TY - JOUR
T1 - Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis
T2 - Results from ASCLEPIOS I and II
AU - Gärtner, Jutta
AU - Hauser, Stephen L.
AU - Bar-Or, Amit
AU - Montalban, Xavier
AU - Cohen, Jeffrey A.
AU - Cross, Anne H.
AU - Deiva, Kumaran
AU - Ganjgahi, Habib
AU - Häring, Dieter A.
AU - Li, Bingbing
AU - Pingili, Ratnakar
AU - Ramanathan, Krishnan
AU - Su, Wendy
AU - Willi, Roman
AU - Kieseier, Bernd
AU - Kappos, Ludwig
N1 - Publisher Copyright:
© The Author(s), 2022.
PY - 2022/9
Y1 - 2022/9
N2 - Background: In the phase III ASCLEPIOS I and II trials, participants with relapsing multiple sclerosis receiving ofatumumab had significantly better clinical and magnetic resonance imaging (MRI) outcomes than those receiving teriflunomide. Objectives: To assess the efficacy and safety of ofatumumab versus teriflunomide in recently diagnosed, treatment-naive (RDTN) participants from ASCLEPIOS. Methods: 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 analysed post hoc in the protocol-defined RDTN population included annualized relapse rate (ARR), confirmed disability worsening (CDW), progression independent of relapse activity (PIRA) and adverse events. Results: Data were analysed from 615 RDTN participants (ofatumumab: n = 314; teriflunomide: n = 301). Compared with teriflunomide, ofatumumab reduced ARR by 50% (rate ratio (95% confidence interval (CI)): 0.50 (0.33, 0.74); p < 0.001), and delayed 6-month CDW by 46% (hazard ratio (HR; 95% CI): 0.54 (0.30, 0.98); p = 0.044) and 6-month PIRA by 56% (HR: 0.44 (0.20, 1.00); p = 0.049). Safety findings were manageable and consistent with those of the overall ASCLEPIOS population. Conclusion: The favourable benefit–risk profile of ofatumumab versus teriflunomide supports its consideration as a first-line therapy in RDTN patients. ASCLEPIOS I and II are registered at ClinicalTrials.gov (NCT02792218 and NCT02792231).
AB - Background: In the phase III ASCLEPIOS I and II trials, participants with relapsing multiple sclerosis receiving ofatumumab had significantly better clinical and magnetic resonance imaging (MRI) outcomes than those receiving teriflunomide. Objectives: To assess the efficacy and safety of ofatumumab versus teriflunomide in recently diagnosed, treatment-naive (RDTN) participants from ASCLEPIOS. Methods: 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 analysed post hoc in the protocol-defined RDTN population included annualized relapse rate (ARR), confirmed disability worsening (CDW), progression independent of relapse activity (PIRA) and adverse events. Results: Data were analysed from 615 RDTN participants (ofatumumab: n = 314; teriflunomide: n = 301). Compared with teriflunomide, ofatumumab reduced ARR by 50% (rate ratio (95% confidence interval (CI)): 0.50 (0.33, 0.74); p < 0.001), and delayed 6-month CDW by 46% (hazard ratio (HR; 95% CI): 0.54 (0.30, 0.98); p = 0.044) and 6-month PIRA by 56% (HR: 0.44 (0.20, 1.00); p = 0.049). Safety findings were manageable and consistent with those of the overall ASCLEPIOS population. Conclusion: The favourable benefit–risk profile of ofatumumab versus teriflunomide supports its consideration as a first-line therapy in RDTN patients. ASCLEPIOS I and II are registered at ClinicalTrials.gov (NCT02792218 and NCT02792231).
KW - Relapsing multiple sclerosis
KW - neurofilament light chain
KW - no evidence of disease activity
KW - progression independent of relapse activity
KW - recently diagnosed
KW - treatment-naive
UR - https://www.scopus.com/pages/publications/85126236024
U2 - 10.1177/13524585221078825
DO - 10.1177/13524585221078825
M3 - Article
C2 - 35266417
AN - SCOPUS:85126236024
SN - 1352-4585
VL - 28
SP - 1562
EP - 1575
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 10
ER -