall support and outcomes.

The primary aim of this study was to investigate the QOL of patients undergoing treatment for hematologic malignancies and uncover critical areas where interventions are needed to improve overall QOL. The multicenter study was conducted across 13 onco-hematology units in eight Italian regions, focusing on adults diagnosed with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) who received rituximab treatment between March 2018 and June 2022. Patient-reported data were collected using the FACT-Lym questionnaire at the third drug infusion to assess Health-Related Quality of Life (HRQOL) across various domains in individuals with B-cell malignancies.

Researchers included 430 participants (n = 249 male; most were aged 65-75 years). The majority of participants were diagnosed with NHL (90%), followed by CLL (6.3%) and other hematological diseases (3.72%).

The findings suggested that although participants generally report an acceptable QOL across multiple dimensions, functional well-being is the most compromised aspect. Emotional, social, and physical well-being are less adversely affected on average. The researchers noted that pattern indicates the nuanced impact of treatment on different life areas, highlighting the importance of addressing specific domains to enhance overall patient care.

Participants with NHL and CLL reported similar QOL scores, with those with CLL faring slightly better in physical and lymphoma-specific well-being. Individuals with other hematological conditions generally reported lower scores in several domains, indicating a need for targeted interventions to address their QOL.

The other study found that the rate of IRRs as a result of treating patients with chronic lymphoproliferative disorders (cLPDs) with rituximab biosimilars was comparable with previously published data, with no observed differences between the 2 biosimilars studied.

A study was conducted to assess the frequency and severity of IRRs associated with the rituximab biosimilars Rixathon and Blitzima in patients with a cLPD treated at the Clinic for Hematology, University Clinical Center of Serbia from 2020 to 2022. Medical records of 200 patients were analyzed to identify associations between IRR occurrence and various clinical, radiographic, and therapeutic features, and to compare IRR frequencies between different cLPD entities and the 2 rituximab biosimilars. All patients received premedication with methylprednisolone, paracetamol, and loratadine.

IRRs occurred in 71% of patients, particularly during their first infusion. The authors said that a small percentage of patients may need to discontinue rituximab due to serious IRRs, and they observed a low incidence of fatal outcomes (0.07%).

The occurrence of IRRs was not dependent on gender, age, clinical stage, disease localization (extranodal vs nodal), presence of “B” symptoms, bulky mass, Eastern Cooperative Oncology Group performance status, type of adjunct chemotherapy, or the timing of rituximab administration (first cycle vs second cycle and onward).

Patients with diffuse large B-cell lymphoma (DLBCL) exhibited significantly fewer IRRs compared with those with CLL (15% vs 34%; P = .045). Additionally, patients treated in second or later therapeutic lines experienced more IRRs compared with those in the first treatment line (P = .0233). Factors such as arterial hypertension (AH), type 2 diabetes (T2D), coronary artery disease, and smoking did not influence IRR occurrence.

In the subgroup of patients with DLBCL (n = 67), those with AH experienced IRRs more frequently (P = .014). Among patients with CLL (n = 76), those with AH and T2D showed a higher frequency of IRRs (P = .005 and .041, respectively).

References

1. Masnata LJ, Urru S, Alegiani SS, Mayer F, Campomori A. Quality of life (QOL) in patients with hematologic malignancies receiving rituximab biosimilars: results from a real-world setting. Presented at EHA 2024; June 13-16, 2024; Madrid, Spain. Abstract P1689. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.eha/temp/eha24_abstract_bodies/P1689.pdf

2. Vukovic V, Karan-Đurašević T, Pesic A, et al. Infusion-related reactions in patients with chronic lymphoproliferative disorders treated with two rituximab biosimilars: single center experience. Presented at EHA 2024; June 13-16, 2024; Madrid, Spain. Abstract PB3059. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.eha/temp/eha24_abstract_bodies/PB3059.pdf