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Research Article| Volume 66, 104031, October 2022

Simulated treatment comparison of efficacy outcomes for ofatumumab in ASCLEPIOS I/II versus ocrelizumab in OPERA I/II for the treatment of patients with relapsing multiple sclerosis

Published:July 04, 2022DOI:https://doi.org/10.1016/j.msard.2022.104031
Simulated treatment comparison of efficacy outcomes for ofatumumab in ASCLEPIOS I/II versus ocrelizumab in OPERA I/II for the treatment of patients with relapsing multiple sclerosis
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      Highlights

      • •
        Two newer MS therapies were compared using simulated treatment comparisons.
      • •
        ASCLEPIOS I/II patient-level data were used to adjust for cross-trial differences.
      • •
        Ofatumumab significantly lowered the annualized relapse rate versus ocrelizumab.

      Abstract

      Background

      Ofatumumab is a subcutaneously administered anti-CD20 monoclonal antibody (MoAb) therapy that has been evaluated in two identically designed randomized controlled trials (RCTs), ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231), in patients with relapsing multiple sclerosis (RMS). Ocrelizumab is another anti-CD20 MoAb therapy, administered intravenously, that has been evaluated in two identically designed RCTs, OPERA I (NCT01247324) and OPERA II (NCT01412333) in RMS. Given the absence of published RCTs with head-to-head comparisons between these MoAbs, this study assessed the indirect comparative efficacy of ofatumumab and ocrelizumab.

      Methods

      Given the availability of individual patient data for ASCLEPIOS I/II and summary-level data for OPERA I/II, simulated treatment comparisons were used to assess the comparative efficacy of ofatumumab versus ocrelizumab while adjusting for differences in baseline characteristics between trials. Comparative efficacy was estimated for the proportion of patients with 3- and 6-month confirmed disability progression (CDP) and for annualized relapse rate (ARR). Exploratory analyses were conducted for the outcome of no evidence of disease activity based on three parameters (NEDA-3) and magnetic resonance imaging (MRI) outcomes (proportion of patients with gadolinium-enhancing T1 lesions and brain volume change).

      Results

      Although comparative results were not significant for 3-month CDP (hazard ratio [HR]: 0.90 [95% confidence interval [CI]: 0.57−1.42]) or 6-month CDP (HR: 0.84 [95% CI: 0.47−1.49]), ofatumumab showed a significant improvement in ARR (rate ratio: 0.60 [95% CI: 0.43−0.84]) compared with ocrelizumab. Significantly favorable results were also associated with ofatumumab for NEDA-3 and MRI outcomes.

      Conclusion

      Ofatumumab was associated with more favorable efficacy results compared with ocrelizumab for clinical, NEDA-3, and MRI outcomes.

      Keywords

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      Article info

      Publication history

      Published online: July 04, 2022
      Accepted: July 3, 2022
      Received in revised form: May 26, 2022
      Received: February 22, 2022

      Identification

      DOI: https://doi.org/10.1016/j.msard.2022.104031

      Copyright

      © 2022 Elsevier B.V. All rights reserved.

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