A randomized, double-blind, Phase III clinical trial has found that Xacrel, a biosimilar of ocrelizumab, demonstrates equivalent efficacy and safety to the originator drug, Ocrevus, in patients with relapsing-remitting multiple sclerosis (RRMS). The 96-week study, conducted across 15 centers in Iran, provides evidence supporting Xacrel as a potential cost-effective alternative for MS treatment.
Trial Design and Key Findings
The trial enrolled adult patients diagnosed with MS based on the McDonald 2010 criteria, who had a history of at least two documented relapses in the last two years or one relapse in the past year. Participants were randomized (1:1) to receive either Xacrel or Ocrevus, administered as 300 mg intravenous infusions two weeks apart for the first two doses, followed by 600 mg infusions every 24 weeks. All patients received premedication to reduce infusion reactions.
The primary outcome was the annualized relapse rate (ARR) at week 48. Secondary outcomes included time to disability progression, proportion of relapse-free patients at 96 weeks, and MRI lesion activity. The results indicated that Xacrel was equivalent to Ocrevus in reducing ARR, with the 95% confidence intervals falling within the pre-defined equivalence margin (-0.2, 0.2).
Efficacy and Safety Outcomes
Detailed analysis of secondary efficacy outcomes revealed no significant differences between the two treatment groups. The time to confirmed disability progression (CDP) at both 12 and 24 weeks was similar, as was the proportion of relapse-free patients at 96 weeks. MRI results showed comparable numbers of new or enlarged T2 hyperintense lesions and changes in T2 lesion volume between the Xacrel and Ocrevus groups.
Safety assessments indicated that the incidence of adverse events (AEs) and serious adverse events (SAEs) were similar between the two groups. Infusion-related reactions were also comparable. Immunogenicity assessments, measured by anti-drug antibody (ADA) development, showed no significant differences between the groups.
Implications for MS Treatment
Ocrelizumab, a monoclonal antibody targeting CD20-positive B cells, has become a cornerstone in the treatment of RRMS. This study supports the use of Xacrel as a biosimilar, potentially expanding access to this effective therapy. The availability of a biosimilar could lower treatment costs, making it accessible to a broader patient population.
The study authors concluded that Xacrel demonstrates equivalent efficacy and safety to Ocrevus in patients with RRMS, suggesting it could be a valuable alternative for MS treatment. Further research and real-world data will continue to monitor the long-term outcomes and benefits of Xacrel in diverse patient populations.
