Table 4.
Most common adverse events observed with rituximab, ocrelizumab, ofatumumab and ublituximab in phase II/III trials.
| Rituximab | Ocrelizumab | Ofatumumab | Ublituximab | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Phase II HERMES Hauser et al., 2008 |
Phase II/II OLYMPUS, Hawker et al., 2009 | Phase III RIFUND-MS Svenningsson et al., 2022 |
Phase III OPERA I Hauser et al., 2017 | Phase III OPERA II Hauser et al., 2017 |
Phase III ORATORIO Montalban et al., 2017 |
Phase III ASCLEPIOS I Hauser et al., 2020 | Phase III ASCLEPIOS II Hauser et al., 2020 | Phase III ULTIMATE I Steinman et al., 2022 |
Phase III ULTIMATE II Steinman et al., 2022 |
|
|
Administration-related reactions
(% patients) |
Week 0: Rituximab: 78.3% Placebo: 40.0% Week 2: Rituximab: 20.3% Placebo: 40.0% |
Week 0: Rituximab: 67.1% Placebo: 23.1% Week 2: Rituximab: 22.6% Placebo: 15.1% Week 74: Rituximab: 4.9% Placebo: 7.2% |
Rituximab: 40.9% DMF: n/a |
Ocrelizumab: 0.9% IFNb-1a: 6.4% | Ocrelizumab: 37.6% IFNb-1a: 12.0% |
Ofatumumab: 16.1% Teriflunomide:16.5% |
Ofatumumab: 24.1% Teriflunomide: 13.5% |
Ublituximab: 44.0% Teriflunomide: 6.9% |
Ublituximab: 51.5% Teriflunomide: 17.6% |
|
|
Infections (% patients)
All events Serious adverse event |
Rituximab: 69.6% Placebo: 71.4% Rituximab:2.9% Placebo: 5.7% |
Rituximab: 68.2% Placebo: 65.3% Rituximab: 4.5% Placebo: <1.0% |
Upper respiratory tract: Rituximab: 61.5% DMF: 59.9% Urinary tract: Rituximab: 8.6% DMF: 5.1% Rituximab: 0.8% DMF: 0.7% |
Ocrelizumab: 56.9% IFNb-1a: 54.3% Ocrelizumab: 1.2% IFNb-1a: 2.9% |
Ocrelizumab: 60.2% IFNb-1a: 52.5% Ocrelizumab: 1.4% IFNb-1a: 2.9% |
Ocrelizumab: 71.4% Placebo: 69.9% Ocrelizumab: 6.2% Placebo: 5.9% |
Ofatumumab: 49.2% Teriflunomide: 51.5% Ofatumumab: 2.6% Teriflunomide: 1.5% |
Ofatumumab: 53.8% Teriflunomide: 53.8% Ofatumumab: 2.5% Teriflunomide: 2.1% |
Ublituximab: 48.5% Teriflunomide: 48.4% Ublituximab: 5.5% Teriflunomide: 2.2% |
Ublituximab: 62.1% Teriflunomide:60.4% Ublituximab: 4.4% Teriflunomide:3.7% |
| Neoplasm | 1 malignant thyroid neoplasm | n/a | n/a | Ocrelizumab: 0.7% IFNb-1a: 0.2% | Ocrelizumab: 0.2% IFNb-1a: 0.2% | Ocrelizumab: 2.3% Placebo: 0.8% | Ofatumumab: 0.6% Teriflunomide: 0.6% |
Ofatumumab: 0.4% Teriflunomide: 0.2% |
Ublituximab: 0% Teriflunomide: 0% |
Ublituximab: 0.7% Teriflunomide: 0.4% |
n/a, not applicable.