To further characterize the benefit-risk profile of ocrelizumab subcutaneous based on the Week (W) 96 analysis of efficacy, safety and patient-reported outcome data from OCARINA II (NCT05232825).

OCARINA II showed ocrelizumab subcutaneous 920 mg (coformulated with recombinant human hyaluronidase PH20 [rHuPH20]) was noninferior to ocrelizumab intravenous 600 mg regarding drug exposure and had a similar benefit-risk profile in patients with relapsing or primary progressive multiple sclerosis (pwRMS/pwPPMS) up to W72.

Ocrelizumab-naive pwRMS/pwPPMS (18-65 years; Expanded Disability Status Scale score [EDSS]: 0-6.5) were randomized 1:1 to ocrelizumab intravenous 600 mg or ocrelizumab subcutaneous 920 mg. At W24, all patients (ocrelizumab intravenous/subcutaneous and ocrelizumab subcutaneous/subcutaneous) could enter the treatment phase with ocrelizumab subcutaneous up to W96. Safety was evaluated in all patients who received ≥1 dose of ocrelizumab subcutaneous (all-exposure group).

Ocrelizumab subcutaneous resulted in near-complete suppression of MRI and relapse activity up to W96, with 96.7% of patients being relapse free. Up to W96, annualized relapse rate was 0.02 and 0.03 for ocrelizumab intravenous/subcutaneous and subcutaneous/subcutaneous, respectively. EDSS remained stable up to W96, with a mean (SD) change from baseline of −0.12 (0.66) in the ocrelizumab intravenous/subcutaneous arm vs −0.16 (0.81) in the ocrelizumab subcutaneous/subcutaneous arm. In the ocrelizumab subcutaneous all-exposure group, 86.3% of patients had an adverse event (AE), 5.2% had a serious AE and 58.4% had an injection reaction (IR; local IR, 55.4%; systemic IR, 13.3%). All IRs were nonserious and mild/moderate in intensity, most resolved, and the incidence and severity decreased with subsequent injections. No treatment-emergent antidrug antibodies (ADA) to ocrelizumab were reported; 2 patients had treatment-emergent ADA to rHuPH20. Patient-reported outcomes data will be presented.

Ocrelizumab subcutaneous continues to show a favorable benefit-risk profile, similar to that of the well-established intravenous route of administration, and provides flexibility and convenience of administration for pwRMS/pwPPMS.