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Ofatumumab Clinical Summary.pdf (722.28 kB)

Ofatumumab: A Review in Relapsing Forms of Multiple Sclerosis

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posted on 2021-12-08, 21:58 authored by Connie Kang, Hannah A. Blair


Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest
Connie Kang and Hannah Blair are salaried employees of Adis International Ltd/Springer Nature, and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.


Ofatumumab (Kesimpta®) is a fully human anti-CD20 monoclonal antibody that can be self-administered by patients and is approved in several countries worldwide for the treatment of relapsing forms of multiple sclerosis (MS). In two identical phase III trials in adults with relapsing forms of MS, subcutaneous ofatumumab was more effective than oral teriflunomide in reducing the annualized relapse rate, as well as reducing MRI-detected lesion activity and limiting worsening of disability. Ofatumumab had a generally manageable tolerability profile; the most common adverse events (AEs) included nasopharyngitis, headache, upper respiratory tract infections and urinary tract infections. AEs of special interest (AESIs) included infections and injection-related reactions, which were generally manageable. Immunoglobulin M levels were reduced (but stayed above the lower limit of normal) by ofatumumab therapy, but this was not associated with an increased risk of infection. Thus, ofatumumab is a convenient treatment option that is effective and has a generally manageable tolerability profile in adults with relapsing forms of MS.

© Springer Nature Switzerland AG 2021


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