Exit strategies regarding natalizumab: the dilemma in limited-resource scenarios

Address for correspondence: Igor Bessa (email: [e-mail]).

Abstract

Background: Natalizumab (NTZ) is a humanized monoclonal antibody indicated for people with multiple sclerosis (pwMS) with poor response to the first-line treatment or naive patients with highly-active disease. Exposure to NTZ in patients seropositive for the JC virus (JCV) increases the risk of developing a severe opportunistic infection called progressive multifocal leukoencephalopathy (PML). By searching for an exit strategy for NTZ cessation we can undermine PML risk in such patients.

Objective: To evaluate NTZ exit strategies in a Northeastern Brazilian MS center.

Methods: We collected observational data from patients under NTZ treatment between July 2010 and April 2024.

Results: A total of 21 patients were enrolled, with a median follow-up of 7 (IQR: 5–11) years; 86% were female, with a median age of 39 (IQR: 32–44) years and median disease duration of 15 (IQR: 7–23) years. The median EDSS score during NTZ follow-up was of 2 (IQR: 1.5–5), and the average for infusion was of 29 (±20). Although 90% of the patients had disease activity 2 years prior NTZ, only 1 had relapse during treatment. Eighteen patients interrupted NTZ due JCV index higher than 1.5, and 3, between 0.9 and 1.5. out of 21 patients undergoing cessation, 1 switched to fingolimod, 1, to ofatumumab, 5, to rituximab, and 14, to ocrelizumab. There were no relapses after interruption; 2 patients presented signs of radiologic activity, and the median EDSS score remained 2 (IQR: 1.5-5). After cessation, 5 patients under ocrelizumab had infusion delays due availability issues, and the one under fingolimod switched to rituximab due side effects.

Conclusion: The risk of developing PML remains a major concern, and there is a lack of solid strategies for patients under NTZ for more than 24 months and positive JCV. Ocrelizumab has a high patient-per-year cost, and it is not currently available in public health care system in Brazil, which may increase the risk of disease activity due erratic use. Rituximab is an available option in limited-resource scenarios.

 

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Publikationsverlauf

Artikel online veröffentlicht:
02. Oktober 2024