Ofatumumab subcutaneous injection for the treatment of relapsing forms of multiple sclerosis

ABSTRACT

Introduction

In recent years, different studies have highlighted the importance of B cells in the pathophysiology of multiple sclerosis (MS): they secrete cytokines to modulate the inflammatory environment, present antigens for the activation of T lymphocytes, and they secrete antibodies contributing to the destruction of the myelin sheath. Combined, these findings have lead to new possible means for treating MS.

Areas covered

In this review, we provide an up-to-date overview of the characteristics of ofatumumab (aka Kesimpta), and the differences between this drug and the other anti-CD20 monoclonal antibodies used to treat MS.

Expert opinion

The evolution of disease-modifying treatment algorithms in MS underlines the importance of starting treatment as soon as the diagnosis is defined, and with adequate ‘treatment intensity.’ Monoclonal antibodies and other aggressive treatments are now considered as an option at the clinical presentation of the disease, based to the prognostic profile emerging through clinical and paraclinical investigations. The recent adoption of new diagnostic criteria allows for the early diagnosis of MS. This, together with the availability of disease-modifying therapies (DMTs), such as ofatumumab, with a good efficacy/safety profile and which are easy to administer, could contribute to significant improvements in the long-term prognosis of MS.

KEYWORDS:

• Multiple sclerosis
• phase III clinical trials
• B-cells
• ofatumumab

Article highlights

• More than 20 treatments for relapsing-remitting MS are currently available nowadays.

• We reviewed the characteristics, safety, and efficacy of the novel anti-CD20 monoclonal antibody ofatumumab, and how it differs from other anti-CD20 therapies for MS.

• There are similarities and dissimilarities among anti-CD20 monoclonal antibodies, among which the amount of human immunoglobulin they are made of, the different epitopes of the CD20 protein they target, and the route of administration of different drugs.

• Ofatumumab is a fully human monoclonal antibody targeting two extracellular epitopes of the CD20 protein, and it is administered subcutaneously.

• Three-phase II/III randomized clinical trials confirmed ofatumumab’s efficacy on clinical and magnetic resonance imaging (MRI) parameters of disease activity.

• In these trials, the most common adverse effects of ofatumumab were injection-related systemic reaction, infection, and hypogammaglobulinemia. No clear evidence of an increased risk of cancer was observed.

Acknowledgments

We would like to thank Acesm Onlus for the continuous support.

Declaration of interest

G Comi has received personal compensation from outside the submitted work from Novartis, Teva Pharmaceutical Industries Ltd, Teva Italia Srl, Sanofi Genzyme, Genzyme Corporation, Genzyme Europe, Merck KGgA, Merck Seorno SpA, Celgene Group, Biogen Idec, Biogen Italia Srl, F. Hoffman-La Roche, Roche SpA, Almirall SpA, Forward Pharma, Medday and Excemed. G Dalla Costa has received funding for research, travel, and/or speaker honoraria from Biogen, Celgene, Merck, Novartis, Roche, and Teva. L Leocani received honoraria for consulting services and/or speaking activities from Merck, Biogen, Novartis, Roche, Almirall and Excemed. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

Funding This paper was not funded.