Ofatumumab is a fullyhuman monoclonal antibody toCD20, which appears to provide rapidB-cell depletion.[13] Under the brand nameKesimpta, it is approved for the treatment ofmultiple sclerosis in the United States as well as in the European Union and other regions.[9][11] Under the brand nameArzerra, it is approved for the treatment of certain types ofchronic lymphocytic leukemia (CLL) in the United States.[14] It is sold byNovartis under license fromGenmab.[15]
Ofatumumab (Kesimpta 20 mg solution for injection in pre-filled syringe/pen) is indicated for the treatment of relapsing forms ofmultiple sclerosis in adults.[9][11][16] The recommended dose is 20 mg of ofatumumab administered by subcutaneous injection with monthly dosing following loading.[17][18]
Treatment with ofatumumab has been shown to rapidly deplete B-cells[17][18] which aids MS pathogenesis by influencing and regulating different autoimmune process such as T-cell production and APC activity.[19]
Ofatumumab (Arzerra 100 mg or 1000 mg concentrate for solution for infusion) is indicated for the treatment of untreated, relapsed, or refractorychronic lymphocytic leukemia (CLL).[8][20][6][21] The recommended doses for treatment of CLL are higher than MS, with 1000 or 2000 mg infusions administered monthly depending on if the CLL is untreated, relapsed or refractory, following loading.[21]
Ofatumumab (Arzerra) has received ablack box warning regarding the potential for it to causeprogressive multifocal leukoencephalopathy andhepatitis B reactivation.[16][23] Likewise it is also advised that doctors watch cautiously for small bowel obstruction, neutropenia, thrombocytopenia, infusion reactions or an increased risk for infection.[23]
For more information, please refer to the prescribing information or your doctor.
No formal drug interaction studies have been conducted with ofatumumab.[8] Although it is advised that patients are not administered live virus vaccines (e.g. the oral polio vaccine) while undergoing treatment with ofatumumab due to the compromised ability to fight the attenuated viruses seen in patients being treated with ofatumumab.[23] While on treatment with ofatumumab (Kesimpta), all immunizations should be administered according to immunization guidelines at least 4 weeks prior to initiation of ofatumumab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ofatumumab for inactivated vaccines.[22]
Ofatumumab is a fully human anti-CD20 monoclonal antibody whose epitope is distinct from that ofrituximab.[24] Ofatumumab binds to a distinct epitope on small and large extracellular loops of CD20.[25][26] The CD20 antigen is expressed on solely B cell lymphocytes.[24] Compared with rituximab, ofatumumab binds more tightly to CD20 with a slower off-rate.[24] It causes cytotoxicity in the cells that express CD20 by means ofcomplement-dependent cytotoxicity (CDC) andantibody-dependent cellular cytotoxicity (ADCC).[24]
Ofatumumab was jointly developed by Danish biotech Genmab and GlaxoSmithKlineGSK plc who entered into an agreement to co-develop and commercialize ofatumumab in 2006.[27] It was approved as Arzerra for the treatment of chronic lymphocytic leukemia in the United States in October 2009.[28][29]
Ofatumumab (Arzerra) was then approved in the European Union in June 2010,[14] in the United Kingdom in April 2010,[6] and in Canada in August 2012.[30][31]
In 2014, Novartis acquired a number of GSK's oncology products, including the collaboration with Genmab and ofatumumab.[15][32]
For commercial reasons ofatumumab (Arzerra) was withdrawn from the Canadian market in 2017.[30][31] It was withdrawn from the European Union in February 2019.[33][34] Novartis removed it from all of the non-US markets and made it available only for compassionate use in those markets.[35][36]
Ofatumumab (Kesimpta) was approved for the treatment of relapsing forms of multiple sclerosis in adults in the United States in August 2020.[37][38] EU approval was subsequently received in March 2021.[11]
Ofatumumab (Arzerra) was transitioned to an oncology access program to make it available at no cost to chronic lymphocytic leukemia patients in the U.S.[39]
^ab"AusPAR: Ofatumumab".Therapeutic Goods Administration (TGA). 19 August 2021.Archived from the original on 11 September 2021. Retrieved10 September 2021.
^"Arzerra EPAR".European Medicines Agency (EMA). 17 September 2018.Archived from the original on 8 August 2020. Retrieved21 August 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Coiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, et al. (February 2008). "Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study".Blood.111 (3):1094–1100.doi:10.1182/blood-2007-09-111781.PMID18003886.S2CID22333805.
Clinical trial numberNCT01848145 for "Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia" atClinicalTrials.gov
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