The use of divozilimab in real-world clinical practice: a prospective, single-centre study

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system, the pathogenesis of which is underpinned by a combination of autoinflammatory and neurodegenerative processes. Divozilimab (DIV) is the first monoclonal antibody from the anti-CD20 therapy group to be developed and authorised in the Russian Federation for the treatment of relapsing-remitting multiple sclerosis (RRMS) and secondary-progressive multiple sclerosis (SPMS) with relapses in patients aged 18 years and over. The relatively recent introduction of DIV into clinical practice means that there is a limited amount of published data from real-world clinical practice.

Objective: to investigate the efficacy and safety of DIV in real-world clinical practice at a single medical centre.

Material and methods. Forty patients with MS (13 with SPMS) living in the Novosibirsk Region received two doses of DIV (data as at 30 May 2026). Patient data were analysed: clinical [gender, age, clinical manifestations at onset and during relapses, score on the Expanded Disability Status Scale (EDSS), use of disease-modifying therapies, comorbidities, infection status], radiological data (new lesions, enlarged lesions, lesions with contrast enhancement) and laboratory data (complete blood count, urinalysis, blood biochemistry). Efficacy parameters were assessed [mean annual relapse rate (MARR), EDSS score, proportion of patients with confirmed disability progression over 6 months (CDP-6), and radiological activity] as well as safety parameters (number of adverse events, including infectious and oncological events).

Results. During DIV therapy, there was a reduction in MARR – from 1.0±0.85 to zero – and in the proportion of patients with radiological activity – from 60% to zero (p<0.05). However, no changes were observed in EDSS scores or in the incidence of CDP-6 (p>0.05). No increase in the number of infectious or oncological events was observed during DIV therapy (p > 0.05).

Conclusion. DIV therapy, administered at the Regional Centre for Multiple Sclerosis and Other Autoimmune Diseases of the Nervous System at Novosibirsk State Regional Clinical Hospital, has confirmed the high efficacy and safety demonstrated in clinical trials.

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