Ofatumumab for treating chronic lymphocytic leukemia: a safety profile

• Published in: Expert opinion on drug safety Vol. 14; no. 12; p. 1945
• Main Authors: Korycka-Wołowiec, Anna, Wołowiec, Dariusz, Robak, Tadeusz
• Format: Journal Article
• Language: English
• Published: England 02.12.2015
• Subjects: Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Antigens, CD20 - immunology; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Humans; Immunotherapy - methods; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy; Leukemia, Lymphocytic, Chronic, B-Cell - pathology; Rituximab - adverse effects; Rituximab - therapeutic use; Salvage Therapy - methods; chronic lymphocytic leukemia; clinical efficacy; monoclonal antibody; ofatumumab; safety profile
• ISSN: 1744-764X
• DOI: 10.1517/14740338.2015.1113253

Ofatumumab, the first fully human IgG1κ, belongs to the second generation of the first class of anti-CD20 monoclonal antibodies. The drug used alone and in combination with drugs having different mechanisms of action has shown a favorable toxicity profile and significant benefit especially in relapsed/refractory chronic lymphocytic leukemia (CLL) patients in doses up to 2000 mg. This article reviews pharmacokinetic, clinical application for CLL treatment, and safety profile of ofatumumab as well as differences and similarity between ofatumumab and rituximab. Publications in English from 2010 through October 2015 were surveyed on the MEDLINE database for articles. Proceedings of the American Society of Hematology held during the last 5 years were also included. Ofatumumab more effectively than rituximab enhanced complement-dependent cytotoxicity playing the crucial role for its therapeutic activity. The drug is highly effective in the first-line and salvage treatment of CLL, essentially as a part of immunochemotherapy, and probably also as maintenance therapy. Its safety profile is very advantageous, since adverse events are usually limited to grade 1 and 2 infusion-related reactions, which tend to decrease throughout the treatment. Its advantage over the other anti-CD20 monoclonal antibodies in the treatment of CLL remains to be determined in the direct head-to-head trials.