2017, Number 4
Safety and response to treatment of compassionate use of an anti-CD20 monoclonal antibody CIMABior®
Fernández ÁJD, García VYÁ, Hernández CP, Hernández CC, Medina RBA, Viada GCE
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Language: Spanish
References: 0
Page: 35-49
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ABSTRACT
Introduction: The use of monoclonal antibodies transformed the treatment of non-Hodgkin lymphomas. The Center of Molecular Immunology created an anti-CD20 monoclonal antibody (CIMABior®), biosimilar of rituximab, which has been characterized from a biological point of view, but the safety and effectiveness are still being studied.Objective: Evaluate the safety and response to treatment, in patients with B-cell malignancies with compassionate use of CIMABior®.
Methods: A multicenter, exploratory, non-controlled, non-randomized study was conducted with two variants of treatments (monotherapy or combined with chemotherapy). Adults with non-Hodgkin lymphomas and chronic lymphocytic leukemia not eligible for clinical trial with this product were included. Frequency of adverse events was calculated and those were characterized. The response to treatment was defined as: complete response, partial response, stable disease or progressive disease. Overall response rate (complete plus partial remission) was calculated with 95% confidence interval. The relation of some variables with response was estimated per Odss ratio. As a measure of the benefit-risk balance, the Bayes factor was estimated.
Results: The more frequent adverse events were: tremors (12.8 %) and fever (10.3 %). Those related to the product (43.4 %) were minor and evolved to recovery. There were no deaths in reference to the treatment. An overall response of 71.2 % was confirmed (59.6 % complete remissions and 11.5 % partial remission). The monotherapy group objective response was 66.7 % and 73.0 % in the CIMABior® plus chemotherapy group, with complete remissions of 46.7 % and 64.9 % respectively.
Conclusions: The monoclonal antibodies CIMABor® is safe, well tolerated and evidences of its effectiveness was demonstrated. The treatment provided a superior clinical benefit to the risk of developing a severe adverse event.