Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension.

BACKGROUND

Ofatumumab has demonstrated superior efficacy and favorable safety for up to 2.5 years versus teriflunomide in relapsing multiple sclerosis (RMS).

OBJECTIVE

Further characterize efficacy and safety of ofatumumab in RMS.

METHODS

Efficacy set: patients randomized to ofatumumab/teriflunomide in ASCLEPIOS I/II (core). Safety set: patients who received ⩾ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS (all core), or ALITHIOS (umbrella open-label extension). Patients received continuous ofatumumab or were newly switched from teriflunomide. Data cut-off: 25 September 2021.

RESULTS

In the efficacy set (

CONCLUSION

Ofatumumab has a favorable longer-term benefit-risk profile in RMS.

TRIAL REGISTRY

ALITHIOS (NCT03650114): https://clinicaltrials.gov/ct2/show/NCT03650114.

Déclaration de conflit d'intérêts

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: All support for the present manuscript (e.g. funding, provision of study materials, medical writing, article processing charges) and the studies were sponsored and funded by Novartis Pharma AG, Basel, Switzerland. Novartis Pharma AG supported the development of this manuscript, provided data analyses according to the direction of the authors, and provided funding for medical writing support. Open access fee was paid by Novartis. Medical writing support for the development of this publication, under the direction of the authors, was provided by James Currie (BSc, Hons; PhD.), Laura Crocker (BMedSci, Hons), and Philippa Lloyd (BSc, Hons) of Ashfield MedComms, an Inizio company, and was funded by Novartis Pharma AG. Stephen L Hauser currently serves on the scientific advisory board of ACCURE, Alector, Annexon, board of directors of Neurona, and has previously consulted for BD, Moderna, and NGM Bio. Dr Hauser also has received travel reimbursement and writing support from F. Hoffmann-La Roche and Novartis AG for anti-CD20-therapy-related meetings and presentations. Grants: NIH/NINDS (R35NS111644) and Valhalla Foundation; within the past 36 months, no longer active: National Multiple Sclerosis Society (RR 2005-A-13). Ronald Zielman is a full-time employee of Novartis. Ayan Das Gupta is a paid and permanent employee of Novartis. Jing Xi is an employee of Novartis. Dee Stoneman is a full-time employee of Novartis. Goeril Karlsson is a full-time salaried employee of Novartis. Derrick Robertson declares grants or contracts from Anokion, Atara Biotherapeutics, Biogen, GW Pharmaceuticals, Novartis, PRIME CME, TG Therapeutics, CorEvitas, EMD Serono, Genentech, Janssen, PCORI and Sanofi; consulting fees from Biogen, Genentech, EMD Serono, Janssen, Bristol Myers Squibb, Horizon, Novartis, Sanofi, TG Therapeutics, Alexion, Greenwich Biosciences and Mallinckrodt; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Biogen, EMD Serono, Genentech, TG Therapeutics, Bristol Myers Squibb, Janssen, PRIME CME, Sanofi, Alexion and Horizon. Jeffrey A Cohen declares consulting fees from Biogen, Convelo, EMD Serono, Gaossamer Gio, Mylan and PSA; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid for ACTRIMS; other financial or non-financial interests for Sage—serving as an Editor of