Subcutaneous Ocrelizumab Shows Noninferiority to Intravenous Administration in Multiple Sclerosis Treatment

Ocrelizumab has shown to be an effective treatment for patients with relapsing and primary progressive multiple sclerosis (RMS/PPMS). The phase 3 OCARINA II study evaluated the noninferiority of subcutaneous (SC) vs intravenous (IV) administration of ocrelizumab in patients with RMS/PPMS. The study involved 236 patients aged 18 to 65, who were randomized to receive either 600 mg of ocrelizumab IV or 920 mg of ocrelizumab SC. Key endpoints included serum ocrelizumab exposure (measured by area under the concentration-time curve [AUC]) from baseline to week 12, as well as MRI lesion activity, relapse rates, immunogenicity, B-cell depletion, and safety.

The results showed that at week 12, the geometric mean ratio for ocrelizumab AUC was 1.29 (90% CI: 1.23-1.35) for SC compared to IV, indicating noninferiority. Both treatment groups experienced nearly complete suppression of MRI and relapse activity up to week 24, with rapid and sustained B-cell depletion observed in both cohorts. The safety profiles for both routes were similar, with no new safety concerns or detection of antibodies against ocrelizumab or the recombinant human hyaluronidase component.

In conclusion, the study found that SC administration of ocrelizumab is noninferior to IV administration, providing similar results for efficacy and safety. This SC formulation offers greater flexibility and additional treatment options for patients and health care providers in managing RMS/PPMS, according to the authors.

Reference

Newsome S, Krzystanek E, Selmaj K, et al. OCARINA II, Phase III study: Results of subcutaneous ocrelizumab administration in patients with multiple sclerosis. Presented at: the American Academy of Neurology 2024 Annual Meeting; October 25-27, 2024; Paradise, NV; Abstract S31.006.