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Key clinical point: Extended treatment with ofatumumab for up to 3.5 years was well tolerated without any new risks in patients with relapsing multiple sclerosis (RMS).
Major finding: Overall, 83.8% and 9.7% of patients experienced at least 1 adverse event (AE) and serious AE, respectively. Systemic injection-related reactions, infections, and malignancies were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum immunoglobulin (Ig) G and IgM levels were stable and above the lower limit of normal and the risk for serious infections was low.
Study details: Findings are from the ongoing phase 3b ALITHIOS umbrella extension trial involving 1,969 patients with RMS who completed ASCLEPIOS I/II, APLIOS, or APOLITOS trial and continued or switched to ofatumumab in ALITHIOS.
Disclosures: This study was funded by Novartis Pharma AG (Basel, Switzerland). The authors declared receiving consultancy fees, personal compensation, travel reimbursement, research support, or serving on advisory boards for various sources including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.
Source: Hauser SL et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022 (Mar 1). Doi: 10.1177/13524585221079731
Key clinical point: Extended treatment with ofatumumab for up to 3.5 years was well tolerated without any new risks in patients with relapsing multiple sclerosis (RMS).
Major finding: Overall, 83.8% and 9.7% of patients experienced at least 1 adverse event (AE) and serious AE, respectively. Systemic injection-related reactions, infections, and malignancies were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum immunoglobulin (Ig) G and IgM levels were stable and above the lower limit of normal and the risk for serious infections was low.
Study details: Findings are from the ongoing phase 3b ALITHIOS umbrella extension trial involving 1,969 patients with RMS who completed ASCLEPIOS I/II, APLIOS, or APOLITOS trial and continued or switched to ofatumumab in ALITHIOS.
Disclosures: This study was funded by Novartis Pharma AG (Basel, Switzerland). The authors declared receiving consultancy fees, personal compensation, travel reimbursement, research support, or serving on advisory boards for various sources including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.
Source: Hauser SL et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022 (Mar 1). Doi: 10.1177/13524585221079731
Key clinical point: Extended treatment with ofatumumab for up to 3.5 years was well tolerated without any new risks in patients with relapsing multiple sclerosis (RMS).
Major finding: Overall, 83.8% and 9.7% of patients experienced at least 1 adverse event (AE) and serious AE, respectively. Systemic injection-related reactions, infections, and malignancies were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum immunoglobulin (Ig) G and IgM levels were stable and above the lower limit of normal and the risk for serious infections was low.
Study details: Findings are from the ongoing phase 3b ALITHIOS umbrella extension trial involving 1,969 patients with RMS who completed ASCLEPIOS I/II, APLIOS, or APOLITOS trial and continued or switched to ofatumumab in ALITHIOS.
Disclosures: This study was funded by Novartis Pharma AG (Basel, Switzerland). The authors declared receiving consultancy fees, personal compensation, travel reimbursement, research support, or serving on advisory boards for various sources including Novartis Pharma AG. Some authors declared being employees of Novartis Pharma AG.
Source: Hauser SL et al. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022 (Mar 1). Doi: 10.1177/13524585221079731