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Ocrelizumab (Ocrevus; Roche) is being investigated as a twice yearly 10-minute subcutaneous injection compared to the intravenous infusion formulation.
Ocrelizumab (Ocrevus; Roche), an investigational twice yearly 10-minute subcutaneous injection, demonstrated near-complete suppression of clinical relapses and brain lesions for individuals with relapsing or primary progressive multiple sclerosis (MS), further reinforcing the benefits of the drug, according to results from the phase 3 OCARINA II (NCT05232825) study. Furthermore, treatment with ocrelizumab showed a rapid and sustained B-cell depletion in the blood, according to a press release by the company.1
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The data were presented as an oral presentation on the 76th American Academy of Neurology Annual Meeting in Denver, Colorado from April 13 to 18, 2024.1
“With a full year of data demonstrating near-complete suppression of relapse activity and minimal progression of lesion development, this 10-minute subcutaneous [ocrelizumab] injection shows results that are consistent with the long-established benefits of intravenous [ocrelizumab],” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said in the press release. “We look forward to continuing ongoing conversations with regulatory bodies worldwide to potentially bring an additional treatment option to more people living with MS, in a shorter injection time.”1
According to the National Multiple Sclerosis Society, nearly 1 million individuals in the United States are living with MS.2
The OCARINA II trial was a phase 3 global, multicenter, randomized study aimed at evaluating the pharmacokinetics, safety, and radiological and clinical effects of the subcutaneous formulation compared to the intravenous formulation of ocrelizumab. Investigators included 236 individuals with relapsing or primary progressive MS.1
Previously, results were shared that demonstrated the trial met the primary end point of non-inferiority under the serum concentration time curve from day 1 to 12 weeks after the subcutaneous injection compared to the intravenous infusion, according to the press release. The secondary end points included the maximum serum concentration of ocrelizumab, the total number of active, gadolinium-enhancing T1 lesions at weeks 8 to 12, and new or enlarging T2 lesions at weeks 12 and 24. Further, investigators analyzed the safety, immunogenicity, and patient-reported outcomes.1
In the updated longer-term results, ocrelizumab subcutaneous injection showed that 97.2% of individuals had no relapse during the treatment phase and magnetic resonance imaging up to 48 weeks with an absolute risk reduction of 0.04. Further, most patients had no T1 gadolinium-enhancing lesions, a marker of active inflammation, and no new or enlarging T2 lesions, a marker of burden of disease.1
Additionally, the exploratory patient-reported outcomes showed that 92.3% were satisfied or very satisfied, and 90.1% reported that the injection was convenient or very convenient. Investigators also reported that ocrelizumab was consistent with the well-established safety profile of ocrelizumab as an intravenous infusion, with no new safety signals identified.1
The most common adverse events (AEs) included injection site reaction, erythema, pain, swelling, and pruritus, according to the press release. All were mild or moderate, and none led to treatment withdrawal. There were 7 serious AEs, with 3 in the subcutaneous group and 4 in the intravenous group.1
“Updated results from OCARINA II further underline the potential benefits of subcutaneous [ocrelizumab] for patients with both relapsing and progressive forms of MS,” Scott Newsome, DO, from the Johns Hopkins University School of Medicine, said in the press release. “Patients treated with subcutaneous [ocrelizumab] experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity. These results demonstrate the potential of subcutaneous [ocrelizumab] as a treatment option that can be matched to the individual needs of people with MS and health care professionals.”1
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