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Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).
Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.
Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.
Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.
Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148
Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).
Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.
Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.
Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.
Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148
Key clinical point: Masitinib at a dose of 4.5 mg/kg/day may benefit patients with primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (nSPMS).
Major finding: The Expanded Disability Status Scale(EDSS)-based disability worsening was slower with 4.5 mg/kg/day masitinib 4.5 mg/kg/day vs. placebo (change in EDSS 0.001 vs. 0.098), with a between-group difference of −0.097 (P = .027). No new safety signals were identified.
Study details: The findings come from the 96-week, phase 3 Study AB07002 trial involving 611 patients with PPMS or nSPMS who were randomly assigned to parallel groups of either 4.5 mg/kg/day masitinib, 6 mg/kg/day uptitrated masitinib, or an equivalent placebo.
Disclosures: This study was funded by AB Science, Paris, France. A Moussy, C Mansfield, and O Hermine reported being employees and shareholders of AB Science, and the other authors reported receiving research support and nonfinancial support or personal fees from various sources, including AB Science.
Source: Vermersch P et al, on behalf of the AB07002 Study Group. Efficacy and safety of masitinib in progressive forms of multiple sclerosis: A randomized, phase 3, clinical trial. Neurol Neuroimmunol Neuroinflamm. 2022;9(3):e1148 (Feb 21). Doi: 10.1212/NXI.0000000000001148