Ofatumumab Achieves Better Outcomes than Teriflunomide for Relapsing MS
In 2 clinical trials, participants with newly diagnosed relapsing multiple sclerosis (MS) who received ofatumumab (Kesimpta; Novartis; Cambridge, MA) experienced better outcomes in terms of relapse rate, disability progression, and the number of lesions visualized on MRI scans compared with those who received teriflunomide.
When ofatumumab was compared with teriflunomide in the combined trial populations from phase 3 ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) trials, ofatumumab reduced the annualized relapse rate (ARR) by 50% versus teriflunomide (0.09 vs. 0.18); delayed 6-month confirmed disability worsening (CDW) by 46%; and delayed 6-month progression independent of relapse activity (PIRA) by 56%.
Safety findings were manageable and consistent with those of the overall ASCLEPIOS population.
“Ofatumumab had a superior benefit-risk profile in recently diagnosed, treatment-naïve (RTDN) patients compared with teriflunomide,” the study authors concluded, “with an almost complete abrogation of inflammatory disease activity and no unexpected safety signals, supporting its use as a first-line treatment in early MS.”
The objective of the studies was to assess the efficacy and safety of ofatumumab, a fully human anti-CD20 monoclonal antibody that selectively depletes B cells, versus teriflunomide in RDTN participants.
Of the 1,882 participants randomly assigned to treatment in ASCLEPIOS I and II, 615 (32.7%) were RDTN (ofatumumab, 314; teriflunomide, 301). RDTN participants had a median of 0.35 and 0.36 years from diagnosis for the ofatumumab- and teriflunomide- treated patients, respectively, with a range of 0.1 to 2.9 years from diagnosis for both groups. Demographic and disease characteristics were similar between treatment groups and across trials.
Participants were randomized to receive ofatumumab 20 mg subcutaneously every 4 weeks or teriflunomide 14 mg orally once daily for up to 30 months. Endpoints analyzed post hoc in the RDTN population included ARR, CDW, PIRA, and adverse events.