Efficacy and safety of biosimilar rituximab (ZytuxTM) in newly diagnosed patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia.

Alaa Alwan,Duaa Abbas,Manal Abdulsahib,Reem Ensaif,Saraa Abdulsattar

doi:10.4081/hr.2020.8296

Abstract

Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL) are considered parts of mature B cell neoplasms in WHO classification. They are both characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Most of treatment protocols of NHL and CLL contain rituximab in addition to chemotherapy, which has been associated with improved survival. The aim of this study was to assess the efficacy and safety of Zytux™ (AryoGen Pharmed) in newly diagnosed patients with NHL and CLL. A prospective single center study conducted at the National Center of Hematology, Mustansiriyah University, from January 2018 till October 2018. Twenty patients were included in this study, ten of them were NHL and ten patients were CLL. All patients were treated with Zytux™ in addition to designated protocol. All patient were followed up for 6 months and evaluated at the end of each protocol. There were 20 patients in this study; the overall median age for all patients in this study was 66 years. The median age was 57.5 years for NHL and 68.5 years for CLL. There were 13 males and 7 females in total, with male predominance in both groups. Regarding safety profile, Zytux™ demonstrated similar adverse reactions in comparison to MabThera® (Roche Spa). Moreover, the overall response rate in both groups was 85% with complete response achieved in 35% and partial response in remaining 50%.This study concluded that the early results of use of Zytux™ in NHL and CLL were not inferior to reference drug MabThera® in contrast it was comparable and even better in term of safety and efficacy.

Highlights

Hematologic B-cell malignancies com-Correspondence: Alaa Fadhil Alwan, Departments of clinical hematology, National Center of Hematology, Mustansiriya non-Hodgkin lymphoma and chronic lymphocytic leukemia prise a large, heterogeneous group of B-cell lymphoproliferative disorders in which clonal expansion of the various stages of BAlaa Fadhil Alwan,[1] Manal Ali Abdulsahib,[2] Duaa Dhahir Abbas,[3] Saraa Ali Abdulsattar,[3] Reem Talib Ensaif[3] lymphocytes occur in bone marrow, blood or other tissues
Biosimilars can be one of study, pregnancy or lactation, severe autoimmune hemolytic anemia, current ly active infections or underlying diseases such as Hepatitis B or C, HIV, severe carn diac or pulmonary disorders, recent o myocardial infarction, uncontrolled hypertension and epilepsy, diabetes mellitus, elee vated hepatic enzyme levels, serum creatinine more than 2 u mg/dL, known hypersensitivity with anal phylactic reaction to chimeric monoclonal antibodies or any of study drugs
M counts and hemoglobin), especially disease staging were assessed in first visit; all effim cacy and safety measures were o reassessed at each visit prior administration c of chemotherapy regimen. - All patients received combination thern apy with ZytuxTM and chemotherapy o according to designated protocols for CLL N and NHL

Summary

Introduction

Correspondence: Alaa Fadhil Alwan, Departments of clinical hematology, National Center of Hematology, Mustansiriya non-Hodgkin lymphoma and chronic lymphocytic leukemia prise a large, heterogeneous group of B-cell lymphoproliferative disorders in which clonal expansion of the various stages of B. Alaa Fadhil Alwan,[1] Manal Ali Abdulsahib,[2] Duaa Dhahir Abbas,[3] Saraa Ali Abdulsattar,[3] Reem Talib Ensaif[3] lymphocytes occur in bone marrow, blood or other tissues. These disorders classified according to their nature of proliferation, which range from very aggressive lym-

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