Patient/guardian decision, adverse event, and physician decision were the 3 noted reasons for discontinuation with either ofatumumab or teriflunomide.
Data presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22, demonstrated that compliance with home-administered subcutaneous ofatumumab (Kesimpta; Novartis) is high among patients with multiple sclerosis (MS), with fewer patients discontinuing treatment versus teriflunomide (Aubagio; Sanofi).1
Lead author Edward J. Fox, MD, PhD, FAAN, director, Multiple Sclerosis Clinic of Central Texas, and colleagues evaluated treatment discontinuation and compliance with ofatumumab and teriflunomide using patients from the phase 3 ASCLEPIOS trials (NCT02792218 and NCT02792231) as well as assess the transition rates to the open-label ALITHIOS study (NCT03650114).
Compliance was defined as study drug exposure (in days) divided by the on-treatment period (in days) multiplied by 100. Across both trials, more than 95% of patients fell in the greater than 90% compliance category. Additionally, 90% of eligible patients consented to participate in ALITHIOS.
In ASCLEPIOS 1, 759 of 927 (81.9%) randomized patients, including 400 of 465 patients (86%) treated with ofatumumab, completed the trial on study drug. In comparison, 359 of 462 patients (77.7%) completed the trial using teriflunomide. The proportions of discontinuation were 14% for the ofatumumab group compared to 21.1% for teriflunomide. The most common reason for discontinuation, occurring in more than 2% in any group, was patient/guardian decision (ofatumumab, 4.9%; teriflunomide, 8.2%), followed by adverse event (AE; 5.2%; 5.0%), and physician decision (2.2%; 6.5%).
In ASCLEPIOS 2, 753 of 955 randomized patients completed the trial on study drug. Of these, 383 of 481 patients (79.6%) were in the ofatumumab-treated group compared to 370 of 474 (78.1%) of patients treated with teriflunomide. Among the 20% of patients who discontinued from ofatumumab treatment, 7.3% were patient/guardian decision, 5.6% were from AE, and 5.2% were a physician’s decision. In comparison, 21.5% of teriflunomide-treated patients discontinued, 7.8% were patient/guardian decision, 4.9% from AE, and 6.8% from physician decision.
Results from the ASCLEPIOS trials presented at MS Virtual 2020, the 8th Joint ECTRIMS-ACTRIMS meeting, September 11-13, demonstrated low absolute relapse rates (ARRs), very low magnetic resonance imaging (MRI) lesion activity, and prolonged time to disability worsening with treatment with ofatumumab compared with teriflunomide.2
Compared to teriflunomide, treatment with ofatumumab reduced ARR by 50.3% (0.09 vs 0.18; P <.001), 3-month confirmed disability worsening (3mCDW) risk by 38% (10.1% vs 12.8%; P = .065), and 6-month CDW (6mCDW) by 46% (5.9% vs 10.4%; P = .044). The treatment was also superior in reducing gadolinium enhancing T1 lesions per scan by 95.4% (0.02 vs 0.39; P <.001) and new/enlarging T2 lesions/year by 82.0% (0.86 vs 4.78; P <.001).
The FDA granted market approval to ofatumumab for the treatment of relapsing forms of MS in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS in August 2020.3
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