Trial reportJournal of neurology2025
Switch from intravenous anti-CD20 therapy to subcutaneous ofatumumab in patients with relapsing MS: results from the OLIKOS study.
Trial report in Journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04486716 (A Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS)
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9 authors.
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Abstract
backgroundMultiple sclerosis (MS) is a chronic condition, and as such, switching therapies is not uncommon. However, data on switching from intravenous (IV) to subcutaneous (SC) formulations of anti-CD20 therapies are lacking.
methodsOLIKOS, a phase 3b, prospective, single-arm, multicenter study conducted from 2020 to 2024, evaluated the efficacy and safety of switching to SC ofatumumab from IV ocrelizumab or rituximab in adults with relapsing MS. Participants were excluded if they had discontinued anti-CD20 therapy due to suboptimal response or safety concerns. Maintenance of efficacy was defined as either no change or a reduction from baseline in the number of gadolinium-enhancing (Gd +) T1 lesions observed by magnetic resonance imaging (MRI) after 12 months of ofatumumab.
resultsThe full analysis set included 102 participants. Most participants (99%) switched from IV ocrelizumab to SC ofatumumab. Zero Gd+ T1 lesions were observed at Month 12 in participants with evaluable MRI assessments (n = 84), satisfying the primary endpoint. New/enlarging T2 lesions were observed in 2.3% (2/86) of participants at Month 12. There was no change in median Expanded Disability Status Scale score between baseline and Month 12, and annualized relapse rate remained low (0.075). Treatment satisfaction improved from baseline to Month 12 across all domains with the largest increases in the Convenience domain. Treatment-emergent adverse events occurred at similar frequencies as in ofatumumab phase 3 trials, and no new safety signals were identified.
conclusionThe findings indicate efficacy and safety are maintained following a switch from IV anti-CD20 to SC ofatumumab with improved treatment satisfaction.
trial registrationClinicalTrials.gov Identifier: NCT04486716 https://clinicaltrials.gov/study/NCT04486716.
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