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Introduction: The emergence of high-efficacy disease-modifying therapies (HE DMT) for multiple sclerosis (MS) may pose challenges to the administration and monitoring burden of the therapies. This article presents the results of the Delphi consensus method to generate insights from experts on the administration and monitoring burden of HE DMT in Saudi Arabia with a special focus on cladribine., Methods: Between January and March 2023, a two-round modified Delphi method was used to establish consensus regarding the administration and monitoring burden of HE DMTs used for MS. Through a questionnaire, the advisors evaluated 17 properties of six individual HE DMTs on the basis of their clinical experience. Advisors were required to rank each property on a scale of 1-5, with 1 being the lowest burden and 5 being the highest burden., Results: Experts ranked cladribine as having the lowest monitoring burden, followed by ofatumumab and ocrelizumab. Natalizumab and fingolimod were ranked fourth, and alemtuzumab had the highest burden. During the first round, experts agreed on the scores of the administration burden properties, except for hospital visit time and facility use during administration for ofatumumab, route of administration for fingolimod, monitoring of specific side effects and frequency of lab tests at follow-up, and the washout period for natalizumab. During the second round, there was agreement on all properties., Conclusion: In the absence of alternative scientific data, recommendations from experts and their consensus provide useful insights into the administration and monitoring burden of HE DMTs used for MS in Saudi Arabia., Competing Interests: Declarations. Conflict of Interest: Seraj Makkawi received an honorarium for attending the advisory board meeting on which this article is based. Also, he reports personal fees from Roche, Merck, Novartis, Sanofi Genzyme, Biogen, Janssen, Biologix, AstraZeneca, and Horizon Therapeutics outside the submitted work. Salman Aljarallah received an honorarium for attending the advisory board meeting on which this article is based. Also, he reports receiving speaker and consultation fees from Roche, Merck, Novartis, Sanofi Genzyme, Biogen, Janssen, Biologix, AstraZeneca, and Horizon Therapeutics outside the submitted work. All authors participated in the closed meeting that gave rise to this article, which was organized and supported by Merck Serono Middle East FZ-Ltd. Ethical Approval: The study did not involve human participants, human data, or human material; thus, ethics committee approval was not required. The panelists were all authors of this paper., (© 2025. The Author(s).)

Treatment-pattern data suggest that some patients with multiple sclerosis (MS) in the Kingdom of Saudi Arabia (KSA) may not be receiving optimal treatment. A virtual meeting of ten expert Saudi neurologists, held on October 23, 2020, discussed unmet needs in relapsing-remitting MS (RRMS), and the role of ofatumumab as a suitable treatment in the KSA. Multiple unmet needs were identified: poor quality of life, with high rates of depression and anxiety; a negative impact of MS on work ability; treatment choices that may compromise efficacy for safety or vice versa; inconvenient or complex dosage regimens; and limited access to patient education and support. Early use of highly effective disease-modifying treatments (DMTs) results in better patient outcomes than starting with less effective treatments and downstream escalation, but this strategy may be underutilized in the KSA. B cells are important in MS pathogenesis, and treatments targeting these may improve clinical outcomes. Ofatumumab differs from other B cell-depleting therapies, being a fully human monoclonal antibody that binds to CD20 at a completely separate site from the epitope bound by ocrelizumab, and being administered by subcutaneous injection. When compared with teriflunomide in two randomized, phase 3 clinical trials in patients with RRMS, ofatumumab was associated with significant reductions in annualized relapse rates, rates of confirmed disability worsening, and active lesions on magnetic resonance imaging. The incidence of adverse events, including serious infections, was similar with the two treatments. Ofatumumab is a valuable first- or second-line treatment option for RRMS in the KSA, particularly for patients who would benefit from highly effective DMTs early in the disease course, and for those who prefer the convenience of self-injection. Future research will clarify the position of ofatumumab in RRMS treatment, and comparative cost data may support the broad inclusion of ofatumumab in formularies across the KSA., (© 2022. The Author(s).)