Real-World Ofatumumab Use Highlighted Post-Approval for MS


The vast majority of patients with MS, 63.4%, who initiated ofatumumab treatment in the 6 months after its approval had mild disability, while only 29.2% had moderate disability and 7.4% had severe disability.

Patricia K. Coyle, MD, Director, MS Comprehensive Care Center, and professor of neurology, Stony Brook University

Patricia K. Coyle, MD

Data from a cohort of 1015 patients with multiple sclerosis (MS) who had newly initiated treatment with ofatumumab (Kesimpta; Novartis) revealed real-world insights about the recently approved treatment’s use in the clinic.

Ultimately, 33% (n = 335) of the patients—who were identified from the IQVIA open-source pharmacy claims database—who initiated ofatumumab therapy were over the age of 55 years, with 9% (n = 91) over the age of 65 years. The data were presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), October 13-15, by Patricia K. Coyle, MD, Director, MS Comprehensive Care Center, and professor of neurology, Stony Brook University.

“This paper looked at a very large IQVIA database to evaluate, in the real world, patients who were started on ofatumumab in the first 6 months after its approval,” Coyle said in her presentation. “The vast majority of patients starting ofatumumab had mild disability, 63.4%, only 29.2% moderate and 7.4% severe.”

Disease disability was measured by Expanded Disability Status Scale (EDSS) scores. At baseline, 60.3% of those who were treatment-naïve (54.8%; n = 556) had mild disease, while 26.6% and 13.1% had moderate and severe disease disability, respectively. For those who had experience with disease-modifying therapy (DMT; 45.2%; n = 459), 66.7% of patients were mild, 25.5% were moderate, and 7.8% were severe. The majority of patients (80.8%) had not experienced disease relapse in the prior year, most were women (72.5%) and from the southern region of the US (46.2%).

READ MORE: Pfizer COVID-19 Vaccine Safe for Patients With Multiple Sclerosis

As the data were collected during the COVID-19 pandemic, Coyle et al included information about COVID diagnosis and vaccination. In total, 3% (n = 30) patients were diagnosed with COVID pre- or post-indexing, a group that consisted of 3.4% (n = 19) of the DMT-naïve and 2.4% (n = 19) of the DMT-experienced patients. As for vaccination, 1.7% (n = 17) patients were indexed pre- or post-vaccination—1.3% (n = 7) and 2.2% (n = 10) of patients in the DMT-naïve and DMT-experienced groups, respectively.

Among those with prior DMT use, 8.0% of patients used injectable therapies, including glatiramer acetate (4.6%; n = 47) and any interferon ß (3.4%; n = 35); 14.9% used infusion therapies, including natalizumab (Tysabri; Biogen [3.6%; n = 37]), ocrelizumab (Ocrevus; Genentech [10.8%; n = 110]), and rituximab (0.4%; n = 4); and 22.3% used oral treatments, including dimethyl fumarate (9.3%; n = 94), fingolimod (Gilenya; Novartis [3.4%; n = 35]), teriflunomide (Aubagio; Teva [6.1%; n = 62]), cladribine (Mavenclad; EMD Serono [0.2%; n = 2]), siponimod (Mayzent; Novartis [2.2%; n = 22]), ozanimod (Zeposia; Bristol Myers Squibb [0.2%; n = 2]), and diroximel fumarate (Vumerity; Biogen [0.9%; n = 9]). The median washout period was highest among rituximab (191 days), followed by ocrelizumab (174 days), cladribine (98 days), and siponimod (93 days).

“In the real-world pandemic environment, ofatumumab is being prescribed in MS patients above 55 years of age, which is beyond the trial population. A large proportion of patients newly initiated ofatumumab with no treatment in the prior year,” Coyle et al wrote. “Understanding the patient profile, prior DMT use, and corresponding washout periods in the real world may help stakeholders guide treatment decisions.”

Notably, the analysis was limited due to its use of administrative data, allowing for potential coding errors or omissions. Additionally, the authors wrote that the results are from a short period of time, and therefore are not completely generalizable. Coyle and colleagues noted that they hope to provide future data “refreshers” from this study, which are planned to be published or presented once available, “in order to increase our numbers and length of evaluation.”

For more coverage of ECTRIMS 2021, click here.

Coyle PK, Gorritz M, Wade RL, Zhou Z, Cao Y, Deshpande C. Multiple Sclerosis Patients Initiating Ofatumumab in the Real-World: 6 Months Data. Presented at: ECTRIMS Congress; October 13-15, 2021; Virtual. Poster P874.
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