Multiple sclerosis and related disorders · 2026
Long-term comparative outcomes in relapse activity and disability progression among anti-CD20 therapies in relapsing multiple sclerosis: An unanchored matching-adjusted indirect comparison.
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Gold Ralf, Ansaripour Amir, Schmierer Klaus, Barnett Michael, Hartung Hans Peter, Yamout Bassem, de Seze Jerome, Selmaj Krzysztof, Centonze Diego, Grigoriadis Nikolaos, Javanbakht Mehdi, Miskin Hari, Schmitt Andreas B, Cutter Gary
Аннотация
BACKGROUND: Anti-CD20 monoclonal antibodies are widely used in relapsing multiple sclerosis (RMS), but the absence of head-to-head randomized trials limits direct long-term comparisons between agents.
METHODS: An unanchored matching-adjusted indirect comparison (MAIC) was conducted to explore five-year comparative outcomes in annualized relapse rate (ARR) and 24-week confirmed disability progression (CDP24) between ublituximab, ocrelizumab and ofatumumab. Individual patient data from the ULTIMATE I/II trials were reweighted to match published baseline characteristics from the OPERA I/II and ASCLEPIOS I/II trials. Long-term comparator outcomes were obtained from published follow-up data, with reconstruction of comparator patient-level data for time-to-event analyses where required. Sensitivity analyses included restricted mean survival time (RMST) for CDP24.
RESULTS: MAIC-adjusted ublituximab ARR declined from 0.118 to 0.032 over five years versus ocrelizumab and from 0.116 to 0.030 versus ofatumumab. Ublituximab reduced the CDP24 hazard versus ocrelizumab (hazard ratio [HR] 0.560; 95% CI: 0.380-0.826) and ofatumumab (HR 0.509; 95% CI: 0.350-0.741), with 240-week RMST gains of 8 and 13 weeks, respectively.
CONCLUSIONS: These findings suggest directionally favorable long-term outcomes with ublituximab compared with the other two comparators. These findings should be interpreted carefully within the assumptions and inherent limitations of the unanchored MAIC approach.
METHODS: An unanchored matching-adjusted indirect comparison (MAIC) was conducted to explore five-year comparative outcomes in annualized relapse rate (ARR) and 24-week confirmed disability progression (CDP24) between ublituximab, ocrelizumab and ofatumumab. Individual patient data from the ULTIMATE I/II trials were reweighted to match published baseline characteristics from the OPERA I/II and ASCLEPIOS I/II trials. Long-term comparator outcomes were obtained from published follow-up data, with reconstruction of comparator patient-level data for time-to-event analyses where required. Sensitivity analyses included restricted mean survival time (RMST) for CDP24.
RESULTS: MAIC-adjusted ublituximab ARR declined from 0.118 to 0.032 over five years versus ocrelizumab and from 0.116 to 0.030 versus ofatumumab. Ublituximab reduced the CDP24 hazard versus ocrelizumab (hazard ratio [HR] 0.560; 95% CI: 0.380-0.826) and ofatumumab (HR 0.509; 95% CI: 0.350-0.741), with 240-week RMST gains of 8 and 13 weeks, respectively.
CONCLUSIONS: These findings suggest directionally favorable long-term outcomes with ublituximab compared with the other two comparators. These findings should be interpreted carefully within the assumptions and inherent limitations of the unanchored MAIC approach.